Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT02319759

Collaborator

(none)

149

Enrollment

Locations

Arms

21.7

Actual Duration (Months)

3.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab in participants with Active Psoriatic Arthritis (PsA).

Condition or Disease	Intervention/Treatment	Phase
Psoriatic Arthritis	Drug: Guselkumab Drug: Ustekinumab Drug: Placebo	Phase 2

Detailed Description

This is a multi-center (more than one clinical site will work on a medical research study), randomized (study medication assigned to participants by chance), double-blind (neither investigator nor participant knows which treatment the participant receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) study to determine the efficacy and safety of guselkumab in participants with PsA. The study will consist of 4 parts: Screening period (6 weeks), a double-blind treatment period (consists of guselkumab and placebo treatment for 24 weeks), an active treatment period (guselkumab for 20 weeks), and follow-up period (12 weeks). The maximal study duration for a participant will not exceed 62 weeks including the Screening period. Eligible participants will be randomly assigned to one of two groups in a 2:1 ratio to either receive Guselkumab 100 milligram (mg) at Weeks 0, 4 then every 8 weeks or Placebo at Weeks 0, 4 then every 8 weeks until Week 24. At week 24, participants remaining in the placebo group will start to receive guselkumab 100 mg at Weeks 24, 28, 36 and 44. Participants in both treatment groups who have less than (<) 5 percent (%) improvement from baseline in both tender and swollen joint counts at Week 16 will qualify for early escape and will switch to open-label therapy with ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage for the PsA indication in the particular country of study. The efficacy will be assessed primarily by measuring percentage of participants who achieve an American College of Rheumatology (ACR) 20 Response at Week 24. Participants' safety will be monitored throughout the study.

Study Design

Study Type:

Interventional

Actual Enrollment :

149 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects With Active Psoriatic Arthritis

Actual Study Start Date :

Mar 27, 2015

Actual Primary Completion Date :

May 31, 2016

Actual Study Completion Date :

Jan 17, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Guselkumab Participants will receive guselkumab 100 milligram (mg) subcutaneous injection (injected under the skin by way of a needle) at Weeks 0, 4, 12, 20, 28, 36, and 44, and placebo for guselkumab at Week 24 to maintain the blind. Participants who enter early escape at Week 16 will switch to open label therapy with ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage in the particular country of the study.	Drug: Guselkumab In the guselkumab group, Guselkumab 100 mg subcutaneous injection will be administered at Weeks 0, 4, 12, 20, 28, 36 and 44. In the placebo group, guselkumab 100 mg subcutaneous injection will be administered at Weeks 24, 28, 36 and 44 for participants remaining on placebo at Week 24. Drug: Ustekinumab In both placebo and guselkumab groups, if the participants qualify for early escape, they will switch to receive ustekinumab 45 mg or 90 mg subcutaneous injection at Weeks 16, 20, 32, and 44 based on the approved dosage in the particular country of the study. Drug: Placebo In placebo group, Placebo subcutaneous injection will be administered at Weeks 0, 4, 12, and 20. In guselkumab group, placebo subcutaneous injection will be administered at Week 24 to maintain the blind.
Experimental: Placebo Participants will receive placebo for guselkumab at Weeks 0, 4, 12, and 20, and guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36, and 44. Participants who enter early escape at Week 16 will switch to open label therapy with ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage in the particular country of the study.	Drug: Guselkumab In the guselkumab group, Guselkumab 100 mg subcutaneous injection will be administered at Weeks 0, 4, 12, 20, 28, 36 and 44. In the placebo group, guselkumab 100 mg subcutaneous injection will be administered at Weeks 24, 28, 36 and 44 for participants remaining on placebo at Week 24. Drug: Ustekinumab In both placebo and guselkumab groups, if the participants qualify for early escape, they will switch to receive ustekinumab 45 mg or 90 mg subcutaneous injection at Weeks 16, 20, 32, and 44 based on the approved dosage in the particular country of the study. Drug: Placebo In placebo group, Placebo subcutaneous injection will be administered at Weeks 0, 4, 12, and 20. In guselkumab group, placebo subcutaneous injection will be administered at Week 24 to maintain the blind.

Arm

Intervention/Treatment

Experimental: Guselkumab

Participants will receive guselkumab 100 milligram (mg) subcutaneous injection (injected under the skin by way of a needle) at Weeks 0, 4, 12, 20, 28, 36, and 44, and placebo for guselkumab at Week 24 to maintain the blind. Participants who enter early escape at Week 16 will switch to open label therapy with ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage in the particular country of the study.

Drug: Guselkumab

In the guselkumab group, Guselkumab 100 mg subcutaneous injection will be administered at Weeks 0, 4, 12, 20, 28, 36 and 44. In the placebo group, guselkumab 100 mg subcutaneous injection will be administered at Weeks 24, 28, 36 and 44 for participants remaining on placebo at Week 24.

Drug: Ustekinumab

In both placebo and guselkumab groups, if the participants qualify for early escape, they will switch to receive ustekinumab 45 mg or 90 mg subcutaneous injection at Weeks 16, 20, 32, and 44 based on the approved dosage in the particular country of the study.

Drug: Placebo

In placebo group, Placebo subcutaneous injection will be administered at Weeks 0, 4, 12, and 20. In guselkumab group, placebo subcutaneous injection will be administered at Week 24 to maintain the blind.

Experimental: Placebo

Participants will receive placebo for guselkumab at Weeks 0, 4, 12, and 20, and guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36, and 44. Participants who enter early escape at Week 16 will switch to open label therapy with ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage in the particular country of the study.

Drug: Guselkumab

Drug: Ustekinumab

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 24 [Week 24]
ACR 20 response: at least 20% improvement from baseline in both swollen joint (66 joints) and tender joint (68 joints) counts and at least 20% improvement from baseline in 3 of following 5 assessments: patient's assessment of pain (VAS: 0-100 millimeter [mm], 0=no pain and 100=worst possible pain), patient's global assessment of disease activity on arthritis (VAS:0-100mm, 0=excellent and 100=poor), physician's global assessment of disease activity (VAS:0-100mm; 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;derived HAQ-DI ranges from 0=no difficulty, to 3=inability to perform a task in that area) and serum CRP. Treatment Failure (TF) criteria: Discontinued study drug due to lack of efficacy or worsening of PsA, initiated or increased dose of methotrexate or oral corticosteroids, or initiated prohibited PsA treatments. FAS is full analysis set.

Secondary Outcome Measures

Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-75 Response at Week 24 [Week 24]
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (worst condition). PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline. As planned, results data was analyzed and reported for the specified arms for this outcome measure.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 [Baseline and Week 24]
Change from baseline in HAQ-DI score is a measure of the change in the physical function, where a negative change reflects an improvement and a positive change reflects worsening of physical function. HAQ-DI is a 20-question instrument that assesses 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 are scored from 0 indicating no difficulty, to 3 indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning). The total HAQ-DI score ranges from 0-24 with lower score indicating better functioning.
Percentage of Participants Who Achieved an ACR 20 Response at Week 16 [Week 16]
ACR 20 response is defined as at least 20 percent (%) improvement from baseline in both swollen joint (66 joints) and tender joint (68 joints) counts and at least 20% improvement from baseline in 3 of following 5 assessments: patient's assessment of pain (visual analog scale [VAS]: 0-100 millimeter [mm]; 0=no pain and 100=worst possible pain), patient's global assessment of disease activity on arthritis (VAS: 0-100 mm, 0=excellent and 100=poor), physician's global assessment of disease activity (VAS: 0-100mm; 0=no arthritis activity and 100 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0 indicating no difficulty, to 3 indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Percentage of Participants Who an Achieved ACR 50 Response at Week 24 [Week 24]
ACR 50 response is defined as at least 50 % improvement from baseline in both swollen joint (66 joints) and tender joint (68 joints) counts and at least 50% improvement from baseline in 3 of following 5 assessments: patient's assessment of pain (VAS:0-100 mm; 0=no pain and 100=worst possible pain), patient's global assessment of disease activity on arthritis (VAS:0-100mm; 0=excellent and 100=poor), physician's global assessment of disease activity (VAS: 0-100mm; 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;derived HAQ-DI ranges from 0 indicating no difficulty, to 3 indicating inability to perform a task in that area) and serum CRP.
Percent Change From Baseline in Leeds Enthesitis Index (LEI) Scores Among Participants With Enthesitis at Week 24 [Baseline and Week 24]
Enthesitis was assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with psoriatic arthritis (PsA), and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Percent Change From Baseline in Dactylitis Scores Among Participants With Dactylitis at Baseline at Week 24 [Baseline and Week 24]
Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0, 1, 2, 3 indicates none, mild, moderate, severe, respectively in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates more severe dactylitis.
Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, 12, 16, 20, and 24 [Weeks 4, 8, 12, 16, 20, and 24]
ACR 20, 50, and 70 response is defined as at least 20%, 50%, and 70% improvement from baseline in swollen joint (66 joints) and tender joint (68 joints) counts and at least 20%, 50%, and 70% improvement from baseline in 3 of following 5 assessments: patient's assessment of pain (VAS: 0-100mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity on arthritis (VAS: 0-100mm; 0=excellent and 100=poor), physician's global assessment of disease activity (VAS: 0-100mm; 0=no arthritis activity and 100= extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0 indicating no difficulty, to 3 indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 24, 28, 32, 36, 44, and 56 [Weeks 24, 28, 32, 36, 44, and 56]
ACR 20, ACR 50 and ACR 70 response is defined as at least 20%, 50%, and 70% improvement from baseline in swollen joint (66 joints) and tender joint (68 joints) counts and at least 20%, 50%, and 70% improvement from baseline in 3 of following 5 assessments: patient's assessment of pain (VAS: 0-100mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity on arthritis (VAS: 0-100mm; 0=excellent and 100=poor), physician's global assessment of disease activity (VAS; 0-100mm; 0=no arthritis activity and 100 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0 indicating no difficulty, to 3 indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP). As planned, results data was analyzed and reported for the specified arms for this outcome measure.
Percent Change From Baseline in the ACR Components at Weeks 12 and 24 [Baseline and Weeks 12, 24]
The 7 components of ACR response are: swollen joint counts (0-66), tender joint counts (0-68), patient's assessment of pain (PAIN) (VAS:0-100mm; 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (GDPT) on arthritis (VAS:0-100mm; 0=excellent and 100= poor), physician's global assessment of disease activity (GDEV) (VAS: 0-100mm; 0=no arthritis activity and 100 = extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (20-question instrument assessing 8 functional areas (total score of 0-24 with lower score indicating better functioning);derived HAQ-DI ranges from 0 indicating no difficulty, to 3 indicating inability to perform a task in that area) and serum CRP.
Percent Change From Baseline in the ACR Components at Weeks 24, 28, 32, 36, 44 and 56 [Basline and Weeks 24, 28, 32, 36, 44, 56]
The 7 components of ACR response are: swollen joint counts (0-66), tender joint counts (0-68), patient's assessment of pain (PAIN) (VAS:0-100mm; 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (GDPT) on arthritis (VAS:0-100mm; 0=excellent and 100= poor), physician's global assessment of disease activity (GDEV) (VAS: 0-100mm; 0=no arthritis activity and 100 = extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (20-question instrument assessing 8 functional areas (total score of 0-24 with lower score indicating better functioning);derived HAQ-DI ranges from 0 indicating no difficulty, to 3 indicating inability to perform a task in that area) and serum CRP.
Change From Baseline in HAQ-DI Response at Weeks 4, 8, 12, 16, 20, and 24 [Baseline and Weeks 4, 8, 12, 16, 20, 24]
Change from baseline in HAQ-DI score is a measure of the change in the physical function, where a negative change reflects an improvement and a positive change reflects worsening of physical function. HAQ-DI is a 20-question instrument that assesses 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 are scored from 0 indicating no difficulty, to 3 indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning). The total HAQ-DI score ranges from 0-24 with lower score indicating better functioning.
Change From Baseline in HAQ-DI Score at Weeks 24, 28, 32, 36, 44, and 56 [Baseline and Weeks 24, 28, 32, 36, 44, 56]
Change from baseline in HAQ-DI score is a measure of the change in the physical function, where a negative change reflects an improvement and a positive change reflects worsening of physical function. HAQ-DI is a 20-question instrument that assesses 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 are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning). The total HAQ-DI score ranges from 0-24 with lower score indicating better functioning.
Percentage of Participants Who Achieved a HAQ-DI Response With Greater Than or Equal to (>=) 0.3 Improvement From Baseline in HAQ-DI Score at Weeks 4, 8, 12, 16, 20, and 24 [Weeks 4, 8, 12, 16, 20, and 24]
HAQ-DI response was defined as >= 0.3 improvement from baseline in HAQ-DI score. HAQ-DI is a 20-question instrument that assesses 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 are scored from 0 indicating no difficulty, to 3 indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning). The total HAQ-DI score ranges from 0-24 with lower score indicating better functioning.
Percentage of Participants Who Achieved an HAQ-DI Response With >= -0.3 Improvement From Baseline in HAQ-DI Score at Weeks 24, 28, 32, 36, 44, and 56 [Weeks 24, 28, 32, 36, 44, 56]
HAQ-DI response was defined as >= 0.3 improvement from baseline in HAQ-DI score. HAQ-DI is a 20-question instrument that assesses 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 are scored from 0 indicating no difficulty, to 3 indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning). The total HAQ-DI score ranges from 0-24 with lower score indicating better functioning. As planned, results data was analyzed and reported for the specified arms for this outcome measure.
Percent Change From Baseline in Dactylitis Scores at Weeks 4, 8, 16, and 24 [Baseline and Weeks 4, 8, 16, 24]
Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0, 1, 2, 3 indicates none, mild, moderate, severe, respectively in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates more severe dactylitis.
Percent Change From Baseline in Dactylitis Scores at Weeks 24, 28, 32, 44, 56 [Baseline and Weeks 24, 28, 32, 44, 56]
Dactylitis was characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0, 1, 2, 3 indicates none, mild, moderate, severe, respectively in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates more severe dactylitis. As planned, results data was analyzed and reported for the specified arms for this outcome measure.
Percentage of Participants With Dactylitis at Weeks 4, 8, 16, and 24 [Weeks 4, 8, 16, and 24]
Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0, 1, 2, 3 indicates none, mild, moderate, severe, respectively in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Participants with dactylitis had dactylitis score >0. Higher score indicates more severe dactylitis.
Percentage of Participants With Dactylitis at Weeks 24, 28, 32, 44, and 56 [Weeks 24, 28, 32, 44, and 56]
Dactylitis was characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0, 1, 2, 3 indicates none, mild, moderate, severe, respectively in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness.
Percent Change From Baseline in LEI Scores at Week 4, 8, 16, and 24 [Baseline and Weeks 4, 8, 16, 24]
Enthesitis was assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with psoriatic arthritis (PsA), and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Percent Change From Baseline in LEI Scores at Weeks 24, 28, 32, 44, and 56 [Baseline and Weeks 24, 28, 32, 44, 56]
Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Percentage of Participants With Enthesitis Based on LEI Score at Weeks 4, 8, 16, and 24 in Participants With Enthesitis at Baseline [Weeks 4, 8, 16, and 24]
Enthesitis was assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. Participants with enthesitis had LEI score >0. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Percentage of Participants With Enthesitis Based on LEI at Weeks 24, 28, 32, 44, and 56 in Participants With Enthesitis at Baseline [Weeks 24, 28, 32, 44, and 56]
Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. Participants with enthesitis had LEI score >0. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Change From Baseline in Psoriatic ArthritiS Disease Activity Score (PASDAS) Score at Weeks 16 and 24 [Baseline and Weeks 16, 24]
Change from baseline in PASDAS score measures the change in disease activity where a negative value indicates an improvement and a positive value indicates worsening of PsA disease activity. PASDAS is a PsA disease activity score that assesses 4 domains (joints, entheses, dactylitis and quality of life) of PsA. PASDAS is a derived score combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, on a 100-unit VAS), Physician's Global Assessment of Disease Activity (on a 100-unit VAS), swollen joint count (66 joints), tender joint count (68 joints), CRP (mg/L), enthesitis based on LEI (scaled to a 0-6 range), dactylitis count (scoring each digit from 0-3 and recoding to 0-1, where any score > 0 equaled 1), and the PCS score of the SF-36 health survey. The total score range is 0-10 and the cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity.
Change From Baseline in PASDAS Score at Weeks 24 and 44 [Baseline and Weeks 24, 44]
Change from baseline in PASDAS score measures the change in disease activity where a negative value indicates an improvement and a positive value indicates worsening of PsA disease activity. PASDAS is a PsA disease activity score that assesses 4 domains (joints, entheses, dactylitis and quality of life) of PsA. PASDAS is a derived score combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, on a 100-unit VAS), Physician's Global Assessment of Disease Activity (on a 100-unit VAS), swollen joint count (66 joints), tender joint count (68 joints), CRP (mg/L), enthesitis based on LEI (scaled to a 0-6 range), dactylitis count (scoring each digit from 0-3 and recoding to 0-1, where any score > 0 equaled 1), and the PCS score of the SF-36 health survey. The total score range is 0-10 and the cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity.
Change From Baseline in GRAppa Composite scorE (GRACE) Index Score at Weeks 16 and 24 [Baseline and Weeks 16, 24]
Change from baseline in GRACE index score measures the change in disease activity, where a negative change indicates an improvement and a positive change indicates a worsening of PsA disease activity. GRACE index was converted from Arithmetic Mean of the Desirability Function (AMDF). AMDF is calculated by transforming all variables using predefined algorithms and expressing the total score as a mean with a score range of 0 - 1, where 1 indicates a better state than 0. GRACE Index = (1 - AMDF)*10, where GRACE index has a range of 0-10, with higher scores indicate more active disease. As planned, results data was analyzed and reported for the specified arms for this outcome measure.
Change From Baseline in GRACE Index Score at Weeks 24 and 44 [Baseline and Weeks 24, 44]
Change from baseline in GRACE index score measures the change in disease activity, where a negative change indicates an improvement and a positive change indicates a worsening of PsA disease activity. GRACE index was converted from Arithmetic Mean of the Desirability Function (AMDF). AMDF is calculated by transforming all variables using predefined algorithms and expressing the total score as a mean with a score range of 0 - 1, where 1 indicates a better state than 0. GRACE Index = (1 - AMDF)*10, where GRACE index has a range of 0-10, with higher scores indicate more active disease.
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 16 and 24 [Baseline and Weeks 16, 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.
Change From Baseline in mCPDAI Index Score at Weeks 24 and 44 [Baseline and Weeks 24, 44]
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.
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 4, 8, 12, 16, 20 and 24 [Baseline and Weeks 4, 8, 12, 16, 20, 24]
Change from baseline in DAPSA measures the change in disease activity, where a negative change indicates an improvement and a positive change indicates worsening of disease activity. DAPSA score is a the sum of swollen joint count (66 joints), tender joint count (68 joints), CRP (mg/dL), Patient's Assessment of Pain (on a 10-unit VAS;0=no pain, 10=worst possible pain), and Patient's Global Assessment of Disease Activity (arthritis, on a 10-unit VAS; 0 to 100 centimeter [cm] VAS, 0=excellent and 10=poor). Cut-off values for disease activity: 0-4 remission; 5-14 low; 15-28 moderate; >28 high.
Change From Baseline in DAPSA Index Score at Weeks 24, 28, 32, 36, 44, and 56 [Baseline and Weeks 24, 28, 32, 36, 44, 56]
Change from baseline in DAPSA measures the change in disease activity, where a negative change indicates an improvement and a positive change indicates worsening of disease activity. DAPSA score is a the sum of swollen joint count (66 joints), tender joint count (68 joints), CRP (mg/dL), Patient's Assessment of Pain (on a 10-unit VAS;0=no pain, 10=worst possible pain), and Patient's Global Assessment of Disease Activity (arthritis, on a 10-unit VAS; 0 to 10cm VAS, 0=excellent and 10=poor). Cut-off values for disease activity: 0-4 remission; 5-14 low; 15-28 moderate; >28 high.
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 16 and 24 [Weeks 16 and 24]
MDA defines a satisfactory state of disease activity that includes 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity on arthritis and psoriasis, physical function and enthesitis). Participants were classified as achieving MDA if they fulfilled 5 of 7 outcome measures: tender joint count <=1; swollen joint count <=1; PASI <=1; patient pain VAS score of <=15 mm; patient global disease activity on arthritis and psoriasis; VAS score of <=20 mm; Health Assessment Questionnaire score <=0.5; and tender entheseal points <=1.
Percentage of Participants Who Achieved MDA at Weeks 24 and 44 [Weeks 24 and 44]
MDA defines a satisfactory state of disease activity that includes 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity on arthritis and psoriasis, physical function and enthesitis). Participants were classified as achieving MDA if they fulfilled 5 of 7 outcome measures: tender joint count <=1; swollen joint count <=1; PASI <=1; patient pain VAS score of <=15 mm; patient global disease activity on arthritis and psoriasis; VAS score of <=20 mm; Health Assessment Questionnaire score <=0.5; and tender entheseal points <=1.
Change From Baseline in the Physical and Mental Component Summary (PCS and MCS) Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Weeks 16 and 24 [Baseline and Weeks 16, 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 and MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms as presented in this outcome measure. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Change From Baseline in the PCS Scores of SF-36 at Weeks 24 and 44 [Baseline and Weeks 24, 44]
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 as presented in this outcome measure. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Change From Baseline in the MCS Scores of SF-36 at Weeks 24 and 44 [Baseline and Weeks 24, 44]
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 as presented in this outcome measure. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Change From Baseline in Norm-based SF-36 Scales at Week 16 and 24 [Baseline and Weeks 16, 24]
SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. The scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher scores indicate better health. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Change From Baseline in Norm-based SF-36 Scale at Week 24 and 44 [Baseline and Weeks 24, 44]
SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. The scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher scores indicate better health. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Weeks 16 and 24 [Baseline and Weeks 16, 24]
RAPID3 is a multi-dimensional health assessment questionnaire that was designed for use in routine clinical care. Three core data set for function, pain, and patient global estimate of disease activity were recorded. Each was scored 0-10 and the score ranges from 0 to 30 with higher scores indicating worse condition. A negative change from baseline indicates improvement in condition.
Change From Baseline in RAPID3 Score at Weeks 24 and 44 [Baseline and Weeks 24, 44]
RAPID3 is a multi-dimensional health assessment questionnaire that was designed for use in routine clinical care. Three core data set for function, pain, and patient global estimate of disease activity were recorded. Each was scored 0-10 and the score ranges from 0 to 30 with higher scores indicating worse condition. A negative change from baseline indicates improvement in condition.
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 16 and 24 [Weeks 16 and 24]
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 50, 75, 90, and 100 responses were defined as at least a 50%, 75%, 90%, and 100% reduction in PASI relative to Baseline respectively. As planned, results data was analyzed and reported for the specified arms for this outcome measure.
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 24, 28, 32, 44, and 56 [Weeks 24, 28, 32, 44, and 56]
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 50, 75, 90, and 100 responses were defined as at least a 50%, 75%, 90%, and 100% reduction in PASI relative to Baseline respectively.
Percent Change From Baseline in PASI Score at Weeks 4, 8, 16, and 24 [Baseline and Weeks 4, 8, 16, 24]
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A negative percent change from baseline indicates the percent improvement from baseline in the severity of psoriatic lesions. As planned, results data was analyzed and reported for the specified arms for this outcome measure.
Percent Change From Baseline in PASI Score at Weeks 24, 28, 32, 44, and 56 [Baseline and Weeks 24, 28, 32, 44, 56]
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A negative percent change from baseline indicates the percent improvement from baseline in the severity of psoriatic lesions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Has had Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study drug and meet classification criteria for Psoriatic Arthritis (CASPAR) at Screening
Had active PsA as defined by:

At least 3 swollen joints and at least 3 tender joints at Screening and at baseline
C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram (mg)/deciliter (dL) at Screening from the central laboratory

Has 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
Has plaque psoriasis with body surface area (BSA) involvement greater than or equal to (>=) 3% at Screening and baseline
Has active PsA despite current or previous non-biologic disease-modifying antirheumatic drugs (DMARD), oral corticosteroid, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
If using methotrexate (MTX), oral corticosteroids or NSAIDs, the dose must be stable

Exclusion Criteria:

Have other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS), systemic lupus erythematosus, or Lyme disease
Has previously received guselkumab or ustekinumab
Has received more than 1 type of biologic anti-tumor necrosis factor (TNF) agent previously
Have received infliximab (or its biosimilars) or golimumab intraveneous (IV) within 12 weeks before the first administration of study drug
Have received adalimumab (or its biosimilars), golimumab subcutaneous (SC), certolizumab pegol or etanercept (or its biosimilars) within 8 weeks before the first administration of study drug

Contacts and Locations

Locations

	City	State	Country
1	Huntsville	Alabama	United States
2	Trumbull	Connecticut	United States
3	Clearwater	Florida	United States
4	Tampa	Florida	United States
5	Sandy Springs	Georgia	United States
6	Indianapolis	Indiana	United States
7	Boston	Massachusetts	United States
8	Edina	Minnesota	United States
9	Saint Louis	Missouri	United States
10	Wyomissing	Pennsylvania	United States
11	Jackson	Tennessee	United States
12	Arlington	Virginia	United States
13	Barrie	Ontario	Canada
14	London	Ontario	Canada
15	Peterborough	Ontario	Canada
16	Waterloo	Ontario	Canada
17	Berlin		Germany
18	Hamburg		Germany
19	Herne		Germany
20	Kiel		Germany
21	Köln		Germany
22	Lubeck		Germany
23	Bialystok		Poland
24	Elblag		Poland
25	Poznań		Poland
26	Warszawa		Poland
27	Bucharest		Romania
28	Bataysk		Russian Federation
29	Moscow		Russian Federation
30	Novosibirsk		Russian Federation
31	Ryazan		Russian Federation
32	Saratov		Russian Federation
33	St. Petersburg		Russian Federation
34	Ufa		Russian Federation
35	Ulyanovsk		Russian Federation
36	Yaroslavl		Russian Federation
37	Barcelona		Spain
38	Madrid		Spain
39	Sabadell		Spain
40	Santiago de Compostela		Spain
41	Sevilla		Spain

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Janssen Research & Development, LLC

ClinicalTrials.gov Identifier:

NCT02319759

Other Study ID Numbers:

CR105964
2014-003697-17
CNTO1959PSA2001

First Posted:

Dec 18, 2014

Last Update Posted:

Oct 14, 2020

Last Verified:

Sep 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Yes

Keywords provided by Janssen Research & Development, LLC

Additional relevant MeSH terms:

Arthritis

Arthritis, Psoriatic

Ustekinumab

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Placebo (Week 0 to Week 24)	Placebo to Guselkumab (Week 24 to Week 56)	Guselkumab (Week 0 to Week 56)	Placebo to Ustekinumab (Week 16 to Week 56)	Guselkumab to Ustekinumab (Week 16 to Week 56)
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants who received placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20 received guselkumab 100 milligram (mg) subcutaneous injections at Weeks 24, 28, 36 and 44, with a final follow-up at Week 56.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and placebo at Week 24, with a final follow-up at Week 56.	Participants who were randomized to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4 and 12, and had less than (<) 5 percent (%) improvement from baseline in both tender and swollen joint counts at Week 16 were qualified for early escape (EE) and switched to open-label ustekinumab subcutaneous injections at the approved dosage (45 mg or 90 mg) for psoriatic arthritis (PsA) in the particular country of the study at Weeks 16, 20, 32 and 44, with a final follow-up at Week 56.	Participants who were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and had <5% improvement from baseline in both tender and swollen joint counts at Week 16 were qualified for EE and switched to open-label ustekinumab subcutaneous injections at the approved dosage (45 mg or 90 mg) for PsA in the particular country of the study at Weeks 16, 20, 32 and 44, with a final follow-up at Week 56.
Period Title: Week 0 - 16
STARTED	49	0	100	0	0
COMPLETED	48	0	99	0	0
NOT COMPLETED	1	0	1	0	0
Period Title: Week 0 - 16
STARTED	31	0	89	17	10
COMPLETED	29	0	86	17	10
NOT COMPLETED	2	0	3	0	0
Period Title: Week 0 - 16
STARTED	0	29	86	17	10
COMPLETED	0	28	84	15	8
NOT COMPLETED	0	1	2	2	2

Baseline Characteristics

Arm/Group Title	Placebo	Guselkumab	Total
Arm/Group Description	Participants were randomized to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20 and guselkumab 100 milligram (mg) subcutaneous injection at Weeks 24, 28, 36 and 44.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and placebo at Week 24, with a final follow-up at Week 56.	Total of all reporting groups
Overall Participants	49	100	149
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.2 (12.43)	47.4 (12.83)	46.3 (12.75)
Sex: Female, Male (Count of Participants)
Female	25 51%	48 48%	73 49%
Male	24 49%	52 52%	76 51%
Region of Enrollment (Count of Participants)
Canada	2 4.1%	4 4%	6 4%
Germany	2 4.1%	2 2%	4 2.7%
Spain	3 6.1%	6 6%	9 6%
Poland	12 24.5%	13 13%	25 16.8%
Romania	1 2%	4 4%	5 3.4%
Russia	25 51%	64 64%	89 59.7%
United States	4 8.2%	7 7%	11 7.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 24
Description	ACR 20 response: at least 20% improvement from baseline in both swollen joint (66 joints) and tender joint (68 joints) counts and at least 20% improvement from baseline in 3 of following 5 assessments: patient's assessment of pain (VAS: 0-100 millimeter [mm], 0=no pain and 100=worst possible pain), patient's global assessment of disease activity on arthritis (VAS:0-100mm, 0=excellent and 100=poor), physician's global assessment of disease activity (VAS:0-100mm; 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;derived HAQ-DI ranges from 0=no difficulty, to 3=inability to perform a task in that area) and serum CRP. Treatment Failure (TF) criteria: Discontinued study drug due to lack of efficacy or worsening of PsA, initiated or increased dose of methotrexate or oral corticosteroids, or initiated prohibited PsA treatments. FAS is full analysis set.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24): participants randomized and received 1 dose of study drug per assigned treatment regardless of actual treatments received. Data after meeting TF criteria or after EE to ustekinumab and missing data are imputed as non-responders. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	49	100
Number [percentage of participants]	18.4 37.6%	58.0 58%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Guselkumab
	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	Percent difference
	Estimated Value	39.7
	Confidence Interval	(2-Sided) 95% 25.3 to 54.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-75 Response at Week 24
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (worst condition). PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline. As planned, results data was analyzed and reported for the specified arms for this outcome measure.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS) (up to Week 24). Data after EE to ustekinumab and missing data were imputed using last observation carried forward (LOCF). Here 'N' (number of participants analyzed) included all participants who were evaluable for this endpoint.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	48	98
Number [percentage of participants]	12.5 25.5%	78.6 78.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Guselkumab
	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	Percentage (%) Difference
	Estimated Value	66.1
	Confidence Interval	(2-Sided) 95% 53.8 to 78.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
Description	Change from baseline in HAQ-DI score is a measure of the change in the physical function, where a negative change reflects an improvement and a positive change reflects worsening of physical function. HAQ-DI is a 20-question instrument that assesses 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 are scored from 0 indicating no difficulty, to 3 indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning). The total HAQ-DI score ranges from 0-24 with lower score indicating better functioning.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24). Data after EE to ustekinumab and missing data were imputed using LOCF. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	49	100
Mean (Standard Deviation) [units on a scale]	-0.06 (0.530)	-0.42 (0.512)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Guselkumab
	Comments
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	MMRM
	Comments	MMRM stands for Mixed-effects Model Repeated Measures

Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	-0.31
	Confidence Interval	(2-Sided) 95% -0.471 to -0.148
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Participants Who Achieved an ACR 20 Response at Week 16
Description	ACR 20 response is defined as at least 20 percent (%) improvement from baseline in both swollen joint (66 joints) and tender joint (68 joints) counts and at least 20% improvement from baseline in 3 of following 5 assessments: patient's assessment of pain (visual analog scale [VAS]: 0-100 millimeter [mm]; 0=no pain and 100=worst possible pain), patient's global assessment of disease activity on arthritis (VAS: 0-100 mm, 0=excellent and 100=poor), physician's global assessment of disease activity (VAS: 0-100mm; 0=no arthritis activity and 100 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0 indicating no difficulty, to 3 indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24). Data after meeting TF criteria or after EE to ustekinumab and missing data are imputed as non-responders. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	49	100
Number [percentage of participants]	16.3 33.3%	60.0 60%

5. Secondary Outcome

Title	Percentage of Participants Who an Achieved ACR 50 Response at Week 24
Description	ACR 50 response is defined as at least 50 % improvement from baseline in both swollen joint (66 joints) and tender joint (68 joints) counts and at least 50% improvement from baseline in 3 of following 5 assessments: patient's assessment of pain (VAS:0-100 mm; 0=no pain and 100=worst possible pain), patient's global assessment of disease activity on arthritis (VAS:0-100mm; 0=excellent and 100=poor), physician's global assessment of disease activity (VAS: 0-100mm; 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;derived HAQ-DI ranges from 0 indicating no difficulty, to 3 indicating inability to perform a task in that area) and serum CRP.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24). Data after meeting TF criteria or after EE to ustekinumab and missing data are imputed as non-responders. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	49	100
Number [percentage of participants]	10.2 20.8%	34.0 34%

6. Secondary Outcome

Title	Percent Change From Baseline in Leeds Enthesitis Index (LEI) Scores Among Participants With Enthesitis at Week 24
Description	Enthesitis was assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with psoriatic arthritis (PsA), and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24) and had enthesitis at baseline. Data after EE to ustekinumab or missing data are imputed using LOCF. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	31	76
Median (Inter-Quartile Range) [percent change]	-33.33	-100.00

7. Secondary Outcome

Title	Percent Change From Baseline in Dactylitis Scores Among Participants With Dactylitis at Baseline at Week 24
Description	Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0, 1, 2, 3 indicates none, mild, moderate, severe, respectively in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates more severe dactylitis.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24) and had dactylitis at baseline. Data after EE to ustekinumab or missing data were imputed using LOCF. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	23	58
Median (Inter-Quartile Range) [percent change]	-33.33	-100.00

8. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, 12, 16, 20, and 24
Description	ACR 20, 50, and 70 response is defined as at least 20%, 50%, and 70% improvement from baseline in swollen joint (66 joints) and tender joint (68 joints) counts and at least 20%, 50%, and 70% improvement from baseline in 3 of following 5 assessments: patient's assessment of pain (VAS: 0-100mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity on arthritis (VAS: 0-100mm; 0=excellent and 100=poor), physician's global assessment of disease activity (VAS: 0-100mm; 0=no arthritis activity and 100= extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0 indicating no difficulty, to 3 indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Time Frame	Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24). Data after meeting TF criteria or after EE to ustekinumab and missing data are imputed as non-responders. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	49	100
Week 4: ACR 20 responders	0 0%	21.0 21%
Week 4: ACR 50 responders	0 0%	1.0 1%
Week 4: ACR 70 responders	0 0%	0 0%
Week 8: ACR 20 responders	22.4 45.7%	42.0 42%
Week 8: ACR 50 responders	6.1 12.4%	12.0 12%
Week 8: ACR 70 responders	2.0 4.1%	4.0 4%
Week 12: ACR 20 responders	12.2 24.9%	49.0 49%
Week 12: ACR 50 responders	6.1 12.4%	15.0 15%
Week 12: ACR 70 responders	0 0%	7.0 7%
Week 16: ACR 20 responders	16.3 33.3%	60.0 60%
Week 16: ACR 50 responders	6.1 12.4%	30.0 30%
Week 16: ACR 70 responders	4.1 8.4%	9.0 9%
Week 20: ACR 20 responders	22.4 45.7%	63.0 63%
Week 20: ACR 50 responders	10.2 20.8%	37.0 37%
Week 20: ACR 70 responders	2.0 4.1%	11.0 11%
Week 24: ACR 20 responders	18.4 37.6%	58.0 58%
Week 24: ACR 50 responders	10.2 20.8%	34.0 34%
Week 24: ACR 70 responders	2.0 4.1%	14.0 14%

9. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 24, 28, 32, 36, 44, and 56
Description	ACR 20, ACR 50 and ACR 70 response is defined as at least 20%, 50%, and 70% improvement from baseline in swollen joint (66 joints) and tender joint (68 joints) counts and at least 20%, 50%, and 70% improvement from baseline in 3 of following 5 assessments: patient's assessment of pain (VAS: 0-100mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity on arthritis (VAS: 0-100mm; 0=excellent and 100=poor), physician's global assessment of disease activity (VAS; 0-100mm; 0=no arthritis activity and 100 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0 indicating no difficulty, to 3 indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP). As planned, results data was analyzed and reported for the specified arms for this outcome measure.
Time Frame	Weeks 24, 28, 32, 36, 44, and 56

Outcome Measure Data

Analysis Population Description
Post Week 24 Efficacy analysis set: included all randomized participants who did not EE to ustekinumab at Week 24, with observed data. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints.

Arm/Group Title	Placebo to Guselkumab (Week 24 to Week 56)	Guselkumab (Week 24 to Week 52)
Arm/Group Description	Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
Measure Participants	29	86
Week 24: ACR 20 responders	31.0 63.3%	66.3 66.3%
Week 24: ACR 50 responders	17.2 35.1%	39.5 39.5%
Week 24: ACR 70 responders	3.4 6.9%	16.3 16.3%
Week 28: ACR 20 responders	57.1 116.5%	75.3 75.3%
Week 28: ACR 50 responders	28.6 58.4%	44.7 44.7%
Week 28: ACR 70 responders	14.3 29.2%	30.6 30.6%
Week 32: ACR 20 responders	60.7 123.9%	75.0 75%
Week 32: ACR 50 responders	42.9 87.6%	51.2 51.2%
Week 32: ACR 70 responders	21.4 43.7%	29.8 29.8%
Week 36: ACR 20 responders	71.4 145.7%	73.8 73.8%
Week 36: ACR 50 responders	46.4 94.7%	48.8 48.8%
Week 36: ACR 70 responders	29.6 60.4%	31.0 31%
Week 44: ACR 20 responders	75.0 153.1%	77.4 77.4%
Week 44: ACR 50 responders	46.4 94.7%	46.4 46.4%
Week 44: ACR 70 responders	25.0 51%	26.2 26.2%
Week 56: ACR 20 responders	81.5 166.3%	73.5 73.5%
Week 56: ACR 50 responders	66.7 136.1%	53.0 53%
Week 56: ACR 70 responders	28.6 58.4%	32.5 32.5%

10. Secondary Outcome

Title	Percent Change From Baseline in the ACR Components at Weeks 12 and 24
Description	The 7 components of ACR response are: swollen joint counts (0-66), tender joint counts (0-68), patient's assessment of pain (PAIN) (VAS:0-100mm; 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (GDPT) on arthritis (VAS:0-100mm; 0=excellent and 100= poor), physician's global assessment of disease activity (GDEV) (VAS: 0-100mm; 0=no arthritis activity and 100 = extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (20-question instrument assessing 8 functional areas (total score of 0-24 with lower score indicating better functioning);derived HAQ-DI ranges from 0 indicating no difficulty, to 3 indicating inability to perform a task in that area) and serum CRP.
Time Frame	Baseline and Weeks 12, 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24). Data after EE to ustekinumab and missing data were imputed using LOCF. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	49	100
Week 12: Swollen joints (0-66)	-29.41	-64.50
Week 12: Tender joints (0-68)	-13.33	-45.80
Week 12: PAIN (VAS, 0-100 mm)	1.79	-22.05
Week 12: GDPT (VAS, 0-100 mm, arthritis)	-11.39	-55.24
Week 12: GDEV (VAS, 0-100 mm)	-11.39	-55.24
Week 12: HAQ-DI score (0-3)	0.00	-21.43
Week 12: CRP	-3.95	-42.95
Week 24: Swollen joints (0-66)	-11.76	-84.11
Week 24: Tender joints (0-68)	-5.56	-51.05
Week 24: PAIN (VAS, 0-100 mm)	2.38	-32.93
Week 24: GDPT (VAS, 0-100 mm, arthritis)	-2.22	-35.53
Week 24: GDEV (VAS, 0-100 mm)	-8.86	-68.47
Week 24: HAQ-DI score (0-3)	-10.00	-28.57
Week 24: CRP	7.94	-42.64

11. Secondary Outcome

Title	Percent Change From Baseline in the ACR Components at Weeks 24, 28, 32, 36, 44 and 56
Description	The 7 components of ACR response are: swollen joint counts (0-66), tender joint counts (0-68), patient's assessment of pain (PAIN) (VAS:0-100mm; 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (GDPT) on arthritis (VAS:0-100mm; 0=excellent and 100= poor), physician's global assessment of disease activity (GDEV) (VAS: 0-100mm; 0=no arthritis activity and 100 = extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (20-question instrument assessing 8 functional areas (total score of 0-24 with lower score indicating better functioning);derived HAQ-DI ranges from 0 indicating no difficulty, to 3 indicating inability to perform a task in that area) and serum CRP.
Time Frame	Basline and Weeks 24, 28, 32, 36, 44, 56

Outcome Measure Data

Analysis Population Description
Post Week 24 efficacy analysis set, based on observed data. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo to Guselkumab (Week 24 to Week 56)	Guselkumab (Week 24 to Week 52)
Arm/Group Description	Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
Measure Participants	29	86
Week 24: Swollen joints (0-66)	-33.33	-85.71
Week 28: Swollen joints (0-66)	-69.05	-93.75
Week 32: Swollen joints (0-66)	-84.91	-100.00
Week 36: Swollen joints (0-66)	-79.14	-93.93
Week 44: Swollen joints (0-66)	-86.11	-94.56
Week 56: Swollen joints (0-66)	-100.00	-100.00
Week 24: Tender joints (0-68)	-50.00	-72.00
Week 28: Tender joints (0-68)	-65.99	-74.36
Week 32: Tender joints (0-68)	-71.76	-79.66
Week 36: Tender joints (0-68)	-81.67	-73.32
Week 44: Tender joints (0-68)	-86.06	-77.22
Week 56: Tender joints (0-68)	-80.00	-77.27
Week 24: PAIN (VAS, 0-100 mm)	-11.69	-40.98
Week 28: PAIN (VAS, 0-100 mm)	-23.52	-49.40
Week 32: PAIN (VAS, 0-100 mm)	-51.08	-50.00
Week 36: PAIN (VAS, 0-100 mm)	-61.13	-55.83
Week 44: PAIN (VAS, 0-100 mm)	-58.76	-45.50
Week 56: PAIN (VAS, 0-100 mm)	-71.99	-52.44
Week 24: GDPT (VAS, 0-100 mm, arthritis)	-17.74	-41.98
Week 28: GDPT (VAS, 0-100 mm, arthritis)	-40.73	-52.17
Week 32: GDPT (VAS, 0-100 mm, arthritis)	-48.62	-56.83
Week 36: GDPT (VAS, 0-100 mm, arthritis)	-52.17	-52.09
Week 44: GDPT (VAS, 0-100 mm, arthritis)	-49.53	-47.21
Week 56: GDPT (VAS, 0-100 mm, arthritis)	-68.12	-55.32
Week 24: GDEV (VAS, 0-100 mm)	-37.88	-72.41
Week 28: GDEV (VAS, 0-100 mm)	-66.07	-80.26
Week 32: GDEV (VAS, 0-100 mm)	-71.40	-82.14
Week 36: GDEV (VAS, 0-100 mm)	-81.82	-79.75
Week 44: GDEV (VAS, 0-100 mm)	-82.41	-80.00
Week 56: GDEV (VAS, 0-100 mm)	-86.36	-83.93
Week 24: HAQ-DI score (0-3)	-19.38	-37.50
Week 28: HAQ-DI score (0-3)	-31.25	-41.05
Week 32: HAQ-DI score (0-3)	-42.86	-41.18
Week 36: HAQ-DI score (0-3)	-50.00	-37.50
Week 44: HAQ-DI score (0-3)	-57.14	-37.50
Week 56: HAQ-DI score (0-3)	-54.55	-39.23
Week 24: CRP	6.19	-43.62
Week 28: CRP	-35.63	-52.70
Week 32: CRP	-42.61	-50.63
Week 36: CRP	-38.90	-53.22
Week 44: CRP	-53.43	-53.36
Week 56: CRP	-51.26	-54.91

12. Secondary Outcome

Title	Change From Baseline in HAQ-DI Response at Weeks 4, 8, 12, 16, 20, and 24
Description	Change from baseline in HAQ-DI score is a measure of the change in the physical function, where a negative change reflects an improvement and a positive change reflects worsening of physical function. HAQ-DI is a 20-question instrument that assesses 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 are scored from 0 indicating no difficulty, to 3 indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning). The total HAQ-DI score ranges from 0-24 with lower score indicating better functioning.
Time Frame	Baseline and Weeks 4, 8, 12, 16, 20, 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24). Data after EE to ustekinumab and missing data were imputed using LOCF. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	49	100
Week 4	-0.02 (0.329)	-0.17 (0.322)
Week 8	-0.07 (0.440)	-0.32 (0.442)
Week 12	-0.05 (0.450)	-0.33 (0.390)
Week 16	-0.05 (0.428)	-0.38 (0.397)
Week 20	-0.08 (0.479)	-0.41 (0.453)
Week 24	-0.06 (0.530)	-0.42 (0.512)

13. Secondary Outcome

Title	Change From Baseline in HAQ-DI Score at Weeks 24, 28, 32, 36, 44, and 56
Description	Change from baseline in HAQ-DI score is a measure of the change in the physical function, where a negative change reflects an improvement and a positive change reflects worsening of physical function. HAQ-DI is a 20-question instrument that assesses 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 are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning). The total HAQ-DI score ranges from 0-24 with lower score indicating better functioning.
Time Frame	Baseline and Weeks 24, 28, 32, 36, 44, 56

Outcome Measure Data

Analysis Population Description
Post Week 24 efficacy analysis set with observed data. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo to Guselkumab (Week 24 to Week 56)	Guselkumab (Week 24 to Week 52)
Arm/Group Description	Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
Measure Participants	29	86
Week 24	-0.19 (0.581)	-0.46 (0.530)
Week 28	-0.40 (0.646)	-0.51 (0.571)
Week 32	-0.50 (0.624)	-0.56 (0.595)
Week 36	-0.59 (0.650)	-0.53 (0.618)
Week 44	-0.63 (0.612)	-0.54 (0.598)
Week 56	-0.67 (0.558)	-0.55 (0.621)

14. Secondary Outcome

Title	Percentage of Participants Who Achieved a HAQ-DI Response With Greater Than or Equal to (>=) 0.3 Improvement From Baseline in HAQ-DI Score at Weeks 4, 8, 12, 16, 20, and 24
Description	HAQ-DI response was defined as >= 0.3 improvement from baseline in HAQ-DI score. HAQ-DI is a 20-question instrument that assesses 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 are scored from 0 indicating no difficulty, to 3 indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning). The total HAQ-DI score ranges from 0-24 with lower score indicating better functioning.
Time Frame	Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24). Data after EE to ustekinumab and missing data were imputed using LOCF. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	49	100
Week 4	12.2 24.9%	29.0 29%
Week 8	26.5 54.1%	43.0 43%
Week 12	22.4 45.7%	47.0 47%
Week 16	20.4 41.6%	50.0 50%
Week 20	22.4 45.7%	48.0 48%
Week 24	28.6 58.4%	51.0 51%

15. Secondary Outcome

Title	Percentage of Participants Who Achieved an HAQ-DI Response With >= -0.3 Improvement From Baseline in HAQ-DI Score at Weeks 24, 28, 32, 36, 44, and 56
Description	HAQ-DI response was defined as >= 0.3 improvement from baseline in HAQ-DI score. HAQ-DI is a 20-question instrument that assesses 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 are scored from 0 indicating no difficulty, to 3 indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning). The total HAQ-DI score ranges from 0-24 with lower score indicating better functioning. As planned, results data was analyzed and reported for the specified arms for this outcome measure.
Time Frame	Weeks 24, 28, 32, 36, 44, 56

Outcome Measure Data

Analysis Population Description
Post Week 24 efficacy analysis set with observed data. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo to Guselkumab (Week 24 to Week 56)	Guselkumab (Week 24 to Week 52)
Arm/Group Description	Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
Measure Participants	29	86
Week 24	44.8 91.4%	55.8 55.8%
Week 28	53.6 109.4%	60.0 60%
Week 32	57.1 116.5%	56.0 56%
Week 36	64.3 131.2%	59.5 59.5%
Week 44	71.4 145.7%	61.9 61.9%
Week 56	75.0 153.1%	59.0 59%

16. Secondary Outcome

Title	Percent Change From Baseline in Dactylitis Scores at Weeks 4, 8, 16, and 24
Description	Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0, 1, 2, 3 indicates none, mild, moderate, severe, respectively in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates more severe dactylitis.
Time Frame	Baseline and Weeks 4, 8, 16, 24

Outcome Measure Data

Analysis Population Description
FAS (up to week 24) and who had dactylitis at baseline. Data after EE to ustekinumab or missing data were imputed using LOCF. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	23	58
Week 4	-33.33	-32.46
Week 8	-50.00	-75.00
Week 16	-50.00	-100.00
Week 24	-33.33	-100.00

17. Secondary Outcome

Title	Percent Change From Baseline in Dactylitis Scores at Weeks 24, 28, 32, 44, 56
Description	Dactylitis was characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0, 1, 2, 3 indicates none, mild, moderate, severe, respectively in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates more severe dactylitis. As planned, results data was analyzed and reported for the specified arms for this outcome measure.
Time Frame	Baseline and Weeks 24, 28, 32, 44, 56

Outcome Measure Data

Analysis Population Description
Post Week 24 efficacy analysis set with observed data and who had dactylitis at baseline. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo to Guselkumab (Week 24 to Week 56)	Guselkumab (Week 24 to Week 52)
Arm/Group Description	Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
Measure Participants	16	50
Week 24	-45.00	-100.00
Week 28	-70.83	-100.00
Week 32	-100.00	-100.00
Week 44	-100.00	-100.00
Week 56	-100.00	-100.00

18. Secondary Outcome

Title	Percentage of Participants With Dactylitis at Weeks 4, 8, 16, and 24
Description	Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0, 1, 2, 3 indicates none, mild, moderate, severe, respectively in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Participants with dactylitis had dactylitis score >0. Higher score indicates more severe dactylitis.
Time Frame	Weeks 4, 8, 16, and 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24) and who had dactylitis at baseline. Data after EE to ustekinumab or missing data were imputed using LOCF. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	23	58
Week 4	91.3 186.3%	72.4 72.4%
Week 8	69.6 142%	56.9 56.9%
Week 16	78.3 159.8%	48.3 48.3%
Week 24	82.6 168.6%	44.8 44.8%

19. Secondary Outcome

Title	Percentage of Participants With Dactylitis at Weeks 24, 28, 32, 44, and 56
Description	Dactylitis was characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0, 1, 2, 3 indicates none, mild, moderate, severe, respectively in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness.
Time Frame	Weeks 24, 28, 32, 44, and 56

Outcome Measure Data

Analysis Population Description
Post Week 24 efficacy analysis set with observed data and who had dactylitis at baseline. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo to Guselkumab (Week 24 to Week 56)	Guselkumab (Week 24 to Week 52)
Arm/Group Description	Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
Measure Participants	16	50
Week 24	81.3 165.9%	40.0 40%
Week 28	62.5 127.6%	38.8 38.8%
Week 32	31.3 63.9%	36.7 36.7%
Week 44	12.5 25.5%	20.4 20.4%
Week 56	6.3 12.9%	25.0 25%

20. Secondary Outcome

Title	Percent Change From Baseline in LEI Scores at Week 4, 8, 16, and 24
Description	Enthesitis was assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with psoriatic arthritis (PsA), and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Time Frame	Baseline and Weeks 4, 8, 16, 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24) and who had enthesitis at baseline. Data after EE to ustekinumab or missing data are imputed using LOCF. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	31	76
Week 4	0.00	-18.33
Week 8	0.00	-58.33
Week 16	0.00	-50.04
Week 24	-33.33	-100.00

21. Secondary Outcome

Title	Percent Change From Baseline in LEI Scores at Weeks 24, 28, 32, 44, and 56
Description	Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Time Frame	Baseline and Weeks 24, 28, 32, 44, 56

Outcome Measure Data

Analysis Population Description
Post Week 24 efficacy analysis set with observed data and who had enthesitis at baseline. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo to Guselkumab (Week 24 to Week 56)	Guselkumab (Week 24 to Week 52)
Arm/Group Description	Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
Measure Participants	18	67
Week 24	-50.00	-100.00
Week 28	-60.00	-100.00
Week 32	-100.00	-100.00
Week 44	-100.00	-100.00
Week 56	-100.00	-100.00

22. Secondary Outcome

Title	Percentage of Participants With Enthesitis Based on LEI Score at Weeks 4, 8, 16, and 24 in Participants With Enthesitis at Baseline
Description	Enthesitis was assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. Participants with enthesitis had LEI score >0. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Time Frame	Weeks 4, 8, 16, and 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24) and who had enthesitis at baseline. Data after EE to ustekinumab or missing data were imputed using LOCF. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	31	76
Week 4	87.1 177.8%	76.3 76.3%
Week 8	87.1 177.8%	59.2 59.2%
Week 16	83.9 171.2%	53.9 53.9%
Week 24	71.0 144.9%	43.4 43.4%

23. Secondary Outcome

Title	Percentage of Participants With Enthesitis Based on LEI at Weeks 24, 28, 32, 44, and 56 in Participants With Enthesitis at Baseline
Description	Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. Participants with enthesitis had LEI score >0. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Time Frame	Weeks 24, 28, 32, 44, and 56

Outcome Measure Data

Analysis Population Description
Post Week 24 efficacy analysis set with observed data and who had enthesitis at baseline. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo to Guselkumab (Week 24 to Week 56)	Guselkumab (Week 24 to Week 52)
Arm/Group Description	Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
Measure Participants	18	67
Week 24	66.7 136.1%	38.8 38.8%
Week 28	64.7 132%	44.8 44.8%
Week 32	35.3 72%	31.8 31.8%
Week 44	47.1 96.1%	37.9 37.9%
Week 56	37.5 76.5%	29.2 29.2%

24. Secondary Outcome

Title	Change From Baseline in Psoriatic ArthritiS Disease Activity Score (PASDAS) Score at Weeks 16 and 24
Description	Change from baseline in PASDAS score measures the change in disease activity where a negative value indicates an improvement and a positive value indicates worsening of PsA disease activity. PASDAS is a PsA disease activity score that assesses 4 domains (joints, entheses, dactylitis and quality of life) of PsA. PASDAS is a derived score combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, on a 100-unit VAS), Physician's Global Assessment of Disease Activity (on a 100-unit VAS), swollen joint count (66 joints), tender joint count (68 joints), CRP (mg/L), enthesitis based on LEI (scaled to a 0-6 range), dactylitis count (scoring each digit from 0-3 and recoding to 0-1, where any score > 0 equaled 1), and the PCS score of the SF-36 health survey. The total score range is 0-10 and 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 and Weeks 16, 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24). Data after meeting TF criteria or after EE to ustekinumab and missing data are imputed as non-responders. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	49	100
Week 16	-0.45 (1.099)	-2.24 (1.458)
Week 24	-0.49 (1.333)	-2.50 (1.587)

25. Secondary Outcome

Title	Change From Baseline in PASDAS Score at Weeks 24 and 44
Description	Change from baseline in PASDAS score measures the change in disease activity where a negative value indicates an improvement and a positive value indicates worsening of PsA disease activity. PASDAS is a PsA disease activity score that assesses 4 domains (joints, entheses, dactylitis and quality of life) of PsA. PASDAS is a derived score combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, on a 100-unit VAS), Physician's Global Assessment of Disease Activity (on a 100-unit VAS), swollen joint count (66 joints), tender joint count (68 joints), CRP (mg/L), enthesitis based on LEI (scaled to a 0-6 range), dactylitis count (scoring each digit from 0-3 and recoding to 0-1, where any score > 0 equaled 1), and the PCS score of the SF-36 health survey. The total score range is 0-10 and 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 and Weeks 24, 44

Outcome Measure Data

Analysis Population Description
Post Week 24 efficacy analysis set with observed data. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo to Guselkumab (Week 24 to Week 56)	Guselkumab (Week 24 to Week 52)
Arm/Group Description	Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
Measure Participants	29	86
Week 24	-1.05 (1.440)	-2.80 (1.454)
Week 44	-3.17 (1.524)	-3.15 (1.570)

26. Secondary Outcome

Title	Change From Baseline in GRAppa Composite scorE (GRACE) Index Score at Weeks 16 and 24
Description	Change from baseline in GRACE index score measures the change in disease activity, where a negative change indicates an improvement and a positive change indicates a worsening of PsA disease activity. GRACE index was converted from Arithmetic Mean of the Desirability Function (AMDF). AMDF is calculated by transforming all variables using predefined algorithms and expressing the total score as a mean with a score range of 0 - 1, where 1 indicates a better state than 0. GRACE Index = (1 - AMDF)*10, where GRACE index has a range of 0-10, with higher scores indicate more active disease. As planned, results data was analyzed and reported for the specified arms for this outcome measure.
Time Frame	Baseline and Weeks 16, 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24). Data after EE to ustekinumab and missing data were imputed using LOCF. Here 'N' (number of participants analyzed) included all participants who were evaluable for this endpoint.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	48	98
Week 16	-0.29 (1.174)	-2.49 (1.614)
Week 24	-0.35 (1.394)	-2.73 (1.756)

27. Secondary Outcome

Title	Change From Baseline in GRACE Index Score at Weeks 24 and 44
Description	Change from baseline in GRACE index score measures the change in disease activity, where a negative change indicates an improvement and a positive change indicates a worsening of PsA disease activity. GRACE index was converted from Arithmetic Mean of the Desirability Function (AMDF). AMDF is calculated by transforming all variables using predefined algorithms and expressing the total score as a mean with a score range of 0 - 1, where 1 indicates a better state than 0. GRACE Index = (1 - AMDF)*10, where GRACE index has a range of 0-10, with higher scores indicate more active disease.
Time Frame	Baseline and Weeks 24, 44

Outcome Measure Data

Analysis Population Description
Post Week 24 efficacy analysis set with observed data. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo to Guselkumab (Week 24 to Week 56)	Guselkumab (Week 24 to Week 52)
Arm/Group Description	Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
Measure Participants	29	86
Week 24	-0.91 (1.498)	-2.96 (1.717)
Week 44	-3.21 (1.698)	-3.26 (1.856)

28. Secondary Outcome

Title	Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 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 and Weeks 16, 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24). Data after EE to ustekinumab and missing data were imputed using LOCF. Here 'N' (number of participants analyzed) included all participants who were evaluable for this endpoint. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	48	98
Week 16	-0.5 (1.88)	-3.1 (2.48)
Week 24	-0.8 (2.16)	-3.9 (2.72)

29. Secondary Outcome

Title	Change From Baseline in mCPDAI Index Score at Weeks 24 and 44
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 and Weeks 24, 44

Outcome Measure Data

Analysis Population Description
Post Week 24 efficacy analysis set with observed data. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo to Guselkumab (CO) at Week 24	Guselkumab (Week 24 to Week 52)
Arm/Group Description	Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
Measure Participants	29	86
Week 24	-1.4 (2.27)	-4.3 (2.69)
Week 44	-4.2 (2.88)	-4.8 (2.55)

30. Secondary Outcome

Title	Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 4, 8, 12, 16, 20 and 24
Description	Change from baseline in DAPSA measures the change in disease activity, where a negative change indicates an improvement and a positive change indicates worsening of disease activity. DAPSA score is a the sum of swollen joint count (66 joints), tender joint count (68 joints), CRP (mg/dL), Patient's Assessment of Pain (on a 10-unit VAS;0=no pain, 10=worst possible pain), and Patient's Global Assessment of Disease Activity (arthritis, on a 10-unit VAS; 0 to 100 centimeter [cm] VAS, 0=excellent and 10=poor). Cut-off values for disease activity: 0-4 remission; 5-14 low; 15-28 moderate; >28 high.
Time Frame	Baseline and Weeks 4, 8, 12, 16, 20, 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24). Data after early escape (EE) to ustekinumab and missing data were imputed using LOCF. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
Measure Participants	49	100
Week 4	-5.62 (13.030)	-10.03 (11.207)
Week 8	-8.25 (15.158)	-16.65 (15.948)
Week 12	-6.84 (16.334)	-18.84 (16.266)
Week 16	-4.98 (16.045)	-21.26 (17.811)
Week 20	-4.70 (17.408)	-22.56 (19.918)
Week 24	-4.97 (20.114)	-23.08 (20.206)

31. Secondary Outcome

Title	Change From Baseline in DAPSA Index Score at Weeks 24, 28, 32, 36, 44, and 56
Description	Change from baseline in DAPSA measures the change in disease activity, where a negative change indicates an improvement and a positive change indicates worsening of disease activity. DAPSA score is a the sum of swollen joint count (66 joints), tender joint count (68 joints), CRP (mg/dL), Patient's Assessment of Pain (on a 10-unit VAS;0=no pain, 10=worst possible pain), and Patient's Global Assessment of Disease Activity (arthritis, on a 10-unit VAS; 0 to 10cm VAS, 0=excellent and 10=poor). Cut-off values for disease activity: 0-4 remission; 5-14 low; 15-28 moderate; >28 high.
Time Frame	Baseline and Weeks 24, 28, 32, 36, 44, 56

Outcome Measure Data

Analysis Population Description
Post Week 24 efficacy analysis set with observed data. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo to Guselkumab (Week 24 to Week 56)	Guselkumab (Week 24 to Week 52)
Arm/Group Description	Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
Measure Participants	29	86
Week 24	-12.99 (22.328)	-26.93 (18.238)
Week 28	-20.85 (21.434)	-29.71 (18.911)
Week 32	-26.12 (21.309)	-30.59 (19.720)
Week 36	-27.37 (22.480)	-30.43 (18.114)
Week 44	-29.54 (20.785)	-30.55 (18.188)
Week 56	-31.98 (20.359)	-32.02 (18.328)

32. Secondary Outcome

Title	Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 16 and 24
Description	MDA defines a satisfactory state of disease activity that includes 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity on arthritis and psoriasis, physical function and enthesitis). Participants were classified as achieving MDA if they fulfilled 5 of 7 outcome measures: tender joint count <=1; swollen joint count <=1; PASI <=1; patient pain VAS score of <=15 mm; patient global disease activity on arthritis and psoriasis; VAS score of <=20 mm; Health Assessment Questionnaire score <=0.5; and tender entheseal points <=1.
Time Frame	Weeks 16 and 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24). Data after meeting TF criteria or after EE to ustekinumab and missing data are imputed as non-responders. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	49	100
Week 16	0 0%	18.0 18%
Week 24	2.0 4.1%	23.0 23%

33. Secondary Outcome

Title	Percentage of Participants Who Achieved MDA at Weeks 24 and 44
Description	MDA defines a satisfactory state of disease activity that includes 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity on arthritis and psoriasis, physical function and enthesitis). Participants were classified as achieving MDA if they fulfilled 5 of 7 outcome measures: tender joint count <=1; swollen joint count <=1; PASI <=1; patient pain VAS score of <=15 mm; patient global disease activity on arthritis and psoriasis; VAS score of <=20 mm; Health Assessment Questionnaire score <=0.5; and tender entheseal points <=1.
Time Frame	Weeks 24 and 44

Outcome Measure Data

Analysis Population Description
Post Week 24 efficacy analysis set with observed data. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo to Guselkumab (Week 24 to Week 56)	Guselkumab (Week 24 to Week 52)
Arm/Group Description	Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
Measure Participants	29	86
Week 24	3.4 6.9%	26.7 26.7%
Week 44	28.6 58.4%	34.5 34.5%

34. Secondary Outcome

Title	Change From Baseline in the Physical and Mental Component Summary (PCS and MCS) Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Weeks 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 and MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms as presented in this outcome measure. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time Frame	Baseline and Weeks 16, 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24). Data after meeting TF criteria or after EE to ustekinumab and missing data are imputed as non-responders. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	49	100
Week 16: PCS	-0.44 (5.025)	5.86 (7.315)
Week 24: PCS	0.46 (6.513)	6.59 (7.465)
Week 16: MCS	1.14 (7.075)	4.80 (8.952)
Week 24: MCS	0.42 (6.737)	4.95 (9.064)

35. Secondary Outcome

Title	Change From Baseline in the PCS Scores of SF-36 at Weeks 24 and 44
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 as presented in this outcome measure. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time Frame	Baseline and Weeks 24, 44

Outcome Measure Data

Analysis Population Description
Post Week 24 efficacy analysis set with observed data. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo to Guselkumab (Week 24 to Week 56)	Guselkumab (Week 24 to Week 52)
Arm/Group Description	Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
Measure Participants	29	86
Week 24: PCS	2.13 (7.365)	7.40 (7.448)
Week 44: PCS	8.02 (8.647)	8.34 (8.783)

36. Secondary Outcome

Title	Change From Baseline in the MCS Scores of SF-36 at Weeks 24 and 44
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 as presented in this outcome measure. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time Frame	Baseline and Weeks 24, 44

Outcome Measure Data

Analysis Population Description
Post Week 24 efficacy analysis set with observed data. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo to Guselkumab (Week 24 to Week 56)	Guselkumab (Week 24 to Week 52)
Arm/Group Description	Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
Measure Participants	29	86
Week 24: MCS	0.51 (6.770)	5.45 (9.081)
Week 44: MCS	5.53 (9.013)	4.56 (9.548)

37. Secondary Outcome

Title	Change From Baseline in Norm-based SF-36 Scales at Week 16 and 24
Description	SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. The scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher scores indicate better health. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time Frame	Baseline and Weeks 16, 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24). Data after meeting TF criteria or after EE to ustekinumab and missing data are imputed as non-responders. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	49	100
Week 16: Physical functioning	-0.31 (6.657)	6.30 (7.255)
Week 24: Physical functioning	-0.04 (8.227)	6.93 (8.009)
Week 16: Role-physical	-0.23 (5.674)	4.22 (7.146)
Week 24: Role-physical	-0.09 (6.813)	4.69 (7.961)
Week 16: Bodily pain	0.21 (5.675)	6.56 (7.832)
Week 24: Bodily pain	0.81 (6.445)	7.56 (8.288)
Week 16: General health	0.74 (5.857)	6.19 (7.964)
Week 24: General health	1.49 (7.274)	6.48 (7.676)
Week 16: Vitality	0.73 (7.779)	5.85 (8.138)
Week 24: Vitality	1.46 (7.254)	6.39 (8.861)
Week 16: Social functioning	-0.82 (8.272)	5.87 (9.346)
Week 24: Social functioning	-0.82 (7.613)	6.22 (10.426)
Week 16: Role-emotional	1.14 (8.774)	4.77 (9.643)
Week 24: Role-emotional	0.64 (8.754)	4.67 (9.393)
Week 16: Mental health	1.28 (7.007)	5.10 (8.683)
Week 24: Mental health	0.21 (7.020)	5.68 (8.877)

38. Secondary Outcome

Title	Change From Baseline in Norm-based SF-36 Scale at Week 24 and 44
Description	SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. The scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher scores indicate better health. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time Frame	Baseline and Weeks 24, 44

Outcome Measure Data

Analysis Population Description
Post Week 24 efficacy analysis set with observed data. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo to Guselkumab (Week 24 to Week 56)	Guselkumab (Week 24 to Week 52)
Arm/Group Description	Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
Measure Participants	29	86
Week 24: Physical functioning	1.09 (8.953)	7.54 (8.228)
Week 44: Physical functioning	8.41 (9.969)	8.50 (8.633)
Week 24: Role-physical	1.92 (7.119)	5.74 (7.480)
Week 44: Role-physical	6.82 (9.198)	6.66 (7.664)
Week 24: Bodily pain	2.88 (6.856)	8.39 (8.332)
Week 44: Bodily pain	9.42 (8.914)	8.95 (9.952)
Week 24: General health	1.94 (8.185)	7.05 (7.657)
Week 44: General health	6.25 (8.998)	6.74 (8.496)
Week 24: Vitality	1.49 (7.387)	7.39 (8.727)
Week 44: Vitality	7.53 (10.802)	7.11 (9.891)
Week 24: Social functioning	-0.18 (7.776)	6.41 (10.919)
Week 44: Social functioning	6.09 (10.151)	5.73 (10.357)
Week 24: Role-emotional	2.11 (7.891)	5.30 (9.013)
Week 44: Role-emotional	5.47 (9.160)	5.68 (9.635)
Week 24: Mental health	0.19 (7.465)	6.30 (8.994)
Week 44: Mental health	7.29 (9.952)	5.42 (8.978)

39. Secondary Outcome

Title	Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Weeks 16 and 24
Description	RAPID3 is a multi-dimensional health assessment questionnaire that was designed for use in routine clinical care. Three core data set for function, pain, and patient global estimate of disease activity were recorded. Each was scored 0-10 and the score ranges from 0 to 30 with higher scores indicating worse condition. A negative change from baseline indicates improvement in condition.
Time Frame	Baseline and Weeks 16, 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24). Data after meeting TF criteria or after EE to ustekinumab and missing data are imputed as non-responders. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	49	100
Week 16	-0.19 (4.405)	-5.41 (5.307)
Week 24	-0.57 (5.123)	-5.81 (5.968)

40. Secondary Outcome

Title	Change From Baseline in RAPID3 Score at Weeks 24 and 44
Description	RAPID3 is a multi-dimensional health assessment questionnaire that was designed for use in routine clinical care. Three core data set for function, pain, and patient global estimate of disease activity were recorded. Each was scored 0-10 and the score ranges from 0 to 30 with higher scores indicating worse condition. A negative change from baseline indicates improvement in condition.
Time Frame	Baseline and Weeks 24, 44

Outcome Measure Data

Analysis Population Description
Post Week 24 efficacy analysis set with observed data. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo to Guselkumab (CO) at Week 24	Guselkumab
Arm/Group Description	Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
Measure Participants	29	86
Week 24	-2.28 (5.244)	-6.36 (6.205)
Week 44	-7.60 (6.588)	-7.48 (6.310)

41. Secondary Outcome

Title	Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 16 and 24
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 50, 75, 90, and 100 responses were defined as at least a 50%, 75%, 90%, and 100% reduction in PASI relative to Baseline respectively. As planned, results data was analyzed and reported for the specified arms for this outcome measure.
Time Frame	Weeks 16 and 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24). Data after EE to ustekinumab and missing data were imputed using LOCF. Here 'N' (number of participants analyzed) included all participants who were evaluable for this endpoint.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	48	98
Week 16: PASI 50 responders	27.1 55.3%	81.6 81.6%
Week 16: PASI 75 responders	8.3 16.9%	71.4 71.4%
Week 16: PASI 90 responders	6.3 12.9%	53.1 53.1%
Week 16: PASI 100 responders	6.3 12.9%	31.6 31.6%
Week 24: PASI 50 responders	29.2 59.6%	86.7 86.7%
Week 24: PASI 75 responders	12.5 25.5%	78.6 78.6%
Week 24: PASI 90 responders	6.3 12.9%	66.3 66.3%
Week 24: PASI 100 responders	6.3 12.9%	39.8 39.8%

42. Secondary Outcome

Title	Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 24, 28, 32, 44, and 56
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 50, 75, 90, and 100 responses were defined as at least a 50%, 75%, 90%, and 100% reduction in PASI relative to Baseline respectively.
Time Frame	Weeks 24, 28, 32, 44, and 56

Outcome Measure Data

Analysis Population Description
Post Week 24 efficacy analysis set with observed data. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo to Guselkumab (Week 24 to Week 56)	Guselkumab (Week 24 to Week 52)
Arm/Group Description	Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
Measure Participants	29	86
Week 24: PASI 50 responders	37.9 77.3%	89.5 89.5%
Week 24: PASI 75 responders	20.7 42.2%	82.6 82.6%
Week 24: PASI 90 responders	10.3 21%	70.9 70.9%
Week 24: PASI 100 responders	10.3 21%	44.2 44.2%
Week 28: PASI 50 responders	60.7 123.9%	95.2 95.2%
Week 28: PASI 75 responders	35.7 72.9%	84.5 84.5%
Week 28: PASI 90 responders	25.0 51%	72.6 72.6%
Week 28: PASI 100 responders	17.9 36.5%	53.6 53.6%
Week 32: PASI 50 responders	78.6 160.4%	92.8 92.8%
Week 32: PASI 75 responders	67.9 138.6%	86.7 86.7%
Week 32: PASI 90 responders	50.0 102%	80.7 80.7%
Week 32: PASI 100 responders	35.7 72.9%	62.7 62.7%
Week 44: PASI 50 responders	89.3 182.2%	94.0 94%
Week 44: PASI 75 responders	82.1 167.6%	90.4 90.4%
Week 44: PASI 90 responders	75.0 153.1%	81.9 81.9%
Week 44: PASI 100 responders	67.9 138.6%	63.9 63.9%
Week 56: PASI 50 responders	96.3 196.5%	92.7 92.7%
Week 56: PASI 75 responders	81.5 166.3%	85.4 85.4%
Week 56: PASI 90 responders	74.1 151.2%	78.0 78%
Week 56: PASI 100 responders	55.6 113.5%	57.3 57.3%

43. Secondary Outcome

Title	Percent Change From Baseline in PASI Score at Weeks 4, 8, 16, and 24
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A negative percent change from baseline indicates the percent improvement from baseline in the severity of psoriatic lesions. As planned, results data was analyzed and reported for the specified arms for this outcome measure.
Time Frame	Baseline and Weeks 4, 8, 16, 24

Outcome Measure Data

Analysis Population Description
FAS (up to Week 24). Data after EE to ustekinumab and missing data were imputed using LOCF. Here 'N' (number of participants analyzed) included all participants who were evaluable for this endpoint.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.	Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
Measure Participants	48	98
Week 4	0.00	-41.49
Week 8	1.58	-66.67
Week 16	-1.10	-90.55
Week 24	-7.89	-96.21

44. Secondary Outcome

Title	Percent Change From Baseline in PASI Score at Weeks 24, 28, 32, 44, and 56
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A negative percent change from baseline indicates the percent improvement from baseline in the severity of psoriatic lesions.
Time Frame	Baseline and Weeks 24, 28, 32, 44, 56

Outcome Measure Data

Analysis Population Description
Post Week 24 efficacy analysis set with observed data. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints. As planned, results data was analyzed and reported for the specified arms for this outcome measure.

Arm/Group Title	Placebo to Guselkumab (Week 24 to Week 56)	Guselkumab (Week 24 to Week 52)
Arm/Group Description	Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.	Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
Measure Participants	29	86
Week 24	-34.26	-97.85
Week 28	-57.69	-100.00
Week 32	-90.61	-100.00
Week 44	-100.00	-100.00
Week 56	-100.00	-100.00

Adverse Events

	Placebo (Week 0 to Week 24)		Placebo to Guselkumab (Week 24 to Week 56)		Guselkumab (Week 0 to Week 56)		Placebo to Ustekinumab (EE: Week 16 to Week 56)		Guselkumab to Ustekinumab (EE:Week 16 to Week 56)
Time Frame	Up to Week 56
Adverse Event Reporting Description	The safety analysis set included all participants who received at least 1 (partial or complete) dose of study agent and were analyzed based on the actual treatment received.

Arm/Group Title	Placebo (Week 0 to Week 24)		Placebo to Guselkumab (Week 24 to Week 56)		Guselkumab (Week 0 to Week 56)		Placebo to Ustekinumab (EE: Week 16 to Week 56)		Guselkumab to Ustekinumab (EE:Week 16 to Week 56)
Arm/Group Description	Participants received placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20. Data through Week 24 prior to receiving guselkumab or through Week 16 prior to receiving ustekinumab (for participants who early escaped at week 16) were included.		Participants who received placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injections at Week 24, 28, 36 and 44. Data from the first administration of guselkumab (Week 24) through Week 56 (final follow-up) were included.		Participants received guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24. Data from Week 0 through Week 56 (final follow-up) or through Week 16 prior to receiving ustekinumab (for participants who early escaped at week 16) were included.		Participants who received placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and were qualified to early escape (EE) at Week 16 received open-label ustekinumab subcutaneous injections at Weeks 16, 20, 32 and 44 at the approved dosage for PsA in the particular country of the study. Data from the first administration of ustekinumab (Week 16) through Week 56 (final follow-up) were included.		Participants who received guselkumab subcutaneous injections at Weeks 0, 4, 12 and were qualified to early escape (EE) at Week 16 received open-label ustekinumab subcutaneous injections at Weeks 16, 20, 32 and 44 at the approved dosage for PsA in the particular country of the study. Data from the first administration of ustekinumab (Week 16) through Week 56 (final follow-up) were included.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/29 (0%)		0/100 (0%)		0/17 (0%)		0/10 (0%)
Serious Adverse Events
	Placebo (Week 0 to Week 24)		Placebo to Guselkumab (Week 24 to Week 56)		Guselkumab (Week 0 to Week 56)		Placebo to Ustekinumab (EE: Week 16 to Week 56)		Guselkumab to Ustekinumab (EE:Week 16 to Week 56)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/49 (2%)		0/29 (0%)		6/100 (6%)		0/17 (0%)		0/10 (0%)
Cardiac disorders
Myocardial Infarction	0/49 (0%)		0/29 (0%)		1/100 (1%)		0/17 (0%)		0/10 (0%)
Eye disorders
Pupils Unequal	0/49 (0%)		0/29 (0%)		1/100 (1%)		0/17 (0%)		0/10 (0%)
Ulcerative Keratitis	0/49 (0%)		0/29 (0%)		1/100 (1%)		0/17 (0%)		0/10 (0%)
Infections and infestations
Pneumonia	0/49 (0%)		0/29 (0%)		1/100 (1%)		0/17 (0%)		0/10 (0%)
Injury, poisoning and procedural complications
Joint Injury	1/49 (2%)		0/29 (0%)		0/100 (0%)		0/17 (0%)		0/10 (0%)
Radius Fracture	0/49 (0%)		0/29 (0%)		1/100 (1%)		0/17 (0%)		0/10 (0%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	0/49 (0%)		0/29 (0%)		1/100 (1%)		0/17 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Placebo (Week 0 to Week 24)		Placebo to Guselkumab (Week 24 to Week 56)		Guselkumab (Week 0 to Week 56)		Placebo to Ustekinumab (EE: Week 16 to Week 56)		Guselkumab to Ustekinumab (EE:Week 16 to Week 56)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/49 (14.3%)		3/29 (10.3%)		24/100 (24%)		8/17 (47.1%)		3/10 (30%)
Blood and lymphatic system disorders
Leukopenia	0/49 (0%)		1/29 (3.4%)		5/100 (5%)		0/17 (0%)		0/10 (0%)
Infections and infestations
Bronchitis	1/49 (2%)		0/29 (0%)		2/100 (2%)		1/17 (5.9%)		0/10 (0%)
Cystitis	0/49 (0%)		0/29 (0%)		0/100 (0%)		1/17 (5.9%)		0/10 (0%)
Nasopharyngitis	5/49 (10.2%)		0/29 (0%)		10/100 (10%)		2/17 (11.8%)		0/10 (0%)
Urinary Tract Infection	0/49 (0%)		0/29 (0%)		2/100 (2%)		1/17 (5.9%)		0/10 (0%)
Investigations
Alanine Aminotransferase Increased	1/49 (2%)		2/29 (6.9%)		4/100 (4%)		0/17 (0%)		0/10 (0%)
Aspartate Aminotransferase Increased	0/49 (0%)		2/29 (6.9%)		3/100 (3%)		0/17 (0%)		1/10 (10%)
Weight Increased	1/49 (2%)		0/29 (0%)		0/100 (0%)		1/17 (5.9%)		0/10 (0%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	0/49 (0%)		0/29 (0%)		0/100 (0%)		0/17 (0%)		1/10 (10%)
Nervous system disorders
Headache	0/49 (0%)		0/29 (0%)		0/100 (0%)		1/17 (5.9%)		0/10 (0%)
Psychiatric disorders
Depressive Symptom	0/49 (0%)		0/29 (0%)		0/100 (0%)		1/17 (5.9%)		0/10 (0%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain	0/49 (0%)		0/29 (0%)		0/100 (0%)		0/17 (0%)		1/10 (10%)
Upper Respiratory Tract Inflammation	0/49 (0%)		0/29 (0%)		1/100 (1%)		1/17 (5.9%)		0/10 (0%)
Skin and subcutaneous tissue disorders
Psoriasis	1/49 (2%)		0/29 (0%)		1/100 (1%)		1/17 (5.9%)		0/10 (0%)

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.

Results Point of Contact

Name/Title	Senior Director
Organization	Janssen Research & Development, LLC
Phone	844-434-4210
Email	ClinicalTrialDisclosure@its.jnj.com

Responsible Party:

Janssen Research & Development, LLC

ClinicalTrials.gov Identifier:

NCT02319759

Other Study ID Numbers:

CR105964
2014-003697-17
CNTO1959PSA2001

First Posted:

Dec 18, 2014

Last Update Posted:

Oct 14, 2020

Last Verified:

Sep 1, 2020

Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)

Study Details

Study Description

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Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

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Inclusion Criteria:

Exclusion Criteria:

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Baseline Characteristics

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Statistical Analysis 1

Outcome Measure Data

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Adverse Events

All Cause Mortality

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Other (Not Including Serious) Adverse Events

Limitations/Caveats

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Results Point of Contact