Trial Outcomes & Findings for Special Investigation in Patients With Rheumatoid Arthritis (Working Productivity Activity Impairment) (NCT NCT01346488)

NCT ID: NCT01346488

Last Updated: 2017-04-13

Results Overview

Absenteeism, presented as the mean percentage of work time missed due to RA (as reported on the WPAI-RA), and calculated as: 100\*number of hours of work missed due to RA / (number of hours of work missed due to RA + 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 each subsequent time point.

• Recruitment status: COMPLETED
• Target enrollment: 2088 participants
• Primary outcome timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of adalimumab (ADA) therapy, and at final assessment (up to Week 48)
• Results posted on: 2017-04-13

Participant Flow

Data sources in this study are from medical charts. Investigators in this study transcribed a participant's data from medical charts to a case report form (CRF) developed by AbbVie.

A total of 2088 participants filled out registration forms. A total of 1973 participant CRFs were retrieved for use in the study, and 1968 of these were included in the analysis.

Participant milestones

Measure	Participants Receiving Adalimumab Participants with rheumatoid arthritis (RA) treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
Overall Study STARTED	1968
Overall Study COMPLETED	1262
Overall Study NOT COMPLETED	706

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Special Investigation in Patients With Rheumatoid Arthritis (Working Productivity Activity Impairment)

Baseline characteristics by cohort

Measure	Participants Receiving Adalimumab n=1968 Participants Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
Age, Continuous	55.8 years STANDARD_DEVIATION 13.5 • n=93 Participants
Sex: Female, Male Female	1484 Participants n=93 Participants
Sex: Female, Male Male	484 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of adalimumab (ADA) therapy, and at final assessment (up to Week 48)

Population: Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point.

Absenteeism, presented as the mean percentage of work time missed due to RA (as reported on the WPAI-RA), and calculated as: 100*number of hours of work missed due to RA / (number of hours of work missed due to RA + 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 each subsequent time point.

Outcome measures

Measure	Participants Receiving Adalimumab n=782 Participants Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Baseline	7.23 percentage of work time missed Standard Deviation 18.90
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Change at Week 12	3.80 percentage of work time missed Standard Deviation 17.61
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Change at Week 24	3.73 percentage of work time missed Standard Deviation 16.56
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Change at Week 36	3.85 percentage of work time missed Standard Deviation 15.79
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Change at Week 48	4.48 percentage of work time missed Standard Deviation 17.91
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Change at ADA discontinuation	1.25 percentage of work time missed Standard Deviation 14.46
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Change at final assessment	4.23 percentage of work time missed Standard Deviation 17.77

PRIMARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48)

Population: Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point.

Presenteeism (the extent to which RA decreased productivity) is presented as the mean percentage of impairment while working due to RA, 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. "Change" was calculated as the value at baseline minus the value at each subsequent time point.

Outcome measures

Measure	Participants Receiving Adalimumab n=858 Participants Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to RA (Presenteeism) Baseline	39.60 percentage of impairment while working Standard Deviation 28.53
Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to RA (Presenteeism) Change at Week 12	17.18 percentage of impairment while working Standard Deviation 26.45
Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to RA (Presenteeism) Change at Week 24	20.20 percentage of impairment while working Standard Deviation 27.54
Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to RA (Presenteeism) Change at Week 36	22.18 percentage of impairment while working Standard Deviation 28.37
Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to RA (Presenteeism) Change at Week 48	23.32 percentage of impairment while working Standard Deviation 27.27
Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to RA (Presenteeism) Change at ADA discontinuation	7.64 percentage of impairment while working Standard Deviation 29.87
Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to RA (Presenteeism) Change at final assessment	19.30 percentage of impairment while working Standard Deviation 29.02

PRIMARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48)

Population: Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point.

The mean percentage of OWPI due to RA (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which RA decreased productivity (%)* [number of hours worked / (number of hours of work missed due to RA + 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 each subsequent time point.

Outcome measures

Measure	Participants Receiving Adalimumab n=771 Participants Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to RA Baseline	41.06 percentage of OWPI Standard Deviation 29.58
Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to RA Change at Week 12	17.08 percentage of OWPI Standard Deviation 27.60
Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to RA Change at Week 24	20.83 percentage of OWPI Standard Deviation 28.83
Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to RA Change at Week 36	22.31 percentage of OWPI Standard Deviation 29.42
Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to RA Change at Week 48	24.40 percentage of OWPI Standard Deviation 28.37
Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to RA Change at ADA discontinuation	6.30 percentage of OWPI Standard Deviation 29.60
Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to RA Change at final assessment	19.77 percentage of OWPI Standard Deviation 29.99

PRIMARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)

Population: Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point.

Activity impairment due to RA (the extent to which RA affected the ability to perform usual daily activities) 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. "Change" was calculated as the value at baseline minus the value at each subsequent time point.

Outcome measures

Measure	Participants Receiving Adalimumab n=1546 Participants Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to RA Baseline	48.42 percentage of activity impairment Standard Deviation 28.11
Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to RA Change at Week 12	19.42 percentage of activity impairment Standard Deviation 25.86
Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to RA Change at Week 24	23.30 percentage of activity impairment Standard Deviation 28.07
Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to RA Change at Week 36	25.53 percentage of activity impairment Standard Deviation 27.91
Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to RA Change at Week 48	26.33 percentage of activity impairment Standard Deviation 28.17
Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to RA Change at ADA discontinuation	11.42 percentage of activity impairment Standard Deviation 29.83
Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to RA Change at final assessment	22.36 percentage of activity impairment Standard Deviation 29.44

PRIMARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)

Population: Participants with evaluable HAQ-DI assessments; number analyzed=participants with an evaluable assessment at given time point.

The HAQ-DI is a patient-reported questionnaire specific for RA. It 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 response 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 (no disability) to 3 (very severe, high-dependency disability). A negative change from Baseline in the score indicates improvement.

Outcome measures

Measure	Participants Receiving Adalimumab n=1595 Participants Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score Baseline	0.93 units on a scale Standard Deviation 0.75
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score Change at Week 12	0.34 units on a scale Standard Deviation 0.51
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score Change at Week 24	0.41 units on a scale Standard Deviation 0.55
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score Change at Week 36	0.42 units on a scale Standard Deviation 0.55
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score Change at Week 48	0.44 units on a scale Standard Deviation 0.54
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score Change at ADA discontinuation	0.21 units on a scale Standard Deviation 0.58
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score Change at final assessment	0.38 units on a scale Standard Deviation 0.57

PRIMARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)

Population: Participants with evaluable HAQ-DI assessments; number analyzed=participants with an evaluable assessment at given time point.

The HAQ-DI is a patient-reported questionnaire specific for RA. It 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 response 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 (no disability) to 3 (very severe, high-dependency disability). Categories were defined as: high (> 1.5), moderate (≤ 1.5 to > 1.0), low (≤ 1.0 to > 0.5), remission (≤ 0.5 to > 0), 0 (0).

Outcome measures

Measure	Participants Receiving Adalimumab n=1595 Participants Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
Number of Participants Per Category of the HAQ-DI Baseline · High	326 Participants
Number of Participants Per Category of the HAQ-DI Baseline · Moderate	253 Participants
Number of Participants Per Category of the HAQ-DI Baseline · Low	416 Participants
Number of Participants Per Category of the HAQ-DI Baseline · Remission	411 Participants
Number of Participants Per Category of the HAQ-DI Baseline · 0	189 Participants
Number of Participants Per Category of the HAQ-DI Week 12 · High	135 Participants
Number of Participants Per Category of the HAQ-DI Week 12 · Moderate	164 Participants
Number of Participants Per Category of the HAQ-DI Week 12 · Low	286 Participants
Number of Participants Per Category of the HAQ-DI Week 12 · Remission	417 Participants
Number of Participants Per Category of the HAQ-DI Week 12 · 0	411 Participants
Number of Participants Per Category of the HAQ-DI Week 24 · High	94 Participants
Number of Participants Per Category of the HAQ-DI Week 24 · Moderate	106 Participants
Number of Participants Per Category of the HAQ-DI Week 24 · Low	195 Participants
Number of Participants Per Category of the HAQ-DI Week 24 · Remission	354 Participants
Number of Participants Per Category of the HAQ-DI Week 24 · 0	433 Participants
Number of Participants Per Category of the HAQ-DI Week 36 · High	62 Participants
Number of Participants Per Category of the HAQ-DI Week 36 · Moderate	68 Participants
Number of Participants Per Category of the HAQ-DI Week 36 · Low	129 Participants
Number of Participants Per Category of the HAQ-DI Week 36 · Remission	284 Participants
Number of Participants Per Category of the HAQ-DI Week 36 · 0	369 Participants
Number of Participants Per Category of the HAQ-DI Week 48 · High	44 Participants
Number of Participants Per Category of the HAQ-DI Week 48 · Moderate	57 Participants
Number of Participants Per Category of the HAQ-DI Week 48 · Low	115 Participants
Number of Participants Per Category of the HAQ-DI Week 48 · Remission	223 Participants
Number of Participants Per Category of the HAQ-DI Week 48 · 0	340 Participants
Number of Participants Per Category of the HAQ-DI At discontinuation of ADA therapy · High	69 Participants
Number of Participants Per Category of the HAQ-DI At discontinuation of ADA therapy · Moderate	59 Participants
Number of Participants Per Category of the HAQ-DI At discontinuation of ADA therapy · Low	88 Participants
Number of Participants Per Category of the HAQ-DI At discontinuation of ADA therapy · Remission	78 Participants
Number of Participants Per Category of the HAQ-DI At discontinuation of ADA therapy · 0	70 Participants
Number of Participants Per Category of the HAQ-DI At final assessment · High	158 Participants
Number of Participants Per Category of the HAQ-DI At final assessment · Moderate	153 Participants
Number of Participants Per Category of the HAQ-DI At final assessment · Low	280 Participants
Number of Participants Per Category of the HAQ-DI At final assessment · Remission	421 Participants
Number of Participants Per Category of the HAQ-DI At final assessment · 0	583 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)

Population: Participants with evaluable HAQ-DI assessments; number analyzed=participants with an evaluable assessment at given time point.

DAS28-4 CRP was calculated using the number of tender and swollen joints (out of 28 counted), CRP level, and the participant's global assessment of disease activity via a visual analog scale (VAS). The calculated range of DAS28-4 is 0 (no disease activity) to 10 (maximal disease activity). A decrease from Baseline in score indicates improvement of disease activity.

Outcome measures

Measure	Participants Receiving Adalimumab n=1689 Participants Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
Change From Baseline in Disease Activity Score 28-4 C-Reactive Protein (DAS 28-4 CRP) Baseline	4.20 units on a scale Standard Deviation 1.26
Change From Baseline in Disease Activity Score 28-4 C-Reactive Protein (DAS 28-4 CRP) Change at Week 12	1.55 units on a scale Standard Deviation 1.23
Change From Baseline in Disease Activity Score 28-4 C-Reactive Protein (DAS 28-4 CRP) Change at Week 24	1.81 units on a scale Standard Deviation 1.25
Change From Baseline in Disease Activity Score 28-4 C-Reactive Protein (DAS 28-4 CRP) Change at Week 36	1.91 units on a scale Standard Deviation 1.30
Change From Baseline in Disease Activity Score 28-4 C-Reactive Protein (DAS 28-4 CRP) Change at Week 48	2.01 units on a scale Standard Deviation 1.26
Change From Baseline in Disease Activity Score 28-4 C-Reactive Protein (DAS 28-4 CRP) Change at ADA discontinuation	0.91 units on a scale Standard Deviation 1.39
Change From Baseline in Disease Activity Score 28-4 C-Reactive Protein (DAS 28-4 CRP) Change at final assessment	1.71 units on a scale Standard Deviation 1.39

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)

Population: Participants with evaluable DAS28-4 CRP assessments; number analyzed=participants with an evaluable assessment at given time point.

DAS28-4 CRP was calculated using the number of tender and swollen joints (out of 28 counted), CRP level, and the participant's global assessment of disease activity via a VAS. The calculated range of DAS28-4 is 0 (no disease activity) to 10 (maximal disease activity). Categories were defined as: high (> 5.1), moderate (≤ 5.1 to > 3.2), low (≤ 3.2 to ≥ 2.6), remission (< 2.6).

Outcome measures

Measure	Participants Receiving Adalimumab n=1689 Participants Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
Number of Participants Per Category of the DAS28-4 CRP Baseline · High	402 Participants
Number of Participants Per Category of the DAS28-4 CRP Baseline · Moderate	911 Participants
Number of Participants Per Category of the DAS28-4 CRP Baseline · Low	199 Participants
Number of Participants Per Category of the DAS28-4 CRP Baseline · Remission	177 Participants
Number of Participants Per Category of the DAS28-4 CRP Week 12 · High	65 Participants
Number of Participants Per Category of the DAS28-4 CRP Week 12 · Moderate	356 Participants
Number of Participants Per Category of the DAS28-4 CRP Week 12 · Low	233 Participants
Number of Participants Per Category of the DAS28-4 CRP Week 12 · Remission	846 Participants
Number of Participants Per Category of the DAS28-4 CRP Week 24 · High	23 Participants
Number of Participants Per Category of the DAS28-4 CRP Week 24 · Moderate	203 Participants
Number of Participants Per Category of the DAS28-4 CRP Week 24 · Low	203 Participants
Number of Participants Per Category of the DAS28-4 CRP Week 24 · Remission	853 Participants
Number of Participants Per Category of the DAS28-4 CRP Week 36 · High	11 Participants
Number of Participants Per Category of the DAS28-4 CRP Week 36 · Moderate	152 Participants
Number of Participants Per Category of the DAS28-4 CRP Week 36 · Low	139 Participants
Number of Participants Per Category of the DAS28-4 CRP Week 36 · Remission	775 Participants
Number of Participants Per Category of the DAS28-4 CRP Week 48 · High	4 Participants
Number of Participants Per Category of the DAS28-4 CRP Week 48 · Moderate	96 Participants
Number of Participants Per Category of the DAS28-4 CRP Week 48 · Low	117 Participants
Number of Participants Per Category of the DAS28-4 CRP Week 48 · Remission	703 Participants
Number of Participants Per Category of the DAS28-4 CRP At ADA discontinuation · High	76 Participants
Number of Participants Per Category of the DAS28-4 CRP At ADA discontinuation · Moderate	181 Participants
Number of Participants Per Category of the DAS28-4 CRP At ADA discontinuation · Low	61 Participants
Number of Participants Per Category of the DAS28-4 CRP At ADA discontinuation · Remission	154 Participants
Number of Participants Per Category of the DAS28-4 CRP At final assessment · High	91 Participants
Number of Participants Per Category of the DAS28-4 CRP At final assessment · Moderate	319 Participants
Number of Participants Per Category of the DAS28-4 CRP At final assessment · Low	215 Participants
Number of Participants Per Category of the DAS28-4 CRP At final assessment · Remission	1064 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)

Population: Participants with evaluable DAS28-4 ESR assessments; number analyzed=participants with an evaluable assessment at given time point.

DAS28-4 ESR, a combined index that measures activity of RA, was calculated based on the number of tender and swollen joints (out of 28 counted), general health evaluated by a VAS, and ESR. DAS28-4 ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity). A decrease from Baseline in scores indicates improvement of disease activity.

Outcome measures

Measure	Participants Receiving Adalimumab n=1403 Participants Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR) Baseline	4.76 units on a scale Standard Deviation 1.35
Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR) Change at Week 12	1.61 units on a scale Standard Deviation 1.28
Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR) Change at Week 24	1.91 units on a scale Standard Deviation 1.34
Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR) Change at Week 36	2.01 units on a scale Standard Deviation 1.35
Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR) Change at Week 48	2.08 units on a scale Standard Deviation 1.33
Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR) Change at ADA discontinuation	0.97 units on a scale Standard Deviation 1.43
Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR) Change at final assessment	1.80 units on a scale Standard Deviation 1.45

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)

Population: Participants with evaluable DAS28-4 CRP assessments; number analyzed=participants with an evaluable assessment at given time point.

DAS28-4 ESR, a combined index that measures activity of RA, was calculated based on the number of tender and swollen joints (out of 28 counted), general health evaluated by a VAS, and ESR. DAS28-4 ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity). Categories were defined as: high (> 5.1), moderate (≤ 5.1 to > 3.2), low (≤ 3.2 to ≥ 2.6), remission (< 2.6).

Outcome measures

Measure	Participants Receiving Adalimumab n=1403 Participants Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
Number of Participants Per Category of the DAS28-4 ESR Week 48 · Remission	447 Participants
Number of Participants Per Category of the DAS28-4 ESR Baseline · High	564 Participants
Number of Participants Per Category of the DAS28-4 ESR Baseline · Moderate	662 Participants
Number of Participants Per Category of the DAS28-4 ESR Baseline · Low	101 Participants
Number of Participants Per Category of the DAS28-4 ESR Baseline · Remission	76 Participants
Number of Participants Per Category of the DAS28-4 ESR Week 12 · High	113 Participants
Number of Participants Per Category of the DAS28-4 ESR Week 12 · Moderate	437 Participants
Number of Participants Per Category of the DAS28-4 ESR Week 12 · Low	223 Participants
Number of Participants Per Category of the DAS28-4 ESR Week 12 · Remission	468 Participants
Number of Participants Per Category of the DAS28-4 ESR Week 24 · High	47 Participants
Number of Participants Per Category of the DAS28-4 ESR Week 24 · Moderate	311 Participants
Number of Participants Per Category of the DAS28-4 ESR Week 24 · Low	183 Participants
Number of Participants Per Category of the DAS28-4 ESR Week 24 · Remission	517 Participants
Number of Participants Per Category of the DAS28-4 ESR Week 36 · High	33 Participants
Number of Participants Per Category of the DAS28-4 ESR Week 36 · Moderate	226 Participants
Number of Participants Per Category of the DAS28-4 ESR Week 36 · Low	163 Participants
Number of Participants Per Category of the DAS28-4 ESR Week 36 · Remission	467 Participants
Number of Participants Per Category of the DAS28-4 ESR Week 48 · High	16 Participants
Number of Participants Per Category of the DAS28-4 ESR Week 48 · Moderate	169 Participants
Number of Participants Per Category of the DAS28-4 ESR Week 48 · Low	135 Participants
Number of Participants Per Category of the DAS28-4 ESR At ADA discontinuation · High	96 Participants
Number of Participants Per Category of the DAS28-4 ESR At ADA discontinuation · Moderate	165 Participants
Number of Participants Per Category of the DAS28-4 ESR At ADA discontinuation · Low	39 Participants
Number of Participants Per Category of the DAS28-4 ESR At ADA discontinuation · Remission	81 Participants
Number of Participants Per Category of the DAS28-4 ESR At final assessment · High	124 Participants
Number of Participants Per Category of the DAS28-4 ESR At final assessment · Moderate	398 Participants
Number of Participants Per Category of the DAS28-4 ESR At final assessment · Low	227 Participants
Number of Participants Per Category of the DAS28-4 ESR At final assessment · Remission	654 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)

Population: Participants with evaluable CDAI assessments; number analyzed=participants with an evaluable assessment at given time point.

The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a VAS from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). "Change" was calculated as the value at baseline minus the value at each subsequent time point.

Outcome measures

Measure	Participants Receiving Adalimumab n=1696 Participants Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
Change From Baseline in Clinical Disease Activity Index (CDAI) Baseline	21.44 units on a scale Standard Deviation 12.24
Change From Baseline in Clinical Disease Activity Index (CDAI) Change at Week 12	11.98 units on a scale Standard Deviation 11.06
Change From Baseline in Clinical Disease Activity Index (CDAI) Change at Week 24	13.93 units on a scale Standard Deviation 11.12
Change From Baseline in Clinical Disease Activity Index (CDAI) Change at Week 36	14.26 units on a scale Standard Deviation 11.56
Change From Baseline in Clinical Disease Activity Index (CDAI) Change at Week 48	14.63 units on a scale Standard Deviation 11.19
Change From Baseline in Clinical Disease Activity Index (CDAI) Change at discontinuation of ADA therapy	8.00 units on a scale Standard Deviation 12.14
Change From Baseline in Clinical Disease Activity Index (CDAI) Change at final assessment	12.94 units on a scale Standard Deviation 12.11

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)

Population: Participants with evaluable CDAI assessments; number analyzed=participants with an evaluable assessment at given time point.

The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a VAS from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). Categories were defined as: high (> 22.1), moderate (≤ 22.0 to > 10.0), low (≤ 10.0 to < 2.8), and remission (≤ 2.8).

Outcome measures

Measure	Participants Receiving Adalimumab n=1696 Participants Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
Number of Participants Per Category of the CDAI Baseline · High	677 Participants
Number of Participants Per Category of the CDAI Baseline · Moderate	749 Participants
Number of Participants Per Category of the CDAI Baseline · Low	249 Participants
Number of Participants Per Category of the CDAI Baseline · Remission	21 Participants
Number of Participants Per Category of the CDAI Week 12 · High	128 Participants
Number of Participants Per Category of the CDAI Week 12 · Moderate	374 Participants
Number of Participants Per Category of the CDAI Week 12 · Low	676 Participants
Number of Participants Per Category of the CDAI Week 12 · Remission	337 Participants
Number of Participants Per Category of the CDAI Week 24 · High	51 Participants
Number of Participants Per Category of the CDAI Week 24 · Moderate	245 Participants
Number of Participants Per Category of the CDAI Week 24 · Low	595 Participants
Number of Participants Per Category of the CDAI Week 24 · Remission	405 Participants
Number of Participants Per Category of the CDAI Week 36 · High	34 Participants
Number of Participants Per Category of the CDAI Week 36 · Moderate	183 Participants
Number of Participants Per Category of the CDAI Week 36 · Low	459 Participants
Number of Participants Per Category of the CDAI Week 36 · Remission	403 Participants
Number of Participants Per Category of the CDAI Week 48 · High	19 Participants
Number of Participants Per Category of the CDAI Week 48 · Moderate	113 Participants
Number of Participants Per Category of the CDAI Week 48 · Low	384 Participants
Number of Participants Per Category of the CDAI Week 48 · Remission	400 Participants
Number of Participants Per Category of the CDAI At ADA discontinuation · High	114 Participants
Number of Participants Per Category of the CDAI At ADA discontinuation · Moderate	171 Participants
Number of Participants Per Category of the CDAI At ADA discontinuation · Low	138 Participants
Number of Participants Per Category of the CDAI At ADA discontinuation · Remission	62 Participants
Number of Participants Per Category of the CDAI At final assessment · High	149 Participants
Number of Participants Per Category of the CDAI At final assessment · Moderate	338 Participants
Number of Participants Per Category of the CDAI At final assessment · Low	639 Participants
Number of Participants Per Category of the CDAI At final assessment · Remission	570 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)

Population: Participants with evaluable EQ-5D assessments; number analyzed=participants with an evaluable assessment at given time point.

The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.594 to 1 (with higher scores indicating better health state). "Change" was calculated as the value at baseline minus the value at each subsequent time point.

Outcome measures

Measure	Participants Receiving Adalimumab n=1566 Participants Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
Change From Baseline in European Quality of Life-5 Dimensions Questionnaire (EQ-5D) Summary Index Score Baseline	0.6295 units on a scale Standard Deviation 0.1545
Change From Baseline in European Quality of Life-5 Dimensions Questionnaire (EQ-5D) Summary Index Score Change at Week 12	-0.1112 units on a scale Standard Deviation 0.1651
Change From Baseline in European Quality of Life-5 Dimensions Questionnaire (EQ-5D) Summary Index Score Change at Week 24	-0.1380 units on a scale Standard Deviation 0.1805
Change From Baseline in European Quality of Life-5 Dimensions Questionnaire (EQ-5D) Summary Index Score Change at Week 36	-0.1574 units on a scale Standard Deviation 0.1836
Change From Baseline in European Quality of Life-5 Dimensions Questionnaire (EQ-5D) Summary Index Score Change at Week 48	-0.1541 units on a scale Standard Deviation 0.2020
Change From Baseline in European Quality of Life-5 Dimensions Questionnaire (EQ-5D) Summary Index Score Change at discontinuation of ADA therapy	-0.0597 units on a scale Standard Deviation 0.1577
Change From Baseline in European Quality of Life-5 Dimensions Questionnaire (EQ-5D) Summary Index Score Change at final assessment	-0.1356 units on a scale Standard Deviation 0.1908

SECONDARY outcome

Timeframe: up to Week 52

Population: Safety Analysis Set (all evaluable participants with validated CRFs)

AEs, which were defined as any untoward medical occurrence observed in participants who received adalimumab in this study, were summarized.

Outcome measures

Measure	Participants Receiving Adalimumab n=1968 Participants Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Deaths AEs	475 Participants
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Deaths SAEs	103 Participants
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Deaths Deaths	5 Participants

SECONDARY outcome

Timeframe: up to Week 52

Population: Safety Analysis Set (all evaluable participants with validated CRFs)

Adverse drug reactions were defined as AEs of which a causal relationship with adalimumab could not be ruled out.

Outcome measures

Measure	Participants Receiving Adalimumab n=1968 Participants Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
Number of Participants With Adverse Drug Reactions	451 Participants

Adverse Events

Participants Receiving Adalimumab

Serious events: 103 serious events

Other events: 202 other events

Deaths: 0 deaths

Serious adverse events

Measure	Participants Receiving Adalimumab n=1968 participants at risk Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
Infections and infestations Appendicitis	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Bronchopulmonary aspergillosis	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Cellulitis	0.15% 3/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Herpes zoster	0.10% 2/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Meningitis salmonella	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Meningitis viral	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Pharyngitis	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Pneumonia	0.46% 9/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Pneumonia mycoplasmal	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Pneumonia pneumococcal	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Pyelonephritis acute	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Tonsillitis	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Muscle abscess	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Arthritis bacterial	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Bacterial sepsis	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Urinary tract infection bacterial	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Staphylococcal infection	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Pneumonia bacterial	0.10% 2/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Bursitis infective	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Infectious pleural effusion	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Pneumocystis jirovecii pneumonia	0.25% 5/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioblastoma	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.10% 2/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma malignant	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.15% 3/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic carcinoma of the bladder	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicle centre lymphoma, follicular grade I, II, III	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papillary mucinous neoplasm	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleomorphic adenoma	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Blood and lymphatic system disorders Pancytopenia	0.10% 2/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Psychiatric disorders Completed suicide	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Nervous system disorders Cerebellar infarction	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Nervous system disorders Cerebral haemorrhage	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Nervous system disorders Cerebral infarction	0.15% 3/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Nervous system disorders Subarachnoid haemorrhage	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Eye disorders Cataract	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Eye disorders Uveitis	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Eye disorders Vitreous haemorrhage	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Eye disorders Polypoidal choroidal vasculopathy	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Ear and labyrinth disorders Hypoacusis	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Cardiac disorders Acute myocardial infarction	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Vascular disorders Aortic aneurysm rupture	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Vascular disorders Rheumatoid vasculitis	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Respiratory, thoracic and mediastinal disorders Asthma	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.41% 8/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.10% 2/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Gastrointestinal disorders Enterocolitis	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Gastrointestinal disorders Pancreatitis acute	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Gastrointestinal disorders Vomiting	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Hepatobiliary disorders Cholecystitis	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Hepatobiliary disorders Cholelithiasis	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Hepatobiliary disorders Hepatic function abnormal	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Hepatobiliary disorders Liver disorder	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Hepatobiliary disorders Drug-induced liver injury	0.10% 2/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Skin and subcutaneous tissue disorders Alopecia	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Skin and subcutaneous tissue disorders Dermatomyositis	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Skin and subcutaneous tissue disorders Toxic skin eruption	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Musculoskeletal and connective tissue disorders Lupus-like syndrome	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Reproductive system and breast disorders Cervical dysplasia	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
General disorders Death	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
General disorders Pyrexia	0.15% 3/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Investigations White blood cell count decreased	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Injury, poisoning and procedural complications Femoral neck fracture	0.15% 3/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Injury, poisoning and procedural complications Femur fracture	0.25% 5/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Injury, poisoning and procedural complications Humerus fracture	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Injury, poisoning and procedural complications Spinal cord injury cervical	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Injury, poisoning and procedural complications Tendon rupture	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Injury, poisoning and procedural complications Pelvic fracture	0.05% 1/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).

Other adverse events

Measure	Participants Receiving Adalimumab n=1968 participants at risk Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
Infections and infestations Bronchitis	1.4% 27/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Infections and infestations Nasopharyngitis	1.6% 32/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	1.4% 28/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Hepatobiliary disorders Hepatic function abnormal	3.0% 59/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
Skin and subcutaneous tissue disorders Rash	1.7% 34/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
General disorders Injection site erythema	1.1% 22/1968 • up to Week 52 Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).

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