Study in Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) Patients to Evaluate Work Productivity Before and After the Start of Adalimumab Therapy in Daily Practice in Belgium

The mean percentage of TWPI due to disease (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which disease decreased productivity (%)\* \[number of hours worked / (number of hours of work missed due to disease + number of hours worked)\]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change was calculated as the value at baseline minus the value at Month 18.

Time frame: Baseline, Month 18

Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with professional activity and with a questionnaire completed at given time point are included.

CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL. Last observation is the last observation after baseline at which an assessment was completed.

Time frame: Baseline, Months 3, 6, 12, 18

Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with an assessment at given time point are included.

The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity. Last observation is the last observation after baseline at which an assessment was completed.

Time frame: Baseline, Months 3, 6, 12, 18

Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with an assessment at given time point are included.

The BASDAI is used for measuring and evaluating disease activity in ankylosing spondylitis. This index consists of 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (or enthesitis, defined as inflammation of tendons and ligaments), duration of morning stiffness, severity of morning stiffness. A visual analogue scale ranging from 0 (none) to 10 (very severe) is used to answer the questions. The final BASDAI score averages the individual assessments for a final score range of 0 to 10 (0 being no problem and 10 being the worst problem). Last observation is the last observation after baseline at which any of the questionnaire items was completed.

Time frame: Baseline, Months 3, 6, 12, 18

Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.

The mean percentage of TWPI due to disease (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which disease decreased productivity (%)\* \[number of hours worked / (number of hours of work missed due to disease + number of hours worked)\]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change was calculated as the value at baseline minus the value at Month 18.

Time frame: Baseline, Month 18

Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with professional activity and with a questionnaire completed at given time point are included.

The DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0); responses are summed. The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. Last observation is the last observation after baseline at which any of the questionnaire items was completed.

Time frame: Baseline, Months 3, 6, 12, 18

Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.

The DAS-28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS-28 score. Scores on the DAS-28 range from 0 to 10. A DAS-28 score \> 5.1 indicates high disease activity, a DAS-28 score \< 3.2 indicates low disease activity, and a DAS-28 score \< 2.6 indicates clinical remission. Last observation is the last observation after baseline at which any of the questionnaire items was completed.

Time frame: Baseline, Months 3, 6, 12, 18

Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.

The HAQ-DI is a self-reported assessment of how the participant's disease affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores: dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. Scores range from 0 to 3, with a lower score demonstrating less disability. Last observation is the last observation after baseline at which any of the questionnaire items was completed.

Time frame: Baseline, Months 3, 6, 12, 18

Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.

The HAQ-S is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 \[without any difficulty\] to 3 \[unable to do\]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (very severe, high-dependency disability). Last observation is the last observation after baseline at which any of the questionnaire items was completed.

Time frame: Baseline, Months 3, 6, 12, 18

Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.

As assessed by the WPAI questionnaire, a questionnaire used to evaluate lost work productivity due to disease (yes=employed; no=not employed). Last observation is the last observation after baseline at which any of the questionnaire items was completed.

Time frame: Baseline, Months 3, 6, 12, 18

Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.

The VAS score assessed by participants was used to determine the disease activity of ankylosing spondylitis and psoriatic arthritis in the past week. The level of disease activity was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (none) to 100 (most disease activity).

Time frame: Baseline, Months 3, 6, 12, 18

Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with an assessment completed at given time point are included.

The VAS score assessed by participants was used to determine the pain due to ankylosing spondylitis and 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).

Time frame: Baseline, Months 3, 6, 12, 18

Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with an assessment completed at given time point are included.

Activity impairment due to disease (the extent to which disease affected the ability to perform usual daily activities, as reported on the WPAI) is presented as the mean percentage of activity impairment, calculated as 100\*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Last observation is the last observation after baseline at which any of the questionnaire items was completed.

Time frame: Baseline, Months 3, 6, 12, 18

Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a professional activity and with a questionnaire completed at given time point are included.

Percentage of BSA affected by psoriatic arthritis was assessed by clinical evaluation. Last observation is the last observation after baseline at which any of the questionnaire items was completed.

Time frame: Baseline, Months 3, 6, 12, 18

Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a BSA assessment at given time point are included.

As measured by the WPAI-Specific Health Problem questionnaire. Presenteeism (the extent to which disease decreased productivity, as reported on the WPAI) is presented as the mean percentage of impairment while working due to disease, and calculated as: 100\*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Last observation is the last observation after baseline at which any of the questionnaire items was completed.

Time frame: Baseline, Months 3, 6, 12, 18

Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a professional activity and with a questionnaire completed at given time point are included.

Absenteeism, presented as the mean percentage of work time missed due to disease (as reported on the WPAI), and calculated as: 100\*number of hours of work missed due to disease / (number of hours of work missed due to disease + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Last observation is the last observation after baseline at which any of the questionnaire items was completed.

Time frame: Baseline, Months 3, 6, 12, 18

Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a professional activity and with a questionnaire completed at given time point are included.

The VAS score assessed by physicians was used to determine the disease activity of ankylosing spondylitis and psoriatic arthritis in the past week. The level of disease activity was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (none) to 100 (most disease activity).

Time frame: Baseline, Months 3, 6, 12, 18

Population: Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with an assessment completed at given time point are included.