Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid arthritis
Brief summary
This is a single-arm, multi-center, prospective cohort study (post-marketing observational study). The observation period for each participant is 48 weeks. This study is designed to provide additional data on treatment effects of adalimumab during 48 weeks of treatment in patients with RA under conditions of routine rheumatology care. Course of work productivity and work ability, the course of health-related quality of life, and changes in functionality during 48 weeks treatment with adalimumab are to be documented.
Detailed description
This study was designed as a non-interventional observational study. Adalimumab was prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to 87 Years
Healthy volunteers
No
Inclusion criteria
RA patients treated with adalimumab who satisfied the following conditions: 1. Paid worker (PW) RA patients who are engaged in paid work for more than 35 hours per week 2. Home worker (HW) * Category 1 unpaid workers; RA patients who are engaged in paid work for less than 35 hours per week * Category 2 unpaid workers; RA patients who perform basic activities of daily life (household duties, shopping, child caring, exercise, study, etc.) other than PW
Exclusion criteria
1. RA patients showing lowered basic activities of daily life, such as hospitalization and being bedridden 2. RA patients with a history of previous treatment with adalimumab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of adalimumab (ADA) therapy, and at final assessment (up to Week 48) | 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. |
| Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to RA (Presenteeism) | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48) | 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. |
| Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to RA | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48) | 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. |
| Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to RA | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) | 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. |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) | 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. |
| Number of Participants Per Category of the HAQ-DI | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in European Quality of Life-5 Dimensions Questionnaire (EQ-5D) Summary Index Score | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) | 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. |
| Change From Baseline in Disease Activity Score 28-4 C-Reactive Protein (DAS 28-4 CRP) | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) | 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. |
| Number of Participants With Adverse Drug Reactions | up to Week 52 | Adverse drug reactions were defined as AEs of which a causal relationship with adalimumab could not be ruled out. |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Deaths | up to Week 52 | AEs, which were defined as any untoward medical occurrence observed in participants who received adalimumab in this study, were summarized. |
| Number of Participants Per Category of the DAS28-4 CRP | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) | 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). |
| Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR) | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) | 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. |
| Number of Participants Per Category of the DAS28-4 ESR | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) | 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). |
| Change From Baseline in Clinical Disease Activity Index (CDAI) | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) | 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. |
| Number of Participants Per Category of the CDAI | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) | 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). |
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Participants Receiving Adalimumab 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). | 1,968 |
| Total | 1,968 |
Baseline characteristics
| Characteristic | Participants Receiving Adalimumab |
|---|---|
| Age, Continuous | 55.8 years STANDARD_DEVIATION 13.5 |
| Sex: Female, Male Female | 1484 Participants |
| Sex: Female, Male Male | 484 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 202 / 1,968 |
| serious Total, serious adverse events | 103 / 1,968 |
Outcome results
Primary
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score | Baseline | 0.93 units on a scale | Standard Deviation 0.75 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
Comparison: Week 12p-value: <0.0001Paired t-test
Comparison: Week 24p-value: <0.0001Paired t-test
Comparison: Week 36p-value: <0.0001Paired t-test
Comparison: Week 48p-value: <0.0001Paired t-test
Comparison: at discontinuation of ADA therapyp-value: <0.0001Paired t-test
Comparison: at final assessmentp-value: <0.0001Paired t-test
Primary
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 18.9 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
Comparison: Week 12p-value: <0.0001Paired t-test
Comparison: Week 24p-value: <0.0001Paired t-test
Comparison: Week 36p-value: <0.0001Paired t-test
Comparison: Week 48p-value: <0.0001Paired t-test
Comparison: at discontinuation of ADA therapyp-value: 1Paired t-test
Comparison: at final assessmentp-value: <0.0001Paired t-test
Primary
Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to RA
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
Comparison: Week 12p-value: <0.0001Paired t-test
Comparison: Week 24p-value: <0.0001Paired t-test
Comparison: Week 36p-value: <0.0001Paired t-test
Comparison: Week 48p-value: <0.0001Paired t-test
Comparison: at discontinuation of ADA therapyp-value: <0.0001Paired t-test
Comparison: at final assessmentp-value: <0.0001Paired t-test
Primary
Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to RA (Presenteeism)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
Comparison: Week 12p-value: <0.0001Paired t-test
Comparison: Week 24p-value: <0.0001Paired t-test
Comparison: Week 36p-value: <0.0001Paired t-test
Comparison: Week 48p-value: <0.0001Paired t-test
Comparison: at discontinuation of ADA therapyp-value: 0.0054Paired t-test
Comparison: at final assessmentp-value: <0.0001Paired t-test
Primary
Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to RA
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 29.6 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 27.6 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
Comparison: Week 12p-value: <0.0001Paired t-test
Comparison: Week 24p-value: <0.0001Paired t-test
Comparison: Week 36p-value: <0.0001Paired t-test
Comparison: Week 48p-value: <0.0001Paired t-test
Comparison: at discontinuation of ADA therapyp-value: 0.0592Paired t-test
Comparison: at final assessmentp-value: <0.0001Paired t-test
Primary
Number of Participants Per Category of the HAQ-DI
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).
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Baseline | Low | 416 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Baseline | 0 | 189 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Week 12 | High | 135 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Week 12 | Moderate | 164 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Week 12 | Low | 286 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Week 24 | High | 94 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Week 24 | Low | 195 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Week 24 | 0 | 433 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Week 36 | High | 62 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Week 48 | Remission | 223 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | At discontinuation of ADA therapy | Low | 88 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Baseline | High | 326 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Baseline | Moderate | 253 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Baseline | Remission | 411 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Week 12 | Remission | 417 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Week 12 | 0 | 411 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Week 24 | Moderate | 106 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Week 24 | Remission | 354 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Week 36 | Moderate | 68 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Week 36 | Low | 129 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Week 36 | Remission | 284 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Week 36 | 0 | 369 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Week 48 | High | 44 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Week 48 | Moderate | 57 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Week 48 | Low | 115 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | Week 48 | 0 | 340 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | At discontinuation of ADA therapy | High | 69 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | At discontinuation of ADA therapy | Moderate | 59 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | At discontinuation of ADA therapy | Remission | 78 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | At discontinuation of ADA therapy | 0 | 70 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | At final assessment | High | 158 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | At final assessment | Moderate | 153 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | At final assessment | Low | 280 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | At final assessment | Remission | 421 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the HAQ-DI | At final assessment | 0 | 583 Participants |
Comparison: Week 12 (Remission)p-value: <0.0001McNemar
Comparison: Week 24 (Remission)p-value: <0.0001McNemar
Comparison: Week 36 (Remission)p-value: <0.0001McNemar
Comparison: Week 48 (Remission)p-value: <0.0001McNemar
Comparison: at discontinuation of ADA therapy (Remission)p-value: =0.0005McNemar
Comparison: at final assessment (Remission)p-value: <0.0001McNemar
Secondary
Change From Baseline in Clinical Disease Activity Index (CDAI)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Change From Baseline in Clinical Disease Activity Index (CDAI) | Change at final assessment | 12.94 units on a scale | Standard Deviation 12.11 |
| Participants Receiving Adalimumab | Change From Baseline in Clinical Disease Activity Index (CDAI) | Baseline | 21.44 units on a scale | Standard Deviation 12.24 |
| Participants Receiving Adalimumab | Change From Baseline in Clinical Disease Activity Index (CDAI) | Change at Week 12 | 11.98 units on a scale | Standard Deviation 11.06 |
| Participants Receiving Adalimumab | Change From Baseline in Clinical Disease Activity Index (CDAI) | Change at Week 24 | 13.93 units on a scale | Standard Deviation 11.12 |
| Participants Receiving Adalimumab | Change From Baseline in Clinical Disease Activity Index (CDAI) | Change at Week 36 | 14.26 units on a scale | Standard Deviation 11.56 |
| Participants Receiving Adalimumab | Change From Baseline in Clinical Disease Activity Index (CDAI) | Change at Week 48 | 14.63 units on a scale | Standard Deviation 11.19 |
| Participants Receiving Adalimumab | 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 |
Comparison: Week 12p-value: <0.0001Paired t-test
Comparison: Week 24p-value: <0.0001Paired t-test
Comparison: Week 36p-value: <0.0001Paired t-test
Comparison: Week 48p-value: <0.0001Paired t-test
Comparison: at discontinuation of ADA therapyp-value: <0.0001Paired t-test
Comparison: at final assessmentp-value: <0.0001Paired t-test
Secondary
Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR) | Baseline | 4.76 units on a scale | Standard Deviation 1.35 |
| Participants Receiving Adalimumab | Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR) | Change at Week 12 | 1.61 units on a scale | Standard Deviation 1.28 |
| Participants Receiving Adalimumab | Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR) | Change at Week 24 | 1.91 units on a scale | Standard Deviation 1.34 |
| Participants Receiving Adalimumab | Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR) | Change at Week 36 | 2.01 units on a scale | Standard Deviation 1.35 |
| Participants Receiving Adalimumab | Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR) | Change at Week 48 | 2.08 units on a scale | Standard Deviation 1.33 |
| Participants Receiving Adalimumab | Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR) | Change at ADA discontinuation | 0.97 units on a scale | Standard Deviation 1.43 |
| Participants Receiving Adalimumab | Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR) | Change at final assessment | 1.80 units on a scale | Standard Deviation 1.45 |
Comparison: Week 12p-value: <0.0001Paired t-test
Comparison: Week 24p-value: <0.0001Paired t-test
Comparison: Week 36p-value: <0.0001Paired t-test
Comparison: Week 48p-value: <0.0001Paired t-test
Comparison: at discontinuation of ADA therapyp-value: <0.0001Paired t-test
Comparison: at final assessmentp-value: <0.0001Paired t-test
Secondary
Change From Baseline in Disease Activity Score 28-4 C-Reactive Protein (DAS 28-4 CRP)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 1.3 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
Comparison: Week 12p-value: <0.0001Paired t-test
Comparison: Week 24p-value: <0.0001Paired t-test
Comparison: Week 36p-value: <0.0001Paired t-test
Comparison: Week 48p-value: <0.0001Paired t-test
Comparison: at discontinuation of ADA therapyp-value: <0.0001Paired t-test
Comparison: at final assessmentp-value: <0.0001Paired t-test
Secondary
Change From Baseline in European Quality of Life-5 Dimensions Questionnaire (EQ-5D) Summary Index Score
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 0.202 |
| Participants Receiving Adalimumab | 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 |
| Participants Receiving Adalimumab | 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 |
Comparison: Week 12p-value: <0.0001Paired t-test
Comparison: Week 24p-value: <0.0001Paired t-test
Comparison: Week 36p-value: <0.0001Paired t-test
Comparison: Week 48p-value: <0.0001Paired t-test
Comparison: at discontinuation of ADA therapyp-value: <0.0001Paired t-test
Comparison: at final assessmentp-value: <0.0001Paired t-test
Secondary
Number of Participants Per Category of the CDAI
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).
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | Week 24 | Low | 595 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | Week 36 | Moderate | 183 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | Week 36 | Remission | 403 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | At ADA discontinuation | Low | 138 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | Baseline | High | 677 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | Baseline | Moderate | 749 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | Baseline | Low | 249 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | Baseline | Remission | 21 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | Week 12 | High | 128 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | Week 12 | Moderate | 374 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | Week 12 | Low | 676 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | Week 12 | Remission | 337 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | Week 24 | High | 51 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | Week 24 | Moderate | 245 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | Week 24 | Remission | 405 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | Week 36 | High | 34 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | Week 36 | Low | 459 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | Week 48 | High | 19 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | Week 48 | Moderate | 113 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | Week 48 | Low | 384 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | Week 48 | Remission | 400 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | At ADA discontinuation | High | 114 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | At ADA discontinuation | Moderate | 171 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | At ADA discontinuation | Remission | 62 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | At final assessment | High | 149 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | At final assessment | Moderate | 338 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | At final assessment | Low | 639 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the CDAI | At final assessment | Remission | 570 Participants |
Comparison: at final assessment (Remission)p-value: <0.0001McNemar
Comparison: Week 12 (Remission)p-value: <0.0001McNemar
Comparison: Week 24 (Remission)p-value: <0.0001McNemar
Comparison: Week 36 (Remission)p-value: <0.0001McNemar
Comparison: Week 48 (Remission)p-value: <0.0001McNemar
Comparison: at discontinuation of ADA therapy (Remission)p-value: <0.0001McNemar
Secondary
Number of Participants Per Category of the DAS28-4 CRP
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).
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | Baseline | High | 402 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | Baseline | Moderate | 911 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | Week 24 | Moderate | 203 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | Week 24 | Low | 203 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | Week 24 | Remission | 853 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | Week 36 | Moderate | 152 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | Week 48 | Moderate | 96 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | Week 48 | Low | 117 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | Week 48 | Remission | 703 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | At ADA discontinuation | Moderate | 181 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | At ADA discontinuation | Low | 61 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | At final assessment | High | 91 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | At final assessment | Moderate | 319 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | At final assessment | Low | 215 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | At final assessment | Remission | 1064 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | Baseline | Low | 199 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | Baseline | Remission | 177 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | Week 12 | High | 65 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | Week 12 | Moderate | 356 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | Week 12 | Low | 233 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | Week 12 | Remission | 846 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | Week 24 | High | 23 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | Week 36 | High | 11 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | Week 36 | Low | 139 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | Week 36 | Remission | 775 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | Week 48 | High | 4 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | At ADA discontinuation | High | 76 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 CRP | At ADA discontinuation | Remission | 154 Participants |
Comparison: Week 12 (Remission)p-value: <0.0001McNemar
Comparison: Week 24 (Remission)p-value: <0.0001McNemar
Comparison: Week 36 (Remission)p-value: <0.0001McNemar
Comparison: Week 48 (Remission)p-value: <0.0001McNemar
Comparison: at discontinuation of ADA therapy (Remission)p-value: <0.0001McNemar
Comparison: at final assessment (Remission)p-value: <0.0001McNemar
Secondary
Number of Participants Per Category of the DAS28-4 ESR
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).
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | Week 24 | Remission | 517 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | Week 36 | High | 33 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | Week 36 | Moderate | 226 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | Week 36 | Low | 163 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | Week 48 | Moderate | 169 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | At final assessment | High | 124 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | Baseline | High | 564 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | Baseline | Moderate | 662 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | Baseline | Low | 101 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | Baseline | Remission | 76 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | Week 12 | High | 113 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | Week 12 | Moderate | 437 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | Week 12 | Low | 223 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | Week 12 | Remission | 468 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | Week 24 | High | 47 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | Week 24 | Moderate | 311 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | Week 24 | Low | 183 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | Week 48 | Remission | 447 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | Week 36 | Remission | 467 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | Week 48 | High | 16 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | Week 48 | Low | 135 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | At ADA discontinuation | High | 96 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | At ADA discontinuation | Moderate | 165 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | At ADA discontinuation | Low | 39 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | At ADA discontinuation | Remission | 81 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | At final assessment | Moderate | 398 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | At final assessment | Low | 227 Participants |
| Participants Receiving Adalimumab | Number of Participants Per Category of the DAS28-4 ESR | At final assessment | Remission | 654 Participants |
Comparison: Week 12 (Remission)p-value: <0.0001McNemar
Comparison: Week 24 (Remission)p-value: <0.0001McNemar
Comparison: Week 36 (Remission)p-value: <0.0001McNemar
Comparison: Week 48 (Remission)p-value: <0.0001McNemar
Comparison: at discontinuation of ADA therapy (Remission)p-value: <0.0001McNemar
Comparison: at final assessment (Remission)p-value: <0.0001McNemar
Secondary
Number of Participants With Adverse Drug Reactions
Adverse drug reactions were defined as AEs of which a causal relationship with adalimumab could not be ruled out.
Time frame: up to Week 52
Population: Safety Analysis Set (all evaluable participants with validated CRFs)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Receiving Adalimumab | Number of Participants With Adverse Drug Reactions | 451 Participants |
Secondary
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Deaths
AEs, which were defined as any untoward medical occurrence observed in participants who received adalimumab in this study, were summarized.
Time frame: up to Week 52
Population: Safety Analysis Set (all evaluable participants with validated CRFs)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving Adalimumab | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Deaths | Deaths | 5 Participants |
| Participants Receiving Adalimumab | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Deaths | AEs | 475 Participants |
| Participants Receiving Adalimumab | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Deaths | SAEs | 103 Participants |