Multi-country Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab (Humira®) in Patients With Ankylosing Spondylitis and Psoriatic Arthritis

• Sponsor: AbbVie (prior sponsor, Abbott) (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01474876
• Collaborator: (none)
• Enrollment: 566
• Duration (Months): 30

Study Details

Study Description

Brief Summary

This 12-month postmarketing observational study (PMOS) was a prospective, single-arm, multicenter, multi-country study, with follow-up visits at 3, 6, 9, and 12 months after the initial baseline visit. The study was conducted to determine the long-term effectiveness of treatment with adalimumab in routine clinical use in participants with Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) in Central and Eastern European Countries.

Condition or Disease	Intervention/Treatment	Phase
Ankylosing Spondylitis; Psoriatic Arthritis

Detailed Description

Additional study objectives were to evaluate AS and PsA with regard to extra-articular manifestations (EAMs), functional status, the use of concomitant nonsteroidal anti-inflammatory medication, and work productivity impairment. In addition, the Ankylosing Spondylitis Disease Activity Score (ASDAS), a new disease activity index in AS, was measured in parallel with the standard Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score to assess the effectiveness of adalimumab in treating axial symptoms.

Study Design

• Study Type: Observational
• Actual Enrollment: 566 participants
• Time Perspective: Prospective
• Official Title: Multicountry Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab in Patients With Ankylosing Spondylitis and Psoriatic Arthritis
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Ankylosing Spondylitis Participants with a diagnosis of ankylosing spondylitis
Psoriatic Arthritis Participants with a diagnosis of psoriatic arthritis

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With a 50% or More Decrease in Bath Ankylosing Spondylitis Daily Activity Index (BASDAI) Score at 12 Months Relative to Baseline [Baseline (Visit 0) to 12 months]

   The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.

2. Percentage of Participants With a Disease Activity Score 28 (DAS28) Decrease ≥1.2 at 12 Months Relative to Baseline [Baseline (Visit 0) to 12 months]

   The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.

3. Percentage of Participants With Active Axial Symptoms in Remission [Baseline (Visit 0) to 12 months]

   The Ankylosing Spondylitis Disease Score (ASDAS) tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Remission was defined as ASDAS <1.3 at 12 months.

4. Percentage of Participants With Peripheral Symptoms in Remission [Baseline (Visit 0) to 12 months]

   The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. Remission was defined as DAS28 ≤2.6 at 12 months.

Secondary Outcome Measures

1. Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Ankylosing Spondylitis [Baseline (Visit 0) to 12 months]

   The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C- reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.

2. Mean Change in Ankylosing Spondylitis Disease Activity Score (ASDAS) [Baseline (Visit 0) to 12 months]

   The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Remission is defined as ASDAS score <1.3. Clinically important improvement is defined as a change ≥ 1.1 units, and major improvement is defined as a change ≥ 2.0 units.

3. Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis [Baseline (Visit 0) to 12 months]

   BASDAI score (ranging from 0 to 10) was calculated using a questionnaire. Participants marked responses on a 10 cm visual analog scale ranging from 0 (none) to 10 (very severe) regarding fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. ASDAS is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Spearman's rank correlation coefficient (CC) was calculated for BASDAI vs. ASDAS(subscript)CRP(subscript) and BASDAI vs. ASDAS(subscript)ESR(subscript ).

4. Predictors of Maintained Treatment Response and Remission in Participants With Ankylosing Spondylitis [Baseline (Visit 0) to 12 months]

   A mathematical technique called logistic regression was performed to identify factors that could be used to predict maintained treatment response and remission. The following baseline variables were used in the logistic regression analyses: age, gender, disease of interest, result of tuberculosis screening, time since diagnosis and extra-articular manifestations (symptoms and diseases that occur in parts of the body other than joints) at baseline. The BASDAI score at baseline was forced to serve as a predictor in each model.

5. Mean Change in Health Assessment Questionnaire Disability Index (HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Ankylosing Spondylitis [Baseline (Visit 0) to 12 months]

   HAQ-DI consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, with a higher score representing a high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ-DI remission, indicating normal physical function, is defined as HAQ-DI < 0.5. The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. A visual analogue scale (with 0 being "easy" and 10 "impossible") is used. The BASFI score ranges from 0 to 10 and is derived as the mean of the single items. A higher score indicates a higher impairment of functioning.

6. Mean Frequency of Extra-articular Manifestations (EAMs) [Baseline (Visit 0) to 12 months]

   Extra-articular manifestations (EAMs) are symptoms and diseases that occur in parts of the body other than joints. The number of EAMs was determined at each study visit. These included the presence of enthesitis (inflammation of ligaments and/or tendons at the site of insertion into bones), uveitis (inflammation of the middle layer of the eye), psoriasis (a skin condition that causes itchy or sore patches of thick, red skin with silvery scales), and Inflammatory bowel disease (Crohn's disease or ulcerative colitis).

7. Duration of Treatment With Adalimumab [Baseline (Visit 0) to 12 months]

   The duration of treatment with adalimumab was calculated separately for participants who discontinued the medication during the study and for those who did not.

8. Percentage of Participants Whose Co-medication With Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Was Stopped During the Study [Baseline (Visit 0) to 12 months]

   Participants were surveyed at each study visit for their use of NSAID medication.

9. Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Ankylosing Spondylitis [Baseline (Visit 0) to 12 months]

   Work Productivity and Activity Impairment (WPAI) Questionnaire is a quantitative assessment of the amount of absenteeism, presenteeism, total work productivity impairment, and total activity impairment attributable to a specific health problem (WPAI-SHP), expressed as a percentage. Participants were queried regarding their current employment status, hours missed from work because of problems associated with their AS, hours missed from work because of any other reason, number of hours worked, how much AS affected work productivity (0=AS had no effect,10= AS completely prevented me from working), and how much AS affected ability to do regular daily activities, other than work at a job (0= AS had no effect, 10= AS completely prevented me from doing my daily activities) in the past 7 days.

10. Change in the Percentage of Ankylosing Spondylitis Participants Who Have Paid Work [Baseline (Visit 0) to 12 months]

    Working status (Working full-time, working part-time, working at home, unemployed but seeking work, work disabled, retired, student) was documented at each study visit.

11. Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Psoriatic Arthritis [Baseline (Visit 0) to 12 months]

    The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C- reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.

12. Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Psoriatic Arthritis [Baseline (Visit 0) to 12 months]

    BASDAI score (ranging from 0 to 10) was calculated using a questionnaire. Participants marked responses on a 10 cm visual analog scale ranging from 0 (none) to 10 (very severe) regarding fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. ASDAS score consists of a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Spearman's rank correlation coefficient (CC) was calculated for BASDAI vs. ASDAS(subscript)CRP(subscript) and BASDAI vs. ASDAS(subscript)ESR(subscript).

13. Predictors of Maintained Treatment Response and Remission in Participants With Psoriatic Arthritis [Baseline (Visit 0) to 12 months]

    A mathematical technique called logistic regression was performed to identify factors that could be used to predict maintained treatment response and remission. The following baseline variables were used in the logistic regression analyses: age, gender, disease of interest, result of tuberculosis screening, time since diagnosis and extra-articular manifestations (symptoms and diseases that occur in parts of the body other than joints) at baseline. The BASDAI score at baseline was forced to serve as a predictor in each model.

14. Mean Change in Health Assessment Questionnaire Disability Index ( HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Psoriatic Arthritis [Baseline (Visit 0) to 12 months]

    HAQ-DI consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, with a higher score representing a high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ-DI remission, indicating normal physical function, is defined as HAQ-DI < 0.5. The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. A visual analogue scale (with 0 being "easy" and 10 "impossible") is used. The BASFI score ranges from 0 to 10 and is derived as the mean of the single items. A higher score indicates a higher impairment of functioning.

15. Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Psoriatic Arthritis [Baseline (Visit 0) to 12 months]

    The Work Productivity and Activity Impairment (WPAI) Questionnaire is a quantitative assessment of the amount of absenteeism, presenteeism, total work productivity impairment, and total activity impairment attributable to a specific health problem (WPAI-SHP), expressed as a percentage. Participants were queried regarding their current employment status, hours missed from work because of problems associated with their PsA, hours missed from work because of any other reason, number of hours worked, how much PsA affected work productivity (0= PsA had no effect,10= PsA completely prevented me from working), and how much PsA affected ability to do regular daily activities, other than work at a job (0= PsA had no effect, 10= PsA completely prevented me from doing my daily activities) in the past 7 days.

16. Change in the Percentage of Psoriatic Arthritis Participants Who Have Paid Work [Baseline (Visit 0) to 12 months]

    Working status (Working full-time, working part-time, working at home, unemployed but seeking work, work disabled, retired, student) was documented at each study visit.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

Patients will be enrolled in this Postmarketing observational study PMOS if they fulfill all of the below criteria:

1. Adult patients with diagnosis of Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA).

2. Eligible for adalimumab therapy according to the local product label and prescription/reimbursement guidelines.

3. Have been prescribed adalimumab within a maximum of one (1) month prior to the study enrolment.

4. Have negative result of Tuberculosis (TB) screening test or TB prophylaxis as per local guidelines.

5. Are willing to provide Authorization to the investigator to use and/or disclose personal and/or health data, or to provide Informed Consent if requested by the Local Regulations, before entry into the study.

Exclusion Criteria:

Patients fulfilling below exclusion criteria will not be eligible for this Postmarketing study (PMOS):

1. Meet contraindications for treatment with adalimumab as outlined in the latest version of the local Summary of Product Characteristics (SmPC)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie (prior sponsor, Abbott)

Investigators

• Study Director: Isidro Villanueva Torrecillas, MD, AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01474876
• Other Study ID Numbers: P12-768
• First Posted: Nov 18, 2011
• Last Update Posted: Jul 8, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by AbbVie (prior sponsor, Abbott): Post-marketing observational study (PMOS) Protocol; Effectiveness of Adalimumab (HUMIRA®); Psoriatic Arthritis; Ankylosing Spondylitis
• Additional relevant MeSH terms: Spondylitis; Arthritis; Spondylarthritis; Arthritis, Psoriatic; Spondylitis, Ankylosing

Study Results

Participant Flow

Pre-assignment Detail	A total of 566 participants were enrolled, and 11 participants were lost to follow-up after the baseline visit. According to the pre-specified analysis strategy in the statistical analysis plan, these participants were excluded from the full analysis set, which consisted of 555 participants.

Arm/Group Title	Ankylosing Spondylitis	Psoriatic Arthritis	Disease State Unknown
Arm/Group Description	Participants with a diagnosis of ankylosing spondylitis	Participants with a diagnosis of psoriatic arthritis	For one participant, information regarding the underlying disease was not available
Period Title: Overall Study
STARTED	403	151	1
COMPLETED	337	128	1
NOT COMPLETED	66	23	0

Baseline Characteristics

Arm/Group Title	Ankylosing Spondylitis	Psoriatic Arthritis	Disease State Unknown	Total
Arm/Group Description	Participants with a diagnosis of ankylosing spondylitis	Participants with a diagnosis of psoriatic arthritis	For one participant, information regarding the underlying disease was not available	Total of all reporting groups
Overall Participants	403	151	1	555
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.0 (12.8)	49.7 (12.1)	40 (NA)	45.6 (12.9)
Sex: Female, Male (Count of Participants)
Female	109 27%	65 43%	0 0%	174 31.4%
Male	294 73%	86 57%	1 100%	381 68.6%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With a 50% or More Decrease in Bath Ankylosing Spondylitis Daily Activity Index (BASDAI) Score at 12 Months Relative to Baseline
Description	The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.
Time Frame	Baseline (Visit 0) to 12 months

Outcome Measure Data

Analysis Population Description

Participants with active axial symptoms (a baseline value of the BASDAI > 4).

Arm/Group Title	Ankylosing Spondylitis	Psoriatic Arthritis
Arm/Group Description	Participants with a diagnosis of ankylosing spondylitis	Participants with a diagnosis of psoriatic arthritis
Measure Participants	366	52
Number (95% Confidence Interval) [Percentage of participants]	76.5 19%	73.1 48.4%

2. Primary Outcome

Title	Percentage of Participants With a Disease Activity Score 28 (DAS28) Decrease ≥1.2 at 12 Months Relative to Baseline
Description	The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Time Frame	Baseline (Visit 0) to 12 months

Outcome Measure Data

Analysis Population Description

Participants with peripheral symptoms (DAS28 > 5.1 at baseline)

Arm/Group Title	Ankylosing Spondylitis	Psoriatic Arthritis
Arm/Group Description	Participants with a diagnosis of ankylosing spondylitis	Participants with a diagnosis of psoriatic arthritis
Measure Participants	18	61
Number (95% Confidence Interval) [Percentage of participants]	83.3 20.7%	83.6 55.4%

3. Primary Outcome

Title	Percentage of Participants With Active Axial Symptoms in Remission
Description	The Ankylosing Spondylitis Disease Score (ASDAS) tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Remission was defined as ASDAS <1.3 at 12 months.
Time Frame	Baseline (Visit 0) to 12 months

Outcome Measure Data

Analysis Population Description

Participants with active axial symptoms (a baseline value of BASDAI > 4)

Arm/Group Title	Ankylosing Spondylitis	Psoriatic Arthritis
Arm/Group Description	Participants with a diagnosis of ankylosing spondylitis	Participants with a diagnosis of psoriatic arthritis
Measure Participants	361	52
Number (95% Confidence Interval) [Percentage of participants]	34.3 8.5%	28.8 19.1%

4. Secondary Outcome

Title	Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Ankylosing Spondylitis
Description	The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C- reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Time Frame	Baseline (Visit 0) to 12 months

Outcome Measure Data

Analysis Population Description

Participants with ankylosing spondylitis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4)

Arm/Group Title	Ankylosing Spondylitis
Arm/Group Description	Participants with a diagnosis of ankylosing spondylitis
Measure Participants	366
Mean change in BASDAI score, n=366	-4.6 (2.3)
Mean change in DAS28 score, n=18	-1.9 (1.3)

5. Secondary Outcome

Title	Mean Change in Ankylosing Spondylitis Disease Activity Score (ASDAS)
Description	The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Remission is defined as ASDAS score <1.3. Clinically important improvement is defined as a change ≥ 1.1 units, and major improvement is defined as a change ≥ 2.0 units.
Time Frame	Baseline (Visit 0) to 12 months

Outcome Measure Data

Analysis Population Description

Participants with active axial symptoms (a baseline value of BASDAI > 4)

Arm/Group Title	Ankylosing Spondylitis	Psoriatic Arthritis
Arm/Group Description	Participants with a diagnosis of ankylosing spondylitis	Participants with a diagnosis of psoriatic arthritis
Measure Participants	358	51
Mean change in ASDAS-CRP, n=299 and 45	-2.6 (1.2)	-1.9 (1.7)
Mean change in ASDAS-ESR, n=358 and 51	-2.3 (1.1)	-1.9 (1.4)

6. Secondary Outcome

Title	Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis
Description	BASDAI score (ranging from 0 to 10) was calculated using a questionnaire. Participants marked responses on a 10 cm visual analog scale ranging from 0 (none) to 10 (very severe) regarding fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. ASDAS is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Spearman's rank correlation coefficient (CC) was calculated for BASDAI vs. ASDAS(subscript)CRP(subscript) and BASDAI vs. ASDAS(subscript)ESR(subscript ).
Time Frame	Baseline (Visit 0) to 12 months

Outcome Measure Data

Analysis Population Description

Participants with ankylosing spondylitis and active axial symptoms (a baseline value of BASDAI > 4)

Arm/Group Title	Ankylosing Spondylitis
Arm/Group Description	Participants with a diagnosis of ankylosing spondylitis
Measure Participants	358
Correlation BASDAI and ASDAS-CRP, n=299	0.62
Correlation BASDAI and ASDAS-ESR, n=358	0.71

7. Secondary Outcome

Title	Predictors of Maintained Treatment Response and Remission in Participants With Ankylosing Spondylitis
Description	A mathematical technique called logistic regression was performed to identify factors that could be used to predict maintained treatment response and remission. The following baseline variables were used in the logistic regression analyses: age, gender, disease of interest, result of tuberculosis screening, time since diagnosis and extra-articular manifestations (symptoms and diseases that occur in parts of the body other than joints) at baseline. The BASDAI score at baseline was forced to serve as a predictor in each model.
Time Frame	Baseline (Visit 0) to 12 months

Outcome Measure Data

Analysis Population Description

Participants with ankylosing spondylitis and active axial symptoms (a baseline value of BASDAI > 4)

Arm/Group Title	Ankylosing Spondylitis
Arm/Group Description	Participants with a diagnosis of ankylosing spondylitis
Measure Participants	361
Response (Age), n=361	0.98
Response (Enthesitis at V0), n=361	2.47
Response (BASDAI at V0), n=361	1.18
Remission (Age), n=356	0.96
Remission (TB positive at V0), n=356	0.57
Remission (Male gender), n=356	1.77
Remission (BASDAI at V0), n=356	0.94

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ankylosing Spondylitis
	Comments	Treatment response and participant age
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0164
	Comments
	Method	Regression, Logistic
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ankylosing Spondylitis
	Comments	Treatment response and presence of enthesitis at Visit 0
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0200
	Comments
	Method	Regression, Logistic
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ankylosing Spondylitis
	Comments	Treatment response and BASDAI score at Visit 0
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0867
	Comments
	Method	Regression, Logistic
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Ankylosing Spondylitis
	Comments	Remission and participant age
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Regression, Logistic
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Ankylosing Spondylitis
	Comments	Remission and positive tuberculosis screening at Visit 0
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0734
	Comments
	Method	Regression, Logistic
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Ankylosing Spondylitis
	Comments	Remission and male gender
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0438
	Comments
	Method	Regression, Logistic
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Ankylosing Spondylitis
	Comments	Remission and BASDAI score at Visit 0
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5030
	Comments
	Method	Regression, Logistic
	Comments

8. Secondary Outcome

Title	Mean Change in Health Assessment Questionnaire Disability Index (HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Ankylosing Spondylitis
Description	HAQ-DI consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, with a higher score representing a high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ-DI remission, indicating normal physical function, is defined as HAQ-DI < 0.5. The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. A visual analogue scale (with 0 being "easy" and 10 "impossible") is used. The BASFI score ranges from 0 to 10 and is derived as the mean of the single items. A higher score indicates a higher impairment of functioning.
Time Frame	Baseline (Visit 0) to 12 months

Outcome Measure Data

Analysis Population Description

Participants with ankylosing spondylitis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4)

Arm/Group Title	Ankylosing Spondylitis
Arm/Group Description	Participants with a diagnosis of ankylosing spondylitis
Measure Participants	346
Mean change in HAQ-DI, n=30	-0.9 (0.6)
Mean change in BASFI, n=346	-4.1 (2.5)

9. Secondary Outcome

Title	Mean Frequency of Extra-articular Manifestations (EAMs)
Description	Extra-articular manifestations (EAMs) are symptoms and diseases that occur in parts of the body other than joints. The number of EAMs was determined at each study visit. These included the presence of enthesitis (inflammation of ligaments and/or tendons at the site of insertion into bones), uveitis (inflammation of the middle layer of the eye), psoriasis (a skin condition that causes itchy or sore patches of thick, red skin with silvery scales), and Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
Time Frame	Baseline (Visit 0) to 12 months

Outcome Measure Data

Analysis Population Description

Participants who received adalimumab treatment

Arm/Group Title	Ankylosing Spondylitis	Psoriatic Arthritis
Arm/Group Description	Participants with a diagnosis of ankylosing spondylitis	Participants with a diagnosis of psoriatic arthritis
Measure Participants	403	151
Baseline (Visit 0), n=403, 151	0.5 (0.6)	1.1 (0.6)
Visit 1 , n=400, 150	0.2 (0.4)	0.6 (0.6)
Visit 2, n=357, 137	0.1 (0.3)	0.5 (0.6)
Visit 3, n=339, 124	0.1 (0.3)	0.5 (0.5)
Visit 4, n=324, 124	0.1 (0.3)	0.5 (0.5)
Visit 4-LOCF, n=401, 151	0.1 (0.3)	0.5 (0.5)

10. Secondary Outcome

Title	Duration of Treatment With Adalimumab
Description	The duration of treatment with adalimumab was calculated separately for participants who discontinued the medication during the study and for those who did not.
Time Frame	Baseline (Visit 0) to 12 months

Outcome Measure Data

Analysis Population Description

Participants who received adalimumab treatment

Arm/Group Title	Ankylosing Spondylitis	Psoriatic Arthritis
Arm/Group Description	Participants with a diagnosis of ankylosing spondylitis	Participants with a diagnosis of psoriatic arthritis
Measure Participants	381	140
No discontinuation of treatment, n=315, 117	11.8 (1.2)	11.6 (1.1)
Discontinuation of treatment, n=66, 23	4.8 (3.0)	5.0 (3.2)

11. Secondary Outcome

Title	Percentage of Participants Whose Co-medication With Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Was Stopped During the Study
Description	Participants were surveyed at each study visit for their use of NSAID medication.
Time Frame	Baseline (Visit 0) to 12 months

Outcome Measure Data

Analysis Population Description

Participants who were receiving NSAID medication at baseline

Arm/Group Title	Ankylosing Spondylitis	Psoriatic Arthritis
Arm/Group Description	Participants with a diagnosis of ankylosing spondylitis	Participants with a diagnosis of psoriatic arthritis
Measure Participants	265	39
Number [Percentage of participants]	96.6 24%	94.9 62.8%

12. Secondary Outcome

Title	Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Ankylosing Spondylitis
Description	Work Productivity and Activity Impairment (WPAI) Questionnaire is a quantitative assessment of the amount of absenteeism, presenteeism, total work productivity impairment, and total activity impairment attributable to a specific health problem (WPAI-SHP), expressed as a percentage. Participants were queried regarding their current employment status, hours missed from work because of problems associated with their AS, hours missed from work because of any other reason, number of hours worked, how much AS affected work productivity (0=AS had no effect,10= AS completely prevented me from working), and how much AS affected ability to do regular daily activities, other than work at a job (0= AS had no effect, 10= AS completely prevented me from doing my daily activities) in the past 7 days.
Time Frame	Baseline (Visit 0) to 12 months

Outcome Measure Data

Analysis Population Description

For presenteeism, absenteeism, and total work productivity impairment endpoints: participants with ankylosing spondylitis who were employed at the time of the documentation. For the total activity impairment endpoint: participants with ankylosing spondylitis who received adalimumab treatment.

Arm/Group Title	Ankylosing Spondylitis
Arm/Group Description	Participants with a diagnosis of ankylosing spondylitis
Measure Participants	342
Mean change in absenteeism, n=170	-9.7 (24.4)
Mean change in presenteeism, n=160	-37.3 (28.0)
Mean change in work productivity impairment, n=160	-38.6 (28.8)
Mean change in total activity impairment, n=342	-36.5 (26.7)

13. Secondary Outcome

Title	Change in the Percentage of Ankylosing Spondylitis Participants Who Have Paid Work
Description	Working status (Working full-time, working part-time, working at home, unemployed but seeking work, work disabled, retired, student) was documented at each study visit.
Time Frame	Baseline (Visit 0) to 12 months

Outcome Measure Data

Analysis Population Description

Participants with ankylosing spondylitis who received adalimumab treatment

Arm/Group Title	Ankylosing Spondylitis
Arm/Group Description	Participants with a diagnosis of ankylosing spondylitis
Measure Participants	403
Working at Baseline (Visit 0), n=403	56.6 14%
Working at last visit- valid data, n=351	56.1 13.9%

14. Secondary Outcome

Title	Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Psoriatic Arthritis
Description	The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C- reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Time Frame	Baseline (Visit 0) to 12 months

Outcome Measure Data

Analysis Population Description

Participants with psoriatic arthritis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4)

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with a diagnosis of psoriatic arthritis
Measure Participants	61
Mean change in BASDAI score, n=52	-4.2 (2.4)
Mean change in DAS28 score, n=61	-2.4 (1.3)

15. Secondary Outcome

Title	Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Psoriatic Arthritis
Description	BASDAI score (ranging from 0 to 10) was calculated using a questionnaire. Participants marked responses on a 10 cm visual analog scale ranging from 0 (none) to 10 (very severe) regarding fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. ASDAS score consists of a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Spearman's rank correlation coefficient (CC) was calculated for BASDAI vs. ASDAS(subscript)CRP(subscript) and BASDAI vs. ASDAS(subscript)ESR(subscript).
Time Frame	Baseline (Visit 0) to 12 months

Outcome Measure Data

Analysis Population Description

Participants with psoriatic arthritis and active axial symptoms (a baseline value of BASDAI > 4)

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with a diagnosis of psoriatic arthritis
Measure Participants	51
Correlation BASDAI and ASDAS-CRP, n=45	0.75
Correlation BASDAI and ASDAS-ESR, n=51	0.84

16. Secondary Outcome

Title	Predictors of Maintained Treatment Response and Remission in Participants With Psoriatic Arthritis
Description	A mathematical technique called logistic regression was performed to identify factors that could be used to predict maintained treatment response and remission. The following baseline variables were used in the logistic regression analyses: age, gender, disease of interest, result of tuberculosis screening, time since diagnosis and extra-articular manifestations (symptoms and diseases that occur in parts of the body other than joints) at baseline. The BASDAI score at baseline was forced to serve as a predictor in each model.
Time Frame	Baseline (Visit 0) to 12 months

Outcome Measure Data

Analysis Population Description

Participants with psoriatic arthritis and active axial symptoms (a baseline value of BASDAI > 4)

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with a diagnosis of psoriatic arthritis
Measure Participants	52
Treatment response (Enthesitis at Visit 0)	0.23
Treatment response (BASDAI score at Visit 0)	1.35
Remission (Psoriasis at Visit 0)	0.21
Remission (BASDAI score at Visit 0)	0.87

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ankylosing Spondylitis
	Comments	Treatment response and presence of enthesitis at Visit 0
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0576
	Comments
	Method	Regression, Logistic
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ankylosing Spondylitis
	Comments	Treatment response and BASDAI score at Visit 0
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1739
	Comments
	Method	Regression, Logistic
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ankylosing Spondylitis
	Comments	Remission and Psoriasis at Visit 0
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0733
	Comments
	Method	Regression, Logistic
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Ankylosing Spondylitis
	Comments	Remission and BASDAI at Visit 0
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5000
	Comments
	Method	Regression, Logistic
	Comments

17. Secondary Outcome

Title	Mean Change in Health Assessment Questionnaire Disability Index ( HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Psoriatic Arthritis
Description	HAQ-DI consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, with a higher score representing a high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ-DI remission, indicating normal physical function, is defined as HAQ-DI < 0.5. The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. A visual analogue scale (with 0 being "easy" and 10 "impossible") is used. The BASFI score ranges from 0 to 10 and is derived as the mean of the single items. A higher score indicates a higher impairment of functioning.
Time Frame	Baseline (Visit 0) to 12 months

Outcome Measure Data

Analysis Population Description

Participants with psoriatic arthritis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4)

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with a diagnosis of psoriatic arthritis
Measure Participants	88
Mean change in HAQ-DI, n=88	-0.7 (0.6)
Mean change in BASFI, n=47	-3.8 (2.8)

18. Secondary Outcome

Title	Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Psoriatic Arthritis
Description	The Work Productivity and Activity Impairment (WPAI) Questionnaire is a quantitative assessment of the amount of absenteeism, presenteeism, total work productivity impairment, and total activity impairment attributable to a specific health problem (WPAI-SHP), expressed as a percentage. Participants were queried regarding their current employment status, hours missed from work because of problems associated with their PsA, hours missed from work because of any other reason, number of hours worked, how much PsA affected work productivity (0= PsA had no effect,10= PsA completely prevented me from working), and how much PsA affected ability to do regular daily activities, other than work at a job (0= PsA had no effect, 10= PsA completely prevented me from doing my daily activities) in the past 7 days.
Time Frame	Baseline (Visit 0) to 12 months

Outcome Measure Data

Analysis Population Description

For presenteeism, absenteeism, and total work productivity impairment endpoints: participants with psoriatic arthritis who were employed at the time of the documentation. For the total activity impairment endpoint: participants with psoriatic arthritis who received adalimumab treatment.

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with a diagnosis of psoriatic arthritis
Measure Participants	119
Mean change in absenteeism, n=57	-6.0 (29.0)
Mean change in presenteeism, n=54	-32.8 (24.9)
Mean change in work productivity impairment, n=54	-33.6 (25.4)
Mean change in total activity impairment, n=119	-34.7 (25.7)

19. Primary Outcome

Title	Percentage of Participants With Peripheral Symptoms in Remission
Description	The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. Remission was defined as DAS28 ≤2.6 at 12 months.
Time Frame	Baseline (Visit 0) to 12 months

Outcome Measure Data

Analysis Population Description

Participants with peripheral symptoms (DAS28 > 5.1 at baseline)

Arm/Group Title	Ankylosing Spondylitis	Psoriatic Arthritis
Arm/Group Description	Participants with a diagnosis of ankylosing spondylitis	Participants with a diagnosis of psoriatic arthritis
Measure Participants	18	61
Number (95% Confidence Interval) [Percentage of participants]	11.1 2.8%	14.8 9.8%

20. Secondary Outcome

Title	Change in the Percentage of Psoriatic Arthritis Participants Who Have Paid Work
Description	Working status (Working full-time, working part-time, working at home, unemployed but seeking work, work disabled, retired, student) was documented at each study visit.
Time Frame	Baseline (Visit 0) to 12 months

Outcome Measure Data

Analysis Population Description

Participants with psoriatic arthritis who received adalimumab treatment

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with a diagnosis of psoriatic arthritis
Measure Participants	151
Working at Baseline (Visit 0), n=151	55.6 13.8%
Working at last visit- valid data, n=140	54.3 13.5%

Adverse Events

Time Frame	Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks.
Adverse Event Reporting Description	In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Arm/Group Title	Overall Study Population
Arm/Group Description	Participants who received adalimumab treatment
All Cause Mortality
	Overall Study Population
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Overall Study Population
	Affected / at Risk (%)	# Events
Total	26/555 (4.7%)
Ear and labyrinth disorders
Hypoacusis	1/555 (0.2%)
Tinnitus	1/555 (0.2%)
Eye disorders
Cataract	1/555 (0.2%)
Gastrointestinal disorders
Abdominal pain	1/555 (0.2%)
Abdominal pain upper	1/555 (0.2%)
Hyperchlorhydria	1/555 (0.2%)
Nausea	2/555 (0.4%)
Oral mucosal blistering	1/555 (0.2%)
Vomiting	2/555 (0.4%)
General disorders
Feeling abnormal	1/555 (0.2%)
Injection site erythema	1/555 (0.2%)
Injection site induration	1/555 (0.2%)
Injection site rash	1/555 (0.2%)
Pyrexia	1/555 (0.2%)
Immune system disorders
Hypersensitivity	1/555 (0.2%)
Infections and infestations
Erysipelas	1/555 (0.2%)
Lymphadenitis bacterial	1/555 (0.2%)
Pharyngitis	1/555 (0.2%)
Investigations
Alanine aminotransferase increased	1/555 (0.2%)
Aspartate aminotransferase increased	1/555 (0.2%)
C-reactive protein increased	1/555 (0.2%)
Gamma-glutamyltransferase increased	1/555 (0.2%)
White blood cell count decreased	1/555 (0.2%)
Musculoskeletal and connective tissue disorders
Arthritis	1/555 (0.2%)
Intervertebral disc protrusion	1/555 (0.2%)
Morphoea	1/555 (0.2%)
Osteoarthritis	1/555 (0.2%)
Pain in extremity	1/555 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia	1/555 (0.2%)
Nervous system disorders
Carpal tunnel syndrome	1/555 (0.2%)
Dysgeusia	1/555 (0.2%)
Guillain-Barre syndrome	1/555 (0.2%)
Headache	1/555 (0.2%)
Syncope	1/555 (0.2%)
Skin and subcutaneous tissue disorders
Dermatitis	1/555 (0.2%)
Dermatitis allergic	1/555 (0.2%)
Dermatitis atopic	1/555 (0.2%)
Skin hypopigmentation	1/555 (0.2%)
Skin ulcer	2/555 (0.4%)
Toxic skin eruption	1/555 (0.2%)
Surgical and medical procedures
Carpal tunnel decompression	1/555 (0.2%)
Cataract operation	1/555 (0.2%)
Hip surgery	1/555 (0.2%)
Lymphadenectomy	1/555 (0.2%)
Phlebectomy	1/555 (0.2%)
Spinal laminectomy	1/555 (0.2%)
Vascular disorders
Hypertension	1/555 (0.2%)
Thrombophlebitis superficial	1/555 (0.2%)
Other (Not Including Serious) Adverse Events
	Overall Study Population
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.