Greek Study on Work Productivity and Sleep in Patients With Rheumatic Diseases Treated With Adalimumab

• Sponsor: AbbVie (prior sponsor, Abbott) (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01282372
• Collaborator: (none)
• Enrollment: 500
• Duration (Months): 40

Study Details

Study Description

Brief Summary

Treatment with tumor necrosis factor (TNF) inhibitors, especially adalimumab, demonstrated an improvement in work productivity in participants with rheumatic diseases: rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). Limited data was available for the effect of adalimumab treatment on sleep in all three diseases (RA, PsA, and AS) and no data was available for the effect of adalimumab treatment on work productivity in PsA. This long term Health-Related Quality of Life (HRQL) observational study was conducted to evaluate the effect of treatment with adalimumab on work productivity and sleep disturbance in Greek participants with moderate to severe rheumatic diseases (RA, PsA, and AS).

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

Detailed Description

This was a multi-center, uncontrolled, prospective, observational study in participants with moderate to severe rheumatic disease (RA, PsA, or AS) who received adalimumab under normal clinical practice in accordance with Summary of Product Characteristics (SmPC), with or without other anti-rheumatic treatments.

Study Design

• Study Type: Observational
• Actual Enrollment: 500 participants
• Time Perspective: Prospective
• Official Title: A 2-year HRQL Observational Study Evaluating the Effect of Treatment With Adalimumab on Work Productivity and Sleep in Patients With Rheumatic Diseases in Greece
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Participants with moderate to severe rheumatic disease Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline in Work Time Missed Due to Health Problem [Baseline (Day 1) and Month 24]

   The 'work time missed due to health problem' was assessed using the Work Productivity and Activity Impairment-General Health Problem (WPAI-GHP) questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'work time missed due to health problem' was calculated based on two items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit and (Q4) the number of actual work hours in the past seven days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

2. Mean Change From Baseline in Impairment While Working Due to Health Problem [Baseline (Day 1) and Month 24]

   The 'impairment while working due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'impairment while working due to health problem' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

3. Mean Change From Baseline in Overall Work Impairment Due to Health Problem [Baseline (Day 1) and Month 24]

   The 'overall work impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the disease impair the productivity while working past seven days from visit). The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

4. Mean Change From Baseline in Overall Activity Impairment Due to Health Problem [Baseline (Day 1) and Month 24]

   The 'overall activity impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall activity impairment due to health problem' was calculated based on one item: (Q6) to what degree did the disease impair the ability to do regular activities in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

Secondary Outcome Measures

1. Mean Change From Baseline in Work Time Missed Due to Health Problem by Disease Subgroups [Baseline (Day 1) and Month 24]

   The 'work time missed due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'work time missed due to health problem' was calculated based on two items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit and (Q4) the number of actual work hours in the past seven days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

2. Mean Change From Baseline in Impairment While Working Due to Health Problem by Disease Subgroups [Baseline (Day 1) and Month 24]

   The 'impairment while working due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'impairment while working due to health problem' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

3. Mean Change From Baseline in Overall Work Impairment Due to Health Problem by Disease Subgroups [Baseline (Day 1) and Month 24]

   The 'overall work impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the disease impair the productivity while working past seven days from visit). The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

4. Mean Change From Baseline in Overall Activity Impairment Due to Health Problem by Disease Subgroups [Baseline (Day 1) and Month 24]

   The 'overall activity impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall activity impairment due to health problem' was calculated based on one item: (Q6) to what degree did the disease impair the ability to do regular activities in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

5. Mean Disease Activity Score 28 (DAS28) [Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24]

   The DAS28, a combined index that measured rheumatoid arthritis disease activity, was calculated based on: (1) the number of tender joints among 28 joints evaluated; (2) the number of swollen joints among 28 joints evaluated; (3) general health evaluated by a visual analog scale (VAS); (4) erythrocyte sedimentation rate (ESR); and (5) C-reactive protein (CRP). The DAS28 scores ranged from 0 (no disease activity) to 10 (maximal disease activity); decrease in DAS28 scores indicate improvement of disease. The DAS28 score less than or equal to 2.6 is defined as clinical remission. Data are presented as mean DAS28 score +/- standard deviation.

6. Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score [Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24]

   The HAQ-DI was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past seven days using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0-1 represented mild disability and 2-3 represented severe disability. Data are presented as mean HAQ-DI score +/- standard deviation.

7. Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score [Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24]

   The BASDAI was a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration. The mean measurement (score) of questions 5 and 6 is added to the scores from questions 1 to 4 and divided by 5 to calculate the total BASDAI score. It was scored on a numerical rating scale that ranged from 0 (no symptoms) to 10 (severe symptoms), higher scores indicating severe disability due to AS disease. Data are presented as mean total BASDAI score +/- standard deviation.

8. Mean Psoriatic Arthritis Response Criteria (PsARC) Score [Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24]

   As the patient and physician global assessments were performed using a 0-100 VAS scale instead of the 5 point Likert scale, the PsARC score could not be calculated, although data on joint pain and swelling were collected. Hence, the psoriatic arthritis disease activity was evaluated by the percentage of patients with tender and swollen joints, acute phase reactants (ESR and CRP), and VAS Score (patient and physician). Data are reported under outcome measures 13 through 16.

9. Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero [Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24]

   Joints (68 or 66) were assessed by pressure and joint manipulation on physical examination for TJC or SJC, respectively. Both joint tenderness and swelling were classified as present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The total TJC or SJC was derived as the sum of the tender and swollen joints; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively with higher scores indicated worse conditions. Data are presented as percentage of participants with TJC and SJC.

10. Mean Erythrocyte Sedimentation Rate (ESR) [Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24]

    Plasma concentrations were assessed to evaluate ESR, a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Data are presented as mean ESR value in millimeters per hour (mm/hr) ± standard deviation.

11. Mean Plasma Concentrations of C-Reactive Protein (CRP) [Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24]

    Plasma concentrations were assessed to evaluate CRP, a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Data are presented as mean CRP value in milligrams per liter (mg/L) ± standard deviation.

12. Mean Visual Analogue Scale (VAS) Score [Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24]

    The VAS score assessed by participants (pt) and physicians (ph) was used to determine the pain due to psoriatic arthritis in the past week. The level of pain was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (no pain) to 100 (severe pain). Data are presented as mean VAS score +/- standard deviation.

13. Mean Sleep Disturbance Subscale Score [Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24]

    The Medical Outcome Study (MOS) sleep scale was a 12-item, participant-reported, non-disease-specific measure related to sleep that yielded 7 subscales (4-item sleep disturbance, 2-item sleep adequacy, 1-item quantity of sleep, 3-item somnolence, 1-item snoring, 1-item shortness of breath, and 9-item overall sleep problems index). Only sleep disturbance subscale was assessed by calculating the average of the 4-items with total score ranging from 0 to 100 (higher scores indicating greater sleep disturbance). Data are presented as mean score on a scale +/- standard deviation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Participants with moderate or severe active rheumatic disease, who received adalimumab under normal clinical practice in accordance with the approved local SmPC.

2. Participants who provided their consent for data collection and use by AbbVie.

Exclusion Criteria:

1. Contraindications according to the SmPC.

2. Participants who did not participate in other observational studies conducted by Abbvie.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie (prior sponsor, Abbott)

Investigators

• Study Chair: Theofilos Karatsourakis, MD, AbbVie Pharmaceuticals S.A.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01282372
• Other Study ID Numbers: P12-179
• First Posted: Jan 25, 2011
• Last Update Posted: Nov 9, 2015
• Last Verified: Oct 1, 2015

• Keywords provided by AbbVie (prior sponsor, Abbott): Ankylosing spondylitis; Sleep; Psoriatic arthritis; Work Productivity; Rheumatoid Arthritis
• Additional relevant MeSH terms: Spondylitis; Arthritis; Arthritis, Rheumatoid; Spondylarthritis; Arthritis, Psoriatic; Spondylitis, Ankylosing; Rheumatic Diseases; Collagen Diseases

Study Results

Participant Flow

Pre-assignment Detail	The 'reason 1' and 'reason 2' for discontinuation for 'other' categories listed in participant flow is "relocation, regression of symptoms, pregnancy, and loss of insurance coverage" and "participant withdrew consent and loss of insurance coverage", respectively. AE = Adverse Event.

Arm/Group Title	Participants With Moderate to Severe Rheumatic Disease
Arm/Group Description	Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
Period Title: Overall Study
STARTED	500
COMPLETED	421
NOT COMPLETED	79

Baseline Characteristics

Arm/Group Title	Participants With Moderate to Severe Rheumatic Disease
Arm/Group Description	Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
Overall Participants	500
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	52.5 (14.8)
Sex: Female, Male (Count of Participants)
Female	289 57.8%
Male	211 42.2%
Employment Status (Number) [Number]
Housewife	127 25.4%
Retired	118 23.6%
Employee	116 23.2%
Self-employed	95 19%
Unemployed	35 7%
Student	9 1.8%

Outcome Measures

1. Secondary Outcome

Title	Mean Change From Baseline in Work Time Missed Due to Health Problem by Disease Subgroups
Description	The 'work time missed due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'work time missed due to health problem' was calculated based on two items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit and (Q4) the number of actual work hours in the past seven days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Time Frame	Baseline (Day 1) and Month 24

Outcome Measure Data

Analysis Population Description

The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.

Arm/Group Title	Participants With Moderate to Severe Rheumatic Disease - RA	Participants With Moderate to Severe Rheumatic Disease - PsA	Participants With Moderate to Severe Rheumatic Disease - AS
Arm/Group Description	Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label	Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label	Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
Measure Participants	41	59	69
Baseline	20.7 (25.3)	24.8 (31.1)	17.8 (25.0)
Change from Baseline to Month 24 (N=22, 34, 44)	-25.5 (28.6)	-21.6 (29.7)	-13.5 (26.7)

2. Primary Outcome

Title	Mean Change From Baseline in Work Time Missed Due to Health Problem
Description	The 'work time missed due to health problem' was assessed using the Work Productivity and Activity Impairment-General Health Problem (WPAI-GHP) questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'work time missed due to health problem' was calculated based on two items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit and (Q4) the number of actual work hours in the past seven days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Time Frame	Baseline (Day 1) and Month 24

Outcome Measure Data

Analysis Population Description

The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.

Arm/Group Title	Participants With Moderate to Severe Rheumatic Disease
Arm/Group Description	Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
Measure Participants	169
Baseline	21.0 (27.4)
Change from Baseline to Month 24	-18.9 (28.3)

3. Secondary Outcome

Title	Mean Change From Baseline in Impairment While Working Due to Health Problem by Disease Subgroups
Description	The 'impairment while working due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'impairment while working due to health problem' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Time Frame	Baseline (Day 1) and Month 24

Outcome Measure Data

Analysis Population Description

The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.

Arm/Group Title	Participants With Moderate to Severe Rheumatic Disease - RA	Participants With Moderate to Severe Rheumatic Disease - PsA	Participants With Moderate to Severe Rheumatic Disease - AS
Arm/Group Description	Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label	Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label	Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
Measure Participants	40	57	69
Baseline	57.0 (24.4)	49.3 (26.9)	53.3 (26.7)
Change from Baseline to Month 24 (N=21, 34, 43)	-50.5 (25.0)	-33.5 (30.4)	-40.0 (33.4)

4. Primary Outcome

Title	Mean Change From Baseline in Impairment While Working Due to Health Problem
Description	The 'impairment while working due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'impairment while working due to health problem' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Time Frame	Baseline (Day 1) and Month 24

Outcome Measure Data

Analysis Population Description

The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.

Arm/Group Title	Participants With Moderate to Severe Rheumatic Disease
Arm/Group Description	Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
Measure Participants	166
Baseline	52.8 (26.2)
Change from Baseline to Month 24	-40.0 (31.1)

5. Secondary Outcome

Title	Mean Change From Baseline in Overall Work Impairment Due to Health Problem by Disease Subgroups
Description	The 'overall work impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the disease impair the productivity while working past seven days from visit). The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Time Frame	Baseline (Day 1) and Month 24

Outcome Measure Data

Analysis Population Description

The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.

Arm/Group Title	Participants With Moderate to Severe Rheumatic Disease - RA	Participants With Moderate to Severe Rheumatic Disease - PsA	Participants With Moderate to Severe Rheumatic Disease - AS
Arm/Group Description	Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label	Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label	Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
Measure Participants	40	53	66
Baseline	62.3 (25.1)	53.9 (27.4)	58.3 (27.6)
Change from Baseline to Month 24 (N=21, 31, 42)	-55.2 (26.0)	-40.6 (32.7)	-47.1 (32.1)

6. Primary Outcome

Title	Mean Change From Baseline in Overall Work Impairment Due to Health Problem
Description	The 'overall work impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the disease impair the productivity while working past seven days from visit). The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Time Frame	Baseline (Day 1) and Month 24

Outcome Measure Data

Analysis Population Description

The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.

Arm/Group Title	Participants With Moderate to Severe Rheumatic Disease
Arm/Group Description	Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
Measure Participants	159
Baseline	57.8 (26.9)
Change from Baseline to Month 24	-46.8 (31.2)

7. Secondary Outcome

Title	Mean Change From Baseline in Overall Activity Impairment Due to Health Problem by Disease Subgroups
Description	The 'overall activity impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall activity impairment due to health problem' was calculated based on one item: (Q6) to what degree did the disease impair the ability to do regular activities in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Time Frame	Baseline (Day 1) and Month 24

Outcome Measure Data

Analysis Population Description

The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.

Arm/Group Title	Participants With Moderate to Severe Rheumatic Disease - RA	Participants With Moderate to Severe Rheumatic Disease - PsA	Participants With Moderate to Severe Rheumatic Disease - AS
Arm/Group Description	Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label	Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label	Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
Measure Participants	184	166	150
Baseline	64.5 (24.4)	59.4 (23.3)	62.1 (24.9)
Change from Baseline to Month 24 (N=155, 139, 127)	-47.5 (28.2)	-45.8 (26.1)	-47.6 (28.5)

8. Primary Outcome

Title	Mean Change From Baseline in Overall Activity Impairment Due to Health Problem
Description	The 'overall activity impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall activity impairment due to health problem' was calculated based on one item: (Q6) to what degree did the disease impair the ability to do regular activities in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Time Frame	Baseline (Day 1) and Month 24

Outcome Measure Data

Analysis Population Description

The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.

Arm/Group Title	Participants With Moderate to Severe Rheumatic Disease
Arm/Group Description	Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
Measure Participants	500
Baseline	62.1 (24.2)
Change from Baseline to Month 24	-47.0 (27.6)

9. Secondary Outcome

Title	Mean Disease Activity Score 28 (DAS28)
Description	The DAS28, a combined index that measured rheumatoid arthritis disease activity, was calculated based on: (1) the number of tender joints among 28 joints evaluated; (2) the number of swollen joints among 28 joints evaluated; (3) general health evaluated by a visual analog scale (VAS); (4) erythrocyte sedimentation rate (ESR); and (5) C-reactive protein (CRP). The DAS28 scores ranged from 0 (no disease activity) to 10 (maximal disease activity); decrease in DAS28 scores indicate improvement of disease. The DAS28 score less than or equal to 2.6 is defined as clinical remission. Data are presented as mean DAS28 score +/- standard deviation.
Time Frame	Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24

Outcome Measure Data

Analysis Population Description

The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available DAS28 score at the study time points.

Arm/Group Title	Participants With Moderate to Severe Rheumatic Disease
Arm/Group Description	Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
Measure Participants	184
Baseline	5.95 (1.16)
Month 3 (N= 179)	4.05 (1.35)
Month 6 (N=175)	3.39 (1.26)
Month 12 (N=164)	3.08 (1.27)
Month 18 (N=160)	2.90 (1.21)
Month 24 (N=153)	2.72 (1.28)

10. Secondary Outcome

Title	Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Description	The HAQ-DI was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past seven days using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0-1 represented mild disability and 2-3 represented severe disability. Data are presented as mean HAQ-DI score +/- standard deviation.
Time Frame	Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24

Outcome Measure Data

Analysis Population Description

The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available HAQ-DI score at the study time points.

Arm/Group Title	Participants With Moderate to Severe Rheumatic Disease
Arm/Group Description	Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
Measure Participants	181
Baseline	1.60 (0.61)
Month 3 (N=179)	0.98 (0.62)
Month 6 (N=176)	0.77 (0.55)
Month 12 (N=164)	0.65 (0.54)
Month 18 (N=159)	0.58 (0.55)
Month 24 (N=153)	0.51 (0.53)

11. Secondary Outcome

Title	Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Description	The BASDAI was a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration. The mean measurement (score) of questions 5 and 6 is added to the scores from questions 1 to 4 and divided by 5 to calculate the total BASDAI score. It was scored on a numerical rating scale that ranged from 0 (no symptoms) to 10 (severe symptoms), higher scores indicating severe disability due to AS disease. Data are presented as mean total BASDAI score +/- standard deviation.
Time Frame	Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24

Outcome Measure Data

Analysis Population Description

The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available BASDAI score at the study time points.

Arm/Group Title	Participants With Moderate to Severe Rheumatic Disease
Arm/Group Description	Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
Measure Participants	146
Baseline	5.75 (1.67)
Month 3	3.34 (1.71)
Month 6 (N=138)	2.51 (1.55)
Month 12 (N=130)	2.05 (1.48)
Month 18 (N=125)	1.69 (1.24)
Month 24 (N=125)	1.50 (1.28)

12. Secondary Outcome

Title	Mean Psoriatic Arthritis Response Criteria (PsARC) Score
Description	As the patient and physician global assessments were performed using a 0-100 VAS scale instead of the 5 point Likert scale, the PsARC score could not be calculated, although data on joint pain and swelling were collected. Hence, the psoriatic arthritis disease activity was evaluated by the percentage of patients with tender and swollen joints, acute phase reactants (ESR and CRP), and VAS Score (patient and physician). Data are reported under outcome measures 13 through 16.
Time Frame	Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24

Outcome Measure Data

Analysis Population Description

The PsARC score was not assessed in this study.

Arm/Group Title	Participants With Moderate to Severe Rheumatic Disease - PsA
Arm/Group Description	Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
Measure Participants	0

13. Secondary Outcome

Title	Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero
Description	Joints (68 or 66) were assessed by pressure and joint manipulation on physical examination for TJC or SJC, respectively. Both joint tenderness and swelling were classified as present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The total TJC or SJC was derived as the sum of the tender and swollen joints; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively with higher scores indicated worse conditions. Data are presented as percentage of participants with TJC and SJC.
Time Frame	Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24

Outcome Measure Data

Analysis Population Description

The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points.

Arm/Group Title	Participants With Moderate to Severe Rheumatic Disease - PsA
Arm/Group Description	Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
Measure Participants	166
TJC at Baseline	98.8 19.8%
TJC at Month 3 (N=163)	72.4 14.5%
TJC at Month 6 (N=155)	48.4 9.7%
TJC at Month 12 (N=147)	34.0 6.8%
TJC at Month 18 (N=144)	32.6 6.5%
TJC at Month 24 (N=139)	28.1 5.6%
SJC at Baseline	91.0 18.2%
SJC at Month 3 (N=163)	52.8 10.6%
SJC at Month 6 (N=155)	32.3 6.5%
SJC at Month 12 (N=147)	26.5 5.3%
SJC at Month 18 (N=144)	28.5 5.7%
SJC at Month 24 (N=139)	17.3 3.5%

14. Secondary Outcome

Title	Mean Erythrocyte Sedimentation Rate (ESR)
Description	Plasma concentrations were assessed to evaluate ESR, a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Data are presented as mean ESR value in millimeters per hour (mm/hr) ± standard deviation.
Time Frame	Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24

Outcome Measure Data

Analysis Population Description

The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points.

Arm/Group Title	Participants With Moderate to Severe Rheumatic Disease - PsA
Arm/Group Description	Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
Measure Participants	158
Baseline	40.2 (22.1)
Month 3 (N=157)	25.3 (15.4)
Month 6 (N=150)	21.7 (16.3)
Month 12 (N=146)	18.5 (13.3)
Month 18 (N=140)	17.6 (12.6)
Month 24 (N=137)	16.2 (11.5)

15. Secondary Outcome

Title	Mean Plasma Concentrations of C-Reactive Protein (CRP)
Description	Plasma concentrations were assessed to evaluate CRP, a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Data are presented as mean CRP value in milligrams per liter (mg/L) ± standard deviation.
Time Frame	Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24

Outcome Measure Data

Analysis Population Description

The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points.

Arm/Group Title	Participants With Moderate to Severe Rheumatic Disease - PsA
Arm/Group Description	Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
Measure Participants	150
Baseline	9.94 (13.93)
Month 3 (N=144)	5.05 (9.48)
Month 6 (N=140)	3.26 (6.49)
Month 12 (N=141)	1.94 (3.05)
Month 18 (N=137)	1.99 (3.60)
Month 24 (N=133)	1.91 (4.16)

16. Secondary Outcome

Title	Mean Visual Analogue Scale (VAS) Score
Description	The VAS score assessed by participants (pt) and physicians (ph) was used to determine the pain due to psoriatic arthritis in the past week. The level of pain was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (no pain) to 100 (severe pain). Data are presented as mean VAS score +/- standard deviation.
Time Frame	Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24

Outcome Measure Data

Analysis Population Description

The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available VAS score at the study time points.

Arm/Group Title	Participants With Moderate to Severe Rheumatic Disease
Arm/Group Description	Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
Measure Participants	166
VAS pt at Baseline	65.80 (16.90)
VAS pt at Month 3 (N=163)	32.00 (19.40)
VAS pt at Month 6 (N=155)	21.90 (18.20)
VAS pt at Month 12 (N=147)	15.10 (13.90)
VAS pt at Month 18 (N=144)	14.10 (13.20)
VAS pt at Month 24 (N=139)	12.00 (13.60)
VAS ph at Baseline	62.55 (16.70)
VAS ph at Month 3 (N=163)	29.30 (19.40)
VAS ph at Month 6 (N=155)	19.67 (17.40)
VAS ph at Month 12 (N=147)	14.20 (15.10)
VAS ph at Month 18 (N=144)	12.75 (12.10)
VAS ph at Month 24 (N=139)	11.31 (13.90)

17. Secondary Outcome

Title	Mean Sleep Disturbance Subscale Score
Description	The Medical Outcome Study (MOS) sleep scale was a 12-item, participant-reported, non-disease-specific measure related to sleep that yielded 7 subscales (4-item sleep disturbance, 2-item sleep adequacy, 1-item quantity of sleep, 3-item somnolence, 1-item snoring, 1-item shortness of breath, and 9-item overall sleep problems index). Only sleep disturbance subscale was assessed by calculating the average of the 4-items with total score ranging from 0 to 100 (higher scores indicating greater sleep disturbance). Data are presented as mean score on a scale +/- standard deviation.
Time Frame	Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24

Outcome Measure Data

Analysis Population Description

The analysis was performed using safety analysis set defined as all participants who received at least one dose of adalimumab.

Arm/Group Title	Participants With Moderate to Severe Rheumatic Disease
Arm/Group Description	Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
Measure Participants	500
Baseline	50.9 (23.6)
Month 3 (N=492)	30.3 (18.0)
Month 6 (N=472)	23.4 (16.7)
Month 12 (N=446)	19.7 (16.9)
Month 18 (N=432)	18.3 (15.7)
Month 24 (N=421)	16.6 (15.6)

Adverse Events

Time Frame	Up to 2 years from signing of informed consent
Adverse Event Reporting Description	The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
Arm/Group Title	Participants With Moderate to Severe Rheumatic Disease
Arm/Group Description	Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
All Cause Mortality
	Participants With Moderate to Severe Rheumatic Disease
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Participants With Moderate to Severe Rheumatic Disease
	Affected / at Risk (%)	# Events
Total	33/500 (6.6%)
Cardiac disorders
Atrial fibrillation	1/500 (0.2%)
Gastrointestinal disorders
Abdominal pain	1/500 (0.2%)
Diarrhoea	1/500 (0.2%)
Vomiting	1/500 (0.2%)
General disorders
Asthenia	2/500 (0.4%)
Chills	1/500 (0.2%)
Fatigue	1/500 (0.2%)
Pain	1/500 (0.2%)
Pyrexia	3/500 (0.6%)
Immune system disorders
Anaphylactic shock	1/500 (0.2%)
Infections and infestations
Rash pustular	1/500 (0.2%)
Injury, poisoning and procedural complications
Fall	1/500 (0.2%)
Hip fracture	1/500 (0.2%)
Pelvic fracture	1/500 (0.2%)
VIIth nerve injury	1/500 (0.2%)
Metabolism and nutrition disorders
Decreased appetite	1/500 (0.2%)
Obesity	1/500 (0.2%)
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis	1/500 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma	1/500 (0.2%)
Choroid plexus papilloma	1/500 (0.2%)
Gastric cancer	1/500 (0.2%)
Nervous system disorders
Hypoaesthesia	1/500 (0.2%)
Hypoglycaemic coma	1/500 (0.2%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	1/500 (0.2%)
Reproductive system and breast disorders
Ovarian cyst	1/500 (0.2%)
Respiratory, thoracic and mediastinal disorders
Dysphonia	1/500 (0.2%)
Respiratory distress	1/500 (0.2%)
Suffocation feeling	1/500 (0.2%)
Skin and subcutaneous tissue disorders
Hyperhidrosis	1/500 (0.2%)
Vascular disorders
Hypertension	1/500 (0.2%)
Other (Not Including Serious) Adverse Events
	Participants With Moderate to Severe Rheumatic Disease
	Affected / at Risk (%)	# Events
Total	158/500 (31.6%)
Blood and lymphatic system disorders
Neutropenia	1/500 (0.2%)
Thrombocytosis	1/500 (0.2%)
Cardiac disorders
Atrial fibrillation	1/500 (0.2%)
Congenital, familial and genetic disorders
Sturge-Weber syndrome	1/500 (0.2%)
Gastrointestinal disorders
Crohn's disease	1/500 (0.2%)
Flatulence	1/500 (0.2%)
Gastritis	1/500 (0.2%)
Hemorrhoids	1/500 (0.2%)
Rectal haemorrhage	1/500 (0.2%)
Toothache	1/500 (0.2%)
Vomiting	1/500 (0.2%)
General disorders
Drug effect incomplete	1/500 (0.2%)
Drug ineffective	24/500 (4.8%)
Influenza like illness	1/500 (0.2%)
Oedema peripheral	1/500 (0.2%)
Pain	3/500 (0.6%)
Peripheral swelling	1/500 (0.2%)
Polyp	1/500 (0.2%)
Pyrexia	10/500 (2%)
Hepatobiliary disorders
Hypertransaminasemia	1/500 (0.2%)
Infections and infestations
Bronchitis	3/500 (0.6%)
Bronchopneumonia	1/500 (0.2%)
Furuncle	1/500 (0.2%)
Gastroenteritis	3/500 (0.6%)
Gastroenteritis viral	1/500 (0.2%)
Herpes zoster	2/500 (0.4%)
Metabolism and nutrition disorders	1/500 (0.2%)
Pharyngitis	1/500 (0.2%)
Respiratory tract infection	13/500 (2.6%)
Respiratory tract infection viral	1/500 (0.2%)
Sinusitis	1/500 (0.2%)
Tonsillitis	1/500 (0.2%)
Tooth abscess	2/500 (0.4%)
Upper respiratory tract infection	4/500 (0.8%)
Urinary tract infection	6/500 (1.2%)
Vaginal infection	1/500 (0.2%)
Viral infection	1/500 (0.2%)
Injury, poisoning and procedural complications
Compression fracture	1/500 (0.2%)
Drug dose omission	1/500 (0.2%)
Foetal exposure during pregnancy	1/500 (0.2%)
Foot fracture	1/500 (0.2%)
Investigations
Blood glucose increased	1/500 (0.2%)
C-reactive protein increased	1/500 (0.2%)
Drug specific antibody present	1/500 (0.2%)
Glycosylated hemoglobin increased	1/500 (0.2%)
Red blood cell sedimentation rate increased	1/500 (0.2%)
White blood cell count decreased	1/500 (0.2%)
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis	1/500 (0.2%)
Fibromyalgia	1/500 (0.2%)
Muscle rigidity	1/500 (0.2%)
Musculoskeletal chest pain	1/500 (0.2%)
Osteoarthritis	1/500 (0.2%)
Osteoporosis	1/500 (0.2%)
Psoriatic arthropathy	3/500 (0.6%)
Rheumatoid arthritis	11/500 (2.2%)
Sacroiliitis	2/500 (0.4%)
Synovial cyst	1/500 (0.2%)
Nervous system disorders
Burning sensation	1/500 (0.2%)
Headache	1/500 (0.2%)
Memory impairment	1/500 (0.2%)
Sciatica	1/500 (0.2%)
Pregnancy, puerperium and perinatal conditions
Normal newborn	1/500 (0.2%)
Psychiatric disorders
Anxiety disorder	1/500 (0.2%)
Depression	3/500 (0.6%)
Insomnia	1/500 (0.2%)
Renal and urinary disorders
Albuminuria	1/500 (0.2%)
Focal segmental glomerulosclerosis	1/500 (0.2%)
Mesangioproliferative glomerulonephritis	1/500 (0.2%)
Respiratory, thoracic and mediastinal disorders
Apnoea	1/500 (0.2%)
Rhinorrhoea	1/500 (0.2%)
Skin and subcutaneous tissue disorders
Alopecia	1/500 (0.2%)
Guttate psoriasis	1/500 (0.2%)
Ingrowing nail	1/500 (0.2%)
Psoriasis	3/500 (0.6%)
Purpura	1/500 (0.2%)
Pustular psoriasis	1/500 (0.2%)
Rash	3/500 (0.6%)
Rash generalised	1/500 (0.2%)
Vascular disorders
Hypertension	1/500 (0.2%)

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.