A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis

• Sponsor: Janssen Research & Development, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03158285
• Collaborator: (none)
• Enrollment: 741
• Locations: 138
• Arms: 3
• Actual Duration (Months): 40
• Patients Per Site: 5.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Psoriatic	Drug: Guselkumab; Drug: Placebo	Phase 3

Detailed Description

This is a study of guselkumab in participants with active PsA who are biologically naive and have had inadequate response to standard therapies. It will evaluate the clinical efficacy of guselkumab in the reduction of signs and symptoms, structural damage inhibition and the safety profile of guselkumab in the treatment of PsA. The study will consist of a screening phase (up to 6 weeks), a blinded treatment phase (approximately 100 weeks) including a placebo controlled period from Week 0 to Week 24 and an active treatment period from Week 24 to Week 100 and a safety follow-up phase of 12 weeks after the last administration of study agent. Efficacy, health economics, safety, pharmacokinetics, immunogenicity, biomarker and pharmacogenomics evaluations will be performed in the study at defined schedule.

Study Design

• Study Type: Interventional
• Actual Enrollment: 741 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis
• Actual Study Start Date: Jul 12, 2017
• Actual Primary Completion Date: Feb 25, 2019
• Actual Study Completion Date: Nov 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: Guselkumab Participants will receive subcutaneous (SC) guselkumab 100 milligram (mg) once every 4 weeks (q4w) from Week 0 through Week 100.	Drug: Guselkumab; Participants will receive 100 mg of guselkumab as a sterile liquid for SC injection.; Other Names: CNTO 1959
Experimental: Group 2: Guselkumab and Placebo Participants will receive SC guselkumab 100 mg at Weeks 0 and 4 then once every 8 weeks (q8w) (Weeks 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, and 100) and placebo injections at other visits (Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, and 96) to maintain the blind.	Drug: Guselkumab; Participants will receive 100 mg of guselkumab as a sterile liquid for SC injection.; Other Names: CNTO 1959 ; Drug: Placebo; Participants will receive matching placebo as SC injection.
Experimental: Group 3: Placebo Followed by Guselkumab Participants will receive SC placebo q4w from Week 0 to Week 20 and will cross over at Week 24 to receive SC guselkumab 100 mg q4w from Week 24 through Week 100.	Drug: Guselkumab; Participants will receive 100 mg of guselkumab as a sterile liquid for SC injection.; Other Names: CNTO 1959 ; Drug: Placebo; Participants will receive matching placebo as SC injection.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 [Week 24]

   ACR 20 response: >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP. Treatment Failure (TF) criteria- discontinued study drug, initiated/increased dose of non-biologic disease-modifying antirheumatic drugs (DMARDs) or oral corticosteroids, initiated prohibited psoriatic arthritis treatment.

Secondary Outcome Measures

1. Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 [Baseline and Week 24]

   HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.

2. Percentage of Participants Who Achieved an ACR 50 Response at Week 24 [Week 24]

   ACR 50 response was defined as greater than or equal to (>=)50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and C-Reactive Protein (CRP).

3. Percentage of Participants Who Achieved Psoriasis Response With IGA Score of 0 (Cleared) or 1 (Minimal) and >=2 Grade Reduction From Baseline at Week 24 Among Participants With >=3% BSA Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline [Week 24]

   A psoriasis Investigator's Global Assessment (IGA) response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >=2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

4. Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16 [Week 16]

   ACR 20 response was defined as >= 20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.

5. Change From Baseline in Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24 [Baseline and Week 24]

   Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

6. Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline [Week 24]

   Enthesitis was assessed using the Leeds Enthesitis Index (LEI), a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI>0. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.

7. Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline [Week 24]

   The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score >0. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.

8. Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline [Baseline and Week 24]

   Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.

9. Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline [Baseline and Week 24]

   The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement of dactylitis. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.

10. Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 [Baseline and Week 24]

    SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

11. Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24 [Baseline and Week 24]

    The Disease Activity Index Score (DAS28) based on C-Reactive Protein (CRP) is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis.

12. Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Week 24 [Baseline and Week 24]

    SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

13. Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16 [Week 16]

    ACR 50 response was defined as >= 50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.

14. Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 24 [Week 24]

    ACR 70 response was defined as >= 70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.

15. Percentage of Participants Who Achieved ACR 20 Response Through Week 24 [Weeks 2, 4, 8, 12, 16, 20 and 24]

    ACR 20 response was defined as >= 20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.

16. Percentage of Participants Who Achieved ACR 50 Response Through Week 24 [Weeks 2, 4, 8, 12, 16, 20 and 24]

    ACR 50 response was defined as >= 50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.

17. Percentage of Participants Who Achieved ACR 70 Response Through Week 24 [Weeks 2, 4, 8, 12, 16, 20 and 24]

    ACR 70 response was defined as >= 70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.

18. Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 [Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

    ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment (PtGA) of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment (PGA) of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (milligram/deciliter [mg/dL]).

19. Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 [Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

    HAQ-DI score assess functional status of participant. It is a 20 question instrument that assess the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative changes from baseline indicate improvement of physical function.

20. Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline [Weeks 2, 4, 8, 12, 16, 20 and 24]

    HAQ-DI score assess functional status of participant. It is a 20 question instrument that assess the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.

21. Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 [Weeks 2, 4, 8, 12, 16, 20 and 24]

    DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS 28 (CRP) response criteria was defined as follows: Good response: <=3.2 at visit and >1.2 improvement; Moderate response: >3.2 at visit and >1.2 improvement or <=5.1 at visit and >0.6-1.2 improvement; No response: <=0.6 improvement, or >5.1 at visit and <=1.2 improvement. The values are 0=best to 10=worst. A DAS28 (CRP) responder is defined as achieving a good or moderate DAS28 response at a specific visit.

22. Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 [Weeks 2, 4, 8, 12, 16, 20 and 24]

    DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS 28 (CRP) remission was defined as DAS 28 (CRP) value <2.6 at the analysis visit.

23. Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 [Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24]

    DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis.

24. Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 [Weeks 2, 4, 8, 12, 16, 20 and 24]

    The modified PsARC response was defined as improvement in at least 2 of the four criteria: >=30% decrease in swollen joint count, >=30% decrease in tender joint count, >=20% improvement in patient's Global Assessment of Disease Activity (arthritis) on a VAS (0-100 mm, 0=excellent and 100= poor), >=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.

25. Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline [Weeks 2, 4, 8, 16 and 24]

    Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI>0.

26. Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline [Weeks 2, 4, 8, 16 and 24]

    The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score >0.

27. Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline [Baseline, Weeks 2, 4, 8, 16 and 24]

    Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis.

28. Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline [Baseline, Weeks 2, 4, 8, 16 and 24]

    The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement of dactylitis.

29. Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24 [Baseline, Weeks 8, 16 and 24]

    PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS [0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS [0-100 mm, 0=no arthritis activity and 100=extremely active arthritis]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 [where 0= no tenderness and 3= extreme tenderness] and recoding to 0-1, where any score > 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity.

30. Change From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24 [Baseline, Weeks 16 and 24]

    GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), patient's global assessment of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), patient's global assessment of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + [2.367*HAQ-DI]-[0.234*SF-PCS]-[0.244*SF-MCS]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score ranges from 0-100, higher scores= better quality of life) and SF-MCS (score ranges from 0-100, higher scores= better quality of life). Total score is from 0-10, lower score=better response. Higher score indicates more active disease activity. Negative change from baseline indicates improvement of PsA disease activity.

31. Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24 [Baseline, Weeks 16 and 24]

    Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

32. Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24 [Baseline, Weeks 16 and 24]

    Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

33. Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24 [Baseline, Weeks 16 and 24]

    Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAi-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

34. Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24 [Baseline, Weeks 16 and 24]

    Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

35. Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24 [Baseline, Weeks 16 and 24]

    The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity.

36. Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 [Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24]

    DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL, value <lower limit of quantification [LLOQ] is considered equal to half of the value of LLOQ for numerical calculations), patient assessment of pain (0-10cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.

37. Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24 [Weeks 16 and 24]

    MDA is a measure that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved the PsA MDA at a visit if the participant has fulfilled at least 5 of the following 7 criteria at that visit: Tender joint count (68 joints)<=1, Swollen joint count (66 joints) <=1, Psoriasis activity and severity index <=1, Patient's Assessment of Pain <=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) <=20 on a 100-unit VAS, HAQ-DI score <=0.5, and Tender entheseal points <= 1 (LEI index score <= 1).

38. Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline [Weeks 8, 16 and 24]

    Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.

39. Percentage of Participants Who Achieved PASI 75 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 16 and 24]

    PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 75 response: >=75% improvement in PASI score from baseline.

40. Percentage of Participants Who Achieved PASI 90 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 16 and 24]

    PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 90 response: >=90% improvement in PASI score from baseline.

41. Percentage of Participants Who Achieved PASI 100 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline [Weeks 16 and 24]

    PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 100 response: 100% improvement in PASI score from baseline.

42. Percentage of Participants With an IGA Score of 0 (Cleared) Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 16 and 24]

    A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >=2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

43. Change From Baseline in PASI Score at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Baseline, Weeks 16 and 24]

    PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative change from baseline indicates improvement of psoriasis.

44. Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Through Week 24 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 8, 16, 24]

    Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. A DLQI score of 0 or 1 indicates psoriasis had no effect at all on patient's life.

45. Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score Through Week 24 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 8, 16, 24]

    Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. An improvement of 5 points was considered clinically meaningful.

46. Change From Baseline in DLQI Score at Weeks 8, 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Baseline, Weeks 8, 16 and 24]

    Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. Negative changes from baseline indicate improvement of life quality impacted by psoriasis.

47. Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 16 and 24]

    In PASI, each area (head, trunk, upper and lower extremities) was assessed for % of area involved and translated to numeric score from 0 (no involvement) to 6 (90-100% involvement) and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score from 0 to 72. Higher scores=more severe disease. PASI 75: >=75% improvement in PASI score from baseline. ACR 20: >=20% improvement in swollen joint count (SJC) (66 joints) + tender joint count (TJC) (68 joints) and >=20% improvement in 3 of 5: patient's assessment of pain (VAS; 0-100 mm, 0=no pain to 100=worst possible pain), PtGA of disease activity (VAS; 0-100 mm, 0=excellent to 100=poor), PGA of disease activity (VAS; 0-100 mm, 0=no arthritis to 100=extremely active arthritis), patient's assessment of physical function (HAQ-DI -20-question instrument; range- 0=no difficulty to 3=inability to perform task) and CRP.

48. Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 16 and 24]

    In PASI, each area (head, trunk, upper and lower extremities) was assessed separately for % of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score range from 0 to 72. Higher scores=more severe disease. PASI 75 response: >=75% improvement in PASI score from baseline. Modified PsARC response: improvement in at least 2 of 4 criteria: >=30% decrease in SJC and TJC, >=20% improvement in PtGA of Disease Activity (arthritis) on VAS (0-100 mm, 0=excellent and 100=poor), >=20% improvement in PGA of Disease Activity on VAS (VAS: 0-100 mm, 0=no arthritis and 100=extremely active arthritis), and at least 1 of 2 joint criteria with no deterioration in other criteria.

49. Change From Baseline in Modified vdH-S Erosion Score at Week 24 [Baseline and Week 24]

    Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

50. Change From Baseline in Modified vdH-S Joint Space Narrowing (JSN) Score at Week 24 [Baseline and Week 24]

    The modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). The JSN score is the total JSN score in 40 joints of the two hands and 12 joints of the 2 feet. Each joint is scored from 0 to 4 with 0 indicating no JSN, and 4 indicating a complete loss of joint space, bony ankylosis, or complete luxation, for a maximum JSN score of 208. Higher score indicates more severe joint space narrowing. A positive change from baseline in the modified vdH-S JSN score indicates progression of joint space narrowing.

51. Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 [Baseline and Week 24]

    Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand (Hand erosion score) scored according to 0 (no erosion) to 5 (complete collapse of bone) for a maximum hand erosion score of 200, and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum foot erosion score of 120. Higher scores indicate more joint damage. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum Hand JSN score of 160 and maximum Foot JSN score of 48. Higher scores indicate more joint damage. Hand Score (sum of Hand Erosion Score and Hand JSN Score) scored as 0-360 and Foot score (sum of foot erosion score and foot JSN score) scored as 0-168. Higher scores indicate more joint damage.

52. Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24 [Week 24]

    Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

53. Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24 [Week 24]

    Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

54. Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24 [Week 24]

    The modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). The JSN score is the sum of JSN score in 40 joints of the two hands and 12 joints of the 2 feet. Each joint is scored from 0 - 4 with 0 indicating no JSN, and 4 indicating a complete loss of joint space, bony ankylosis, or complete luxation, for a maximum JSN score of 208. Higher score indicates more severe joint space narrowing. Change from baseline in the modified vdH-S JSN score <=0 (assessed by both readers) or <=0.5 (assessed by at least one reader) was considered as no progression of JSN.

55. Percentage of Participants Without Radiographic Progression (Based on the Smallest Detectable Change [SDC]) From Baseline at Week 24 [Week 24]

    Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic progression was defined as change from baseline in the modified vdH-S score <=SDC of 2.18.

56. Percentage of Participants Without Radiographic Joint Erosion Progression (Based on SDC) From Baseline at Week 24 [Week 24]

    Modified vdH-S score is sum of erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC defined as the cut-off above which changes can be detected beyond measurement error. Without radiographic joint erosion progression was defined as change from baseline in modified vdH-S erosion score <=SDC of 1.83.

57. Percentage of Participants Without Radiographic JSN Progression (Based on the SDC) From Baseline at Week 24 [Week 24]

    The modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). The JSN score is the sum of JSN score in 40 joints of the two hands and 12 joints of the 2 feet. Each joint is scored from 0 - 4 with 0 indicating no JSN, and 4 indicating a complete loss of joint space, bony ankylosis, or complete luxation, for a maximum JSN score of 208. Higher score indicates more severe joint space narrowing. The smallest detectable change (SDC) was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic JSN progression was defined as change from baseline in the modified vdH-S JSN score <=SDC of 1.11.

58. Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24 [Baseline and Week 24]

    Pencil in Cup or Gross Osteolytis Deformities are radiographic features specific for psoriatic arthritis.

59. Change From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24 [Baseline, Weeks 8, 16 and 24]

    SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

60. Change From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24 [Baseline, Weeks 8, 16 and 24]

    SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

61. Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 [Baseline and Weeks 8, 16 and 24]

    SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales: physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health. The scores 0-100 (where higher scores indicated a better quality of life) from each subscale of SF-36 were normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better health status. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

62. Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24 [Week 8, 16 and 24]

    SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.

63. Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24 [Week 8, 16 and 24]

    SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.

64. Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 [Baseline, Weeks 8, 16 and 24]

    The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.

65. Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24 [Weeks 8, 16 and 24]

    The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.

66. Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VAS [Baseline, Weeks 16 and 24]

    EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status

67. Change From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D Index [Baseline, Weeks 16 and 24]

    EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (full health). A higher score indicates better health and positive changes from baseline indicate improvement of health.

68. Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 [Weeks 24, 28, 36, 44 and 52]

    ACR 20 response was defined as >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

69. Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 [Weeks 24, 28, 36, 44 and 52]

    ACR 50 response was defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

70. Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 [Weeks 24, 28, 36, 44 and 52]

    ACR 70 response was defined as >=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

71. ACR Components at Weeks 24, 28, 36, 44 and 52 [Weeks 24, 28, 36, 44 and 52]

    ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).

72. Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 [Baseline, Weeks 24, 28, 36, 44 and 52]

    ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).

73. Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 [Baseline, Weeks 24, 28, 36, 44 and 52]

    ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).

74. Percentage of Participants Who Maintained an ACR 20 Response at Week 52 Among Participants Who Achieved an ACR 20 Response at Week 24 [Week 52]

    ACR 20 response was defined as >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

75. Percentage of Participants Who Maintained an ACR 50 Response at Week 52 Among Participants Who Achieved an ACR 50 Response at Week 24 [Week 52]

    ACR 50 response was defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

76. Percentage of Participants Who Maintained an ACR 70 Response at Week 52 Among Participants Who Achieved an ACR 70 Response at Week 24 [Week 52]

    ACR 70 response was defined as >=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 millimeters [mm], 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

77. Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 [Baseline, Weeks 24, 28, 36, 44 and 52]

    HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.

78. Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline [Weeks 24, 28, 36, 44 and 52]

    HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.

79. Percentage of Participants Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 52 Among Participants Who Achieved a HAQ-DI Response at Week 24 [Week 52]

    HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.

80. Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 [Weeks 24, 28, 36, 44 and 52]

    DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) response criteria was defined as follows: Good response: <=3.2 at visit and >1.2 improvement; Moderate response: >3.2 at visit and >1.2 improvement or <=5.1 at visit and >0.6-1.2 improvement; No response: <=0.6 improvement, or >5.1 at visit and <=1.2 improvement. The values are 0=best to 10=worst. A DAS28 (CRP) responder was defined as achieving a good or moderate DAS28 response at a specific visit.

81. Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 [Weeks 24, 28, 36, 44 and 52]

    DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission was defined as DAS28 (CRP) value <2.6 at the analysis visit.

82. Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 [Baseline, Weeks 24, 28, 36, 44 and 52]

    DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis.

83. Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 [Weeks 24, 28, 36, 44 and 52]

    The modified PsARC response was defined as improvement in at least 2 of the four criteria: >=30% decrease in swollen joint count, >=30% decrease in tender joint count, >=20% improvement in patient's Global Assessment of Disease Activity (arthritis) on a VAS (0-100 mm, 0=excellent and 100= poor), >=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.

84. Percentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline [Weeks 24 and 52]

    Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI>0.

85. Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline [Baseline, Weeks 24 and 52]

    Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis.

86. Percentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at Baseline [Weeks 24 and 52]

    The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score >0.

87. Change From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at Baseline [Baseline, Weeks 24 and 52]

    The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. A higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement in dactylitis.

88. Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52 [Baseline, Weeks 24 and 52]

    PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS [0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS [0-100 mm, 0=no arthritis activity and 100=extremely active arthritis]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 [where 0= no tenderness and 3= extreme tenderness] and recoding to 0-1, where any score > 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity.

89. Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52 [Weeks 24 and 52]

    PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS [0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS [0-100 mm, 0=no arthritis activity and 100=extremely active arthritis]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 [where 0= no tenderness and 3= extreme tenderness] and recoding to 0-1, where any score > 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity.

90. Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 [Baseline, Weeks 24 and 52]

    GRACE index is a composite PsA disease activity score converted from AMDF, which was derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), patient's global assessment of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100= poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), patient's global assessment of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL =25.355 + [2.367*HAQ-DI] - [0.234*SF-PCS] - [0.244*SF-MCS]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score ranges from 0 to 100, higher scores= better quality of life) and SF-MCS (score ranges from 0 to 100, higher scores= better quality of life). The total score is from 0-10, where lower score indicates better response. Higher score indicates more active disease activity. Negative change from baseline indicates improvement of PsA disease activity.

91. Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 [Weeks 24 and 52]

    GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), PtGA of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), PtGA of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + [2.367*HAQ-DI]-[0.234*SF-PCS]-[0.244*SF-MCS]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score range= 0-100, higher scores= better quality of life) and SF-MCS (score range=0-100, higher scores= better quality of life). Total score is 0-10, lower score=better response. Higher score= more active disease activity. Negative change from baseline indicates improvement of PsA disease activity. GRACE low disease activity is GRACE score <=2.3 at the analysis visit.

92. Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 [Baseline, Weeks 24, 28, 36, 44 and 52]

    DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL), patient assessment of pain (0-10cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.

93. Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 [Baseline, Weeks 24 and 52]

    The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity.

94. Percentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 [Weeks 24 and 52]

    The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. mCPDAI low disease activity is defined as mCPDAI score <=3.2 at the analysis visit.

95. Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52 [Weeks 24 and 52]

    MDA is a measure that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved the PsA MDA at a visit if the participant has fulfilled at least 5 of the following 7 criteria at that visit: Tender joint count (68 joints)<=1, Swollen joint count (66 joints) <=1, Psoriasis activity and severity index <=1, Patient's Assessment of Pain <=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) <=20 on a 100-unit VAS, HAQ-DI score <=0.5, and Tender entheseal points <= 1 (LEI index score <= 1).

96. Percentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52 [Weeks 24 and 52]

    A measurement that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved VLDA at a visit if the participant fulfilled all 7 criteria (tender joint count <=1; swollen joint count <=1; PASI <=1; patient pain VAS score of <=15; patient global disease activity VAS [arthritis and psoriasis] score of <=20; Health Assessment Questionnaire (HAQ) score <=0.5; and tender entheseal points <=1) at that visit.

97. Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis at Baseline [Baseline, Weeks 24 and 52]

    Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.

98. Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline [Weeks 24 and 52]

    Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.

99. Change From Baseline in PASI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Baseline, Weeks 24 and 52]

    PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative change from baseline indicates improvement of psoriasis.

100. Percentage of Participants Who Achieved PASI 50 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 24 and 52]

     PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 50 response: >=50% improvement in PASI score from baseline.

101. Percentage of Participants Who Achieved PASI 75 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 24 and 52]

     PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 75 response: >=75% improvement in PASI score from baseline.

102. Percentage of Participants Who Achieved PASI 90 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 24 and 52]

     PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 90 response: >=90% improvement in PASI score from baseline.

103. Percentage of Participants Who Achieved PASI 100 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 24 and 52]

     PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 100 response: 100% improvement in PASI score from baseline.

104. Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 24 and 52]

     In PASI, each area (head, trunk, upper and lower extremities) was assessed for % of area involved and translated to numeric score from 0 (no involvement) to 6 (90-100% involvement) and for erythema, induration, and scaling, each rated on scale of 0 to 4. PASI produces numeric score from 0 to 72. Higher scores=more severe disease. PASI 75: >=75% improvement in PASI score from baseline. ACR 20: >=20% improvement in SJC (66 joints)+TJC (68 joints) and >=20% improvement in 3 of 5: patient's assessment of pain (VAS; 0-100 mm, 0=no pain to 100=worst possible pain), PtGA of disease activity (VAS; 0-100 mm, 0=excellent to 100=poor), PGA of disease activity (VAS; 0-100 mm, 0=no arthritis to 100=extremely active arthritis), patient's assessment of physical function (HAQ-DI -20-question instrument; range- 0=no difficulty to 3=inability to perform task) and CRP.

105. Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 24 and 52]

     In PASI, each area (head, trunk, upper and lower extremities) was assessed separately for % of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4. PASI produces numeric score range from 0 to 72. Higher scores=more severe disease. PASI75 response: >=75% improvement in PASI score from baseline. Modified PsARC response: improvement in at least 2 of 4 criteria: >=30% decrease in SJC and TJC, >=20% improvement in PtGA of Disease Activity (arthritis) on VAS (0-100 mm, 0=excellent and 100=poor), >=20% improvement in PGA of Disease Activity on VAS (VAS: 0-100 mm, 0=no arthritis and 100=extremely active arthritis), and at least 1 of 2 joint criteria with no deterioration in other criteria.

106. Percentage of Participants Who Achieved an IGA Response at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 24 and 52]

     A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

107. Percentage of Participants Who Achieved an IGA Score of 0 (Cleared) at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 24 and 52]

     A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

108. Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 24 and 52 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 24 and 52]

     Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. A DLQI score of 0 or 1 indicates psoriasis had no effect at all on patient's life.

109. Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 24 and 52]

     Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. An improvement of 5 points was considered clinically meaningful.

110. Change From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Baseline, Weeks 24 and 52]

     Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. Negative changes from baseline indicate improvement of life quality impacted by psoriasis.

111. Change From Baseline in Modified vdH-S Score at Week 52 [Baseline and Week 52]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

112. Change in Total Modified vdH-S Score From Week 24 to Week 52 [From Week 24 to Week 52]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage.

113. Change From Baseline in Modified vdH-S Erosion Score at Week 52 [Baseline and Week 52]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

114. Change in Modified vdH-S Erosion Score From Week 24 to Week 52 [From Week 24 to Week 52]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage.

115. Change From Baseline in Modified vdH-S JSN Score at Week 52 [Baseline and Week 52]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

116. Change in Modified vdH-S JSN Score From Week 24 to Week 52 [From Week 24 to Week 52]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage.

117. Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 [Baseline and Week 52]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand (Hand erosion score) scored according to 0 (no erosion) to 5 (complete collapse of bone) for a maximum hand erosion score of 200, and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum foot erosion score of 120. Higher scores indicate more joint damage. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum Hand JSN score of 160 and maximum Foot JSN score of 48. Higher scores indicate more joint damage. Hand Score (sum of Hand Erosion Score and Hand JSN Score) scored as 0-360 and Foot score (sum of foot erosion score and foot JSN score) scored as 0-168. Higher scores indicate more joint damage.

118. Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52 [Week 52]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

119. Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52 [Week 52]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

120. Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52 [Week 52]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

121. Percentage of Participants Without Radiographic Progression Based on the (SDC) From Baseline at Week 52 [Week 52]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic progression was defined as change from baseline in the modified vdH-S score <=SDC of 2.39.

122. Percentage of Participants Without Radiographic Joint Erosion Progression Based on (SDC) From Baseline at Week 52 [Week 52]

     Modified vdH-S score is sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is summary of erosion severity in 40 joints of hand scored according to surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic joint erosion progression was defined as change from baseline in modified vdH-S erosion score <=SDC of 2.22.

123. Percentage of Participants Without Radiographic JSN Progression Based on (SDC) From Baseline at Week 52 [Week 52]

     Modified vdH-S score is sum of erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is summary of erosion severity in 40 joints of hand scored according to surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as cut-off above which changes can be detected beyond measurement error. Without radiographic JSN progression was defined as change from baseline in modified vdH-S JSN score <=SDC of 1.02.

124. Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52 [Baseline and Week 52]

     Percentage of Participants with Pencil in cup or Gross Osteolysis Deformities were reported. Pencil in Cup or Gross Osteolytis Deformities are radiographic features specific for psoriatic arthritis.

125. Change From Baseline in SF-36 PCS Score at Weeks 24 and 52 [Baseline, Weeks 24 and 52]

     SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

126. Change From Baseline in SF-36 MCS Score at Weeks 24 and 52 [Baseline, Weeks 24 and 52]

     SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

127. Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 [Baseline, Weeks 24 and 52]

     SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales: physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health. The scores 0-100 (where higher scores indicated a better quality of life) from each subscale of SF-36 were normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better health status. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

128. Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52 [Weeks 24 and 52]

     SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.

129. Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52 [Weeks 24 and 52]

     SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.

130. Change From Baseline in FACIT-Fatigue Score at Weeks 24 and 52 [Baseline, Weeks 24 and 52]

     The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.

131. Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52 [Weeks 24 and 52]

     The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.

132. Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VAS [Baseline, Weeks 24 and 52]

     EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status.

133. Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D Index [Baseline, Weeks 24 and 52]

     EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (full health). A higher score indicates better health and positive changes from baseline indicate improvement of health.

134. Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52 [Baseline, Weeks 24 and 52]

     Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

135. Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52 [Baseline, Weeks 24 and 52]

     Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

136. Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52 [Baseline, Weeks 24 and 52]

     Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

137. Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52 [Baseline, Weeks 24 and 52]

     Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

138. Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 [Weeks 52, 68, 76, 84 and 100]

     ACR 20 response was defined as >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

139. Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 [Weeks 52, 68, 76, 84 and 100]

     ACR 50 response was defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

140. Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 [Weeks 52, 68, 76, 84 and 100]

     ACR 70 response was defined as >=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

141. ACR Components at Weeks 52, 68, 76, 84 and 100 [Weeks 52, 68, 76, 84 and 100]

     ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).

142. Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 [Baseline, Weeks 52, 68, 76, 84 and 100]

     ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).

143. Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 [Baseline, Weeks 52, 68, 76, 84 and 100]

     ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).

144. Percentage of Participants Who Maintained an ACR 20 Response at Week 100 Among Participants Who Achieved an ACR 20 Response at Week 52 [Week 100]

     ACR 20 response was defined as >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

145. Percentage of Participants Who Maintained an ACR 50 Response at Week 100 Among Participants Who Achieved an ACR 50 Response at Week 52 [Week 100]

     ACR 50 response was defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

146. Percentage of Participants Who Maintained an ACR 70 Response at Week 100 Among Participants Who Achieved an ACR 70 Response at Week 52 [Week 100]

     ACR 70 response was defined as >=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 millimeters [mm], 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

147. Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 [Baseline, Weeks 52, 68, 76, 84 and 100]

     HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.

148. Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline [Weeks 52, 68, 76, 84 and 100]

     HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.

149. Percentage of Participants Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 100 Among Participants Who Achieved a HAQ-DI Response at Week 52 [Week 100]

     HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.

150. Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 [Weeks 52, 68, 76, 84 and 100]

     DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) response criteria was defined as follows: Good response: <=3.2 at visit and >1.2 improvement; Moderate response: >3.2 at visit and >1.2 improvement or <=5.1 at visit and >0.6-1.2 improvement; No response: <=0.6 improvement, or >5.1 at visit and <=1.2 improvement. The values are 0=best to 10=worst. A DAS28 (CRP) responder was defined as achieving a good or moderate DAS28 response at a specific visit.

151. Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 [Weeks 52, 68, 76, 84 and 100]

     DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission was defined as DAS28 (CRP) value <2.6 at the analysis visit.

152. Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 [Baseline, Weeks 52, 68, 76, 84 and 100]

     DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis.

153. Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 [Weeks 52, 68, 76, 84 and 100]

     The modified PsARC response was defined as improvement in at least 2 of the four criteria: >=30% decrease in swollen joint count, >=30% decrease in tender joint count, >=20% improvement in patient's Global Assessment of Disease Activity (arthritis) on a VAS (0-100 mm, 0=excellent and 100= poor), >=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.

154. Percentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at Baseline [Weeks 52, 76, and 100]

     Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI>0.

155. Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at Baseline [Baseline, Weeks 52, 76 and 100]

     Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis.

156. Percentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at Baseline [Weeks 52, 76 and 100]

     The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score >0.

157. Change From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at Baseline [Baseline, Weeks 52, 76 and 100]

     The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement of dactylitis.

158. Change From Baseline in PASDAS Score at Weeks 52, 76 and 100 [Baseline, Weeks 52, 76 and 100]

     PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS [0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS [0-100 mm, 0=no arthritis activity and 100=extremely active arthritis]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 [where 0= no tenderness and 3= extreme tenderness] and recoding to 0-1, where any score > 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity.

159. Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 [Weeks 52, 76 and 100]

     PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining PtGA of Disease Activity (arthritis and psoriasis, using VAS [0-100 mm, 0=excellent and 100= poor), PGA of Disease Activity (using VAS [0-100 mm, 0=no arthritis activity and 100=extremely active arthritis]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 [where 0= no tenderness and 3= extreme tenderness] and recoding to 0-1, where any score > 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity. Low: PASDAS <= 3.2; Very low: PASDAS <= 1.9.

160. Change From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100 [Baseline, Weeks 52, 76 and 100]

     GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), patient's global assessment of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), patient's global assessment of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + [2.367*HAQ-DI]-[0.234*SF-PCS]-[0.244*SF-MCS]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score ranges from 0-100, higher scores= better quality of life) and SF-MCS (score ranges from 0-100, higher scores= better quality of life). Total score is from 0-10, lower score=better response. Higher score indicates more active disease activity. Negative change from baseline indicates improvement of PsA disease activity.

161. Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 52, 76 and 100 [Weeks 52, 76 and 100]

     GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), PtGA of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), PtGA of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + [2.367*HAQ-DI]-[0.234*SF-PCS]-[0.244*SF-MCS]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score range= 0-100, higher scores= better quality of life) and SF-MCS (score range=0-100, higher scores= better quality of life). Total score is 0-10, lower score=better response. Higher score= more active disease activity. Negative change from baseline indicates improvement of PsA disease activity. GRACE low disease activity is GRACE score <=2.3 at the analysis visit.

162. Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 [Baseline, Weeks 52, 68, 76, 84 and 100]

     DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL, value <lower limit of quantification [LLOQ] is considered equal to half of the value of LLOQ for numerical calculations), patient assessment of pain (0-10cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.

163. Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 [Weeks 52, 68, 76, 84 and 100]

     DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL), patient assessment of pain (0-10 cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. The assessment does not have a score range with an upper or lower bound. Low: DAPSA<=14; Remission: DAPSA<=4.

164. Change From Baseline in mCPDAI Score at Weeks 52, 76 and 100 [Baseline, Weeks 52, 76 and 100]

     The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity.

165. Percentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100 [Weeks 52, 76 and 100]

     The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. mCPDAI low disease activity is defined as mCPDAI score <=3.2 at the analysis visit.

166. Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100 [Weeks 52, 76 and 100]

     MDA is a measure that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved the PsA MDA at a visit if the participant has fulfilled at least 5 of the following 7 criteria at that visit: Tender joint count (68 joints)<=1, Swollen joint count (66 joints) <=1, Psoriasis activity and severity index <=1, Patient's Assessment of Pain <=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) <=20 on a 100-unit VAS, HAQ-DI score <=0.5, and Tender entheseal points <= 1 (LEI index score <= 1).

167. Percentage of Participants With VLDA at Weeks 52, 76 and 100 [Weeks 52, 76 and 100]

     A measurement that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved VLDA at a visit if the participant fulfilled all 7 criteria (tender joint count <=1; swollen joint count <=1; PASI <=1; patient pain VAS score of <=15; patient global disease activity VAS [arthritis and psoriasis] score of <=20; Health Assessment Questionnaire (HAQ) score <=0.5; and tender entheseal points <=1) at that visit.

168. Change From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at Baseline [Baseline, Weeks 52, 76 and 100]

     Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.

169. Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline [Weeks 52, 76 and 100]

     Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.

170. Change From Baseline in PASI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Baseline, Weeks 52, 76 and 100]

     PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative change from baseline indicates improvement of psoriasis.

171. Percentage of Participants Who Achieved PASI 50 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 52, 76 and 100]

     PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 50 response: >=50% improvement in PASI score from baseline.

172. Percentage of Participants Who Achieved PASI 75 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 52, 76 and 100]

     PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 75 response: >=75% improvement in PASI score from baseline.

173. Percentage of Participants Who Achieved PASI 90 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 52, 76 and 100]

     PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 90 response: >=90% improvement in PASI score from baseline.

174. Percentage of Participants Who Achieved PASI 100 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 52, 76 and 100]

     PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 100 response: 100% improvement in PASI score from baseline.

175. Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 52, 76 and 100]

     In PASI, each area (head, trunk, upper and lower extremities) was assessed for % of area involved and translated to numeric score from 0 (no involvement) to 6 (90-100% involvement) and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score from 0 to 72. Higher scores=more severe disease. PASI 75: >=75% improvement in PASI score from baseline. ACR 20: >=20% improvement in swollen joint count (SJC) (66 joints) + tender joint count (TJC) (68 joints) and >=20% improvement in 3 of 5: patient's assessment of pain (VAS; 0-100 mm, 0=no pain to 100=worst possible pain), PtGA of disease activity (VAS; 0-100 mm, 0=excellent to 100=poor), PGA of disease activity (VAS; 0-100 mm, 0=no arthritis to 100=extremely active arthritis), patient's assessment of physical function (HAQ-DI -20-question instrument; range- 0=no difficulty to 3=inability to perform task) and CRP.

176. Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 52, 76, and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 52, 76 and 100]

     In PASI, each area (head, trunk, upper and lower extremities) was assessed separately for % of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score range from 0 to 72. Higher scores=more severe disease. PASI 75 response: >=75% improvement in PASI score from baseline. Modified PsARC response: improvement in at least 2 of 4 criteria: >=30% decrease in SJC and TJC, >=20% improvement in PtGA of Disease Activity (arthritis) on VAS (0-100 mm, 0=excellent and 100=poor), >=20% improvement in PGA of Disease Activity on VAS (VAS: 0-100 mm, 0=no arthritis and 100=extremely active arthritis), and at least 1 of 2 joint criteria with no deterioration in other criteria.

177. Percentage of Participants With an IGA Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 52, 76 and 100]

     A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). IGA Response is defined as achieving IGA score of 0 or 1, and >=2 grade reduction from baseline.

178. Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 52, 76 and 100]

     A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

179. Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 52, 76 and 100 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 52, 76 and 100]

     Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. A DLQI score of 0 or 1 indicates psoriasis had no effect at all on patient's life.

180. Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Weeks 52, 76 and 100]

     Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. An improvement of 5 points was considered clinically meaningful.

181. Change From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Baseline, Weeks 52, 76 and 100]

     Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. Negative changes from baseline indicate improvement of life quality impacted by psoriasis.

182. Change in Modified vdH-S Score From Baseline to Week 100 [Baseline to Week 100]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

183. Change in Total Modified vdH-S Score From Week 52 to Week 100 [From Week 52 to Week 100]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage.

184. Change in Modified vdH-s Erosion Score From Baseline to Week 100 [Baseline to Week 100]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

185. Change in Modified vdH-s Erosion Score From Week 52 to Week 100 [From Week 52 to Week 100]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

186. Change in Modified vdH-s JSN Score From Baseline to Week 100 [Baseline to Week 100]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

187. Change in Modified vdH-s JSN Score From Week 52 to Week 100 [From Week 52 to Week 100]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

188. Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) [Baseline to Week 100]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand (Hand erosion score) scored according to 0 (no erosion) to 5 (complete collapse of bone) for a maximum hand erosion score of 200, and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum foot erosion score of 120. Higher scores indicate more joint damage. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum Hand JSN score of 160 and maximum Foot JSN score of 48. Higher scores indicate more joint damage. Hand Score (sum of Hand Erosion Score and Hand JSN Score) scored as 0-360 and Foot score (sum of foot erosion score and foot JSN score) scored as 0-168. Higher scores indicate more joint damage.

189. Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Score [Baseline to Week 100]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

190. Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion Score [Baseline to Week 100]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

191. Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN Score [Baseline to Week 100]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.

192. Percentage of Participants Without Radiographic Modified vdH-S Progression Based on (SDC) From Baseline to Week 100 [Baseline to Week 100]

     Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic progression was defined as change from baseline in the modified vdH-S score <=SDC of 3.46.

193. Percentage of Participants Without Radiographic Erosion Progression (Based on SDC) From Baseline to Week 100 [Baseline to Week 100]

     Modified vdH-S score is sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is summary of erosion severity in 40 joints of hand scored according to surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic erosion progression was defined as change from baseline in the modified vdH-S erosion score <=SDC of 2.66.

194. Percentage of Participants Without Radiographic JSN Progression (Based on SDC) From Baseline to Week 100 [Baseline to Week 100]

     Modified vdH-S score is sum of erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is summary of erosion severity in 40 joints of hand scored according to surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic JSN progression was defined as change from baseline in the modified vdH-S JSN score <=SDC of 1.66.

195. Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100 [Baseline, Weeks 24, 52, and 100]

     Pencil in Cup or Gross Osteolytis Deformities are radiographic features specific for psoriatic arthritis.

196. Change From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 [Baseline, Weeks 52, 76 and 100]

     SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

197. Change From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 [Baseline, Weeks 52, 76 and 100]

     SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

198. Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 [Baseline, Weeks 52, 76 and 100]

     SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales: physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health. The scores 0-100 (where higher scores indicated a better quality of life) from each subscale of SF-36 were normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better health status. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

199. Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 [Weeks 52, 76 and 100]

     SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.

200. Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 [Weeks 52, 76 and 100]

     SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.

201. Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100 [Baseline, Weeks 52, 76 and 100]

     The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.

202. Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100 [Weeks 52, 76 and 100]

     The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.

203. Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VAS [Baseline, Weeks 52, 76 and 100]

     EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status.

204. Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D Index [Baseline, Weeks 52, 76 and 100]

     EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (full health). A higher score indicates better health and positive changes from baseline indicate improvement of health.

205. Change From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100 [Baseline, Weeks 52, 76 and 100]

     Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

206. Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100 [Baseline, Weeks 52, 76 and 100]

     Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

207. Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100 [Baseline, Weeks 52, 76 and 100]

     Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

208. Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100 [Baseline, Weeks 52, 76 and 100]

     Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have a diagnosis of Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening

• Have active PsA as defined by: at least 5 swollen joints and at least 5 tender joints at screening and at baseline, and CRP greater than or equal to (>=) 0.6 milligram per deciLitre (mg/dL) at screening from the central laboratory

• Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis (confirmation of sacroiliitis should be performed at the screening visit by a locally performed pelvic x-ray [single anterior-posterior view] unless a pelvic or SI joint x-ray or pelvic magnetic resonance imaging (MRI) has been previously performed. Results must be documented)

• Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeter (cm) diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis

• Have active PsA despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy

Exclusion Criteria:

• Has other inflammatory diseases that might confound the evaluations or benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease

• Has previously received any biologic treatment

• Has ever received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor

• Has received any systemic immunosuppressants (eg, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study agent

• Is currently receiving 2 or more non-biologic DMARDs (other than methotrexate [MTX], sulfasalazine [SSZ], Hydroxychloroquine [HCQ], leflunomide [LEF]) including, but not limited to chloroquine, gold preparations, and penicillamine within 4 weeks before the first administration of study agent

• Has received apremilast within 4 weeks prior to the first administration of study agent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rheumatology Associates	Birmingham	Alabama	United States	35205
2	Arizona Arthritis & Rheumatology Associates PC	Glendale	Arizona	United States	85306
3	Arizona Arthritis & Rheumatology Research, PLLC	Mesa	Arizona	United States	85210
4	Clinical Research Center of Connecticut	Danbury	Connecticut	United States	06810
5	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana	United States	46256-4697
6	University of Michigan	Ann Arbor	Michigan	United States	48109
7	Arthritis Consultants	Saint Louis	Missouri	United States	63141
8	Austin Regional Clinic	Austin	Texas	United States	78731-3146
9	Multiprofile Hospital for Active Treatment - Plovdiv	Plovdiv		Bulgaria	4003
10	Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv	Plovdiv		Bulgaria	4004
11	Medical Center 'Teodora'	Ruse		Bulgaria	7003
12	Diagnostic Consulting Center No 17	Sofia		Bulgaria	1505
13	Military Medical Academy	Sofia		Bulgaria	1606
14	Medical Centre Synexus	Sofia		Bulgaria	1794
15	MHAT-Targovishte, AD	Targovishte		Bulgaria	7700
16	Revmacentrum MUDr. Mostera, s.r.o.	Brno - Zidenice		Czechia	615 00
17	Revmaclinic	Brno		Czechia	61141
18	MUDr. Rosypalova, s.r.o	Ostrava		Czechia	70800
19	Revmatologicka ambulance	Praha 4		Czechia	14000
20	Revmatologicky institut	Praha		Czechia	12850
21	Medical Plus S.R.O.	Uherske Hradiste		Czechia	68601
22	PV-Medical S.R.O	Zlin		Czechia	76001
23	Parnu Hospital	Parnu		Estonia	80010
24	OU Innomedica	Tallinn		Estonia	10117
25	East Tallinn Central Hospital	Tallinn		Estonia	11312
26	Clinical Research Centre	Tartu		Estonia	50106
27	Daugavpils Regional Hospital	Daugavpils		Latvia	LV5417
28	Derma Clinic Riga	Riga		Latvia	LV1003
29	J Kisis Ltd	Riga		Latvia	LV1003
30	Orto Clinic Ltd	Riga		Latvia	LV1005
31	Vakk, Jsc	Kaunas		Lithuania	LT50128
32	Siauliai Republican Hospital, Public Institution	Siauliai		Lithuania	LT-76231
33	Central Outpatient Clinic	Vilnius		Lithuania	LT01117
34	National Osteoporosis Centre	Vilnius		Lithuania	LT09310
35	Hospital Selayang	Batu Caves		Malaysia	68100
36	Hospital Raja Permaisuri Bainun	Ipoh		Malaysia	30990
37	Sarawak General Hospital	Kuching		Malaysia	Sarawak
38	Hospital Melaka	Melaka		Malaysia	75400
39	Hospital Putrajaya	Putrajaya		Malaysia	62250
40	Hospital Tuanku Jaafar	Seremban		Malaysia	70300
41	Szpital Uniwersytecki Nr 2 w Bydgoszczy	Bydgoszcz		Poland	85-168
42	NSZOZ Unica CR	Dabrowka		Poland	62-069
43	Centrum Kliniczno Badawcze	Elblag		Poland	82-300
44	Centrum Badań Klinicznych PI-House sp. z o.o.	Gdansk		Poland	80-546
45	Centrum Badawcze Wspolczesnej Terapii	Lodz		Poland	90-242
46	Centrum Medyczne AMED oddzial w Lodzi	Lodz		Poland	91-363
47	NZOZ Lecznica MAK-MED. S.C.	Nadarzyn		Poland	05-830
48	Etyka Osrodek Badan Klinicznych	Olsztyn		Poland	10-117
49	Centrum Medyczne Hetmańska	Poznań		Poland	60-218
50	Lubelskie Centrum Diagnostyczne	Swidnik		Poland	21-040
51	Nasz Lekarz Przychodnie Medyczne	Torun		Poland	87-100
52	Medycyna Kliniczna	Warsaw		Poland	00-874
53	Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher	Warszawa		Poland	02-637
54	Centrum Medyczne AMED Warszawa Targowek	Warszawa		Poland	03-291
55	Wromedica	Wroclaw		Poland	51-685
56	Biogenes Sp. z o. o.	Wrocław		Poland	53-224
57	Chelyabinsk Regional Clinical Dermatovenerological Dispensary	Chelyabinsk		Russian Federation	454092
58	Medical and Sanitary Unit ''Severstal''	Cherepovets		Russian Federation	162600
59	Research Institute of Dermatovenerology, Immunology	Ekaterinburg		Russian Federation	620076
60	Regional Clinical Hospital for War Veterans	Kemerovo		Russian Federation	650000
61	Medical Centre Maximum Health	Kemerovo		Russian Federation	650066
62	Family polyclinic #4	Korolev		Russian Federation	141060
63	Krasnodar Clinical Dermatovenerologic Dispensary	Krasnodar		Russian Federation	350020
64	Krasnoyarsk State Medical University	Krasnoyarsk		Russian Federation	660022
65	Lipetsk Regional Dermatovenerological Dispensary	Lipetsk		Russian Federation	398005
66	Moscow State Medical and Stomatological University	Moscow		Russian Federation	111398
67	Clinical Diagnostic Center 'Ultramed'	Omsk		Russian Federation	644024
68	Orenburg State Medical University	Orenburg		Russian Federation	460000
69	Republican Hospital n.a.V.A.Baranov	Petrozavodsk		Russian Federation	185019
70	Rostov Regional Clinical Dermatovenerological Dispensary	Rostov		Russian Federation	344007
71	Ryazan Regional Clinical Dermatovenerological Dispensary	Ryazan		Russian Federation	390046
72	Saratov Regional Clinical Hospital	Saratov		Russian Federation	410053
73	Smolensk regional hospital on Smolensk railway station	Smolensk		Russian Federation	214025
74	City Clinic №25 - City Rheumatology Centre	St-Petersburg		Russian Federation	190068
75	Leningrad region clinical hospital	St-Petersburg		Russian Federation	194291
76	Tula Regional Clinical Dermatovenerological Dispensary	Tula		Russian Federation	300053
77	Regional Clinical Hospital	Tver		Russian Federation	170036
78	Republican Clinical Hospital - G.G. Kuvatov	Ufa		Russian Federation	450005
79	Clinical Emergency Hospital n.a. N.V. Solovyev	Yaroslavl		Russian Federation	150003
80	Clinical Hospital #3	Yaroslavl		Russian Federation	150007
81	Clinical Hospital #10	Yaroslavl		Russian Federation	150023
82	Hosp. Univ. A Coruña	A Coruna		Spain	15006
83	Hosp. Univ. de Cruces	Barakaldo		Spain	48903
84	Hosp. Univ. de Basurto	Bilbao		Spain	48013
85	Hosp. Reina Sofia	Cordoba		Spain	14004
86	Hosp. Univ. Infanta Leonor	Madrid		Spain	28031
87	Hosp. Univ. Ramon Y Cajal	Madrid		Spain	28034
88	Hospital Regional Carlos Haya	Málaga		Spain	29009
89	Hosp. de Merida	Mérida		Spain	06800
90	H.U. Infanta Sofía	San Sebastián de los Reyes		Spain	28702
91	Hosp. Clinico Univ. de Santiago	Santiago de Compostela		Spain	15706
92	Hosp. Infanta Luisa	Sevilla		Spain	41010
93	Hosp. Unv. de Valme	Sevilla		Spain	414014
94	Hosp. Univ. Dr. Peset	Valencia		Spain	46017
95	Hosp. Univ. I Politecni La Fe	Valencia		Spain	46026
96	Hosp. Do Meixoeiro	Vigo		Spain	36214
97	Hualien Tzu Chi Hospital	Hualien City		Taiwan	970
98	Chang Gung Memorial Hospital Kaohsiung Branch	Kaohsiung		Taiwan	833
99	National Cheng Kung University Medical Center	Tainan		Taiwan	704
100	Chang Kung Memorial Hospital	Taipei		Taiwan	105
101	Chang-Gung Memorial Hospital, LinKou Branch	Taoyuan		Taiwan	333
102	Ankara Bilkent City Hospital	Ankara		Turkey	06800
103	Hacettepe University Medical Faculty	Ankara		Turkey	6100
104	Akdeniz University Medical Faculty	Antalya		Turkey	7059
105	Uludag University Medical Faculty	Bursa		Turkey	16059
106	Osmangazi University Medical Faculty	Eskisehir		Turkey	26480
107	Bakirkoy Training and Research Hospital	Istanbul		Turkey	34147
108	Marmara University Medical Faculty	Istanbul		Turkey	34899
109	Dokuz Eylul Universitesi Tip Fakultesi	Izmir		Turkey	35340
110	Izmir Katip Celebi University Medical Faculty Ataturk Training and Research Hospital	Izmir		Turkey	35360
111	Communal Noncommercial Enterprise 'Cherkasy Regional Hospital of Cherkasy Regional Council'	Cherkasy		Ukraine	18009
112	Municipal health care institution Chernihiv Regional Hospital	Chernihiv		Ukraine	14029
113	Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital	Ivano-Frankivsk		Ukraine
114	Communal Institution of Health Kharkiv City multifield hospital №18	Kharkiv		Ukraine	61029
115	Kharkiv Railway Clinical Hospital N1 Of Brance 'Health Center'	Kharkiv		Ukraine	61029
116	State Institution Institute of therapy named after L.T.Malaya AMS Ukraine	Kharkiv		Ukraine	61039
117	Municipal Institution Regional hospital-center of emergency care and disasters medicine	Kharkiv		Ukraine
118	Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh'	Kherson		Ukraine	73000
119	Khmelnitckiy regional hospital	Khmelnytsky		Ukraine	29000
120	City Clinical Hospital No. 2	Kryvyi Rih		Ukraine	50056
121	Kyiv City Clinical Hospital #3	Kyiv		Ukraine	02125
122	Medical Center 'Consylium Medical'	Kyiv		Ukraine	04050
123	Kyiv Regional Clinical Hospital	Kyiv		Ukraine	04107
124	Kyiv Railway Station Clinical Hospital #2	Kyiv		Ukraine
125	SI 'National Scientific Center Institute of Cardiology of M.D. Strazhesko' of NAMS of Ukraine	Kyiv		Ukraine
126	Danylo Halytsky Lviv National Medical University	Lviv		Ukraine
127	Lviv Communcal City Clinical Hospital #4	Lviv		Ukraine
128	Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council	Odessa		Ukraine	65025
129	Multidisciplinary Medical Center of Odessa National Medical University	Odessa		Ukraine	65026
130	Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy	Poltava		Ukraine
131	Sumy State University	Sumy		Ukraine
132	Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'	Ternopil		Ukraine	46002
133	Municipal Non-commercial Enterprise 'Ternopil University Hospital' of Ternopil Regional Council	Ternopil		Ukraine
134	MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council	Uzhgorod		Ukraine	88000
135	Medical Center LTD Health Clinic Department of Cardiology and Rheumatology	Vinnytsya		Ukraine	21009
136	VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council	Vinnytsya		Ukraine
137	Zaporizhzhya Regional Clinical Hospital	Zaporizhzhya		Ukraine
138	Municipal institution Central Clinical Hospital #1 Zhytomir	Zhytomir		Ukraine	10002

Sponsors and Collaborators

• Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

• Study Protocol - May 1, 2020
• Statistical Analysis Plan - Mar 21, 2019

More Information

Publications

None provided.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT03158285
• Other Study ID Numbers: CR108219; CNTO1959PSA3002; 2016-001224-63
• First Posted: May 18, 2017
• Last Update Posted: Jan 4, 2022
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Arthritis; Arthritis, Psoriatic

Study Results

Participant Flow

Pre-assignment Detail	A total of 741 participants were randomized and 739 participants received at least one dose of study drug: 246 in placebo group, 248 in guselkumab 100 mg q8w group, and 245 in guselkumab 100 mg q4w group. Two participants were randomized in error and were never treated. Disposition is presented till active treatment period (Week100).

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Period Title: Placebo-controlled Period: Week 0 - 24
STARTED	246	248	245
Pooled Population: Enthesitis Assessment	255	230	243
Pooled Population: Dactylitis Assessment	154	160	159
COMPLETED	240	240	236
NOT COMPLETED	6	8	9
Period Title: Placebo-controlled Period: Week 0 - 24
STARTED	238	240	234
COMPLETED	228	234	227
NOT COMPLETED	10	6	7
Period Title: Placebo-controlled Period: Week 0 - 24
STARTED	228	232	227
COMPLETED	210	223	219
NOT COMPLETED	18	9	8

Baseline Characteristics

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w	Total
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.	Total of all reporting groups
Overall Participants	246	248	245	739
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.3 (11.68)	44.9 (11.89)	45.9 (11.47)	45.7 (11.68)
Sex: Female, Male (Count of Participants)
Female	129 52.4%	119 48%	103 42%	351 47.5%
Male	117 47.6%	129 52%	142 58%	388 52.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 0.4%	1 0.4%	0 0%	2 0.3%
Not Hispanic or Latino	245 99.6%	247 99.6%	245 100%	737 99.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	4 1.6%	8 3.2%	3 1.2%	15 2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	242 98.4%	240 96.8%	242 98.8%	724 98%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
BULGARIA	14 5.7%	9 3.6%	6 2.4%	29 3.9%
CZECH REPUBLIC	13 5.3%	5 2%	15 6.1%	33 4.5%
ESTONIA	5 2%	8 3.2%	5 2%	18 2.4%
LATVIA	3 1.2%	3 1.2%	0 0%	6 0.8%
LITHUANIA	8 3.3%	8 3.2%	4 1.6%	20 2.7%
MALAYSIA	3 1.2%	6 2.4%	3 1.2%	12 1.6%
POLAND	35 14.2%	27 10.9%	23 9.4%	85 11.5%
RUSSIAN FEDERATION	92 37.4%	77 31%	104 42.4%	273 36.9%
SPAIN	3 1.2%	12 4.8%	4 1.6%	19 2.6%
TAIWAN	0 0%	1 0.4%	0 0%	1 0.1%
TURKEY	2 0.8%	8 3.2%	6 2.4%	16 2.2%
UKRAINE	65 26.4%	83 33.5%	73 29.8%	221 29.9%
UNITED STATES	3 1.2%	1 0.4%	2 0.8%	6 0.8%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
Description	ACR 20 response: >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP. Treatment Failure (TF) criteria- discontinued study drug, initiated/increased dose of non-biologic disease-modifying antirheumatic drugs (DMARDs) or oral corticosteroids, initiated prohibited psoriatic arthritis treatment.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

Analysis population is full analysis set 1 (FAS1). Participants who achieved ACR 20 response at Week 24 and did not meet any treatment failure (TF) criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Number [percentage of participants]	32.9 13.4%	64.1 25.8%	63.7 26%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q8w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	31.2
	Confidence Interval	(2-Sided) 95%; 22.9 to 39.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q4w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	30.8
	Confidence Interval	(2-Sided) 95%; 22.4 to 39.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
Description	HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Least Squares Mean (95% Confidence Interval) [units on a scale]	-0.1300	-0.3672	-0.4004

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q8w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Square (LS) Mean difference
	Estimated Value	-0.2372
	Confidence Interval	(2-Sided) 95%; -0.3210 to -0.1534
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q4w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean difference
	Estimated Value	-0.2704
	Confidence Interval	(2-Sided) 95%; -0.3544 to -0.1864
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percentage of Participants Who Achieved an ACR 50 Response at Week 24
Description	ACR 50 response was defined as greater than or equal to (>=)50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and C-Reactive Protein (CRP).
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Participants who achieved ACR 50 response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Number [percentage of participants]	14.2 5.8%	31.5 12.7%	33.1 13.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q8w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Nominal
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	17.2
	Confidence Interval	() 95%; 10.0 to 24.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q4w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Nominal
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	18.8
	Confidence Interval	(2-Sided) 95%; 11.5 to 26.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Participants Who Achieved Psoriasis Response With IGA Score of 0 (Cleared) or 1 (Minimal) and >=2 Grade Reduction From Baseline at Week 24 Among Participants With >=3% BSA Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline
Description	A psoriasis Investigator's Global Assessment (IGA) response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >=2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

FAS1 among participants with >=3% BSA psoriatic involvement and an IGA score >=2 (mild) at baseline. Participants who achieved psoriasis IGA response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	183	176	184
Number [percentage of participants]	19.1 7.8%	70.5 28.4%	68.5 28%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q8w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	50.9
	Confidence Interval	(2-Sided) 95%; 42.2 to 59.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q4w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	49.8
	Confidence Interval	(2-Sided) 95%; 41.2 to 58.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16
Description	ACR 20 response was defined as >= 20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Participants who achieved ACR 20 response at Week 16 and did not meet any TF criteria before Week 16 were considered as responders. Participants who met 1 or more TF criteria before Week 16 or with missing data were considered as non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Number [percentage of participants]	33.7 13.7%	55.2 22.3%	55.9 22.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q8w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Nominal
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	21.5
	Confidence Interval	(2-Sided) 95%; 13.1 to 30.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q4w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Nominal
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	22.2
	Confidence Interval	(2-Sided) 95%; 13.7 to 30.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Change From Baseline in Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

FAS1 for structural damage (FAS1-SD) included all participants who received at least 1 dose (complete/partial) of study agent according to randomized treatment group regardless of treatment actually received. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be MAR and imputed using MI.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Least Squares Mean (95% Confidence Interval) [units on a scale]	0.95	0.52	0.29

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q8w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.072
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean difference
	Estimated Value	-0.43
	Confidence Interval	(2-Sided) 95%; -0.90 to 0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q4w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.011
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean difference
	Estimated Value	-0.66
	Confidence Interval	(2-Sided) 95%; -1.13 to -0.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline
Description	Enthesitis was assessed using the Leeds Enthesitis Index (LEI), a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI>0. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

FAS1 among participants with enthesitis at baseline pooled from CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Participants with enthesitis resolution at Week 24 and did not meet any TF criteria before Week 24 considered responders. Participants who met 1/more TF criteria or with missing data considered non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	255	230	243
Number [percentage of participants]	29.4 12%	49.6 20%	44.9 18.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q8w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.030
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in response rates
	Estimated Value	20.1
	Confidence Interval	(2-Sided) 95%; 11.8 to 28.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q4w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.030
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in response rates
	Estimated Value	14.6
	Confidence Interval	(2-Sided) 95%; 6.4 to 22.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline
Description	The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score >0. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

FAS1 among participants with dactylitis at baseline pooled from CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Participants with dactylitis resolution at Week 24 and did not meet any TF criteria before Week 24 considered responders. Participants who met 1/more TF criteria or with missing data considered non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	154	160	159
Number [percentage of participants]	42.2 17.2%	59.4 24%	63.5 25.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q8w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.030
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in response rates
	Estimated Value	18.0
	Confidence Interval	(2-Sided) 95%; 7.4 to 28.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q4w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.011
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in response rates
	Estimated Value	21.3
	Confidence Interval	(2-Sided) 95%; 10.5 to 32.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline
Description	Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1 among participants with enthesitis at baseline pooled from both CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random and imputed using multiple imputation.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	255	230	243
Least Squares Mean (95% Confidence Interval) [units on a scale]	-1.02	-1.52	-1.59

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q8w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Nominal
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.50
	Confidence Interval	(2-Sided) 95%; -0.77 to -0.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q4w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Nominal
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.57
	Confidence Interval	(2-Sided) 95%; -0.83 to -0.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline
Description	The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement of dactylitis. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1 among participants with dactylitis at baseline pooled from both from CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random and imputed using multiple imputation.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	154	160	159
Least Squares Mean (95% Confidence Interval) [units on a scale]	-4.21	-6.10	-5.97

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q8w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Nominal
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.89
	Confidence Interval	(2-Sided) 95%; -2.99 to -0.79
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q4w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	Nominal
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.77
	Confidence Interval	(2-Sided) 95%; -2.87 to -0.66
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
Description	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Least Squares Mean (95% Confidence Interval) [units on a scale]	3.42	7.39	7.04

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q8w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.011
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean difference
	Estimated Value	3.97
	Confidence Interval	(2-Sided) 95%; 2.75 to 5.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q4w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.011
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean difference
	Estimated Value	3.62
	Confidence Interval	(2-Sided) 95%; 2.39 to 4.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24
Description	The Disease Activity Index Score (DAS28) based on C-Reactive Protein (CRP) is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Least Squares Mean (95% Confidence Interval) [units on a scale]	-0.97	-1.59	-1.62

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q8w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Nominal
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean difference
	Estimated Value	-0.61
	Confidence Interval	(2-Sided) 95%; -0.80 to -0.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q4w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Nominal
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean difference
	Estimated Value	-0.65
	Confidence Interval	(2-Sided) 95%; -0.83 to -0.47
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Week 24
Description	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Least Squares Mean (95% Confidence Interval) [units on a scale]	2.14	4.17	4.22

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q8w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.072
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean difference
	Estimated Value	2.02
	Confidence Interval	(2-Sided) 95%; 0.56 to 3.49
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q4w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.072
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean difference
	Estimated Value	2.07
	Confidence Interval	(2-Sided) 95%; 0.60 to 3.54
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16
Description	ACR 50 response was defined as >= 50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Participants who achieved ACR 50 response at Week 16 and did not meet any TF criteria before Week 16 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Number [percentage of participants]	9.3 3.8%	28.6 11.5%	20.8 8.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q8w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Nominal
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	19.3
	Confidence Interval	(2-Sided) 95%; 12.6 to 25.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q4w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Nominal
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	11.5
	Confidence Interval	(2-Sided) 95%; 5.2 to 17.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 24
Description	ACR 70 response was defined as >= 70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Participants who achieved ACR 70 response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Number [percentage of participants]	4.1 1.7%	18.5 7.5%	13.1 5.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q8w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Nominal
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	14.5
	Confidence Interval	(2-Sided) 95%; 9.1 to 19.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo to Guselkumab 100 mg q4w, Guselkumab 100 mg q4w
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	Nominal
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	9.0
	Confidence Interval	(2-Sided) 95%; 4.1 to 13.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR 20 Response Through Week 24
Description	ACR 20 response was defined as >= 20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time Frame	Weeks 2, 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Participants who achieved ACR 20 response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 2	8.1 3.3%	10.1 4.1%	10.6 4.3%
Week 4	11.8 4.8%	19.8 8%	21.6 8.8%
Week 8	17.5 7.1%	39.1 15.8%	40.0 16.3%
Week 12	26.4 10.7%	49.6 20%	51.0 20.8%
Week 16	33.7 13.7%	55.2 22.3%	55.9 22.8%
Week 20	29.7 12.1%	62.9 25.4%	58.8 24%
Week 24	32.9 13.4%	64.1 25.8%	63.7 26%

17. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR 50 Response Through Week 24
Description	ACR 50 response was defined as >= 50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time Frame	Weeks 2, 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Participants who achieved ACR 50 response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 2	0.4 0.2%	1.6 0.6%	0.4 0.2%
Week 4	1.2 0.5%	4.0 1.6%	3.3 1.3%
Week 8	4.1 1.7%	10.1 4.1%	11.0 4.5%
Week 12	6.1 2.5%	19.0 7.7%	16.7 6.8%
Week 16	9.3 3.8%	28.6 11.5%	20.8 8.5%
Week 20	16.3 6.6%	31.5 12.7%	29.8 12.2%
Week 24	14.2 5.8%	31.5 12.7%	33.1 13.5%

18. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR 70 Response Through Week 24
Description	ACR 70 response was defined as >= 70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time Frame	Weeks 2, 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Participants who achieved ACR 70 response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 2	0 0%	0 0%	0 0%
Week 4	0.8 0.3%	0.4 0.2%	0.8 0.3%
Week 8	0.8 0.3%	3.6 1.5%	2.0 0.8%
Week 12	0.4 0.2%	8.1 3.3%	4.9 2%
Week 16	0.8 0.3%	13.7 5.5%	8.2 3.3%
Week 20	3.3 1.3%	15.3 6.2%	13.9 5.7%
Week 24	4.1 1.7%	18.5 7.5%	13.1 5.3%

19. Secondary Outcome

Title	Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24
Description	ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment (PtGA) of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment (PGA) of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (milligram/deciliter [mg/dL]).
Time Frame	Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Here 'n' (number analyzed) signifies number of participants with observed data regardless meeting TF criteria at specified categories.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 2: Swollen Joint Count	-18.9 (32.16)	-18.8 (39.68)	-18.5 (38.38)
Week 4: Swollen Joint Count	-27.1 (37.29)	-30.5 (36.92)	-33.6 (37.57)
Week 8: Swollen Joint Count	-37.4 (39.03)	-46.8 (40.68)	-46.7 (37.69)
Week 12: Swollen Joint Count	-46.1 (41.20)	-57.6 (39.22)	-58.3 (35.42)
Week 16: Swollen Joint Count	-48.6 (43.01)	-64.1 (35.46)	-63.7 (34.42)
Week 20: Swollen Joint Count	-54.2 (41.70)	-69.3 (33.63)	-71.4 (30.42)
Week 24: Swollen Joint Count	-53.9 (45.54)	-71.3 (34.06)	-73.1 (30.67)
Week 2: Tender Joint Count	-9.4 (25.99)	-10.4 (40.31)	-14.8 (28.31)
Week 4: Tender Joint Count	-14.1 (36.04)	-15.0 (41.57)	-22.6 (32.91)
Week 8: Tender Joint Count	-21.9 (37.83)	-31.0 (42.36)	-33.8 (37.58)
Week 12: Tender Joint Count	-30.4 (37.57)	-40.9 (42.73)	-43.0 (35.90)
Week 16: Tender Joint Count	-30.6 (41.87)	-47.0 (40.96)	-48.1 (37.01)
Week 20: Tender Joint Count	-33.9 (44.22)	-53.9 (37.83)	-54.2 (35.43)
Week 24: Tender Joint Count	-33.3 (44.87)	-54.2 (37.15)	-57.3 (34.98)
Week 2: Patient's Assessment of Pain	0.05 (35.794)	-8.92 (32.374)	-4.66 (32.229)
Week 4: Patient's Assessment of Pain	-0.64 (35.849)	-12.58 (33.065)	-7.96 (37.958)
Week 8: Patient's Assessment of Pain	-6.76 (34.213)	-21.61 (36.705)	-17.05 (44.783)
Week 12: Patient's Assessment of Pain	-9.01 (36.061)	-26.26 (40.223)	-25.91 (37.862)
Week 16: Patient's Assessment of Pain(0-10cm)	-9.70 (41.673)	-31.94 (42.882)	-27.85 (38.913)
Week 20: Patient's Assessment of Pain	-10.85 (46.497)	-35.16 (39.471)	-35.35 (39.016)
Week 24: Patient's Assessment of Pain	-11.84 (48.324)	-38.06 (40.565)	-36.52 (38.423)
Week 2: PtGA of Disease Activity	-1.12 (35.882)	-10.15 (31.060)	-5.25 (32.658)
Week 4: PtGA of Disease Activity	-2.27 (34.291)	-12.71 (34.440)	-11.02 (33.605)
Week 8: PtGA of Disease Activity	-6.51 (35.908)	-21.58 (33.697)	-19.13 (40.545)
Week 12: PtGA of Disease Activity	-9.30 (37.185)	-27.86 (38.900)	-28.33 (34.058)
Week 16: PtGA of Disease Activity	-12.34 (39.207)	-32.25 (40.056)	-28.60 (39.759)
Week 20: PtGA of Disease Activity	-12.52 (42.498)	-35.31 (36.205)	-35.11 (37.791)
Week 24: PtGA of Disease Activity	-13.87 (45.650)	-37.05 (38.372)	-34.13 (51.445)
Week 2: PGA of Disease Activity	-9.79 (25.687)	-15.06 (27.150)	-13.85 (23.307)
Week 4: PGA of Disease Activity	-16.63 (27.573)	-23.72 (27.658)	-22.32 (28.183)
Week 8: PGA of Disease Activity	-23.29 (28.416)	-36.54 (31.224)	-37.99 (29.970)
Week 12: PGA of Disease Activity	-27.63 (32.379)	-46.54 (30.489)	-42.84 (31.305)
Week 16: PGA of Disease Activity	-31.11 (32.023)	-52.02 (31.915)	-49.18 (31.383)
Week 20: PGA of Disease Activity	-34.13 (36.576)	-54.32 (30.941)	-54.59 (29.336)
Week 24: PGA of Disease Activity	-36.59 (33.740)	-57.22 (32.480)	-58.70 (28.255)
Week 2: HAQ-DI Score	-0.3191 (36.62364)	-6.3577 (50.81980)	-0.2385 (57.44896)
Week 4: HAQ-DI Score	-2.8744 (46.90795)	-9.1272 (53.41051)	-5.1209 (85.16625)
Week 8: HAQ-DI Score	-5.0965 (39.89566)	-12.7684 (67.23239)	-9.8081 (86.78973)
Week 12: HAQ-DI Score	-8.0811 (46.90093)	-18.0336 (66.96524)	-17.7758 (67.44643)
Week 16: HAQ-DI Score	-7.1776 (48.33253)	-19.3627 (70.83578)	-26.6732 (53.14973)
Week 20: HAQ-DI Score	-10.4296 (50.87958)	-24.9496 (64.86820)	-28.9317 (60.67279)
Week 24: HAQ-DI Score	-6.7995 (54.78602)	-25.2578 (63.15450)	-33.8837 (51.59441)
Week 2: CRP	86.677 (645.0281)	0.935 (91.3783)	10.664 (132.5947)
Week 4: CRP	28.042 (208.6385)	-16.885 (79.3501)	1.128 (168.9301)
Week 8: CRP	45.451 (322.4433)	-11.214 (150.1689)	-17.474 (112.3803)
Week 12: CRP	47.034 (313.9875)	-25.620 (97.1384)	-22.277 (122.3489)
Week 16: CRP	28.595 (237.6660)	-19.874 (134.5210)	-26.592 (86.8465)
Week 20: CRP	42.282 (284.1330)	-13.551 (193.3814)	-28.701 (83.0912)
Week 24: CRP	19.263 (149.5120)	-27.470 (109.5239)	-28.125 (87.7229)

20. Secondary Outcome

Title	Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24
Description	HAQ-DI score assess functional status of participant. It is a 20 question instrument that assess the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative changes from baseline indicate improvement of physical function.
Time Frame	Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 2	-0.0594	-0.1423	-0.0795
Week 4	-0.0722	-0.1472	-0.1605
Week 8	-0.0942	-0.2294	-0.2336
Week 12	-0.1332	-0.2870	-0.3010
Week 16	-0.1167	-0.3177	-0.3442
Week 20	-0.1565	-0.3536	-0.4019
Week 24	-0.1300	-0.3672	-0.4004

21. Secondary Outcome

Title	Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline
Description	HAQ-DI score assess functional status of participant. It is a 20 question instrument that assess the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.
Time Frame	Weeks 2, 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

FAS1 among participants with HAQ-DI >=0.35 at baseline. Participants with HAQ-DI >=0.35 improvement from baseline at specific timepoint and did not meet any TF criteria before, were considered responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	236	228	228
Week 2	19.9 8.1%	30.7 12.4%	23.2 9.5%
Week 4	23.7 9.6%	32.0 12.9%	35.1 14.3%
Week 8	28.0 11.4%	43.4 17.5%	42.5 17.3%
Week 12	31.8 12.9%	47.4 19.1%	46.9 19.1%
Week 16	30.9 12.6%	50.0 20.2%	51.8 21.1%
Week 20	38.6 15.7%	48.7 19.6%	53.1 21.7%
Week 24	31.4 12.8%	50.0 20.2%	56.1 22.9%

22. Secondary Outcome

Title	Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24
Description	DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS 28 (CRP) response criteria was defined as follows: Good response: <=3.2 at visit and >1.2 improvement; Moderate response: >3.2 at visit and >1.2 improvement or <=5.1 at visit and >0.6-1.2 improvement; No response: <=0.6 improvement, or >5.1 at visit and <=1.2 improvement. The values are 0=best to 10=worst. A DAS28 (CRP) responder is defined as achieving a good or moderate DAS28 response at a specific visit.
Time Frame	Weeks 2, 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Participants who achieved a DAS28 (CRP) response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 2	21.5 8.7%	23.8 9.6%	24.5 10%
Week 4	32.9 13.4%	38.7 15.6%	40.8 16.7%
Week 8	38.6 15.7%	56.9 22.9%	54.7 22.3%
Week 12	51.2 20.8%	67.3 27.1%	65.7 26.8%
Week 16	51.2 20.8%	69.8 28.1%	72.7 29.7%
Week 20	50.4 20.5%	75.0 30.2%	76.3 31.1%
Week 24	52.4 21.3%	75.4 30.4%	80.0 32.7%

23. Secondary Outcome

Title	Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24
Description	DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS 28 (CRP) remission was defined as DAS 28 (CRP) value <2.6 at the analysis visit.
Time Frame	Weeks 2, 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Participants who achieved a DAS28 (CRP) remission at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 2	0.8 0.3%	2.4 1%	2.4 1%
Week 4	2.0 0.8%	5.2 2.1%	4.9 2%
Week 8	0.8 0.3%	10.5 4.2%	9.0 3.7%
Week 12	6.1 2.5%	14.1 5.7%	11.8 4.8%
Week 16	6.5 2.6%	18.5 7.5%	16.3 6.7%
Week 20	9.8 4%	23.0 9.3%	21.2 8.7%
Week 24	8.5 3.5%	24.6 9.9%	23.3 9.5%

24. Secondary Outcome

Title	Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24
Description	DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis.
Time Frame	Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 2	-0.29	-0.42	-0.43
Week 4	-0.44	-0.62	-0.65
Week 8	-0.59	-0.99	-0.98
Week 12	-0.85	-1.27	-1.22
Week 16	-0.88	-1.39	-1.37
Week 20	-1.00	-1.52	-1.56
Week 24	-0.97	-1.59	-1.62

25. Secondary Outcome

Title	Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24
Description	The modified PsARC response was defined as improvement in at least 2 of the four criteria: >=30% decrease in swollen joint count, >=30% decrease in tender joint count, >=20% improvement in patient's Global Assessment of Disease Activity (arthritis) on a VAS (0-100 mm, 0=excellent and 100= poor), >=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.
Time Frame	Weeks 2, 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Participants who achieved a modified PsARC response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 2	13.0 5.3%	22.2 9%	18.0 7.3%
Week 4	27.2 11.1%	32.7 13.2%	29.8 12.2%
Week 8	35.8 14.6%	48.8 19.7%	50.2 20.5%
Week 12	40.7 16.5%	60.9 24.6%	60.8 24.8%
Week 16	44.7 18.2%	66.5 26.8%	66.5 27.1%
Week 20	46.7 19%	72.2 29.1%	69.0 28.2%
Week 24	44.7 18.2%	72.6 29.3%	68.6 28%

26. Secondary Outcome

Title	Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline
Description	Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI>0.
Time Frame	Weeks 2, 4, 8, 16 and 24

Outcome Measure Data

Analysis Population Description

FAS1 among participants with enthesitis at baseline. Participants with enthesitis resolution at specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	178	158	170
Week 2	16.3 6.6%	17.7 7.1%	17.1 7%
Week 4	18.0 7.3%	21.5 8.7%	25.3 10.3%
Week 8	24.7 10%	31.0 12.5%	27.6 11.3%
Week 16	30.9 12.6%	47.5 19.2%	40.6 16.6%
Week 24	30.3 12.3%	53.8 21.7%	43.5 17.8%

27. Secondary Outcome

Title	Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline
Description	The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score >0.
Time Frame	Weeks 2, 4, 8, 16 and 24

Outcome Measure Data

Analysis Population Description

FAS1 among participants with dactylitis at baseline. Participants who achieved dactylitis resolution at specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	99	111	121
Week 2	12.1 4.9%	13.5 5.4%	13.2 5.4%
Week 4	18.2 7.4%	19.8 8%	20.7 8.4%
Week 8	29.3 11.9%	30.6 12.3%	31.4 12.8%
Week 16	36.4 14.8%	45.0 18.1%	52.1 21.3%
Week 24	38.4 15.6%	56.8 22.9%	63.6 26%

28. Secondary Outcome

Title	Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline
Description	Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis.
Time Frame	Baseline, Weeks 2, 4, 8, 16 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1 among participants with enthesitis at baseline. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random and imputed using multiple imputation.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	178	158	170
Week 2	-0.33	-0.37	-0.49
Week 4	-0.46	-0.56	-0.69
Week 8	-0.67	-0.92	-0.88
Week 16	-0.94	-1.37	-1.42
Week 24	-1.03	-1.60	-1.52

29. Secondary Outcome

Title	Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline
Description	The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement of dactylitis.
Time Frame	Baseline, Weeks 2, 4, 8, 16 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1 among participants with dactylitis at baseline. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random and imputed using multiple imputation.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	99	111	121
Week 2	-0.21	-1.11	-0.78
Week 4	-1.10	-2.11	-1.56
Week 8	-2.17	-3.17	-3.11
Week 16	-3.40	-4.88	-4.80
Week 24	-4.03	-5.95	-5.88

30. Secondary Outcome

Title	Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24
Description	PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS [0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS [0-100 mm, 0=no arthritis activity and 100=extremely active arthritis]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 [where 0= no tenderness and 3= extreme tenderness] and recoding to 0-1, where any score > 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity.
Time Frame	Baseline, Weeks 8, 16 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on Mixed-effect repeated measures (MMRM) model that included data from all visits for all participants included in the model.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 8	-0.863	-1.452	-1.413
Week 16	-1.158	-2.110	-1.994
Week 24	-1.336	-2.403	-2.399

31. Secondary Outcome

Title	Change From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24
Description	GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), patient's global assessment of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), patient's global assessment of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + [2.367*HAQ-DI]-[0.234*SF-PCS]-[0.244*SF-MCS]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score ranges from 0-100, higher scores= better quality of life) and SF-MCS (score ranges from 0-100, higher scores= better quality of life). Total score is from 0-10, lower score=better response. Higher score indicates more active disease activity. Negative change from baseline indicates improvement of PsA disease activity.
Time Frame	Baseline, Weeks 16 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 16	-1.029	-2.326	-2.214
Week 24	-1.198	-2.593	-2.589

32. Secondary Outcome

Title	Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24
Description	Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time Frame	Baseline, Weeks 16 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Data after meeting 1/more TF criteria imputed as no change from baseline. Missing data assumed MAR. LS mean is based on MMRM model that included data from all visits for all participants included in model. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	155	145	145
Week 16	-4.553	-3.451	-4.717
Week 24	-3.491	-3.103	-3.827

33. Secondary Outcome

Title	Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24
Description	Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time Frame	Baseline, Weeks 16 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Data after meeting 1/more TF criteria imputed as no change from baseline. Missing data assumed MAR. LS mean is based on MMRM model that included data from all visits for all participants included in model. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	131	129	133
Week 16	-10.281	-16.054	-15.083
Week 24	-10.157	-19.366	-19.492

34. Secondary Outcome

Title	Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24
Description	Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAi-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time Frame	Baseline, Weeks 16 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Data after meeting 1/more TF criteria imputed as no change from baseline. Missing data assumed MAR. LS mean is based on MMRM model that included data from all visits for all participants included in model. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	131	129	133
Week 16	-11.232	-15.926	-15.808
Week 24	-10.869	-19.711	-20.023

35. Secondary Outcome

Title	Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24
Description	Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time Frame	Baseline, Weeks 16 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Data after meeting 1/more TF criteria imputed as no change from baseline. Missing data assumed MAR. LS mean is based on MMRM model that included data from all visits for all participants included in model. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	244	247	245
Week 16	-10.569	-17.107	-17.029
Week 24	-10.320	-21.467	-20.480

36. Secondary Outcome

Title	Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24
Description	The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity.
Time Frame	Baseline, Weeks 16 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 16	-1.18	-2.39	-2.57
Week 24	-1.30	-2.94	-3.09

37. Secondary Outcome

Title	Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24
Description	DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL, value <lower limit of quantification [LLOQ] is considered equal to half of the value of LLOQ for numerical calculations), patient assessment of pain (0-10cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.
Time Frame	Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 2	-4.6447	-6.7838	-6.3783
Week 4	-7.6695	-9.9687	-10.2484
Week 8	-10.4480	-15.3303	-15.8657
Week 12	-14.2915	-18.9772	-19.9687
Week 16	-14.8556	-21.6939	-21.4722
Week 20	-16.1375	-23.3163	-24.6844
Week 24	-15.8489	-24.0359	-25.1583

38. Secondary Outcome

Title	Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24
Description	MDA is a measure that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved the PsA MDA at a visit if the participant has fulfilled at least 5 of the following 7 criteria at that visit: Tender joint count (68 joints)<=1, Swollen joint count (66 joints) <=1, Psoriasis activity and severity index <=1, Patient's Assessment of Pain <=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) <=20 on a 100-unit VAS, HAQ-DI score <=0.5, and Tender entheseal points <= 1 (LEI index score <= 1).
Time Frame	Weeks 16 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Participants who achieved MDA at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 16	3.3 1.3%	16.9 6.8%	13.1 5.3%
Week 24	6.1 2.5%	25.0 10.1%	18.8 7.7%

39. Secondary Outcome

Title	Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline
Description	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.
Time Frame	Weeks 8, 16 and 24

Outcome Measure Data

Analysis Population Description

FAS1 with spondylitis and peripheral arthritis and BASDAI score >0 at baseline. Participants with the specified improvement in BASDAI at specific time point and did not meet TF criteria before, considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point considered non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	92	67	83
Week 8: Participants with >=20% Improvement	38.0 15.4%	46.3 18.7%	53.0 21.6%
Week 16: Participants with >=20% Improvement	39.1 15.9%	58.2 23.5%	69.9 28.5%
Week 24: Participants with >=20% Improvement	42.4 17.2%	59.7 24.1%	68.7 28%
Week 8: Participants with >=50% Improvement	6.5 2.6%	17.9 7.2%	18.1 7.4%
Week 16: Participants with >=50% Improvement	17.4 7.1%	37.3 15%	26.5 10.8%
Week 24: Participants with >=50% Improvement	21.7 8.8%	38.8 15.6%	37.3 15.2%
Week 8: Participants with >=70% Improvement	3.3 1.3%	11.9 4.8%	4.8 2%
Week 16: Participants with >=70% Improvement	5.4 2.2%	23.9 9.6%	9.6 3.9%
Week 24: Participants with >=70% Improvement	8.7 3.5%	20.9 8.4%	15.7 6.4%
Week 8: Participants with >=90% Improvement	0 0%	1.5 0.6%	0 0%
Week 16: Participants with >=90% Improvement	1.1 0.4%	0 0%	2.4 1%
Week 24: Participants with >=90% Improvement	2.2 0.9%	1.5 0.6%	3.6 1.5%

40. Secondary Outcome

Title	Percentage of Participants Who Achieved PASI 75 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 75 response: >=75% improvement in PASI score from baseline.
Time Frame	Weeks 16 and 24

Outcome Measure Data

Analysis Population Description

FAS1 among participants with >=3% BSA of psoriasis and IGA score >=2 at baseline. Participants with PASI 75 response at specific time point and did not meet any TF criteria before, were considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point were considered non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	183	176	184
Week 16	18.6 7.6%	73.3 29.6%	73.9 30.2%
Week 24	23.0 9.3%	79.0 31.9%	78.3 32%

41. Secondary Outcome

Title	Percentage of Participants Who Achieved PASI 90 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 90 response: >=90% improvement in PASI score from baseline.
Time Frame	Weeks 16 and 24

Outcome Measure Data

Analysis Population Description

FAS1 among participants with >=3% BSA of psoriasis and IGA score >=2 at baseline. Participants with PASI 90 response at specific time point and did not meet any TF criteria before, were considered responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	183	176	184
Week 16	8.2 3.3%	55.1 22.2%	53.8 22%
Week 24	9.8 4%	68.8 27.7%	60.9 24.9%

42. Secondary Outcome

Title	Percentage of Participants Who Achieved PASI 100 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
Description	PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 100 response: 100% improvement in PASI score from baseline.
Time Frame	Weeks 16 and 24

Outcome Measure Data

Analysis Population Description

FAS1 among participants with >=3% BSA of psoriasis and IGA score >=2 at baseline. Participants with PASI 100 response at specific time point and did not meet any TF criteria before, were considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point were considered non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	183	176	184
Week 16	3.8 1.5%	27.3 11%	33.2 13.6%
Week 24	2.7 1.1%	45.5 18.3%	44.6 18.2%

43. Secondary Outcome

Title	Percentage of Participants With an IGA Score of 0 (Cleared) Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >=2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame	Weeks 16 and 24

Outcome Measure Data

Analysis Population Description

FAS1 among participants with >=3% BSA of psoriasis and IGA score >=2 at baseline. Participants with IGA score of 0(cleared) at specific time point and did not meet TF criteria before, were considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point were considered non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	183	176	184
Week 16	6.0 2.4%	38.6 15.6%	40.8 16.7%
Week 24	7.7 3.1%	50.0 20.2%	51.5 21%

44. Secondary Outcome

Title	Change From Baseline in PASI Score at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative change from baseline indicates improvement of psoriasis.
Time Frame	Baseline, Weeks 16 and 24

Outcome Measure Data

Analysis Population Description

FAS1 among participants who had >=3% BSA of psoriatic involvement and IGA score >=2 (mild) at baseline. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be MAR. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	183	176	184
Week 16	-3.482	-11.151	-11.278
Week 24	-3.904	-11.407	-11.471

45. Secondary Outcome

Title	Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Through Week 24 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. A DLQI score of 0 or 1 indicates psoriasis had no effect at all on patient's life.
Time Frame	Weeks 8, 16, 24

Outcome Measure Data

Analysis Population Description

FAS1 among participants with DLQI >1, >=3% BSA of psoriasis and IGA score >=2 (mild) at baseline. Participants with DLQI score of 0/1 at specific time point and did not meet TF criteria before, considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point considered non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	170	158	173
Week 8	7.6 3.1%	33.5 13.5%	26.6 10.9%
Week 16	10.0 4.1%	51.3 20.7%	45.1 18.4%
Week 24	11.8 4.8%	63.9 25.8%	59.0 24.1%

46. Secondary Outcome

Title	Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score Through Week 24 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. An improvement of 5 points was considered clinically meaningful.
Time Frame	Weeks 8, 16, 24

Outcome Measure Data

Analysis Population Description

FAS1 with DLQI>=5, >=3% BSA of psoriasis and IGA score >=2 (mild) at baseline. Participants with >=5-point improvement from baseline in DLQI score at specific time point and did not meet TF criteria before, considered responders at that time point. Participants who met 1/more TF criteria before or with missing data considered non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	143	132	152
Week 8	30.1 12.2%	71.2 28.7%	69.7 28.4%
Week 16	36.4 14.8%	79.5 32.1%	79.6 32.5%
Week 24	37.8 15.4%	83.3 33.6%	86.8 35.4%

47. Secondary Outcome

Title	Change From Baseline in DLQI Score at Weeks 8, 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. Negative changes from baseline indicate improvement of life quality impacted by psoriasis.
Time Frame	Baseline, Weeks 8, 16 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1 among participants with >=3% BSA of psoriasis and an IGA score >=2 (mild) at baseline. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. LS mean is based on MMRM model that included data from all visits for all participants included in model.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	183	176	184
Week 8	-1.653	-6.818	-6.396
Week 16	-2.410	-8.545	-8.147
Week 24	-2.129	-8.954	-8.853

48. Secondary Outcome

Title	Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	In PASI, each area (head, trunk, upper and lower extremities) was assessed for % of area involved and translated to numeric score from 0 (no involvement) to 6 (90-100% involvement) and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score from 0 to 72. Higher scores=more severe disease. PASI 75: >=75% improvement in PASI score from baseline. ACR 20: >=20% improvement in swollen joint count (SJC) (66 joints) + tender joint count (TJC) (68 joints) and >=20% improvement in 3 of 5: patient's assessment of pain (VAS; 0-100 mm, 0=no pain to 100=worst possible pain), PtGA of disease activity (VAS; 0-100 mm, 0=excellent to 100=poor), PGA of disease activity (VAS; 0-100 mm, 0=no arthritis to 100=extremely active arthritis), patient's assessment of physical function (HAQ-DI -20-question instrument; range- 0=no difficulty to 3=inability to perform task) and CRP.
Time Frame	Weeks 16 and 24

Outcome Measure Data

Analysis Population Description

FAS1 participants with >=3% BSA psoriatic involvement and IGA score >=2 at baseline. Participants with both PASI75 and ACR20 responses at specific timepoint and did not meet TF criteria before, considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point considered non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	183	176	184
Week 16	10.4 4.2%	48.9 19.7%	48.4 19.8%
Week 24	11.5 4.7%	56.8 22.9%	57.1 23.3%

49. Secondary Outcome

Title	Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	In PASI, each area (head, trunk, upper and lower extremities) was assessed separately for % of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score range from 0 to 72. Higher scores=more severe disease. PASI 75 response: >=75% improvement in PASI score from baseline. Modified PsARC response: improvement in at least 2 of 4 criteria: >=30% decrease in SJC and TJC, >=20% improvement in PtGA of Disease Activity (arthritis) on VAS (0-100 mm, 0=excellent and 100=poor), >=20% improvement in PGA of Disease Activity on VAS (VAS: 0-100 mm, 0=no arthritis and 100=extremely active arthritis), and at least 1 of 2 joint criteria with no deterioration in other criteria.
Time Frame	Weeks 16 and 24

Outcome Measure Data

Analysis Population Description

FAS1 with >=3% BSA psoriatic involvement and IGA score >=2 at baseline. Participants with both PASI 75 and modified PsARC responses at specific timepoint and did not meet TF criteria before, considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point considered non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	183	176	184
Week 16	13.1 5.3%	56.8 22.9%	54.3 22.2%
Week 24	15.3 6.2%	65.3 26.3%	60.9 24.9%

50. Secondary Outcome

Title	Change From Baseline in Modified vdH-S Erosion Score at Week 24
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Least Squares Mean (95% Confidence Interval) [units on a scale]	0.58	0.36	0.13

51. Secondary Outcome

Title	Change From Baseline in Modified vdH-S Joint Space Narrowing (JSN) Score at Week 24
Description	The modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). The JSN score is the total JSN score in 40 joints of the two hands and 12 joints of the 2 feet. Each joint is scored from 0 to 4 with 0 indicating no JSN, and 4 indicating a complete loss of joint space, bony ankylosis, or complete luxation, for a maximum JSN score of 208. Higher score indicates more severe joint space narrowing. A positive change from baseline in the modified vdH-S JSN score indicates progression of joint space narrowing.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Least Squares Mean (95% Confidence Interval) [units on a scale]	0.37	0.16	0.16

52. Secondary Outcome

Title	Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand (Hand erosion score) scored according to 0 (no erosion) to 5 (complete collapse of bone) for a maximum hand erosion score of 200, and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum foot erosion score of 120. Higher scores indicate more joint damage. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum Hand JSN score of 160 and maximum Foot JSN score of 48. Higher scores indicate more joint damage. Hand Score (sum of Hand Erosion Score and Hand JSN Score) scored as 0-360 and Foot score (sum of foot erosion score and foot JSN score) scored as 0-168. Higher scores indicate more joint damage.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1-SD. Observed data were summarized regardless if 1 or more TF criteria were met. Here, 'n' (number analyzed) signifies the number of participants analyzed for a specified score.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Hand Erosion Score	0.40 (1.555)	0.18 (1.280)	-0.03 (1.514)
Hand JSN Score	0.26 (1.106)	0.10 (0.637)	0.08 (0.607)
Hand Score	0.66 (2.441)	0.28 (1.649)	0.05 (1.881)
Foot Erosion Score	0.14 (0.801)	0.15 (0.982)	0.14 (0.894)
Foot JSN Score	0.10 (0.516)	0.02 (0.516)	0.07 (0.632)
Foot Score	0.24 (1.116)	0.17 (1.180)	0.21 (1.210)

53. Secondary Outcome

Title	Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Change of <=0 from Baseline	64.7 26.3%	63.5 25.6%	67.3 27.5%
Change of <=0.5 from Baseline	72.1 29.3%	74.4 30%	78.0 31.8%

54. Secondary Outcome

Title	Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Change of <=0 from Baseline	66.8 27.2%	66.3 26.7%	71.4 29.1%
Change of <=0.5 from Baseline	72.9 29.6%	76.8 31%	80.2 32.7%

55. Secondary Outcome

Title	Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24
Description	The modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). The JSN score is the sum of JSN score in 40 joints of the two hands and 12 joints of the 2 feet. Each joint is scored from 0 - 4 with 0 indicating no JSN, and 4 indicating a complete loss of joint space, bony ankylosis, or complete luxation, for a maximum JSN score of 208. Higher score indicates more severe joint space narrowing. Change from baseline in the modified vdH-S JSN score <=0 (assessed by both readers) or <=0.5 (assessed by at least one reader) was considered as no progression of JSN.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Change of <=0 from Baseline	78.6 32%	78.8 31.8%	80.1 32.7%
Change of <=0.5 from Baseline	85.5 34.8%	88.1 35.5%	88.3 36%

56. Secondary Outcome

Title	Percentage of Participants Without Radiographic Progression (Based on the Smallest Detectable Change [SDC]) From Baseline at Week 24
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic progression was defined as change from baseline in the modified vdH-S score <=SDC of 2.18.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Number [percentage of participants]	86.4 35.1%	87.8 35.4%	89.3 36.4%

57. Secondary Outcome

Title	Percentage of Participants Without Radiographic Joint Erosion Progression (Based on SDC) From Baseline at Week 24
Description	Modified vdH-S score is sum of erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC defined as the cut-off above which changes can be detected beyond measurement error. Without radiographic joint erosion progression was defined as change from baseline in modified vdH-S erosion score <=SDC of 1.83.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Number [percentage of participants]	84.0 34.1%	89.0 35.9%	89.9 36.7%

58. Secondary Outcome

Title	Percentage of Participants Without Radiographic JSN Progression (Based on the SDC) From Baseline at Week 24
Description	The modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). The JSN score is the sum of JSN score in 40 joints of the two hands and 12 joints of the 2 feet. Each joint is scored from 0 - 4 with 0 indicating no JSN, and 4 indicating a complete loss of joint space, bony ankylosis, or complete luxation, for a maximum JSN score of 208. Higher score indicates more severe joint space narrowing. The smallest detectable change (SDC) was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic JSN progression was defined as change from baseline in the modified vdH-S JSN score <=SDC of 1.11.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Number [percentage of participants]	91.3 37.1%	93.5 37.7%	91.7 37.4%

59. Secondary Outcome

Title	Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24
Description	Pencil in Cup or Gross Osteolytis Deformities are radiographic features specific for psoriatic arthritis.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1-SD. Observed data were summarized regardless if 1 or more TF criteria were met.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Baseline	4.5 1.8%	3.6 1.5%	3.7 1.5%
Week 24	4.9 2%	3.6 1.5%	3.8 1.6%

60. Secondary Outcome

Title	Change From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24
Description	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time Frame	Baseline, Weeks 8, 16 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 8	2.75	4.83	4.34
Week 16	3.03	6.65	5.93
Week 24	3.42	7.39	7.04

61. Secondary Outcome

Title	Change From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24
Description	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time Frame	Baseline, Weeks 8, 16 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 8	1.11	2.28	2.87
Week 16	1.96	4.28	3.41
Week 24	2.14	4.17	4.22

62. Secondary Outcome

Title	Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24
Description	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales: physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health. The scores 0-100 (where higher scores indicated a better quality of life) from each subscale of SF-36 were normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better health status. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time Frame	Baseline and Weeks 8, 16 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be MAR. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 8: Physical Function Score	2.095	3.879	3.936
Week 16: Physical Function Score	2.581	6.124	5.618
Week 24: Physical Function Score	3.254	6.703	6.624
Week 8: Role-physical Score	2.619	3.599	3.107
Week 16: Role-physical Score	2.965	5.616	4.942
Week 24: Role-physical Score	3.365	6.549	6.241
Week 8: Bodily Pain Score	2.760	5.456	4.901
Week 16: Bodily Pain Score	3.086	7.485	6.613
Week 24: Bodily Pain Score	3.482	7.811	7.739
Week 8: General Health Score	1.662	4.111	4.174
Week 16: General Health Score	2.520	5.719	4.808
Week 24: General Health Score	2.290	5.794	5.269
Week 8: Vitality Score	2.505	4.286	4.669
Week 16: Vitality Score	3.554	6.967	5.901
Week 24: Vitality Score	3.835	7.373	7.009
Week 8: Social Function Score	1.929	3.337	4.306
Week 16: Social Function Score	2.884	5.584	5.022
Week 24: Social Function Score	2.978	5.806	5.922
Week 8: Role-emotional Score	1.108	2.459	2.294
Week 16: Role-emotional Score	1.530	4.497	3.596
Week 24: Role-emotional Score	1.813	4.382	4.255
Week 8: Mental Health Score	1.081	2.380	3.048
Week 16: Mental Health Score	2.195	4.529	3.896
Week 24: Mental Health Score	2.335	4.490	4.767

63. Secondary Outcome

Title	Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24
Description	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.
Time Frame	Week 8, 16 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Participants who achieved >=5-point improvement from baseline in SF-36 MCS score at specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 8	26.4 10.7%	33.1 13.3%	27.3 11.1%
Week 16	31.7 12.9%	42.3 17.1%	31.8 13%
Week 24	30.9 12.6%	37.5 15.1%	34.3 14%

64. Secondary Outcome

Title	Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24
Description	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.
Time Frame	Week 8, 16 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Participants who achieved >=5-point improvement from baseline in SF-36 PCS score at specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 8	37.8 15.4%	45.2 18.2%	41.2 16.8%
Week 16	35.8 14.6%	59.3 23.9%	51.0 20.8%
Week 24	40.2 16.3%	60.1 24.2%	55.9 22.8%

65. Secondary Outcome

Title	Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24
Description	The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Time Frame	Baseline, Weeks 8, 16 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed MAR. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 8	2.451	5.031	4.850
Week 16	3.696	6.977	6.598
Week 24	3.559	7.550	7.111

66. Secondary Outcome

Title	Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24
Description	The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Time Frame	Weeks 8, 16 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Participants who achieved >=4-point improvement from baseline in FACIT-fatigue score at specific time point and did not meet any TF criteria before, were considered responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered non-responders.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 8	45.9 18.7%	56.0 22.6%	51.8 21.1%
Week 16	50.4 20.5%	60.9 24.6%	56.7 23.1%
Week 24	45.5 18.5%	60.5 24.4%	59.6 24.3%

67. Secondary Outcome

Title	Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VAS
Description	EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status
Time Frame	Baseline, Weeks 16 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 16	6.477	17.496	14.646
Week 24	6.796	18.371	18.089

68. Secondary Outcome

Title	Change From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D Index
Description	EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (full health). A higher score indicates better health and positive changes from baseline indicate improvement of health.
Time Frame	Baseline, Weeks 16 and 24

Outcome Measure Data

Analysis Population Description

Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	246	248	245
Week 16	0.058	0.112	0.101
Week 24	0.053	0.115	0.116

69. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52
Description	ACR 20 response was defined as >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time Frame	Weeks 24, 28, 36, 44 and 52

Outcome Measure Data

Analysis Population Description

Full analysis set 2 (FAS2) included all randomized participants who were still on study treatment at Week 24. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	34.0 13.8%	66.8 26.9%	66.2 27%
Week 28	48.3 19.6%	71.2 28.7%	72.0 29.4%
Week 36	68.8 28%	77.7 31.3%	78.7 32.1%
Week 44	69.7 28.3%	79.7 32.1%	76.7 31.3%
Week 52	68.7 27.9%	79.1 31.9%	75.9 31%

70. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52
Description	ACR 50 response was defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time Frame	Weeks 24, 28, 36, 44 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	15.2 6.2%	32.8 13.2%	34.3 14%
Week 28	22.7 9.2%	41.4 16.7%	40.5 16.5%
Week 36	39.3 16%	44.1 17.8%	45.7 18.7%
Week 44	43.8 17.8%	48.3 19.5%	48.7 19.9%
Week 52	43.7 17.8%	51.3 20.7%	49.1 20%

71. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52
Description	ACR 70 response was defined as >=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time Frame	Weeks 24, 28, 36, 44 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	4.6 1.9%	19.3 7.8%	13.7 5.6%
Week 28	7.6 3.1%	21.1 8.5%	21.1 8.6%
Week 36	15.4 6.3%	27.3 11%	24.7 10.1%
Week 44	20.9 8.5%	29.9 12.1%	24.4 10%
Week 52	19.2 7.8%	29.5 11.9%	28.1 11.5%

72. Secondary Outcome

Title	ACR Components at Weeks 24, 28, 36, 44 and 52
Description	ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).
Time Frame	Weeks 24, 28, 36, 44 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24: Swollen Joint Count	5.8 (6.99)	3.4 (5.19)	4.1 (5.77)
Week 28: Swollen Joint Count	4.1 (5.17)	2.9 (4.95)	3.2 (5.53)
Week 36: Swollen Joint Count	2.5 (3.77)	2.4 (4.58)	2.7 (4.67)
Week 44: Swollen Joint Count	2.1 (3.19)	2.3 (4.42)	2.8 (5.65)
Week 52: Swollen Joint Count	2.1 (3.59)	2.1 (4.16)	2.5 (4.83)
Week 24: Tender Joint Count	14.4 (13.16)	9.1 (9.94)	10.5 (11.82)
Week 28: Tender Joint Count	11.7 (11.87)	7.9 (9.02)	8.6 (10.03)
Week 36: Tender Joint Count	8.5 (10.00)	7.0 (8.72)	7.5 (9.25)
Week 44: Tender Joint Count	7.5 (9.42)	6.3 (8.45)	7.0 (9.42)
Week 52: Tender Joint Count	7.4 (10.24)	6.2 (8.18)	7.3 (9.46)
Week 24: Patient's Assessment of Pain	5.21 (2.368)	3.77 (2.457)	3.70 (2.193)
Week 28: Patient's Assessment of Pain	4.66 (2.341)	3.50 (2.311)	3.45 (2.259)
Week 36: Patient's Assessment of Pain	3.78 (2.297)	3.28 (2.336)	3.20 (2.242)
Week 44: Patient's Assessment of Pain	3.67 (2.312)	3.22 (2.370)	3.24 (2.277)
Week 52: Patient's Assessment of Pain	3.53 (2.253)	3.10 (2.333)	3.21 (2.371)
Week 24: PtGA of Disease Activity	5.29 (2.367)	4.01 (2.516)	3.93 (2.276)
Week 28: PtGA of Disease Activity	4.75 (2.338)	3.76 (2.348)	3.62 (2.275)
Week 36: PtGA of Disease Activity	3.84 (2.295)	3.52 (2.390)	3.30 (2.318)
Week 44: PtGA of Disease Activity	3.78 (2.378)	3.36 (2.447)	3.50 (2.323)
Week 52: PtGA of Disease Activity	3.68 (2.318)	3.23 (2.383)	3.28 (2.354)
Week 24: PGA of Disease Activity	4.22 (2.342)	2.74 (2.113)	2.66 (1.906)
Week 28: PGA of Disease Activity	3.27 (1.930)	2.44 (1.941)	2.33 (1.668)
Week 36: PGA of Disease Activity	2.28 (1.594)	2.10 (1.777)	2.06 (1.716)
Week 44: PGA of Disease Activity	2.06 (1.649)	1.97 (1.842)	1.93 (1.631)
Week 52: PGA of Disease Activity	1.90 (1.654)	1.77 (1.645)	1.77 (1.616)
Week 24: HAQ-DI score	1.1350 (0.61984)	0.8766 (0.59893)	0.8194 (0.57287)
Week 28: HAQ-DI score	1.0457 (0.59051)	0.8497 (0.61863)	0.7985 (0.56677)
Week 36: HAQ-DI score	0.9621 (0.60695)	0.8091 (0.61588)	0.7376 (0.56257)
Week 44: HAQ-DI score	0.9117 (0.63353)	0.7927 (0.59979)	0.7804 (0.57721)
Week 52: HAQ-DI score	0.9069 (0.63695)	0.7917 (0.59527)	0.7364 (0.58655)
Week 24: CRP	1.543 (2.1572)	0.961 (1.2868)	0.790 (0.8390)
Week 28: CRP	1.120 (1.5140)	0.956 (1.3749)	0.885 (1.0299)
Week 36: CRP	0.920 (1.4674)	0.892 (1.3109)	0.837 (1.0730)
Week 44: CRP	0.858 (1.0558)	0.812 (1.0139)	0.992 (1.9875)
Week 52: CRP	0.907 (1.5985)	0.937 (1.2422)	0.910 (1.2756)

73. Secondary Outcome

Title	Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52
Description	ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).
Time Frame	Baseline, Weeks 24, 28, 36, 44 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24: Swollen Joint Count	-6.4 (7.25)	-8.2 (6.09)	-8.8 (5.50)
Week 28: Swollen Joint Count	-8.1 (6.99)	-8.8 (5.98)	-9.6 (6.65)
Week 36: Swollen Joint Count	-9.9 (6.47)	-9.2 (5.81)	-10.2 (6.76)
Week 44: Swollen Joint Count	-10.1 (6.77)	-9.3 (6.24)	-10.2 (6.28)
Week 52: Swollen Joint Count	-10.2 (6.79)	-9.6 (6.28)	-10.4 (6.17)
Week 24: Tender Joint Count	-7.0 (10.91)	-10.4 (9.51)	-11.9 (9.98)
Week 28: Tender Joint Count	-9.7 (10.78)	-11.7 (9.24)	-13.7 (10.53)
Week 36: Tender Joint Count	-13.2 (10.78)	-12.5 (9.68)	-14.6 (10.31)
Week 44: Tender Joint Count	-14.0 (11.02)	-13.3 (9.56)	-15.2 (10.25)
Week 52: Tender Joint Count	-14.1 (11.39)	-13.4 (10.03)	-15.0 (10.51)
Week 24: Patient's Assessment of Pain	-1.08 (2.441)	-2.55 (2.477)	-2.41 (2.335)
Week 28: Patient's Assessment of Pain	-1.63 (2.420)	-2.83 (2.519)	-2.66 (2.416)
Week 36: Patient's Assessment of Pain	-2.51 (2.588)	-3.02 (2.534)	-2.89 (2.540)
Week 44: Patient's Assessment of Pain	-2.62 (2.640)	-3.07 (2.644)	-2.87 (2.601)
Week 52: Patient's Assessment of Pain	-2.75 (2.659)	-3.20 (2.555)	-2.89 (2.681)
Week 24: PtGA of Disease Activity	-1.25 (2.601)	-2.52 (2.490)	-2.40 (2.383)
Week 28: PtGA of Disease Activity	-1.79 (2.543)	-2.79 (2.560)	-2.70 (2.382)
Week 36: PtGA of Disease Activity	-2.70 (2.555)	-2.99 (2.569)	-3.01 (2.445)
Week 44: PtGA of Disease Activity	-2.76 (2.741)	-3.15 (2.650)	-2.86 (2.559)
Week 52: PtGA of Disease Activity	-2.85 (2.757)	-3.29 (2.558)	-3.06 (2.527)
Week 24: PGA of Disease Activity	-2.45 (2.248)	-3.84 (2.316)	-3.93 (2.227)
Week 28: PGA of Disease Activity	-3.42 (2.189)	-4.16 (2.175)	-4.28 (2.054)
Week 36: PGA of Disease Activity	-4.39 (2.052)	-4.49 (2.116)	-4.53 (2.173)
Week 44: PGA of Disease Activity	-4.61 (2.043)	-4.55 (2.139)	-4.70 (2.084)
Week 52: PGA of Disease Activity	-4.77 (2.007)	-4.78 (1.996)	-4.81 (2.120)
Week 24: HAQ-DI score	-0.1646 (0.53253)	-0.4044 (0.54194)	-0.4257 (0.50337)
Week 28: HAQ-DI score	-0.2547 (0.50426)	-0.4383 (0.55648)	-0.4429 (0.51556)
Week 36: HAQ-DI score	-0.3423 (0.52951)	-0.4702 (0.55698)	-0.5000 (0.55438)
Week 44: HAQ-DI score	-0.3868 (0.57065)	-0.4824 (0.57091)	-0.4652 (0.56121)
Week 52: HAQ-DI score	-0.3848 (0.58049)	-0.4824 (0.56167)	-0.5082 (0.58255)
Week 24: CRP	-0.547 (2.5657)	-1.038 (2.0932)	-1.052 (2.1295)
Week 28: CRP	-0.993 (2.3669)	-1.028 (2.0476)	-0.976 (2.1663)
Week 36: CRP	-1.202 (2.3234)	-1.098 (2.1102)	-1.020 (2.1985)
Week 44: CRP	-1.262 (2.5377)	-1.145 (2.1378)	-0.861 (2.8133)
Week 52: CRP	-1.237 (2.8242)	-1.021 (2.2289)	-0.937 (2.4116)

74. Secondary Outcome

Title	Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52
Description	ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).
Time Frame	Baseline, Weeks 24, 28, 36, 44 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24: Swollen Joint Count	-53.44 (45.655)	-72.06 (33.971)	-73.17 (30.614)
Week 28: Swollen Joint Count	-66.15 (37.305)	-78.02 (30.197)	-78.85 (28.109)
Week 36: Swollen Joint Count	-80.38 (28.144)	-82.82 (26.054)	-81.49 (27.338)
Week 44: Swollen Joint Count	-81.85 (26.328)	-82.10 (27.742)	-83.32 (24.289)
Week 52: Swollen Joint Count	-82.34 (30.494)	-83.18 (30.121)	-84.07 (24.070)
Week 24: Tender Joint Count	-32.53 (44.850)	-54.81 (37.134)	-57.11 (35.073)
Week 28: Tender Joint Count	-45.52 (41.132)	-62.48 (32.820)	-64.31 (31.767)
Week 36: Tender Joint Count	-62.21 (34.292)	-66.12 (32.829)	-68.50 (30.000)
Week 44: Tender Joint Count	-65.88 (33.344)	-70.90 (29.688)	-72.10 (27.670)
Week 52: Tender Joint Count	-67.29 (35.583)	-70.29 (31.985)	-69.82 (32.122)
Week 24: Patient's Assessment of Pain	-11.52 (48.647)	-38.44 (40.734)	-36.64 (38.086)
Week 28: Patient's Assessment of Pain	-22.20 (42.404)	-42.17 (41.660)	-41.02 (39.624)
Week 36: Patient's Assessment of Pain	-35.65 (43.207)	-45.89 (40.125)	-43.29 (44.442)
Week 44: Patient's Assessment of Pain	-37.45 (43.534)	-46.48 (41.725)	-43.60 (42.560)
Week 52: Patient's Assessment of Pain	-38.23 (47.430)	-49.00 (39.082)	-43.51 (45.742)
Week 24: PtGA of Disease Activity	-13.78 (45.943)	-37.18 (38.628)	-33.90 (51.672)
Week 28: PtGA of Disease Activity	-23.78 (40.895)	-39.92 (40.228)	-40.70 (36.587)
Week 36: PtGA of Disease Activity	-38.82 (37.114)	-44.21 (36.982)	-45.52 (38.659)
Week 44: PtGA of Disease Activity	-38.45 (43.993)	-46.64 (38.228)	-42.45 (39.243)
Week 52: PtGA of Disease Activity	-39.34 (44.933)	-48.73 (38.925)	-45.50 (40.653)
Week 24: PGA of Disease Activity	-36.13 (33.383)	-57.60 (32.634)	-59.06 (28.137)
Week 28: PGA of Disease Activity	-49.72 (30.129)	-62.89 (28.027)	-64.14 (25.784)
Week 36: PGA of Disease Activity	-64.57 (25.695)	-67.98 (25.989)	-67.74 (28.029)
Week 44: PGA of Disease Activity	-68.32 (25.560)	-69.79 (26.949)	-70.27 (24.516)
Week 52: PGA of Disease Activity	-71.05 (25.056)	-73.09 (24.133)	-72.46 (24.485)
Week 24: HAQ-DI score	-6.86 (54.753)	-25.47 (63.639)	-33.72 (51.766)
Week 28: HAQ-DI score	-15.66 (49.522)	-28.82 (73.930)	-33.91 (59.310)
Week 36: HAQ-DI score	-23.34 (46.393)	-31.95 (78.348)	-37.74 (56.329)
Week 44: HAQ-DI score	-27.01 (49.683)	-33.84 (60.164)	-32.45 (72.337)
Week 52: HAQ-DI score	-26.83 (54.380)	-33.49 (63.823)	-35.02 (65.765)
Week 24: CRP	19.81 (150.274)	-26.90 (110.466)	-28.35 (88.038)
Week 28: CRP	-0.80 (155.637)	-21.09 (144.287)	15.69 (468.613)
Week 36: CRP	-6.70 (183.299)	-25.47 (157.839)	-23.97 (104.641)
Week 44: CRP	-8.33 (143.843)	-37.54 (76.302)	-17.44 (127.594)
Week 52: CRP	-0.25 (208.267)	-23.15 (104.461)	-0.99 (193.429)

75. Secondary Outcome

Title	Percentage of Participants Who Maintained an ACR 20 Response at Week 52 Among Participants Who Achieved an ACR 20 Response at Week 24
Description	ACR 20 response was defined as >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

FAS2 among participants achieved ACR20 response at Week 24. Here, N (number of participants analyzed) signifies number of participants analyzed for this OM. OM was planned to assess maintenance of guselkumab effect only through Week 52, hence data is reported for guselkumab 100mg q8w and guselkumab 100mg q4w arms only and not for placebo arm.

Arm/Group Title	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	156	151
Number [percentage of participants]	91.7 37.3%	86.8 35%

76. Secondary Outcome

Title	Percentage of Participants Who Maintained an ACR 50 Response at Week 52 Among Participants Who Achieved an ACR 50 Response at Week 24
Description	ACR 50 response was defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

FAS2 among participants achieved ACR50 response at Week 24. Here, N (number of participants analyzed) signifies number of participants analyzed for this OM. The OM was planned to assess maintenance of guselkumab effect only through Week 52, hence data is reported for guselkumab 100 mg q8w and guselkumab 100 mg q4w arms only and not for placebo arm.

Arm/Group Title	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	78	77
Number [percentage of participants]	87.2 35.4%	79.2 31.9%

77. Secondary Outcome

Title	Percentage of Participants Who Maintained an ACR 70 Response at Week 52 Among Participants Who Achieved an ACR 70 Response at Week 24
Description	ACR 70 response was defined as >=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 millimeters [mm], 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among participants who achieved ACR 70 response at Week 24. The outcome measure was planned to assess the maintenance of guselkumab effect only through Week 52, hence the data in this outcome measure is reported for guselkumab 100 mg q8w and guselkumab 100 mg q4w arms only and not for placebo arm.

Arm/Group Title	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	46	32
Number [percentage of participants]	82.6 33.6%	75.0 30.2%

78. Secondary Outcome

Title	Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52
Description	HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.
Time Frame	Baseline, Weeks 24, 28, 36, 44 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	-0.1646 (0.53253)	-0.4044 (0.54194)	-0.4257 (0.50337)
Week 28	-0.2547 (0.50426)	-0.4383 (0.55648)	-0.4429 (0.51556)
Week 36	-0.3423 (0.52951)	-0.4702 (0.55698)	-0.5000 (0.55438)
Week 44	-0.3868 (0.57065)	-0.4824 (0.57091)	-0.4652 (0.56121)
Week 52	-0.3848 (0.58049)	-0.4824 (0.56167)	-0.5082 (0.58255)

79. Secondary Outcome

Title	Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline
Description	HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.
Time Frame	Weeks 24, 28, 36, 44 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among participants with HAQ-DI score >=0.35 at baseline and who achieved a HAQ-DI response at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	229	221	218
Week 24	34.1 13.9%	52.5 21.2%	58.3 23.8%
Week 28	42.4 17.2%	58.4 23.5%	63.4 25.9%
Week 36	48.4 19.7%	58.2 23.5%	61.9 25.3%
Week 44	50.9 20.7%	60.0 24.2%	61.4 25.1%
Week 52	50.5 20.5%	60.9 24.6%	62.9 25.7%

80. Secondary Outcome

Title	Percentage of Participants Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 52 Among Participants Who Achieved a HAQ-DI Response at Week 24
Description	HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among participants who achieved a HAQ-DI response at Week 24. The OM was planned to assess the maintenance of guselkumab effect only through Week 52, hence the data in this outcome measure is reported for guselkumab 100 mg q8w and guselkumab 100 mg q4w arms only and not for placebo arm.

Arm/Group Title	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	112	123
Number [percentage of participants]	92.0 37.4%	88.6 35.7%

81. Secondary Outcome

Title	Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52
Description	DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) response criteria was defined as follows: Good response: <=3.2 at visit and >1.2 improvement; Moderate response: >3.2 at visit and >1.2 improvement or <=5.1 at visit and >0.6-1.2 improvement; No response: <=0.6 improvement, or >5.1 at visit and <=1.2 improvement. The values are 0=best to 10=worst. A DAS28 (CRP) responder was defined as achieving a good or moderate DAS28 response at a specific visit.
Time Frame	Weeks 24, 28, 36, 44 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	55.5 22.6%	79.0 31.9%	83.8 34.2%
Week 28	72.3 29.4%	85.0 34.3%	85.9 35.1%
Week 36	86.5 35.2%	86.9 35%	92.5 37.8%
Week 44	91.0 37%	91.8 37%	91.9 37.5%
Week 52	89.0 36.2%	89.7 36.2%	89.4 36.5%

82. Secondary Outcome

Title	Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52
Description	DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission was defined as DAS28 (CRP) value <2.6 at the analysis visit.
Time Frame	Weeks 24, 28, 36, 44 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	9.3 3.8%	25.6 10.3%	24.4 10%
Week 28	13.2 5.4%	27.5 11.1%	30.4 12.4%
Week 36	25.7 10.4%	36.0 14.5%	39.5 16.1%
Week 44	30.0 12.2%	38.4 15.5%	38.0 15.5%
Week 52	34.2 13.9%	39.7 16%	39.6 16.2%

83. Secondary Outcome

Title	Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52
Description	DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis.
Time Frame	Baseline, Weeks 24, 28, 36, 44 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	-1.02 (1.101)	-1.63 (1.051)	-1.68 (0.976)
Week 28	-1.38 (1.099)	-1.78 (1.038)	-1.86 (1.066)
Week 36	-1.92 (1.086)	-1.97 (1.114)	-2.08 (1.088)
Week 44	-2.04 (1.098)	-2.09 (1.107)	-2.08 (1.063)
Week 52	-2.14 (1.142)	-2.08 (1.121)	-2.11 (1.128)

84. Secondary Outcome

Title	Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52
Description	The modified PsARC response was defined as improvement in at least 2 of the four criteria: >=30% decrease in swollen joint count, >=30% decrease in tender joint count, >=20% improvement in patient's Global Assessment of Disease Activity (arthritis) on a VAS (0-100 mm, 0=excellent and 100= poor), >=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.
Time Frame	Weeks 24, 28, 36, 44 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	46.6 18.9%	76.4 30.8%	72.8 29.7%
Week 28	64.6 26.3%	79.3 32%	83.1 33.9%
Week 36	78.7 32%	82.3 33.2%	84.3 34.4%
Week 44	77.6 31.5%	83.7 33.8%	82.2 33.6%
Week 52	81.2 33%	86.3 34.8%	82.9 33.8%

85. Secondary Outcome

Title	Percentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline
Description	Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI>0.
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among the participants with enthesitis (LEI) at baseline. Here, n (number analyzed) signifies the number of participants evaluable for enthesitis resolution at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	172	152	165
Week 24	32.6 13.3%	57.6 23.2%	45.5 18.6%
Week 52	67.3 27.4%	65.5 26.4%	60.0 24.5%

86. Secondary Outcome

Title	Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline
Description	Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis.
Time Frame	Baseline, Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among the participants with enthesitis (LEI) at baseline. Here n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	172	152	165
Week 24	-1.1 (1.66)	-1.6 (1.75)	-1.6 (1.63)
Week 52	-2.1 (1.61)	-1.9 (1.65)	-2.0 (1.78)

87. Secondary Outcome

Title	Percentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at Baseline
Description	The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score >0.
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among the participants with dactylitis at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	95	108	116
Week 24	41.1 16.7%	60.7 24.5%	68.1 27.8%
Week 52	78.5 31.9%	81.9 33%	81.1 33.1%

88. Secondary Outcome

Title	Change From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at Baseline
Description	The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. A higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement in dactylitis.
Time Frame	Baseline, Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among the participants with dactylitis at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	95	108	116
Week 24	-4.6 (7.88)	-6.1 (7.83)	-6.6 (7.84)
Week 52	-7.4 (9.18)	-7.3 (9.74)	-7.4 (8.59)

89. Secondary Outcome

Title	Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52
Description	PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS [0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS [0-100 mm, 0=no arthritis activity and 100=extremely active arthritis]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 [where 0= no tenderness and 3= extreme tenderness] and recoding to 0-1, where any score > 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity.
Time Frame	Baseline, Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	-1.399 (1.3169)	-2.496 (1.5024)	-2.506 (1.2578)
Week 52	-3.041 (1.4979)	-3.197 (1.5212)	-3.161 (1.4646)

90. Secondary Outcome

Title	Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52
Description	PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS [0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS [0-100 mm, 0=no arthritis activity and 100=extremely active arthritis]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 [where 0= no tenderness and 3= extreme tenderness] and recoding to 0-1, where any score > 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity.
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	8.1 3.3%	31.6 12.7%	24.6 10%
Week 52	38.5 15.7%	45.3 18.3%	46.3 18.9%

91. Secondary Outcome

Title	Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52
Description	GRACE index is a composite PsA disease activity score converted from AMDF, which was derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), patient's global assessment of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100= poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), patient's global assessment of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL =25.355 + [2.367*HAQ-DI] - [0.234*SF-PCS] - [0.244*SF-MCS]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score ranges from 0 to 100, higher scores= better quality of life) and SF-MCS (score ranges from 0 to 100, higher scores= better quality of life). The total score is from 0-10, where lower score indicates better response. Higher score indicates more active disease activity. Negative change from baseline indicates improvement of PsA disease activity.
Time Frame	Baseline, Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	-1.260 (1.4909)	-2.658 (1.6770)	-2.672 (1.4589)
Week 52	-3.085 (1.6277)	-3.271 (1.6453)	-3.267 (1.5646)

92. Secondary Outcome

Title	Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52
Description	GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), PtGA of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), PtGA of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + [2.367*HAQ-DI]-[0.234*SF-PCS]-[0.244*SF-MCS]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score range= 0-100, higher scores= better quality of life) and SF-MCS (score range=0-100, higher scores= better quality of life). Total score is 0-10, lower score=better response. Higher score= more active disease activity. Negative change from baseline indicates improvement of PsA disease activity. GRACE low disease activity is GRACE score <=2.3 at the analysis visit.
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	7.6 3.1%	29.5 11.9%	27.6 11.3%
Week 52	34.9 14.2%	43.2 17.4%	43.0 17.6%

93. Secondary Outcome

Title	Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52
Description	DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL), patient assessment of pain (0-10cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.
Time Frame	Baseline, Weeks 24, 28, 36, 44 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	-16.377 (19.1814)	-24.718 (16.7967)	-26.578 (15.3393)
Week 28	-22.199 (17.9394)	-26.573 (15.5254)	-29.613 (17.6129)
Week 36	-29.251 (18.1137)	-28.889 (16.4372)	-31.782 (16.7698)
Week 44	-30.754 (18.5016)	-30.108 (16.6013)	-32.126 (15.7605)
Week 52	-31.209 (18.9981)	-30.512 (17.5074)	-32.282 (16.6320)

94. Secondary Outcome

Title	Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52
Description	The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity.
Time Frame	Baseline, Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	-1.34 (2.144)	-2.97 (2.382)	-3.32 (2.098)
Week 52	-3.75 (2.391)	-3.84 (2.449)	-4.10 (2.387)

95. Secondary Outcome

Title	Percentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52
Description	The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. mCPDAI low disease activity is defined as mCPDAI score <=3.2 at the analysis visit.
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	15.1 6.1%	48.9 19.7%	43.5 17.8%
Week 52	56.3 22.9%	61.1 24.6%	60.1 24.5%

96. Secondary Outcome

Title	Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52
Description	MDA is a measure that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved the PsA MDA at a visit if the participant has fulfilled at least 5 of the following 7 criteria at that visit: Tender joint count (68 joints)<=1, Swollen joint count (66 joints) <=1, Psoriasis activity and severity index <=1, Patient's Assessment of Pain <=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) <=20 on a 100-unit VAS, HAQ-DI score <=0.5, and Tender entheseal points <= 1 (LEI index score <= 1).
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	6.3 2.6%	26.5 10.7%	19.7 8%
Week 52	31.6 12.8%	32.9 13.3%	36.8 15%

97. Secondary Outcome

Title	Percentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52
Description	A measurement that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved VLDA at a visit if the participant fulfilled all 7 criteria (tender joint count <=1; swollen joint count <=1; PASI <=1; patient pain VAS score of <=15; patient global disease activity VAS [arthritis and psoriasis] score of <=20; Health Assessment Questionnaire (HAQ) score <=0.5; and tender entheseal points <=1) at that visit.
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	1.3 0.5%	4.6 1.9%	5.1 2.1%
Week 52	6.9 2.8%	17.1 6.9%	12.2 5%

98. Secondary Outcome

Title	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis at Baseline
Description	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.
Time Frame	Baseline, Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among the participants with spondylitis and peripheral arthritis and BASDAI score >0 at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	91	66	79
Week 24	-1.374 (2.4269)	-2.652 (2.3825)	-2.674 (1.9941)
Week 52	-2.986 (2.4945)	-2.883 (2.5193)	-3.084 (2.1843)

99. Secondary Outcome

Title	Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline
Description	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among the participants with spondylitis and peripheral arthritis and BASDAI score >0 at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	91	66	79
Week 24: Participants with >=20% Improvement	44.0 17.9%	62.5 25.2%	73.1 29.8%
Week 52: Participants with >=20% Improvement	71.6 29.1%	70.3 28.3%	79.7 32.5%
Week 24: Participants with >=50% Improvement	22.0 8.9%	40.6 16.4%	39.7 16.2%
Week 52: Participants with >=50% Improvement	50.0 20.3%	42.2 17%	50.6 20.7%
Week 24: Participants with >=70% Improvement	8.8 3.6%	21.9 8.8%	16.7 6.8%
Week 52: Participants with >=70% Improvement	23.9 9.7%	26.6 10.7%	30.4 12.4%
Week 24: Participants with >=90% Improvement	2.2 0.9%	1.6 0.6%	3.8 1.6%
Week 52: Participants with >=90% Improvement	6.8 2.8%	10.9 4.4%	8.9 3.6%

100. Secondary Outcome

Title	Change From Baseline in PASI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative change from baseline indicates improvement of psoriasis.
Time Frame	Baseline, Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among the participants who had >=3% BSA of psoriatic involvement and an IGA score >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	176	173	177
Week 24	-2.989 (6.1515)	-11.685 (12.3496)	-12.574 (11.8391)
Week 52	-11.016 (9.9801)	-11.977 (12.0847)	-12.857 (11.3052)

101. Secondary Outcome

Title	Percentage of Participants Who Achieved PASI 50 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 50 response: >=50% improvement in PASI score from baseline.
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among the participants who had >=3% BSA of psoriatic involvement and an IGA score >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	176	173	177
Week 24	39.8 16.2%	94.8 38.2%	93.8 38.3%
Week 52	95.9 39%	97.1 39.2%	98.3 40.1%

102. Secondary Outcome

Title	Percentage of Participants Who Achieved PASI 75 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 75 response: >=75% improvement in PASI score from baseline.
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among the participants who had >=3% BSA of psoriatic involvement and an IGA score >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	176	173	177
Week 24	23.3 9.5%	80.8 32.6%	81.8 33.4%
Week 52	88.4 35.9%	88.8 35.8%	91.9 37.5%

103. Secondary Outcome

Title	Percentage of Participants Who Achieved PASI 90 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 90 response: >=90% improvement in PASI score from baseline.
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among the participants who had >=3% BSA of psoriatic involvement and an IGA score >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	176	173	177
Week 24	10.2 4.1%	70.3 28.3%	63.6 26%
Week 52	76.7 31.2%	77.1 31.1%	81.5 33.3%

104. Secondary Outcome

Title	Percentage of Participants Who Achieved PASI 100 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 100 response: 100% improvement in PASI score from baseline.
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among the participants who had >=3% BSA of psoriatic involvement and an IGA score >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	176	173	177
Week 24	2.8 1.1%	46.5 18.8%	46.6 19%
Week 52	55.2 22.4%	54.7 22.1%	61.3 25%

105. Secondary Outcome

Title	Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	In PASI, each area (head, trunk, upper and lower extremities) was assessed for % of area involved and translated to numeric score from 0 (no involvement) to 6 (90-100% involvement) and for erythema, induration, and scaling, each rated on scale of 0 to 4. PASI produces numeric score from 0 to 72. Higher scores=more severe disease. PASI 75: >=75% improvement in PASI score from baseline. ACR 20: >=20% improvement in SJC (66 joints)+TJC (68 joints) and >=20% improvement in 3 of 5: patient's assessment of pain (VAS; 0-100 mm, 0=no pain to 100=worst possible pain), PtGA of disease activity (VAS; 0-100 mm, 0=excellent to 100=poor), PGA of disease activity (VAS; 0-100 mm, 0=no arthritis to 100=extremely active arthritis), patient's assessment of physical function (HAQ-DI -20-question instrument; range- 0=no difficulty to 3=inability to perform task) and CRP.
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among the participants who had >=3% BSA of psoriatic involvement and an IGA score >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	176	173	177
Week 24	11.4 4.6%	58.1 23.4%	59.7 24.4%
Week 52	59.6 24.2%	73.5 29.6%	69.9 28.5%

106. Secondary Outcome

Title	Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	In PASI, each area (head, trunk, upper and lower extremities) was assessed separately for % of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4. PASI produces numeric score range from 0 to 72. Higher scores=more severe disease. PASI75 response: >=75% improvement in PASI score from baseline. Modified PsARC response: improvement in at least 2 of 4 criteria: >=30% decrease in SJC and TJC, >=20% improvement in PtGA of Disease Activity (arthritis) on VAS (0-100 mm, 0=excellent and 100=poor), >=20% improvement in PGA of Disease Activity on VAS (VAS: 0-100 mm, 0=no arthritis and 100=extremely active arthritis), and at least 1 of 2 joint criteria with no deterioration in other criteria.
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among the participants who had >=3% BSA of psoriatic involvement and an IGA score >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	176	173	177
Week 24	15.3 6.2%	66.9 27%	63.6 26%
Week 52	70.9 28.8%	79.4 32%	76.3 31.1%

107. Secondary Outcome

Title	Percentage of Participants Who Achieved an IGA Response at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among the participants who had >=3% BSA of psoriatic involvement and an IGA score >=2 (mild) at baseline.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	176	173	177
Week 24	19.9 8.1%	72.1 29.1%	71.0 29%
Week 52	84.3 34.3%	77.1 31.1%	84.4 34.4%

108. Secondary Outcome

Title	Percentage of Participants Who Achieved an IGA Score of 0 (Cleared) at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among the participants who had >=3% BSA of psoriatic involvement and an IGA score >=2 (mild) at baseline.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	176	173	177
Week 24	8.0 3.3%	51.2 20.6%	52.8 21.6%
Week 52	66.9 27.2%	60.0 24.2%	66.5 27.1%

109. Secondary Outcome

Title	Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 24 and 52 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. A DLQI score of 0 or 1 indicates psoriasis had no effect at all on patient's life.
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among the participants with DLQI Score >1, with >=3% BSA psoriatic involvement and an IGA score of >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	165	155	166
Week 24	12.1 4.9%	65.6 26.5%	61.4 25.1%
Week 52	56.8 23.1%	68.6 27.7%	68.7 28%

110. Secondary Outcome

Title	Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. An improvement of 5 points was considered clinically meaningful.
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among the participants with DLQI score >=5, >=3% BSA psoriatic involvement and an IGA score of >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	140	131	145
Week 24	40.7 16.5%	85.4 34.4%	90.3 36.9%
Week 52	84.8 34.5%	92.2 37.2%	89.4 36.5%

111. Secondary Outcome

Title	Change From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. Negative changes from baseline indicate improvement of life quality impacted by psoriasis.
Time Frame	Baseline, Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2 among the participants with >=3% BSA psoriatic involvement and an IGA Score of >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	176	173	177
Week 24	-2.142 (6.4593)	-8.901 (7.3657)	-9.249 (7.0988)
Week 52	-8.815 (7.2714)	-9.235 (7.3840)	-9.839 (6.8777)

112. Secondary Outcome

Title	Change From Baseline in Modified vdH-S Score at Week 52
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame	Baseline and Week 52

Outcome Measure Data

Analysis Population Description

FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	230	235	229
Mean (Standard Deviation) [units on a scale]	1.25 (3.508)	0.97 (3.623)	1.07 (3.843)

113. Secondary Outcome

Title	Change in Total Modified vdH-S Score From Week 24 to Week 52
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage.
Time Frame	From Week 24 to Week 52

Outcome Measure Data

Analysis Population Description

FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	230	235	229
Mean (Standard Deviation) [units on a scale]	0.25 (1.635)	0.23 (1.808)	0.62 (2.530)

114. Secondary Outcome

Title	Change From Baseline in Modified vdH-S Erosion Score at Week 52
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame	Baseline and Week 52

Outcome Measure Data

Analysis Population Description

FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	230	235	229
Mean (Standard Deviation) [units on a scale]	0.92 (2.497)	0.67 (2.707)	0.70 (2.631)

115. Secondary Outcome

Title	Change in Modified vdH-S Erosion Score From Week 24 to Week 52
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage.
Time Frame	From Week 24 to Week 52

Outcome Measure Data

Analysis Population Description

FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	230	235	229
Mean (Standard Deviation) [units on a scale]	0.17 (1.277)	0.10 (1.422)	0.39 (1.725)

116. Secondary Outcome

Title	Change From Baseline in Modified vdH-S JSN Score at Week 52
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame	Baseline and Week 52

Outcome Measure Data

Analysis Population Description

FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	230	235	229
Mean (Standard Deviation) [units on a scale]	0.33 (1.356)	0.29 (1.272)	0.38 (1.633)

117. Secondary Outcome

Title	Change in Modified vdH-S JSN Score From Week 24 to Week 52
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage.
Time Frame	From Week 24 to Week 52

Outcome Measure Data

Analysis Population Description

FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	230	235	229
Mean (Standard Deviation) [units on a scale]	0.07 (0.635)	0.13 (0.705)	0.23 (1.088)

118. Secondary Outcome

Title	Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand (Hand erosion score) scored according to 0 (no erosion) to 5 (complete collapse of bone) for a maximum hand erosion score of 200, and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum foot erosion score of 120. Higher scores indicate more joint damage. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum Hand JSN score of 160 and maximum Foot JSN score of 48. Higher scores indicate more joint damage. Hand Score (sum of Hand Erosion Score and Hand JSN Score) scored as 0-360 and Foot score (sum of foot erosion score and foot JSN score) scored as 0-168. Higher scores indicate more joint damage.
Time Frame	Baseline and Week 52

Outcome Measure Data

Analysis Population Description

FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'n' (number analyzed) signifies the number of participants analyzed for a specified score.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Hand Erosion Score	0.66 (1.815)	0.37 (1.969)	0.35 (1.830)
Hand JSN Score	0.29 (1.181)	0.19 (0.913)	0.22 (1.235)
Hand Score	0.95 (2.706)	0.56 (2.589)	0.57 (2.759)
Foot Erosion Score	0.26 (1.014)	0.30 (1.339)	0.34 (1.413)
Foot JSN Score	0.04 (0.353)	0.10 (0.660)	0.16 (0.864)
Foot Score	0.30 (1.220)	0.40 (1.687)	0.50 (1.939)

119. Secondary Outcome

Title	Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, n (number analyzed) signifies the number of participants analyzed at specified category.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Change of <=0 from Baseline	57.4 23.3%	55.7 22.5%	56.8 23.2%
Change of <=0.5 from Baseline	67.4 27.4%	67.2 27.1%	72.1 29.4%

120. Secondary Outcome

Title	Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, n (number analyzed) signifies the number of participants analyzed at specified category.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Change of <=0 from Baseline	58.3 23.7%	59.6 24%	60.3 24.6%
Change of <=0.5 from Baseline	70.4 28.6%	71.1 28.7%	72.1 29.4%

121. Secondary Outcome

Title	Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, n (number analyzed) signifies the number of participants analyzed at specified category.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Change of <=0 from Baseline	78.7 32%	75.3 30.4%	79.5 32.4%
Change of <=0.5 from Baseline	88.3 35.9%	86.0 34.7%	86.5 35.3%

122. Secondary Outcome

Title	Percentage of Participants Without Radiographic Progression Based on the (SDC) From Baseline at Week 52
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic progression was defined as change from baseline in the modified vdH-S score <=SDC of 2.39.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	230	235	229
Number [percentage of participants]	80.4 32.7%	82.6 33.3%	85.2 34.8%

123. Secondary Outcome

Title	Percentage of Participants Without Radiographic Joint Erosion Progression Based on (SDC) From Baseline at Week 52
Description	Modified vdH-S score is sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is summary of erosion severity in 40 joints of hand scored according to surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic joint erosion progression was defined as change from baseline in modified vdH-S erosion score <=SDC of 2.22.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	230	235	229
Number [percentage of participants]	82.2 33.4%	84.3 34%	87.3 35.6%

124. Secondary Outcome

Title	Percentage of Participants Without Radiographic JSN Progression Based on (SDC) From Baseline at Week 52
Description	Modified vdH-S score is sum of erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is summary of erosion severity in 40 joints of hand scored according to surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as cut-off above which changes can be detected beyond measurement error. Without radiographic JSN progression was defined as change from baseline in modified vdH-S JSN score <=SDC of 1.02.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	230	235	229
Number [percentage of participants]	91.3 37.1%	91.5 36.9%	90.4 36.9%

125. Secondary Outcome

Title	Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52
Description	Percentage of Participants with Pencil in cup or Gross Osteolysis Deformities were reported. Pencil in Cup or Gross Osteolytis Deformities are radiographic features specific for psoriatic arthritis.
Time Frame	Baseline and Week 52

Outcome Measure Data

Analysis Population Description

FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Baseline	6.9 2.8%	4.6 1.9%	6.9 2.8%
Week 52	7.8 3.2%	5.1 2.1%	7.0 2.9%

126. Secondary Outcome

Title	Change From Baseline in SF-36 PCS Score at Weeks 24 and 52
Description	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time Frame	Baseline, Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	3.782 (7.1776)	7.838 (8.0335)	7.183 (6.9793)
Week 52	8.124 (8.2192)	9.511 (8.3176)	8.960 (8.5891)

127. Secondary Outcome

Title	Change From Baseline in SF-36 MCS Score at Weeks 24 and 52
Description	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time Frame	Baseline, Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	2.211 (10.1368)	4.452 (9.9560)	4.128 (9.1814)
Week 52	4.297 (10.8960)	4.465 (9.7780)	4.076 (9.1101)

128. Secondary Outcome

Title	Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52
Description	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales: physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health. The scores 0-100 (where higher scores indicated a better quality of life) from each subscale of SF-36 were normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better health status. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time Frame	Baseline, Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24: Physical Function Score	3.602 (7.7388)	7.052 (8.5020)	6.772 (7.5920)
Week 52: Physical Function Score	7.722 (8.9480)	8.489 (8.8599)	8.374 (8.7884)
Week 24: Role-physical Score	3.695 (7.5950)	6.897 (7.7240)	6.381 (7.2203)
Week 52: Role-physical Score	6.560 (8.5399)	7.677 (8.2995)	7.344 (7.7145)
Week 24: Bodily Pain Score	3.882 (8.3009)	8.333 (8.3852)	7.833 (7.3390)
Week 52: Bodily Pain Score	8.460 (8.4659)	10.238 (8.7185)	9.457 (9.7977)
Week 24: General Health Score	2.255 (7.2176)	5.963 (7.8794)	5.067 (7.4182)
Week 52: General Health Score	6.396 (8.5589)	7.173 (7.2703)	6.366 (8.4199)
Week 24: Vitality Score	4.224 (9.0878)	7.914 (9.4638)	6.970 (9.4889)
Week 52: Vitality Score	7.879 (9.4160)	8.646 (9.5131)	7.654 (9.3905)
Week 24: Social Function Score	3.088 (10.4330)	6.551 (9.7076)	5.892 (8.5510)
Week 52: Social Function Score	6.278 (10.9444)	7.199 (10.1315)	6.787 (9.5326)
Week 24: Role-emotional Score	1.910 (10.0772)	4.535 (10.1304)	4.107 (8.9473)
Week 52: Role-emotional Score	4.057 (10.8795)	4.970 (10.1685)	4.607 (8.7627)
Week 24: Mental Health Score	2.583 (9.2222)	4.605 (9.7905)	4.752 (8.9336)
Week 52: Mental Health Score	5.153 (10.0724)	4.829 (9.3665)	4.741 (9.3825)

129. Secondary Outcome

Title	Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52
Description	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	42.2 17.2%	63.4 25.6%	58.5 23.9%
Week 52	63.0 25.6%	67.1 27.1%	65.5 26.7%

130. Secondary Outcome

Title	Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52
Description	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	32.5 13.2%	40.3 16.3%	36.8 15%
Week 52	41.7 17%	44.9 18.1%	38.9 15.9%

131. Secondary Outcome

Title	Change From Baseline in FACIT-Fatigue Score at Weeks 24 and 52
Description	The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Time Frame	Baseline, Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	3.844 (9.0440)	8.034 (9.8888)	6.970 (8.6274)
Week 52	7.548 (9.3745)	8.927 (9.4646)	7.686 (9.0833)

132. Secondary Outcome

Title	Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52
Description	The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Time Frame	Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	49.4 20.1%	63.9 25.8%	62.8 25.6%
Week 52	68.3 27.8%	69.7 28.1%	68.6 28%

133. Secondary Outcome

Title	Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VAS
Description	EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status.
Time Frame	Baseline, Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	8.456 (25.7204)	19.282 (23.5220)	17.500 (22.6981)
Week 52	21.474 (25.5974)	23.295 (23.6270)	19.983 (24.7643)

134. Secondary Outcome

Title	Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D Index
Description	EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (full health). A higher score indicates better health and positive changes from baseline indicate improvement of health.
Time Frame	Baseline, Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	238	240	234
Week 24	0.060 (0.1558)	0.124 (0.1476)	0.117 (0.1307)
Week 52	0.137 (0.1605)	0.146 (0.1587)	0.135 (0.1469)

135. Secondary Outcome

Title	Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52
Description	Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time Frame	Baseline, Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	148	141	136
Week 24	-5.64 (28.355)	-3.77 (28.029)	-1.20 (17.127)
Week 52	-5.37 (25.365)	-4.47 (20.454)	-1.74 (17.084)

136. Secondary Outcome

Title	Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52
Description	Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time Frame	Baseline, Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	126	125	124
Week 24	-12.14 (29.027)	-21.28 (25.621)	-20.08 (22.084)
Week 52	-21.27 (31.502)	-27.93 (25.263)	-22.10 (26.172)

137. Secondary Outcome

Title	Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52
Description	Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time Frame	Baseline, Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	126	125	124
Week 24	-13.42 (29.916)	-21.68 (27.065)	-20.90 (22.814)
Week 52	-22.06 (32.092)	-28.19 (25.536)	-22.24 (26.920)

138. Secondary Outcome

Title	Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52
Description	Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time Frame	Baseline, Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

Analysis population is FAS2. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	237	238	234
Week 24	-10.80 (26.131)	-23.03 (25.559)	-21.07 (21.493)
Week 52	-24.13 (27.436)	-27.14 (25.657)	-26.11 (25.361)

139. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100
Description	ACR 20 response was defined as >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time Frame	Weeks 52, 68, 76, 84 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is full analysis set 3 (FAS3) which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	68.7 27.9%	78.9 31.8%	77.0 31.4%
Week 68	77.0 31.3%	85.2 34.4%	80.7 32.9%
Week 76	75.6 30.7%	83.1 33.5%	82.5 33.7%
Week 84	80.1 32.6%	85.1 34.3%	80.6 32.9%
Week 100	79.2 32.2%	82.1 33.1%	84.9 34.7%

140. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100
Description	ACR 50 response was defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time Frame	Weeks 52, 68, 76, 84 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	44.3 18%	50.9 20.5%	49.6 20.2%
Week 68	49.5 20.1%	60.8 24.5%	58.6 23.9%
Week 76	50.9 20.7%	56.0 22.6%	58.3 23.8%
Week 84	56.3 22.9%	63.8 25.7%	57.8 23.6%
Week 100	55.2 22.4%	60.7 24.5%	62.3 25.4%

141. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100
Description	ACR 70 response was defined as >=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time Frame	Weeks 52, 68, 76, 84 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	19.5 7.9%	29.7 12%	28.3 11.6%
Week 68	27.8 11.3%	35.5 14.3%	36.1 14.7%
Week 76	27.9 11.3%	36.4 14.7%	32.7 13.3%
Week 84	29.6 12%	42.8 17.3%	39.4 16.1%
Week 100	34.3 13.9%	39.3 15.8%	38.6 15.8%

142. Secondary Outcome

Title	ACR Components at Weeks 52, 68, 76, 84 and 100
Description	ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).
Time Frame	Weeks 52, 68, 76, 84 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52: Swollen Joint Count	2.1 (3.58)	2.1 (4.18)	2.5 (4.83)
Week 68: Swollen Joint Count	1.6 (3.10)	1.7 (3.87)	2.0 (3.79)
Week 76: Swollen Joint Count	1.6 (3.17)	1.8 (3.72)	2.3 (4.59)
Week 84: Swollen Joint Count	1.6 (3.02)	1.6 (3.82)	2.0 (5.01)
Week 100: Swollen Joint Count	1.8 (3.75)	1.6 (3.99)	2.0 (4.11)
Week 52: Tender Joint Count	7.4 (10.30)	6.3 (8.20)	7.2 (9.49)
Week 68: Tender Joint Count	6.0 (8.83)	5.0 (6.83)	6.3 (9.27)
Week 76: Tender Joint Count	5.7 (8.31)	5.2 (7.18)	6.2 (8.90)
Week 84: Tender Joint Count	5.1 (7.32)	4.7 (7.20)	5.9 (9.22)
Week 100: Tender Joint Count	5.5 (8.44)	4.7 (6.80)	6.0 (8.90)
Week 52: Patient's Assessment of Pain	3.53 (2.267)	3.12 (2.335)	3.17 (2.343)
Week 68: Patient's Assessment of Pain	3.26 (2.313)	2.68 (2.240)	2.64 (2.105)
Week 76: Patient's Assessment of Pain	3.17 (2.271)	2.73 (2.217)	2.70 (2.115)
Week 84: Patient's Assessment of Pain	2.97 (2.150)	2.67 (2.181)	2.65 (2.217)
Week 100: Patient's Assessment of Pain	2.90 (2.221)	2.59 (2.290)	2.57 (2.138)
Week 52: PtGA of Disease Activity	3.68 (2.331)	3.25 (2.380)	3.24 (2.322)
Week 68: PtGA of Disease Activity	3.50 (2.355)	2.95 (2.282)	2.85 (2.213)
Week 76: PtGA of Disease Activity	3.25 (2.356)	2.90 (2.273)	2.95 (2.222)
Week 84: PtGA of Disease Activity	3.09 (2.273)	2.88 (2.252)	2.83 (2.222)
Week 100: PtGA of Disease Activity	3.15 (2.395)	2.85 (2.378)	2.60 (2.165)
Week 52: PGA of Disease Activity	1.89 (1.654)	1.78 (1.647)	1.77 (1.617)
Week 68: PGA of Disease Activity	1.63 (1.514)	1.56 (1.538)	1.61 (1.466)
Week 76: PGA of Disease Activity	1.45 (1.469)	1.67 (1.660)	1.57 (1.524)
Week 84: PGA of Disease Activity	1.55 (1.492)	1.51 (1.619)	1.50 (1.558)
Week 100: PGA of Disease Activity	1.39 (1.510)	1.49 (1.581)	1.41 (1.405)
Week 52: HAQ-DI score	0.9073 (0.63812)	0.7942 (0.59711)	0.7317 (0.58430)
Week 68: HAQ-DI score	0.8425 (0.61757)	0.7625 (0.59524)	0.6836 (0.56049)
Week 76: HAQ-DI score	0.8311 (0.62101)	0.6978 (0.56588)	0.6996 (0.55988)
Week 84: HAQ-DI score	0.8076 (0.62465)	0.7134 (0.59528)	0.6775 (0.58870)
Week 100: HAQ-DI score	0.7692 (0.59960)	0.6747 (0.57213)	0.6420 (0.56838)
Week 52: CRP	0.904 (1.6039)	0.930 (1.2443)	0.886 (1.2366)
Week 68: CRP	0.861 (1.1586)	0.884 (1.3520)	0.796 (1.1109)
Week 76: CRP	0.903 (1.4624)	0.882 (1.2504)	0.839 (1.1693)
Week 84: CRP	0.898 (1.3229)	0.856 (1.1926)	0.872 (1.3239)
Week 100: CRP	0.880 (1.3415)	0.826 (1.2277)	0.820 (1.1227)

143. Secondary Outcome

Title	Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100
Description	ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).
Time Frame	Baseline, Weeks 52, 68, 76, 84 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52: Swollen Joint Count	-10.2 (6.72)	-9.6 (6.30)	-10.4 (6.16)
Week 68: Swollen Joint Count	-10.7 (6.76)	-10.0 (6.50)	-10.9 (7.22)
Week 76: Swollen Joint Count	-10.7 (5.98)	-10.0 (6.33)	-10.7 (6.18)
Week 84: Swollen Joint Count	-10.6 (6.06)	-10.1 (6.34)	-10.7 (7.08)
Week 100: Swollen Joint Count	-10.6 (6.15)	-10.2 (6.88)	-10.8 (6.66)
Week 52: Tender Joint Count	-14.1 (11.38)	-13.5 (10.04)	-15.2 (10.45)
Week 68: Tender Joint Count	-15.7 (10.94)	-14.8 (10.15)	-16.0 (11.02)
Week 76: Tender Joint Count	-16.1 (10.97)	-14.7 (10.22)	-16.1 (10.91)
Week 84: Tender Joint Count	-16.6 (11.33)	-15.3 (10.50)	-16.0 (11.22)
Week 100: Tender Joint Count	-16.3 (11.27)	-15.3 (11.10)	-16.4 (10.70)
Week 52: Patient's Assessment of Pain	-2.78 (2.645)	-3.20 (2.557)	-2.92 (2.686)
Week 68: Patient's Assessment of Pain	-3.10 (2.707)	-3.62 (2.530)	-3.46 (2.574)
Week 76: Patient's Assessment of Pain	-3.18 (2.724)	-3.57 (2.566)	-3.38 (2.620)
Week 84: Patient's Assessment of Pain	-3.35 (2.595)	-3.64 (2.568)	-3.42 (2.669)
Week 100: Patient's Assessment of Pain	-3.41 (2.578)	-3.69 (2.625)	-3.52 (2.615)
Week 52: PtGA of Disease Activity	-2.87 (2.761)	-3.29 (2.553)	-3.09 (2.523)
Week 68: PtGA of Disease Activity	-3.08 (2.786)	-3.58 (2.446)	-3.49 (2.500)
Week 76: PtGA of Disease Activity	-3.32 (2.860)	-3.63 (2.512)	-3.38 (2.501)
Week 84: PtGA of Disease Activity	-3.46 (2.752)	-3.67 (2.572)	-3.50 (2.579)
Week 100: PtGA of Disease Activity	-3.40 (2.846)	-3.67 (2.612)	-3.73 (2.493)
Week 52: PGA of Disease Activity	-4.79 (1.992)	-4.77 (2.001)	-4.82 (2.117)
Week 68: PGA of Disease Activity	-5.06 (2.037)	-4.98 (1.992)	-5.01 (2.105)
Week 76: PGA of Disease Activity	-5.23 (1.995)	-4.86 (2.044)	-5.03 (2.078)
Week 84: PGA of Disease Activity	-5.13 (2.040)	-5.06 (2.074)	-5.09 (2.142)
Week 100: PGA of Disease Activity	-5.26 (2.098)	-5.05 (2.011)	-5.18 (2.044)
Week 52: HAQ-DI score	-0.3899 (0.58250)	-0.4801 (0.56246)	-0.5111 (0.58347)
Week 68: HAQ-DI score	-0.4668 (0.59226)	-0.5120 (0.54928)	-0.5631 (0.54528)
Week 76: HAQ-DI score	-0.4740 (0.57852)	-0.5694 (0.56421)	-0.5448 (0.54739)
Week 84: HAQ-DI score	-0.5041 (0.59716)	-0.5653 (0.59488)	-0.5656 (0.57921)
Week 100: HAQ-DI score	-0.5356 (0.56707)	-0.5859 (0.58199)	-0.6000 (0.56858)
Week 52: CRP	-1.262 (2.8315)	-1.021 (2.2301)	-0.959 (2.4188)
Week 68: CRP	-1.212 (2.3061)	-1.081 (2.1585)	-1.060 (2.3334)
Week 76: CRP	-1.283 (2.8163)	-1.098 (2.3654)	-1.017 (2.2801)
Week 84: CRP	-1.230 (2.4262)	-1.101 (2.1216)	-0.940 (2.3781)
Week 100: CRP	-1.244 (2.5828)	-1.129 (2.2261)	-1.042 (2.0600)

144. Secondary Outcome

Title	Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100
Description	ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).
Time Frame	Baseline, Weeks 52, 68, 76, 84 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52: Swollen Joint Count	-82.64 (30.161)	-83.03 (30.210)	-84.27 (23.698)
Week 68: Swollen Joint Count	-87.41 (24.049)	-86.08 (29.764)	-86.41 (22.642)
Week 76: Swollen Joint Count	-87.98 (20.617)	-86.05 (21.096)	-85.82 (22.291)
Week 84: Swollen Joint Count	-87.72 (22.243)	-87.68 (23.304)	-87.16 (24.888)
Week 100: Swollen Joint Count	-87.61 (21.214)	-86.19 (40.865)	-86.31 (24.106)
Week 52: Tender Joint Count	-67.29 (35.725)	-70.18 (32.062)	-70.54 (31.311)
Week 68: Tender Joint Count	-74.28 (29.764)	-75.63 (29.437)	-74.40 (29.760)
Week 76: Tender Joint Count	-75.71 (27.653)	-74.71 (29.728)	-75.11 (28.559)
Week 84: Tender Joint Count	-77.21 (27.045)	-78.01 (26.112)	-75.45 (32.489)
Week 100: Tender Joint Count	-77.04 (27.510)	-75.96 (32.600)	-76.21 (27.345)
Week 52: Patient's Assessment of Pain	-39.52 (44.939)	-48.81 (39.191)	-43.86 (45.891)
Week 68: Patient's Assessment of Pain	-44.91 (44.371)	-55.77 (38.780)	-52.43 (41.186)
Week 76: Patient's Assessment of Pain	-46.02 (44.989)	-54.38 (39.135)	-51.34 (41.903)
Week 84: Patient's Assessment of Pain	-49.64 (40.991)	-55.28 (40.388)	-52.59 (43.131)
Week 100: Patient's Assessment of Pain	-50.82 (42.970)	-56.36 (41.310)	-54.27 (40.819)
Week 52: PtGA of Disease Activity	-39.70 (44.981)	-48.48 (38.982)	-46.07 (40.614)
Week 68: PtGA of Disease Activity	-42.93 (44.220)	-53.84 (35.096)	-52.47 (38.155)
Week 76: PtGA of Disease Activity	-46.42 (45.106)	-54.41 (35.276)	-50.66 (40.992)
Week 84: PtGA of Disease Activity	-49.38 (42.315)	-54.17 (37.132)	-51.86 (44.532)
Week 100: PtGA of Disease Activity	-48.17 (44.804)	-55.08 (37.052)	-57.09 (34.970)
Week 52: PGA of Disease Activity	-71.24 (24.771)	-72.95 (24.168)	-72.58 (24.579)
Week 68: PGA of Disease Activity	-74.76 (23.290)	-76.00 (22.550)	-74.48 (26.280)
Week 76: PGA of Disease Activity	-77.68 (23.015)	-74.42 (25.014)	-75.56 (23.613)
Week 84: PGA of Disease Activity	-75.77 (23.674)	-76.77 (24.433)	-76.49 (24.355)
Week 100: PGA of Disease Activity	-78.11 (24.049)	-77.15 (23.217)	-77.82 (22.733)
Week 52: HAQ-DI score	-27.27 (54.587)	-33.28 (64.067)	-35.17 (66.105)
Week 68: HAQ-DI score	-33.34 (49.027)	-37.47 (57.370)	-44.33 (44.064)
Week 76: HAQ-DI score	-34.38 (47.311)	-40.08 (58.932)	-41.84 (47.877)
Week 84: HAQ-DI score	-36.73 (47.541)	-40.10 (58.703)	-43.18 (52.116)
Week 100: HAQ-DI score	-40.36 (44.407)	-42.84 (54.187)	-47.54 (47.265)
Week 52: CRP	-2.67 (205.761)	-23.41 (104.622)	-1.34 (194.673)
Week 68: CRP	-1.68 (330.574)	-28.38 (138.159)	-13.91 (174.522)
Week 76: CRP	-10.76 (226.332)	7.85 (502.170)	-24.22 (110.486)
Week 84: CRP	-0.72 (387.986)	-26.87 (114.471)	-19.89 (131.695)
Week 100: CRP	-4.33 (196.246)	-23.99 (150.816)	-14.35 (171.666)

145. Secondary Outcome

Title	Percentage of Participants Who Maintained an ACR 20 Response at Week 100 Among Participants Who Achieved an ACR 20 Response at Week 52
Description	ACR 20 response was defined as >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time Frame	Week 100

Outcome Measure Data

Analysis Population Description

FAS3 among participants who achieved ACR20 response at Week 52.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	147	178	171
Number [percentage of participants]	94.6 38.5%	90.4 36.5%	93.0 38%

146. Secondary Outcome

Title	Percentage of Participants Who Maintained an ACR 50 Response at Week 100 Among Participants Who Achieved an ACR 50 Response at Week 52
Description	ACR 50 response was defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time Frame	Week 100

Outcome Measure Data

Analysis Population Description

FAS3 among participants who achieved ACR50 response at Week 52.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	96	116	111
Number [percentage of participants]	81.3 33%	81.9 33%	83.8 34.2%

147. Secondary Outcome

Title	Percentage of Participants Who Maintained an ACR 70 Response at Week 100 Among Participants Who Achieved an ACR 70 Response at Week 52
Description	ACR 70 response was defined as >=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 millimeters [mm], 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time Frame	Week 100

Outcome Measure Data

Analysis Population Description

FAS3 among participants who achieved ACR70 response at Week 52.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	43	68	64
Number [percentage of participants]	65.1 26.5%	80.9 32.6%	71.9 29.3%

148. Secondary Outcome

Title	Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100
Description	HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.
Time Frame	Baseline, Weeks 52, 68, 76, 84 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	-0.3899 (0.58250)	-0.4801 (0.56246)	-0.5111 (0.58347)
Week 68	-0.4668 (0.59226)	-0.5120 (0.54928)	-0.5631 (0.54528)
Week 76	-0.4740 (0.57852)	-0.5694 (0.56421)	-0.5448 (0.54739)
Week 84	-0.5041 (0.59716)	-0.5653 (0.59488)	-0.5656 (0.57921)
Week 100	-0.5356 (0.56707)	-0.5859 (0.58199)	-0.6000 (0.56858)

149. Secondary Outcome

Title	Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline
Description	HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.
Time Frame	Weeks 52, 68, 76, 84 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 among participants with HAQ-DI score >=0.35 at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	219	213	211
Week 52	51.1 20.8%	60.6 24.4%	63.3 25.8%
Week 68	57.2 23.3%	64.9 26.2%	69.4 28.3%
Week 76	59.3 24.1%	68.4 27.6%	64.7 26.4%
Week 84	58.9 23.9%	66.8 26.9%	65.5 26.7%
Week 100	63.3 25.7%	70.7 28.5%	70.1 28.6%

150. Secondary Outcome

Title	Percentage of Participants Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 100 Among Participants Who Achieved a HAQ-DI Response at Week 52
Description	HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.
Time Frame	Week 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 among participants with HAQ-DI Score >=0.35 at Baseline and who achieved a HAQ-DI response at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	107	125	131
Number [percentage of participants]	91.6 37.2%	90.4 36.5%	88.5 36.1%

151. Secondary Outcome

Title	Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100
Description	DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) response criteria was defined as follows: Good response: <=3.2 at visit and >1.2 improvement; Moderate response: >3.2 at visit and >1.2 improvement or <=5.1 at visit and >0.6-1.2 improvement; No response: <=0.6 improvement, or >5.1 at visit and <=1.2 improvement. The values are 0=best to 10=worst. A DAS28 (CRP) responder was defined as achieving a good or moderate DAS28 response at a specific visit.
Time Frame	Weeks 52, 68, 76, 84 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	89.3 36.3%	89.7 36.2%	90.2 36.8%
Week 68	92.7 37.7%	92.5 37.3%	92.7 37.8%
Week 76	94.1 38.3%	90.2 36.4%	93.3 38.1%
Week 84	94.8 38.5%	92.7 37.4%	92.5 37.8%
Week 100	94.3 38.3%	90.6 36.5%	92.7 37.8%

152. Secondary Outcome

Title	Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100
Description	DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission was defined as DAS28 (CRP) value <2.6 at the analysis visit.
Time Frame	Weeks 52, 68, 76, 84 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	34.7 14.1%	39.7 16%	40.4 16.5%
Week 68	39.0 15.9%	44.9 18.1%	49.1 20%
Week 76	43.2 17.6%	44.2 17.8%	43.5 17.8%
Week 84	41.8 17%	50.9 20.5%	48.1 19.6%
Week 100	42.4 17.2%	47.5 19.2%	51.6 21.1%

153. Secondary Outcome

Title	Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100
Description	DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis.
Time Frame	Baseline, Weeks 52, 68, 76, 84 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	-2.14 (1.142)	-2.08 (1.124)	-2.14 (1.118)
Week 68	-2.29 (1.132)	-2.25 (1.170)	-2.30 (1.143)
Week 76	-2.35 (1.110)	-2.24 (1.147)	-2.24 (1.087)
Week 84	-2.40 (1.087)	-2.35 (1.181)	-2.31 (1.156)
Week 100	-2.42 (1.144)	-2.37 (1.215)	-2.36 (1.120)

154. Secondary Outcome

Title	Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100
Description	The modified PsARC response was defined as improvement in at least 2 of the four criteria: >=30% decrease in swollen joint count, >=30% decrease in tender joint count, >=20% improvement in patient's Global Assessment of Disease Activity (arthritis) on a VAS (0-100 mm, 0=excellent and 100= poor), >=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.
Time Frame	Weeks 52, 68, 76, 84 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	81.4 33.1%	86.2 34.8%	83.6 34.1%
Week 68	84.3 34.3%	89.9 36.3%	87.6 35.8%
Week 76	84.6 34.4%	88.8 35.8%	90.6 37%
Week 84	87.4 35.5%	87.7 35.4%	87.6 35.8%
Week 100	86.3 35.1%	89.3 36%	88.6 36.2%

155. Secondary Outcome

Title	Percentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at Baseline
Description	Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI>0.
Time Frame	Weeks 52, 76, and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 among the participants with enthesitis (LEI) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	165	147	160
Week 52	67.3 27.4%	66.0 26.6%	61.0 24.9%
Week 76	72.3 29.4%	71.8 29%	67.5 27.6%
Week 100	75.2 30.6%	77.5 31.3%	67.7 27.6%

156. Secondary Outcome

Title	Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at Baseline
Description	Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis.
Time Frame	Baseline, Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 among the participants with enthesitis (LEI) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	165	147	160
Week 52	-2.1 (1.59)	-1.9 (1.66)	-2.1 (1.72)
Week 76	-2.3 (1.52)	-2.1 (1.66)	-2.2 (1.69)
Week 100	-2.4 (1.70)	-2.1 (1.65)	-2.2 (1.80)

157. Secondary Outcome

Title	Percentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at Baseline
Description	The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score >0.
Time Frame	Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 among participants with dactylitis at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	92	104	110
Week 52	78.3 31.8%	81.7 32.9%	80.7 32.9%
Week 76	80.2 32.6%	84.0 33.9%	82.4 33.6%
Week 100	83.7 34%	91.1 36.7%	82.9 33.8%

158. Secondary Outcome

Title	Change From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at Baseline
Description	The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement of dactylitis.
Time Frame	Baseline, Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 among the participants with dactylitis at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	92	104	110
Week 52	-7.4 (9.22)	-7.3 (9.78)	-7.4 (8.66)
Week 76	-8.0 (9.55)	-7.8 (10.24)	-7.6 (8.93)
Week 100	-8.1 (9.63)	-7.9 (10.12)	-7.9 (9.14)

159. Secondary Outcome

Title	Change From Baseline in PASDAS Score at Weeks 52, 76 and 100
Description	PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS [0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS [0-100 mm, 0=no arthritis activity and 100=extremely active arthritis]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 [where 0= no tenderness and 3= extreme tenderness] and recoding to 0-1, where any score > 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity.
Time Frame	Baseline, Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	-3.054 (1.4954)	-3.189 (1.5216)	-3.184 (1.4576)
Week 76	-3.503 (1.4708)	-3.418 (1.5646)	-3.436 (1.4428)
Week 100	-3.574 (1.4785)	-3.586 (1.5425)	-3.549 (1.4635)

160. Secondary Outcome

Title	Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100
Description	PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining PtGA of Disease Activity (arthritis and psoriasis, using VAS [0-100 mm, 0=excellent and 100= poor), PGA of Disease Activity (using VAS [0-100 mm, 0=no arthritis activity and 100=extremely active arthritis]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 [where 0= no tenderness and 3= extreme tenderness] and recoding to 0-1, where any score > 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity. Low: PASDAS <= 3.2; Very low: PASDAS <= 1.9.
Time Frame	Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52: Low	39.0 15.9%	44.8 18.1%	46.7 19.1%
Week 52: Very Low	13.0 5.3%	22.0 8.9%	16.0 6.5%
Week 76: Low	52.1 21.2%	50.0 20.2%	49.8 20.3%
Week 76: Very Low	18.3 7.4%	23.4 9.4%	22.0 9%
Week 100: Low	55.3 22.5%	54.7 22.1%	57.8 23.6%
Week 100: Very Low	19.9 8.1%	26.0 10.5%	23.4 9.6%

161. Secondary Outcome

Title	Change From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100
Description	GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), patient's global assessment of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), patient's global assessment of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + [2.367*HAQ-DI]-[0.234*SF-PCS]-[0.244*SF-MCS]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score ranges from 0-100, higher scores= better quality of life) and SF-MCS (score ranges from 0-100, higher scores= better quality of life). Total score is from 0-10, lower score=better response. Higher score indicates more active disease activity. Negative change from baseline indicates improvement of PsA disease activity.
Time Frame	Baseline, Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	-3.105 (1.6208)	-3.266 (1.6443)	-3.298 (1.5457)
Week 76	-3.499 (1.6303)	-3.528 (1.5778)	-3.541 (1.5048)
Week 100	-3.561 (1.6389)	-3.656 (1.6071)	-3.664 (1.5205)

162. Secondary Outcome

Title	Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 52, 76 and 100
Description	GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), PtGA of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), PtGA of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + [2.367*HAQ-DI]-[0.234*SF-PCS]-[0.244*SF-MCS]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score range= 0-100, higher scores= better quality of life) and SF-MCS (score range=0-100, higher scores= better quality of life). Total score is 0-10, lower score=better response. Higher score= more active disease activity. Negative change from baseline indicates improvement of PsA disease activity. GRACE low disease activity is GRACE score <=2.3 at the analysis visit.
Time Frame	Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	35.4 14.4%	42.7 17.2%	43.8 17.9%
Week 76	45.7 18.6%	48.9 19.7%	49.8 20.3%
Week 100	48.1 19.6%	51.1 20.6%	54.5 22.2%

163. Secondary Outcome

Title	Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100
Description	DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL, value <lower limit of quantification [LLOQ] is considered equal to half of the value of LLOQ for numerical calculations), patient assessment of pain (0-10cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.
Time Frame	Baseline, Weeks 52, 68, 76, 84 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	-31.274 (18.8900)	-30.604 (17.5366)	-32.563 (16.4765)
Week 68	-33.918 (18.0463)	-33.146 (18.1727)	-34.900 (17.5749)
Week 76	-34.391 (17.4074)	-33.062 (17.5186)	-34.590 (16.5401)
Week 84	-35.240 (17.7891)	-33.622 (18.0612)	-34.570 (18.2685)
Week 100	-34.819 (17.9807)	-34.019 (19.2678)	-35.549 (16.5533)

164. Secondary Outcome

Title	Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100
Description	DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL), patient assessment of pain (0-10 cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. The assessment does not have a score range with an upper or lower bound. Low: DAPSA<=14; Remission: DAPSA<=4.
Time Frame	Weeks 52, 68, 76, 84 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52: Low Disease Activity	50.7 20.6%	55.2 22.3%	55.6 22.7%
Week 52: Remission	10.2 4.1%	19.4 7.8%	17.3 7.1%
Week 68: Low Disease Activity	54.1 22%	64.3 25.9%	63.3 25.8%
Week 68: Remission	15.6 6.3%	23.8 9.6%	23.9 9.8%
Week 76: Low Disease Activity	58.2 23.7%	61.2 24.7%	61.4 25.1%
Week 76: Remission	16.4 6.7%	26.8 10.8%	19.7 8%
Week 84: Low Disease Activity	60.6 24.6%	66.5 26.8%	64.6 26.4%
Week 84: Remission	17.8 7.2%	28.0 11.3%	23.6 9.6%
Week 100: Low Disease Activity	61.9 25.2%	65.9 26.6%	68.9 28.1%
Week 100: Remission	18.6 7.6%	26.9 10.8%	23.7 9.7%

165. Secondary Outcome

Title	Change From Baseline in mCPDAI Score at Weeks 52, 76 and 100
Description	The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity.
Time Frame	Baseline, Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	-3.78 (2.392)	-3.83 (2.458)	-4.14 (2.358)
Week 76	-4.39 (2.425)	-4.16 (2.539)	-4.47 (2.347)
Week 100	-4.44 (2.484)	-4.38 (2.433)	-4.52 (2.519)

166. Secondary Outcome

Title	Percentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100
Description	The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. mCPDAI low disease activity is defined as mCPDAI score <=3.2 at the analysis visit.
Time Frame	Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	56.6 23%	61.2 24.7%	60.6 24.7%
Week 76	64.3 26.1%	63.7 25.7%	68.6 28%
Week 100	67.5 27.4%	71.7 28.9%	68.0 27.8%

167. Secondary Outcome

Title	Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100
Description	MDA is a measure that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved the PsA MDA at a visit if the participant has fulfilled at least 5 of the following 7 criteria at that visit: Tender joint count (68 joints)<=1, Swollen joint count (66 joints) <=1, Psoriasis activity and severity index <=1, Patient's Assessment of Pain <=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) <=20 on a 100-unit VAS, HAQ-DI score <=0.5, and Tender entheseal points <= 1 (LEI index score <= 1).
Time Frame	Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	32.0 13%	32.8 13.2%	37.2 15.2%
Week 76	34.7 14.1%	40.0 16.1%	39.0 15.9%
Week 100	42.5 17.3%	44.6 18%	42.7 17.4%

168. Secondary Outcome

Title	Percentage of Participants With VLDA at Weeks 52, 76 and 100
Description	A measurement that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved VLDA at a visit if the participant fulfilled all 7 criteria (tender joint count <=1; swollen joint count <=1; PASI <=1; patient pain VAS score of <=15; patient global disease activity VAS [arthritis and psoriasis] score of <=20; Health Assessment Questionnaire (HAQ) score <=0.5; and tender entheseal points <=1) at that visit.
Time Frame	Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	7.0 2.8%	16.8 6.8%	12.4 5.1%
Week 76	12.2 5%	19.6 7.9%	14.8 6%
Week 100	14.6 5.9%	18.8 7.6%	15.0 6.1%

169. Secondary Outcome

Title	Change From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at Baseline
Description	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.
Time Frame	Baseline, Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 among participants with spondylitis and peripheral arthritis and BASDAI Score>0 at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	88	63	79
Week 52	-2.986 (2.4945)	-2.923 (2.5194)	-3.084 (2.1843)
Week 76	-3.311 (2.6106)	-3.377 (2.5969)	-3.129 (2.1122)
Week 100	-3.718 (2.3960)	-3.472 (2.5233)	-3.330 (2.1598)

170. Secondary Outcome

Title	Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline
Description	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.
Time Frame	Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 among participants with spondylitis and peripheral arthritis and BASDAI score >0 at Baseline. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	88	63	79
Week 52: Participants with >=20% Improvement	71.6 29.1%	69.8 28.1%	79.7 32.5%
Week 76: Participants with >=20% Improvement	74.1 30.1%	82.0 33.1%	81.8 33.4%
Week 100: Participants with >=20% Improvement	87.8 35.7%	77.0 31%	82.9 33.8%
Week 52: Participants with >=50% Improvement	50.0 20.3%	42.9 17.3%	50.6 20.7%
Week 76: Participants with >=50% Improvement	52.9 21.5%	52.5 21.2%	50.6 20.7%
Week 100: Participants with >=50% Improvement	59.8 24.3%	57.4 23.1%	55.3 22.6%
Week 52: Participants with >=70% Improvement	23.9 9.7%	27.0 10.9%	30.4 12.4%
Week 76: Participants with >=70% Improvement	31.8 12.9%	31.1 12.5%	26.0 10.6%
Week 100: Participants with >=70% Improvement	32.9 13.4%	39.3 15.8%	32.9 13.4%
Week 52: Participants with >=90% Improvement	6.8 2.8%	11.1 4.5%	8.9 3.6%
Week 76: Participants with >=90% Improvement	11.8 4.8%	13.1 5.3%	7.8 3.2%
Week 100: Participants with >=90% Improvement	18.3 7.4%	11.5 4.6%	9.2 3.8%

171. Secondary Outcome

Title	Change From Baseline in PASI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative change from baseline indicates improvement of psoriasis.
Time Frame	Baseline, Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 among participants with >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	172	169	174
Week 52	-11.030 (10.0077)	-11.991 (12.1194)	-12.875 (11.2905)
Week 76	-11.313 (10.0631)	-11.991 (12.2656)	-13.242 (11.8845)
Week 100	-11.089 (10.0239)	-12.101 (12.1322)	-13.274 (11.9673)

172. Secondary Outcome

Title	Percentage of Participants Who Achieved PASI 50 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 50 response: >=50% improvement in PASI score from baseline.
Time Frame	Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 among participants with >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	172	169	174
Week 52	95.9 39%	97.0 39.1%	98.3 40.1%
Week 76	97.6 39.7%	96.4 38.9%	97.1 39.6%
Week 100	95.6 38.9%	97.0 39.1%	98.2 40.1%

173. Secondary Outcome

Title	Percentage of Participants Who Achieved PASI 75 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 75 response: >=75% improvement in PASI score from baseline.
Time Frame	Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 among participants with >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	172	169	174
Week 52	88.3 35.9%	88.8 35.8%	91.9 37.5%
Week 76	92.8 37.7%	87.9 35.4%	93.0 38%
Week 100	91.9 37.4%	87.8 35.4%	89.4 36.5%

174. Secondary Outcome

Title	Percentage of Participants Who Achieved PASI 90 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 90 response: >=90% improvement in PASI score from baseline.
Time Frame	Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 among participants with >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	172	169	174
Week 52	76.6 31.1%	76.9 31%	81.5 33.3%
Week 76	85.5 34.8%	75.8 30.6%	80.2 32.7%
Week 100	87.5 35.6%	75.0 30.2%	80.0 32.7%

175. Secondary Outcome

Title	Percentage of Participants Who Achieved PASI 100 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 100 response: 100% improvement in PASI score from baseline.
Time Frame	Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 among participants with >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	172	169	174
Week 52	55.0 22.4%	54.4 21.9%	60.7 24.8%
Week 76	65.1 26.5%	59.4 24%	68.0 27.8%
Week 100	69.4 28.2%	57.3 23.1%	64.1 26.2%

176. Secondary Outcome

Title	Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	In PASI, each area (head, trunk, upper and lower extremities) was assessed for % of area involved and translated to numeric score from 0 (no involvement) to 6 (90-100% involvement) and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score from 0 to 72. Higher scores=more severe disease. PASI 75: >=75% improvement in PASI score from baseline. ACR 20: >=20% improvement in swollen joint count (SJC) (66 joints) + tender joint count (TJC) (68 joints) and >=20% improvement in 3 of 5: patient's assessment of pain (VAS; 0-100 mm, 0=no pain to 100=worst possible pain), PtGA of disease activity (VAS; 0-100 mm, 0=excellent to 100=poor), PGA of disease activity (VAS; 0-100 mm, 0=no arthritis to 100=extremely active arthritis), patient's assessment of physical function (HAQ-DI -20-question instrument; range- 0=no difficulty to 3=inability to perform task) and CRP.
Time Frame	Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 among participants with >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	172	169	174
Week 52	59.4 24.1%	73.4 29.6%	70.5 28.8%
Week 76	71.1 28.9%	75.8 30.6%	76.7 31.3%
Week 100	73.0 29.7%	76.1 30.7%	77.5 31.6%

177. Secondary Outcome

Title	Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 52, 76, and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	In PASI, each area (head, trunk, upper and lower extremities) was assessed separately for % of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score range from 0 to 72. Higher scores=more severe disease. PASI 75 response: >=75% improvement in PASI score from baseline. Modified PsARC response: improvement in at least 2 of 4 criteria: >=30% decrease in SJC and TJC, >=20% improvement in PtGA of Disease Activity (arthritis) on VAS (0-100 mm, 0=excellent and 100=poor), >=20% improvement in PGA of Disease Activity on VAS (VAS: 0-100 mm, 0=no arthritis and 100=extremely active arthritis), and at least 1 of 2 joint criteria with no deterioration in other criteria.
Time Frame	Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 among participants with >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	172	169	174
Week 52	70.8 28.8%	79.3 32%	76.9 31.4%
Week 76	78.3 31.8%	79.4 32%	82.6 33.7%
Week 100	78.8 32%	81.1 32.7%	78.8 32.2%

178. Secondary Outcome

Title	Percentage of Participants With an IGA Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). IGA Response is defined as achieving IGA score of 0 or 1, and >=2 grade reduction from baseline.
Time Frame	Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 among participants with >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	172	169	174
Week 52	84.2 34.2%	76.9 31%	84.4 34.4%
Week 76	85.5 34.8%	77.6 31.3%	86.0 35.1%
Week 100	88.1 35.8%	76.4 30.8%	82.4 33.6%

179. Secondary Outcome

Title	Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame	Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 among participants with >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	172	169	174
Week 52	66.7 27.1%	59.8 24.1%	65.9 26.9%
Week 76	72.9 29.6%	64.2 25.9%	72.1 29.4%
Week 100	76.9 31.3%	58.8 23.7%	67.1 27.4%

180. Secondary Outcome

Title	Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 52, 76 and 100 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. A DLQI score of 0 or 1 indicates psoriasis had no effect at all on patient's life.
Time Frame	Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 among the participants with DLQI Score >1, with >=3% BSA psoriatic involvement and an IGA score of >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	161	152	163
Week 52	56.5 23%	68.4 27.6%	68.5 28%
Week 76	66.9 27.2%	66.7 26.9%	68.9 28.1%
Week 100	74.7 30.4%	69.6 28.1%	64.8 26.4%

181. Secondary Outcome

Title	Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. An improvement of 5 points was considered clinically meaningful.
Time Frame	Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 among the participants with DLQI score >=5, >=3% BSA psoriatic involvement and an IGA score of >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	138	129	143
Week 52	84.8 34.5%	92.2 37.2%	89.4 36.5%
Week 76	91.9 37.4%	89.0 35.9%	90.1 36.8%
Week 100	91.7 37.3%	94.4 38.1%	88.5 36.1%

182. Secondary Outcome

Title	Change From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description	Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. Negative changes from baseline indicate improvement of life quality impacted by psoriasis.
Time Frame	Baseline, Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3 among the participants with >=3% BSA psoriatic involvement and an IGA Score of >=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	172	169	174
Week 52	-8.855 (7.2738)	-9.272 (7.3903)	-9.873 (6.8832)
Week 76	-10.090 (7.0888)	-9.180 (7.2977)	-9.610 (7.0383)
Week 100	-10.130 (7.2798)	-9.291 (7.2851)	-9.635 (7.0884)

183. Secondary Outcome

Title	Change in Modified vdH-S Score From Baseline to Week 100
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame	Baseline to Week 100

Outcome Measure Data

Analysis Population Description

FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	204	216	211
Mean (Standard Deviation) [units on a scale]	1.49 (6.859)	1.50 (4.393)	1.68 (7.018)

184. Secondary Outcome

Title	Change in Total Modified vdH-S Score From Week 52 to Week 100
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage.
Time Frame	From Week 52 to Week 100

Outcome Measure Data

Analysis Population Description

FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	202	216	211
Mean (Standard Deviation) [units on a scale]	0.13 (3.742)	0.46 (2.419)	0.75 (4.021)

185. Secondary Outcome

Title	Change in Modified vdH-s Erosion Score From Baseline to Week 100
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame	Baseline to Week 100

Outcome Measure Data

Analysis Population Description

FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	204	216	211
Mean (Standard Deviation) [units on a scale]	1.01 (4.034)	1.01 (3.355)	1.02 (4.676)

186. Secondary Outcome

Title	Change in Modified vdH-s Erosion Score From Week 52 to Week 100
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame	From Week 52 to Week 100

Outcome Measure Data

Analysis Population Description

FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	202	216	211
Mean (Standard Deviation) [units on a scale]	0.09 (1.978)	0.26 (1.751)	0.45 (2.900)

187. Secondary Outcome

Title	Change in Modified vdH-s JSN Score From Baseline to Week 100
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame	Baseline to Week 100

Outcome Measure Data

Analysis Population Description

FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	204	216	211
Mean (Standard Deviation) [units on a scale]	0.49 (2.984)	0.50 (1.387)	0.66 (2.722)

188. Secondary Outcome

Title	Change in Modified vdH-s JSN Score From Week 52 to Week 100
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame	From Week 52 to Week 100

Outcome Measure Data

Analysis Population Description

FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	202	216	211
Mean (Standard Deviation) [units on a scale]	0.04 (1.904)	0.20 (0.917)	0.30 (1.319)

189. Secondary Outcome

Title	Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores)
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand (Hand erosion score) scored according to 0 (no erosion) to 5 (complete collapse of bone) for a maximum hand erosion score of 200, and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum foot erosion score of 120. Higher scores indicate more joint damage. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum Hand JSN score of 160 and maximum Foot JSN score of 48. Higher scores indicate more joint damage. Hand Score (sum of Hand Erosion Score and Hand JSN Score) scored as 0-360 and Foot score (sum of foot erosion score and foot JSN score) scored as 0-168. Higher scores indicate more joint damage.
Time Frame	Baseline to Week 100

Outcome Measure Data

Analysis Population Description

FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified category.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Hand Erosion Score	0.67 (2.917)	0.67 (2.807)	0.49 (3.007)
Hand JSN Score	0.35 (2.443)	0.34 (1.247)	0.32 (1.845)
Hand Score	1.02 (5.244)	1.02 (3.815)	0.81 (4.532)
Foot Erosion Score	0.34 (1.596)	0.33 (1.362)	0.53 (2.436)
Foot JSN Score	0.13 (0.912)	0.15 (0.652)	0.34 (1.608)
Foot Score	0.48 (2.373)	0.48 (1.652)	0.87 (3.761)

190. Secondary Outcome

Title	Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Score
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame	Baseline to Week 100

Outcome Measure Data

Analysis Population Description

FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified category.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Change of <=0 from Baseline	60.8 24.7%	55.6 22.4%	62.6 25.6%
Change of <=0.5 from Baseline	72.1 29.3%	63.9 25.8%	72.5 29.6%

191. Secondary Outcome

Title	Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion Score
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame	Baseline to Week 100

Outcome Measure Data

Analysis Population Description

FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified category.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Change of <=0 from Baseline	64.2 26.1%	61.1 24.6%	65.4 26.7%
Change of <=0.5 from Baseline	75.0 30.5%	73.1 29.5%	75.4 30.8%

192. Secondary Outcome

Title	Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN Score
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame	Baseline to Week 100

Outcome Measure Data

Analysis Population Description

FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified category.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Change of <=0 from Baseline	77.5 31.5%	68.5 27.6%	73.9 30.2%
Change of <=0.5 from Baseline	84.3 34.3%	79.6 32.1%	81.0 33.1%

193. Secondary Outcome

Title	Percentage of Participants Without Radiographic Modified vdH-S Progression Based on (SDC) From Baseline to Week 100
Description	Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic progression was defined as change from baseline in the modified vdH-S score <=SDC of 3.46.
Time Frame	Baseline to Week 100

Outcome Measure Data

Analysis Population Description

FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	204	216	211
Number [percentage of participants]	86.8 35.3%	84.7 34.2%	87.2 35.6%

194. Secondary Outcome

Title	Percentage of Participants Without Radiographic Erosion Progression (Based on SDC) From Baseline to Week 100
Description	Modified vdH-S score is sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is summary of erosion severity in 40 joints of hand scored according to surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic erosion progression was defined as change from baseline in the modified vdH-S erosion score <=SDC of 2.66.
Time Frame	Baseline to Week 100

Outcome Measure Data

Analysis Population Description

FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	204	216	211
Number [percentage of participants]	86.8 35.3%	87.0 35.1%	88.6 36.2%

195. Secondary Outcome

Title	Percentage of Participants Without Radiographic JSN Progression (Based on SDC) From Baseline to Week 100
Description	Modified vdH-S score is sum of erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is summary of erosion severity in 40 joints of hand scored according to surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic JSN progression was defined as change from baseline in the modified vdH-S JSN score <=SDC of 1.66.
Time Frame	Baseline to Week 100

Outcome Measure Data

Analysis Population Description

FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	204	216	211
Number [percentage of participants]	90.7 36.9%	89.4 36%	88.2 36%

196. Secondary Outcome

Title	Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100
Description	Pencil in Cup or Gross Osteolytis Deformities are radiographic features specific for psoriatic arthritis.
Time Frame	Baseline, Weeks 24, 52, and 100

Outcome Measure Data

Analysis Population Description

FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Baseline	3.7 1.5%	3.9 1.6%	3.6 1.5%
Week 24	3.7 1.5%	3.9 1.6%	4.1 1.7%
Week 52	4.2 1.7%	4.4 1.8%	3.6 1.5%
Week 100	4.9 2%	4.6 1.9%	3.8 1.6%

197. Secondary Outcome

Title	Change From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100
Description	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time Frame	Baseline, Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	8.170 (8.2195)	9.438 (8.2854)	9.023 (8.6263)
Week 76	9.762 (8.5908)	10.814 (9.0290)	9.707 (8.5010)
Week 100	10.508 (8.6819)	11.282 (9.2753)	10.559 (8.7449)

198. Secondary Outcome

Title	Change From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100
Description	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time Frame	Baseline, Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	4.383 (10.9402)	4.540 (9.7848)	4.127 (9.1368)
Week 76	4.838 (11.0526)	5.034 (10.0334)	5.194 (9.4899)
Week 100	4.610 (11.2527)	4.718 (9.9014)	4.936 (9.5935)

199. Secondary Outcome

Title	Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100
Description	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales: physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health. The scores 0-100 (where higher scores indicated a better quality of life) from each subscale of SF-36 were normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better health status. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time Frame	Baseline, Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52: Physical Function Score	7.757 (8.9727)	8.406 (8.8407)	8.493 (8.7691)
Week 76: Physical Function Score	8.824 (9.6648)	9.807 (9.5044)	9.294 (8.2020)
Week 100: Physical Function Score	9.738 (9.8405)	10.953 (9.7761)	10.126 (8.9271)
Week 52: Role-physical Score	6.538 (8.5151)	7.665 (8.2925)	7.372 (7.7581)
Week 76: Role-physical Score	8.372 (8.7202)	9.171 (8.5844)	8.579 (7.6709)
Week 100: Role-physical Score	9.181 (8.6596)	9.342 (9.1746)	8.921 (8.1775)
Week 52: Bodily Pain Score	8.536 (8.4602)	10.201 (8.7312)	9.525 (9.8357)
Week 76: Bodily Pain Score	10.368 (9.1058)	11.552 (9.8591)	10.300 (9.0504)
Week 100: Bodily Pain Score	10.696 (9.3854)	11.585 (10.3527)	10.998 (8.9230)
Week 52: General Health Score	6.533 (8.5245)	7.097 (7.2500)	6.450 (8.4316)
Week 76: General Health Score	7.203 (8.3372)	7.470 (7.6119)	6.761 (7.9631)
Week 100: General Health Score	6.710 (8.7265)	7.066 (7.5829)	7.132 (8.4887)
Week 52: Vitality Score	7.997 (9.3878)	8.695 (9.5033)	7.637 (9.4393)
Week 76: Vitality Score	8.859 (9.4372)	9.388 (9.8618)	8.659 (9.6026)
Week 100: Vitality Score	9.648 (9.4778)	9.827 (9.9348)	9.155 (9.3569)
Week 52: Social Function Score	6.361 (10.9927)	7.304 (10.1003)	6.810 (9.5118)
Week 76: Social Function Score	7.509 (10.4249)	8.623 (9.5176)	7.914 (9.5191)
Week 100: Social Function Score	7.825 (10.8558)	8.080 (9.5383)	8.113 (9.4847)
Week 52: Role-emotional Score	4.111 (10.9413)	4.998 (10.1964)	4.699 (8.7759)
Week 76: Role-emotional Score	5.199 (11.1875)	5.757 (10.0737)	5.433 (9.2389)
Week 100: Role-emotional Score	4.784 (11.9482)	5.720 (10.1991)	5.128 (9.7998)
Week 52: Mental Health Score	5.209 (10.0958)	4.826 (9.4038)	4.839 (9.4029)
Week 76: Mental Health Score	5.481 (10.5927)	5.430 (10.0802)	6.124 (8.7930)
Week 100: Mental Health Score	5.514 (10.6204)	5.477 (10.1202)	6.148 (8.8743)

200. Secondary Outcome

Title	Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100
Description	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.
Time Frame	Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	63.4 25.8%	66.8 26.9%	65.9 26.9%
Week 76	70.6 28.7%	73.8 29.8%	65.5 26.7%
Week 100	72.4 29.4%	70.1 28.3%	68.6 28%

201. Secondary Outcome

Title	Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100
Description	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.
Time Frame	Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	42.3 17.2%	45.3 18.3%	38.9 15.9%
Week 76	43.9 17.8%	44.4 17.9%	43.5 17.8%
Week 100	42.1 17.1%	46.4 18.7%	43.6 17.8%

202. Secondary Outcome

Title	Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100
Description	The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Time Frame	Baseline, Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	7.692 (9.3071)	8.935 (9.5033)	7.699 (9.1417)
Week 76	9.167 (9.0455)	9.596 (10.4788)	8.632 (8.8429)
Week 100	9.435 (9.4513)	10.107 (10.2076)	9.127 (8.9948)

203. Secondary Outcome

Title	Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100
Description	The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Time Frame	Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	68.7 27.9%	69.4 28%	68.1 27.8%
Week 76	70.6 28.7%	69.3 27.9%	74.4 30.4%
Week 100	72.0 29.3%	72.8 29.4%	74.1 30.2%

204. Secondary Outcome

Title	Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VAS
Description	EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status.
Time Frame	Baseline, Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	21.608 (25.5992)	23.392 (23.6990)	20.190 (24.8348)
Week 76	24.176 (27.7205)	25.053 (26.0372)	22.251 (24.6934)
Week 100	25.901 (28.4028)	27.152 (26.5221)	25.909 (26.0995)

205. Secondary Outcome

Title	Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D Index
Description	EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (full health). A higher score indicates better health and positive changes from baseline indicate improvement of health.
Time Frame	Baseline, Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	0.138 (0.1608)	0.150 (0.1445)	0.138 (0.1458)
Week 76	0.154 (0.1744)	0.169 (0.1564)	0.147 (0.1471)
Week 100	0.164 (0.1605)	0.164 (0.1596)	0.156 (0.1543)

206. Secondary Outcome

Title	Change From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100
Description	Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time Frame	Baseline, Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	136	130	130
Week 52	-5.45 (25.544)	-4.50 (20.530)	-1.83 (17.191)
Week 76	-5.92 (26.032)	-6.22 (23.133)	-2.39 (19.277)
Week 100	-8.81 (24.313)	-5.81 (21.606)	-1.56 (16.956)

207. Secondary Outcome

Title	Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100
Description	Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time Frame	Baseline, Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	116	121	122
Week 52	-21.81 (31.391)	-27.93 (25.263)	-22.62 (26.058)
Week 76	-26.90 (28.965)	-29.91 (24.549)	-26.13 (25.412)
Week 100	-30.73 (30.933)	-30.65 (24.771)	-27.77 (26.119)

208. Secondary Outcome

Title	Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100
Description	Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time Frame	Baseline, Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	116	121	122
Week 52	-22.61 (31.979)	-28.19 (25.536)	-22.79 (26.793)
Week 76	-27.98 (29.709)	-30.27 (26.058)	-26.21 (28.115)
Week 100	-31.87 (31.013)	-31.75 (25.615)	-25.21 (26.317)

209. Secondary Outcome

Title	Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100
Description	Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time Frame	Baseline, Weeks 52, 76 and 100

Outcome Measure Data

Analysis Population Description

Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.

Arm/Group Title	Placebo to Guselkumab 100 mg q4w	Guselkumab 100 mg q8w	Guselkumab 100 mg q4w
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
Measure Participants	228	232	227
Week 52	-24.67 (27.106)	-27.16 (25.662)	-26.24 (25.113)
Week 76	-28.05 (26.411)	-31.38 (25.449)	-28.70 (24.635)
Week 100	-30.70 (28.632)	-30.98 (26.650)	-30.68 (25.305)

Adverse Events

Time Frame	From baseline after the first administration of study drug through End of Study (up to Week 112)
Adverse Event Reporting Description	Safety population included participants randomized at Week 0 who received at least 1 (partial or complete) dose of study agent and were analyzed according to the actual treatment received after randomization. Data for Guselkumab 100 mg q8w and q4w arms was planned to be reported separately for Week 0 to 24 and Week 0 to 52.
Arm/Group Title	Placebo (CP)		Guselkumab 100 mg q8w (CP)		Guselkumab 100 mg q4w (CP)		Placebo to Guselkumab 100 mg q4w (After CP Through Week 112)		Guselkumab 100 mg q8w (Through Week 112)		Guselkumab 100 mg q4w (Through Week 112)
Arm/Group Description	Participants received placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (CP). Data prior to the first administration of guselkumab, or through the last follow-up visit if the participant did not receive any guselkumab, were included.		Participants received guselkumab 100 milligram (mg) subcutaneous injections at Weeks 0 and 4 then every 8 weeks and placebo matched to guselkumab injections at other visits through Week 20 in the placebo controlled period (CP). Data through Week 24, or through the last follow-up visit if the participant did not receive any study drug at or after Week 24, were included.		Participants received guselkumab 100 milligram (mg) subcutaneous injections every 4 weeks from Week 0 through Week 20 in the placebo controlled period (CP). Data through Week 24, or through the last follow-up visit if the participant did not receive any study drug at or after Week 24, were included.		Participants who received placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (CP) received guselkumab 100 milligram (mg) subcutaneous injections every 4 weeks from Week 24 through Week 100. Data from the first administration of guselkumab through Week 112 (End of Study) were included.		Participants received guselkumab 100 milligram (mg) subcutaneous injections at Weeks 0 and 4 then every 8 weeks and placebo matched to guselkumab injections at other visits through Week 100. Data from Week 0 through Week 112 (End of Study) were included.		Participants received guselkumab 100 milligram (mg) subcutaneous injections every 4 weeks from Week 0 through Week 100. Data from Week 0 through Week 112 (End of Study) were included.
All Cause Mortality
	Placebo (CP)		Guselkumab 100 mg q8w (CP)		Guselkumab 100 mg q4w (CP)		Placebo to Guselkumab 100 mg q4w (After CP Through Week 112)		Guselkumab 100 mg q8w (Through Week 112)		Guselkumab 100 mg q4w (Through Week 112)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/246 (0%)		0/248 (0%)		0/245 (0%)		1/238 (0.4%)		0/248 (0%)		0/245 (0%)
Serious Adverse Events
	Placebo (CP)		Guselkumab 100 mg q8w (CP)		Guselkumab 100 mg q4w (CP)		Placebo to Guselkumab 100 mg q4w (After CP Through Week 112)		Guselkumab 100 mg q8w (Through Week 112)		Guselkumab 100 mg q4w (Through Week 112)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/246 (2.8%)		3/248 (1.2%)		8/245 (3.3%)		16/238 (6.7%)		22/248 (8.9%)		22/245 (9%)
Cardiac disorders
Acute Myocardial Infarction	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		0/248 (0%)		1/245 (0.4%)
Angina Unstable	1/246 (0.4%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Coronary Artery Disease	0/246 (0%)		1/248 (0.4%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		1/245 (0.4%)
Pericarditis	0/246 (0%)		0/248 (0%)		0/245 (0%)		1/238 (0.4%)		0/248 (0%)		0/245 (0%)
Endocrine disorders
Goitre	0/246 (0%)		0/248 (0%)		0/245 (0%)		2/238 (0.8%)		0/248 (0%)		0/245 (0%)
Eye disorders
Iridocyclitis	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Gastrointestinal disorders
Diverticular Perforation	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		0/248 (0%)		1/245 (0.4%)
Gastric Ulcer	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		0/248 (0%)		1/245 (0.4%)
Inflammatory Bowel Disease	1/246 (0.4%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		0/248 (0%)		0/245 (0%)
Pancreatitis Chronic	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Umbilical Hernia	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		0/248 (0%)		1/245 (0.4%)
General disorders
Pyrexia	0/246 (0%)		1/248 (0.4%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Hepatobiliary disorders
Cholecystitis Chronic	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		2/248 (0.8%)		0/245 (0%)
Cholelithiasis	0/246 (0%)		0/248 (0%)		0/245 (0%)		1/238 (0.4%)		0/248 (0%)		0/245 (0%)
Drug-Induced Liver Injury	1/246 (0.4%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		0/248 (0%)		0/245 (0%)
Post Cholecystectomy Syndrome	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Infections and infestations
Acute Hepatitis B	0/246 (0%)		0/248 (0%)		1/245 (0.4%)		0/238 (0%)		0/248 (0%)		1/245 (0.4%)
Acute Hepatitis C	0/246 (0%)		0/248 (0%)		0/245 (0%)		1/238 (0.4%)		0/248 (0%)		0/245 (0%)
Appendicitis	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Complicated Appendicitis	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		0/248 (0%)		1/245 (0.4%)
Cystitis	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Dacryocystitis	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Dengue Fever	0/246 (0%)		0/248 (0%)		0/245 (0%)		1/238 (0.4%)		0/248 (0%)		0/245 (0%)
Diverticulitis	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Herpes Zoster Disseminated	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Infective Periostitis	0/246 (0%)		0/248 (0%)		0/245 (0%)		1/238 (0.4%)		0/248 (0%)		0/245 (0%)
Influenza	0/246 (0%)		0/248 (0%)		0/245 (0%)		1/238 (0.4%)		0/248 (0%)		0/245 (0%)
Medical Device Site Joint Infection	0/246 (0%)		0/248 (0%)		0/245 (0%)		1/238 (0.4%)		0/248 (0%)		0/245 (0%)
Meningitis Listeria	0/246 (0%)		0/248 (0%)		0/245 (0%)		1/238 (0.4%)		0/248 (0%)		0/245 (0%)
Oophoritis	0/246 (0%)		0/248 (0%)		1/245 (0.4%)		0/238 (0%)		0/248 (0%)		1/245 (0.4%)
Pneumonia	0/246 (0%)		0/248 (0%)		0/245 (0%)		1/238 (0.4%)		2/248 (0.8%)		1/245 (0.4%)
Pneumonia Influenzal	0/246 (0%)		0/248 (0%)		1/245 (0.4%)		0/238 (0%)		0/248 (0%)		1/245 (0.4%)
Pneumonia Necrotising	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Tracheitis	0/246 (0%)		0/248 (0%)		0/245 (0%)		1/238 (0.4%)		0/248 (0%)		0/245 (0%)
Urinary Tract Infection	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Vaginitis Gardnerella	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Vulvovaginitis Trichomonal	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Injury, poisoning and procedural complications
Ankle Fracture	0/246 (0%)		1/248 (0.4%)		0/245 (0%)		0/238 (0%)		3/248 (1.2%)		1/245 (0.4%)
Femur Fracture	0/246 (0%)		0/248 (0%)		1/245 (0.4%)		0/238 (0%)		0/248 (0%)		1/245 (0.4%)
Lower Limb Fracture	0/246 (0%)		0/248 (0%)		1/245 (0.4%)		0/238 (0%)		0/248 (0%)		1/245 (0.4%)
Metal Poisoning	0/246 (0%)		0/248 (0%)		1/245 (0.4%)		0/238 (0%)		0/248 (0%)		1/245 (0.4%)
Multiple Injuries	0/246 (0%)		0/248 (0%)		0/245 (0%)		1/238 (0.4%)		0/248 (0%)		1/245 (0.4%)
Muscle Rupture	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		0/248 (0%)		1/245 (0.4%)
Post Procedural Fistula	1/246 (0.4%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		0/248 (0%)		0/245 (0%)
Road Traffic Accident	0/246 (0%)		0/248 (0%)		0/245 (0%)		1/238 (0.4%)		0/248 (0%)		0/245 (0%)
Thermal Burn	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		0/248 (0%)		1/245 (0.4%)
Obesity	1/246 (0.4%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Musculoskeletal and connective tissue disorders
Costochondritis	0/246 (0%)		0/248 (0%)		0/245 (0%)		1/238 (0.4%)		0/248 (0%)		0/245 (0%)
Foot Deformity	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		0/248 (0%)		1/245 (0.4%)
Osteoarthritis	0/246 (0%)		0/248 (0%)		1/245 (0.4%)		2/238 (0.8%)		0/248 (0%)		2/245 (0.8%)
Psoriatic Arthropathy	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear Cell Renal Cell Carcinoma	1/246 (0.4%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		0/248 (0%)		0/245 (0%)
Ovarian Adenoma	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Nervous system disorders
Extrapyramidal Disorder	0/246 (0%)		0/248 (0%)		0/245 (0%)		1/238 (0.4%)		0/248 (0%)		0/245 (0%)
Ischaemic Stroke	0/246 (0%)		0/248 (0%)		1/245 (0.4%)		0/238 (0%)		0/248 (0%)		2/245 (0.8%)
Transient Ischaemic Attack	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Renal and urinary disorders
Calculus Urinary	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Tubulointerstitial Nephritis	1/246 (0.4%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		0/248 (0%)		0/245 (0%)
Reproductive system and breast disorders
Cervical Polyp	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Dysfunctional Uterine Bleeding	0/246 (0%)		0/248 (0%)		0/245 (0%)		1/238 (0.4%)		0/248 (0%)		0/245 (0%)
Endometrial Hyperplasia	0/246 (0%)		0/248 (0%)		0/245 (0%)		1/238 (0.4%)		0/248 (0%)		0/245 (0%)
Endometriosis	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Metrorrhagia	0/246 (0%)		0/248 (0%)		0/245 (0%)		1/238 (0.4%)		0/248 (0%)		0/245 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		0/248 (0%)		2/245 (0.8%)
Sinus Perforation	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		0/248 (0%)		1/245 (0.4%)
Vascular disorders
Blue Toe Syndrome	0/246 (0%)		0/248 (0%)		1/245 (0.4%)		0/238 (0%)		0/248 (0%)		1/245 (0.4%)
Hypertension	0/246 (0%)		0/248 (0%)		0/245 (0%)		0/238 (0%)		1/248 (0.4%)		0/245 (0%)
Pelvic Venous Thrombosis	0/246 (0%)		0/248 (0%)		0/245 (0%)		1/238 (0.4%)		0/248 (0%)		0/245 (0%)
Other (Not Including Serious) Adverse Events
	Placebo (CP)		Guselkumab 100 mg q8w (CP)		Guselkumab 100 mg q4w (CP)		Placebo to Guselkumab 100 mg q4w (After CP Through Week 112)		Guselkumab 100 mg q8w (Through Week 112)		Guselkumab 100 mg q4w (Through Week 112)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	30/246 (12.2%)		42/248 (16.9%)		52/245 (21.2%)		48/238 (20.2%)		88/248 (35.5%)		79/245 (32.2%)
Infections and infestations
Bronchitis	3/246 (1.2%)		1/248 (0.4%)		10/245 (4.1%)		7/238 (2.9%)		10/248 (4%)		15/245 (6.1%)
Nasopharyngitis	9/246 (3.7%)		10/248 (4%)		12/245 (4.9%)		9/238 (3.8%)		25/248 (10.1%)		21/245 (8.6%)
Upper Respiratory Tract Infection	8/246 (3.3%)		7/248 (2.8%)		13/245 (5.3%)		18/238 (7.6%)		24/248 (9.7%)		20/245 (8.2%)
Investigations
Alanine Aminotransferase Increased	11/246 (4.5%)		15/248 (6%)		22/245 (9%)		11/238 (4.6%)		29/248 (11.7%)		31/245 (12.7%)
Aspartate Aminotransferase Increased	6/246 (2.4%)		14/248 (5.6%)		11/245 (4.5%)		10/238 (4.2%)		23/248 (9.3%)		23/245 (9.4%)
Nervous system disorders
Headache	2/246 (0.8%)		6/248 (2.4%)		3/245 (1.2%)		7/238 (2.9%)		16/248 (6.5%)		7/245 (2.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.