Rheumatoid Arthritis
Conditions
Keywords
Work Productivity, Long-term Observation, Humira, Quality of Life, Rheumatoid Arthritis
Brief summary
The AGIL study was designed to evaluate the effectiveness and safety of adalimumab over 5 years in routine daily clinical practice in Germany, with a focus on the impact of therapy on employment-related outcomes.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Moderate to severe active rheumatoid arthritis in adults with insufficient response to disease-modifying antirheumatic drugs * Inclusive methotrexate * Moderate to severe active rheumatoid arthritis in adults who have not been treated with methotrexate before; In case of incompatibility with methotrexate, Humira can be used as monotherapy.
Exclusion criteria
* Hypersensitivity against the drug or one of the other ingredients * Active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections) * Moderate to severe cardiac insufficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Euroqol Visual Analog Scale (VAS) | Baseline and 3, 6, 12, 24, 36, 48, and 60 months | EuroQol-5 Dimensions (EQ-5D): The EQ-5D is a generic instrument for measuring health-related quality of life. The patient questionnaire consists of two parts. The second part is a vertical, thermometer-like, VAS ranging from 0 to 100 that provides a patient-reported assessment of overall health. Patients are asked to mark how good or bad their health is on that day, with 100 meaning the best health you can imagine and 0 meaning the worst health you can imagine. |
| Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment | Baseline and 3, 6, 12, 24, 36, 48, and 60 months | The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. |
| Change From Baseline in Work Activity Index (WAI) | Baseline and 6, 12, 24, 36, 48, and 60 months | The WAI is a tool designed to record the work ability of employees and consists of 7 questions. The modified WAI used in this study included Questions 1, 2, 4, 6, and 7 of the WAI. Question 3, which involves the number of current diseases diagnosed by a physician, was omitted because this parameter was unlikely to reflect change due to treatment. Question 5 (sick leave during the past year) was replaced with the previous question concerning sick leave days.WAI scores range from 7 (worst) to 49 (best). |
| Change From Baseline in Disease Activity Score - 28 Joints (DAS28) | Baseline and 3, 6, 12, 24, 36, 48, and 60 months | The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \> 5.1 indicates high disease activity, a DAS28 score \< 3.2 indicates low disease activity, and a DAS28 score \< 2.6 indicates clinical remission. |
| Change From Baseline in Tender Joint Count | Baseline and 3, 6, 12, 24, 36, 48, and 60 months | Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. |
| Change From Baseline in Swollen Joint Count | Baseline and 3, 6, 12, 24, 36, 48, and 60 months | Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. |
| Change From Baseline in Erythrocyte Sedimentation Rate | Baseline and 3, 6, 12, 24, 36, 48, and 60 months | — |
| Change From Baseline in C-reactive Protein | Baseline and 3, 6, 12, 24, 36, 48, and 60 months | — |
| Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI) | Baseline and 3, 6, 12, 24, 36, 48, and 60 months | The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing, eating, walking, and hygiene. Patients are asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst), with a higher score representing a high-dependency disability. |
| EuroQol-5 Dimensions (EQ-5D) Scores | Baseline and 3, 6, 12, 24, 36, 48, and 60 months | The EuroQol-5 Dimensions (EQ-5D) is a generic instrument for measuring health-related quality of life. The patient questionnaire consists of two parts. The first part includes statements for the following five areas (dimensions): * agility/mobility * self-care * usual activities * pain, bodily discomfort * anxiety, depression For each dimension the patient is asked for a three-level assessment of their health on the current day: no problems (1), some problems (2), extreme problems (3). |
| Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months | Baseline and 6, 12, 24, 36, 48, and 60 months | Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline. Sick leave days were based on patient recall. |
| Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months | Baseline, 6, 12, 24, 36, 48, and 60 months | Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline. Sick leave days were based on patient recall. |
| Change From Baseline in Work Productivity and Activity Impairment: Absenteeism | Baseline and 3, 6, 12, 24, 36, 48, and 60 months | The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. |
| Change From Baseline in Work Productivity and Activity Impairment: Presenteeism | Baseline and 3, 6, 12, 24, 36, 48, and 60 months | The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. |
| Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment | Baseline and 3, 6, 12, 24, 36, 48, and 60 months | The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Inpatient Hospitalizations in Past 6 Months | Baseline, 6, 12, 24, 36, 48, and 60 months | Participants self-reported the number of hospitalizations they had in the past 6 months. |
| Duration of Inpatient Hospitalizations in Past 6 Months | Baseline, 6, 12, 24, 36, 48, and 60 months | Participants who had been hospitalized were asked how many days they were hospitalized in the past 6 months. |
| Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Baseline, 6, 12, 24, 36, 48, and 60 months | Patients reported the number of days that sickness affected non-occupational activities in four categories: household, child-rearing/parenting, education, and recreational (free-time). Participants with no impairment were considered to have 0 days. |
| Duration of Morning Stiffness | Baseline and 3, 6, 12, 24, 36, 48, and 60 months | — |
| Participant's Assessment of Pain | Baseline and 3, 6, 12, 24, 36, 48, and 60 months | Participants were asked to evaluate their level of pain in the past 7 days on a scale from 0 (no pain) to 10 (unbearable pain). |
| Participant's Assessment of Fatigue | Baseline and 3, 6, 12, 24, 36, 48, and 60 months | Participants were asked to indicate how much they had suffered from abnormal exhaustion and fatigue during the past 7 days on a scale from 0 (none) to 10 (strongly). |
| Percentage of Participants Taking Concomitant RA Medications | Baseline to month 60 | Assessment of concomitant medications included disease-modifying antirheumatic drugs (DMARDs) (methotrexate, Leflunomid, sulfasalazine), systemic glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), Cox-2 inhibitors (coxibs), analgesics and others. |
| Patient Assessment of Adalimumab Therapy | Months 3, 6, 12, 24, 36, 48, and 60 | Participants were asked to rate therapy with adalimumab in comparison with other previous therapies according to the following response options: * Considerably better * Better * About the same * Worse * Noticeably worse |
| Number of Physician Visits in Past 6 Months | Baseline, 6, 12, 24, 36, 48, and 60 months | Participants self-reported the number of physician visits they had in the past 6 months. |
Participant flow
Recruitment details
Adults with rheumatoid arthritis (RA) were enrolled at 326 clinical centers in Germany and seen during regular visits for routine clinical care.
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care. | 7,229 |
| Total | 7,229 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Drug Reaction | 299 |
| Overall Study | Lack of Effectiveness | 1,423 |
| Overall Study | Lost to Follow-up | 3,151 |
| Overall Study | Other Reason | 1,075 |
| Overall Study | Unknown Reason | 71 |
Baseline characteristics
| Characteristic | Adalimumab | — |
|---|---|---|
| Age, Continuous | 54.9 years STANDARD_DEVIATION 13.2 | — |
| C-reactive Protein | 17.3 mg/L STANDARD_DEVIATION 48.7 | — |
| Disease Activity Score - 28 Joints (DAS28) | 4.63 units on a scale STANDARD_DEVIATION 1.51 | — |
| Duration of Disease | 9.6 years STANDARD_DEVIATION 8.8 | — |
| Erythrocyte Sedimentation Rate | 26.5 mm/hr STANDARD_DEVIATION 21.7 | — |
| Euroqol Visual Analog Scale (VAS) | 52.2 units on a scale STANDARD_DEVIATION 22 | — |
| Health-Assessment Questionnaire-Disability Index (HAQ-DI) | 1.19 units on a scale STANDARD_DEVIATION 0.74 | — |
| Number of Missed Work Days in Last 6 Months | 19.9 days STANDARD_DEVIATION 41.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 5267 Participants | — |
| Sex: Female, Male Male | 1909 Participants | — |
| Swollen Joint Count | 5.0 joints STANDARD_DEVIATION 5.3 | — |
| Tender Joint Count | 7.4 joints STANDARD_DEVIATION 6.8 | — |
| Work Activity Index | 32.1 units on a scale STANDARD_DEVIATION 7.8 | — |
| Work Productivity and Activity Impairment Absenteeism | 21.4 percent impairment STANDARD_DEVIATION 36.9 | — |
| Work Productivity and Activity Impairment Presenteeism | 47.2 percent impairment STANDARD_DEVIATION 27.3 | — |
| Work Productivity and Activity Impairment Total activity impairment | 54.9 percent impairment STANDARD_DEVIATION 25 | — |
| Work Productivity and Activity Impairment Total work productivity impairment | 50.9 percent impairment STANDARD_DEVIATION 29.2 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 23 / 7,229 |
| other Total, other adverse events | 831 / 7,229 |
| serious Total, serious adverse events | 932 / 7,229 |
Outcome results
Primary
Change From Baseline in C-reactive Protein
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Change From Baseline in C-reactive Protein | Month 3 | -7.1 mg/L | Standard Deviation 45.2 |
| Adalimumab | Change From Baseline in C-reactive Protein | Month 6 | -7.3 mg/L | Standard Deviation 49.1 |
| Adalimumab | Change From Baseline in C-reactive Protein | Month 12 | -7.5 mg/L | Standard Deviation 59.4 |
| Adalimumab | Change From Baseline in C-reactive Protein | Month 24 | -8.0 mg/L | Standard Deviation 64 |
| Adalimumab | Change From Baseline in C-reactive Protein | Month 36 | -8.6 mg/L | Standard Deviation 65.9 |
| Adalimumab | Change From Baseline in C-reactive Protein | Month 48 | -5.8 mg/L | Standard Deviation 47.5 |
| Adalimumab | Change From Baseline in C-reactive Protein | Month 60 | -7.8 mg/L | Standard Deviation 39.3 |
Primary
Change From Baseline in Disease Activity Score - 28 Joints (DAS28)
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \> 5.1 indicates high disease activity, a DAS28 score \< 3.2 indicates low disease activity, and a DAS28 score \< 2.6 indicates clinical remission.
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Change From Baseline in Disease Activity Score - 28 Joints (DAS28) | Month 3 | -1.34 units on a scale | Standard Deviation 1.39 |
| Adalimumab | Change From Baseline in Disease Activity Score - 28 Joints (DAS28) | Month 6 | -1.56 units on a scale | Standard Deviation 1.46 |
| Adalimumab | Change From Baseline in Disease Activity Score - 28 Joints (DAS28) | Month 12 | -1.71 units on a scale | Standard Deviation 1.55 |
| Adalimumab | Change From Baseline in Disease Activity Score - 28 Joints (DAS28) | Month 24 | -1.84 units on a scale | Standard Deviation 1.57 |
| Adalimumab | Change From Baseline in Disease Activity Score - 28 Joints (DAS28) | Month 36 | -1.94 units on a scale | Standard Deviation 1.61 |
| Adalimumab | Change From Baseline in Disease Activity Score - 28 Joints (DAS28) | Month 48 | -2.01 units on a scale | Standard Deviation 1.59 |
| Adalimumab | Change From Baseline in Disease Activity Score - 28 Joints (DAS28) | Month 60 | -2.15 units on a scale | Standard Deviation 1.63 |
Primary
Change From Baseline in Erythrocyte Sedimentation Rate
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Change From Baseline in Erythrocyte Sedimentation Rate | Month 3 | -7.1 mm/hr | Standard Deviation 20.5 |
| Adalimumab | Change From Baseline in Erythrocyte Sedimentation Rate | Month 6 | -7.9 mm/hr | Standard Deviation 20.6 |
| Adalimumab | Change From Baseline in Erythrocyte Sedimentation Rate | Month 12 | -8.5 mm/hr | Standard Deviation 21.6 |
| Adalimumab | Change From Baseline in Erythrocyte Sedimentation Rate | Month 24 | -9.0 mm/hr | Standard Deviation 22.2 |
| Adalimumab | Change From Baseline in Erythrocyte Sedimentation Rate | Month 36 | -8.9 mm/hr | Standard Deviation 22.1 |
| Adalimumab | Change From Baseline in Erythrocyte Sedimentation Rate | Month 48 | -9.3 mm/hr | Standard Deviation 22.7 |
| Adalimumab | Change From Baseline in Erythrocyte Sedimentation Rate | Month 60 | -9.9 mm/hr | Standard Deviation 22.5 |
Primary
Change From Baseline in Euroqol Visual Analog Scale (VAS)
EuroQol-5 Dimensions (EQ-5D): The EQ-5D is a generic instrument for measuring health-related quality of life. The patient questionnaire consists of two parts. The second part is a vertical, thermometer-like, VAS ranging from 0 to 100 that provides a patient-reported assessment of overall health. Patients are asked to mark how good or bad their health is on that day, with 100 meaning the best health you can imagine and 0 meaning the worst health you can imagine.
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Change From Baseline in Euroqol Visual Analog Scale (VAS) | Month 6 | 11.7 units on a scale | Standard Deviation 24.9 |
| Adalimumab | Change From Baseline in Euroqol Visual Analog Scale (VAS) | Month 12 | 12.9 units on a scale | Standard Deviation 25.8 |
| Adalimumab | Change From Baseline in Euroqol Visual Analog Scale (VAS) | Month 3 | 10.0 units on a scale | Standard Deviation 24 |
| Adalimumab | Change From Baseline in Euroqol Visual Analog Scale (VAS) | Month 24 | 14.9 units on a scale | Standard Deviation 25.4 |
| Adalimumab | Change From Baseline in Euroqol Visual Analog Scale (VAS) | Month 36 | 16.2 units on a scale | Standard Deviation 25.4 |
| Adalimumab | Change From Baseline in Euroqol Visual Analog Scale (VAS) | Month 48 | 15.8 units on a scale | Standard Deviation 25.2 |
| Adalimumab | Change From Baseline in Euroqol Visual Analog Scale (VAS) | Month 60 | 14.9 units on a scale | Standard Deviation 25.4 |
Primary
Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI)
The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing, eating, walking, and hygiene. Patients are asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst), with a higher score representing a high-dependency disability.
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI) | Month 3 | -0.22 units on a scale | Standard Deviation 0.51 |
| Adalimumab | Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI) | Month 6 | -0.24 units on a scale | Standard Deviation 0.54 |
| Adalimumab | Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI) | Month 12 | -0.27 units on a scale | Standard Deviation 0.58 |
| Adalimumab | Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI) | Month 24 | -0.28 units on a scale | Standard Deviation 0.6 |
| Adalimumab | Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI) | Month 36 | -0.30 units on a scale | Standard Deviation 0.62 |
| Adalimumab | Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI) | Month 48 | -0.32 units on a scale | Standard Deviation 0.61 |
| Adalimumab | Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI) | Month 60 | -0.28 units on a scale | Standard Deviation 0.63 |
Primary
Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months
Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline. Sick leave days were based on patient recall.
Time frame: Baseline and 6, 12, 24, 36, 48, and 60 months
Population: Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set), with available data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months | Month 6 | -4.3 days | Standard Deviation 32.7 |
| Adalimumab | Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months | Month 12 | -3.4 days | Standard Deviation 37.3 |
| Adalimumab | Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months | Month 24 | -5.6 days | Standard Deviation 30.3 |
| Adalimumab | Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months | Month 36 | -6.7 days | Standard Deviation 32.2 |
| Adalimumab | Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months | Month 48 | -6.4 days | Standard Deviation 27.7 |
| Adalimumab | Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months | Month 60 | -4.1 days | Standard Deviation 32 |
Primary
Change From Baseline in Swollen Joint Count
Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Change From Baseline in Swollen Joint Count | Month 48 | -5.0 joints | Standard Deviation 5.7 |
| Adalimumab | Change From Baseline in Swollen Joint Count | Month 60 | -5.5 joints | Standard Deviation 6.1 |
| Adalimumab | Change From Baseline in Swollen Joint Count | Month 3 | -3.2 joints | Standard Deviation 4.9 |
| Adalimumab | Change From Baseline in Swollen Joint Count | Month 6 | -3.8 joints | Standard Deviation 5.2 |
| Adalimumab | Change From Baseline in Swollen Joint Count | Month 12 | -4.1 joints | Standard Deviation 5.4 |
| Adalimumab | Change From Baseline in Swollen Joint Count | Month 24 | -4.4 joints | Standard Deviation 5.6 |
| Adalimumab | Change From Baseline in Swollen Joint Count | Month 36 | -4.8 joints | Standard Deviation 5.7 |
Primary
Change From Baseline in Tender Joint Count
Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Change From Baseline in Tender Joint Count | Month 3 | -4.3 joints | Standard Deviation 6.2 |
| Adalimumab | Change From Baseline in Tender Joint Count | Month 6 | -4.9 joints | Standard Deviation 6.5 |
| Adalimumab | Change From Baseline in Tender Joint Count | Month 12 | -5.3 joints | Standard Deviation 6.7 |
| Adalimumab | Change From Baseline in Tender Joint Count | Month 24 | -5.6 joints | Standard Deviation 6.5 |
| Adalimumab | Change From Baseline in Tender Joint Count | Month 36 | -5.9 joints | Standard Deviation 6.7 |
| Adalimumab | Change From Baseline in Tender Joint Count | Month 48 | -6.1 joints | Standard Deviation 6.7 |
| Adalimumab | Change From Baseline in Tender Joint Count | Month 60 | -6.4 joints | Standard Deviation 6.5 |
Primary
Change From Baseline in Work Activity Index (WAI)
The WAI is a tool designed to record the work ability of employees and consists of 7 questions. The modified WAI used in this study included Questions 1, 2, 4, 6, and 7 of the WAI. Question 3, which involves the number of current diseases diagnosed by a physician, was omitted because this parameter was unlikely to reflect change due to treatment. Question 5 (sick leave during the past year) was replaced with the previous question concerning sick leave days.WAI scores range from 7 (worst) to 49 (best).
Time frame: Baseline and 6, 12, 24, 36, 48, and 60 months
Population: Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and at each time point, and with available WAI data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Change From Baseline in Work Activity Index (WAI) | Month 6 | 2.5 units on a scale | Standard Deviation 5.9 |
| Adalimumab | Change From Baseline in Work Activity Index (WAI) | Month 12 | 3.0 units on a scale | Standard Deviation 6.7 |
| Adalimumab | Change From Baseline in Work Activity Index (WAI) | Month 24 | 3.2 units on a scale | Standard Deviation 6.8 |
| Adalimumab | Change From Baseline in Work Activity Index (WAI) | Month 36 | 3.6 units on a scale | Standard Deviation 7 |
| Adalimumab | Change From Baseline in Work Activity Index (WAI) | Month 48 | 3.3 units on a scale | Standard Deviation 6.6 |
| Adalimumab | Change From Baseline in Work Activity Index (WAI) | Month 60 | 3.0 units on a scale | Standard Deviation 7 |
Primary
Change From Baseline in Work Productivity and Activity Impairment: Absenteeism
The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Population: Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and at each time point, and with available WPAI data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Absenteeism | Month 3 | -7.9 percent impairment | Standard Deviation 34.6 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Absenteeism | Month 6 | -8.0 percent impairment | Standard Deviation 37.2 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Absenteeism | Month 12 | -7.3 percent impairment | Standard Deviation 38.3 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Absenteeism | Month 24 | -6.5 percent impairment | Standard Deviation 36.1 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Absenteeism | Month 36 | -8.0 percent impairment | Standard Deviation 34.7 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Absenteeism | Month 48 | -5.2 percent impairment | Standard Deviation 34.6 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Absenteeism | Month 60 | -5.2 percent impairment | Standard Deviation 40.7 |
Primary
Change From Baseline in Work Productivity and Activity Impairment: Presenteeism
The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Population: Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and at each time point, and with available WPAI data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Presenteeism | Month 3 | -11.3 percent impairment | Standard Deviation 25.8 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Presenteeism | Month 6 | -11.8 percent impairment | Standard Deviation 26.7 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Presenteeism | Month 12 | -12.7 percent impairment | Standard Deviation 28.2 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Presenteeism | Month 24 | -12.9 percent impairment | Standard Deviation 28.6 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Presenteeism | Month 36 | -15.3 percent impairment | Standard Deviation 28.8 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Presenteeism | Month 48 | -16.4 percent impairment | Standard Deviation 29.4 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Presenteeism | Month 60 | -15.2 percent impairment | Standard Deviation 27.8 |
Primary
Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment
The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Population: Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and with available WPAI data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment | Month 3 | -11.9 percent impairment | Standard Deviation 26.5 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment | Month 6 | -12.8 percent impairment | Standard Deviation 27.5 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment | Month 12 | -13.8 percent impairment | Standard Deviation 28.6 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment | Month 24 | -14.3 percent impairment | Standard Deviation 28.4 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment | Month 36 | -15.4 percent impairment | Standard Deviation 29.7 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment | Month 48 | -14.8 percent impairment | Standard Deviation 29.4 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment | Month 60 | -14.8 percent impairment | Standard Deviation 28.6 |
Primary
Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment
The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Population: Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and at each time point, and with available WPAI data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment | Month 3 | -13.0 percent impairment | Standard Deviation 27.7 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment | Month 6 | -14.4 percent impairment | Standard Deviation 28.8 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment | Month 12 | -16.4 percent impairment | Standard Deviation 30.3 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment | Month 24 | -15.3 percent impairment | Standard Deviation 30.6 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment | Month 36 | -18.8 percent impairment | Standard Deviation 29.3 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment | Month 48 | -16.7 percent impairment | Standard Deviation 31.6 |
| Adalimumab | Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment | Month 60 | -16.5 percent impairment | Standard Deviation 33.8 |
Primary
EuroQol-5 Dimensions (EQ-5D) Scores
The EuroQol-5 Dimensions (EQ-5D) is a generic instrument for measuring health-related quality of life. The patient questionnaire consists of two parts. The first part includes statements for the following five areas (dimensions): * agility/mobility * self-care * usual activities * pain, bodily discomfort * anxiety, depression For each dimension the patient is asked for a three-level assessment of their health on the current day: no problems (1), some problems (2), extreme problems (3).
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adalimumab | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | Some problems | 1961 Participants |
| Adalimumab | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | Some problems | 2965 Participants |
| Adalimumab | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | Extreme problems | 1288 Participants |
| Adalimumab | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | No problems | 147 Participants |
| Adalimumab | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | Extreme problems | 206 Participants |
| Adalimumab | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | Extreme problems | 115 Participants |
| Adalimumab | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | Extreme problems | 275 Participants |
| Adalimumab | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | Some problems | 1680 Participants |
| Adalimumab | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | No problems | 2599 Participants |
| Adalimumab | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | Extreme problems | 8 Participants |
| Adalimumab | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | Some problems | 2728 Participants |
| Adalimumab | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | Some problems | 3236 Participants |
| Adalimumab | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | No problems | 953 Participants |
| Adalimumab | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | No problems | 1662 Participants |
| Adalimumab | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | No problems | 2159 Participants |
| Month 3 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | No problems | 2072 Participants |
| Month 3 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | No problems | 2792 Participants |
| Month 3 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | Some problems | 1601 Participants |
| Month 3 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | No problems | 1463 Participants |
| Month 3 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | Some problems | 2932 Participants |
| Month 3 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | No problems | 585 Participants |
| Month 3 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | Extreme problems | 12 Participants |
| Month 3 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | Extreme problems | 601 Participants |
| Month 3 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | Some problems | 2511 Participants |
| Month 3 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | No problems | 2328 Participants |
| Month 3 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | Extreme problems | 142 Participants |
| Month 3 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | Extreme problems | 98 Participants |
| Month 3 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | Some problems | 2034 Participants |
| Month 3 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | Extreme problems | 187 Participants |
| Month 3 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | Some problems | 1226 Participants |
| Month 6 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | Some problems | 2508 Participants |
| Month 6 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | No problems | 1431 Participants |
| Month 6 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | Extreme problems | 429 Participants |
| Month 6 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | No problems | 2141 Participants |
| Month 6 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | Some problems | 1989 Participants |
| Month 6 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | Extreme problems | 103 Participants |
| Month 6 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | No problems | 587 Participants |
| Month 6 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | Some problems | 1238 Participants |
| Month 6 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | Extreme problems | 144 Participants |
| Month 6 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | No problems | 1937 Participants |
| Month 6 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | Some problems | 1575 Participants |
| Month 6 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | Extreme problems | 12 Participants |
| Month 6 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | No problems | 2476 Participants |
| Month 6 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | Some problems | 972 Participants |
| Month 6 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | Extreme problems | 75 Participants |
| Month 12 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | Extreme problems | 98 Participants |
| Month 12 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | Some problems | 1989 Participants |
| Month 12 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | Extreme problems | 285 Participants |
| Month 12 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | No problems | 1791 Participants |
| Month 12 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | Some problems | 956 Participants |
| Month 12 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | Extreme problems | 107 Participants |
| Month 12 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | Some problems | 1455 Participants |
| Month 12 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | Extreme problems | 62 Participants |
| Month 12 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | No problems | 1644 Participants |
| Month 12 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | Some problems | 1200 Participants |
| Month 12 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | No problems | 1303 Participants |
| Month 12 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | Extreme problems | 12 Participants |
| Month 12 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | No problems | 2088 Participants |
| Month 12 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | Some problems | 706 Participants |
| Month 12 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | No problems | 582 Participants |
| Month 24 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | No problems | 1190 Participants |
| Month 24 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | Extreme problems | 161 Participants |
| Month 24 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | Some problems | 824 Participants |
| Month 24 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | Extreme problems | 33 Participants |
| Month 24 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | Some problems | 607 Participants |
| Month 24 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | No problems | 1349 Participants |
| Month 24 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | Some problems | 503 Participants |
| Month 24 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | Some problems | 1381 Participants |
| Month 24 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | Some problems | 1015 Participants |
| Month 24 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | Extreme problems | 64 Participants |
| Month 24 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | No problems | 1484 Participants |
| Month 24 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | Extreme problems | 6 Participants |
| Month 24 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | No problems | 478 Participants |
| Month 24 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | Extreme problems | 47 Participants |
| Month 24 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | No problems | 958 Participants |
| Month 36 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | No problems | 977 Participants |
| Month 36 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | Some problems | 696 Participants |
| Month 36 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | Some problems | 395 Participants |
| Month 36 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | No problems | 843 Participants |
| Month 36 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | No problems | 677 Participants |
| Month 36 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | Extreme problems | 28 Participants |
| Month 36 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | Some problems | 554 Participants |
| Month 36 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | Extreme problems | 25 Participants |
| Month 36 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | Extreme problems | 4 Participants |
| Month 36 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | No problems | 383 Participants |
| Month 36 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | No problems | 1038 Participants |
| Month 36 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | Extreme problems | 28 Participants |
| Month 36 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | Some problems | 917 Participants |
| Month 36 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | Extreme problems | 101 Participants |
| Month 36 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | Some problems | 338 Participants |
| Month 48 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | No problems | 705 Participants |
| Month 48 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | No problems | 298 Participants |
| Month 48 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | Extreme problems | 2 Participants |
| Month 48 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | Some problems | 464 Participants |
| Month 48 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | No problems | 503 Participants |
| Month 48 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | Some problems | 631 Participants |
| Month 48 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | No problems | 729 Participants |
| Month 48 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | Extreme problems | 22 Participants |
| Month 48 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | No problems | 614 Participants |
| Month 48 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | Some problems | 265 Participants |
| Month 48 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | Some problems | 376 Participants |
| Month 48 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | Extreme problems | 20 Participants |
| Month 48 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | Extreme problems | 25 Participants |
| Month 48 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | Extreme problems | 63 Participants |
| Month 48 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | Some problems | 243 Participants |
| Month 60 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | Extreme problems | 18 Participants |
| Month 60 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | No problems | 526 Participants |
| Month 60 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | Extreme problems | 3 Participants |
| Month 60 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | Extreme problems | 16 Participants |
| Month 60 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | Some problems | 208 Participants |
| Month 60 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | Extreme problems | 46 Participants |
| Month 60 | EuroQol-5 Dimensions (EQ-5D) Scores | Self-care | No problems | 506 Participants |
| Month 60 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | Some problems | 362 Participants |
| Month 60 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | No problems | 225 Participants |
| Month 60 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | No problems | 353 Participants |
| Month 60 | EuroQol-5 Dimensions (EQ-5D) Scores | Anxiety/depression | Some problems | 190 Participants |
| Month 60 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | No problems | 447 Participants |
| Month 60 | EuroQol-5 Dimensions (EQ-5D) Scores | Pain/discomfort | Some problems | 461 Participants |
| Month 60 | EuroQol-5 Dimensions (EQ-5D) Scores | Mobility | Some problems | 282 Participants |
| Month 60 | EuroQol-5 Dimensions (EQ-5D) Scores | Usual activities | Extreme problems | 17 Participants |
Primary
Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months
Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline. Sick leave days were based on patient recall.
Time frame: Baseline, 6, 12, 24, 36, 48, and 60 months
Population: Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set), with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab | Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months | Month 24 | 27.9 percentage of participants |
| Adalimumab | Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months | Baseline | 44.7 percentage of participants |
| Adalimumab | Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months | Month 6 | 29.5 percentage of participants |
| Adalimumab | Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months | Month 12 | 28.5 percentage of participants |
| Adalimumab | Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months | Month 36 | 26.2 percentage of participants |
| Adalimumab | Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months | Month 48 | 24.1 percentage of participants |
| Adalimumab | Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months | Month 60 | 26.1 percentage of participants |
Secondary
Duration of Inpatient Hospitalizations in Past 6 Months
Participants who had been hospitalized were asked how many days they were hospitalized in the past 6 months.
Time frame: Baseline, 6, 12, 24, 36, 48, and 60 months
Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Duration of Inpatient Hospitalizations in Past 6 Months | Month 48 | 0.7 days | Standard Deviation 3.5 |
| Adalimumab | Duration of Inpatient Hospitalizations in Past 6 Months | Baseline | 2.3 days | Standard Deviation 7.3 |
| Adalimumab | Duration of Inpatient Hospitalizations in Past 6 Months | Month 6 | 1.1 days | Standard Deviation 4.4 |
| Adalimumab | Duration of Inpatient Hospitalizations in Past 6 Months | Month 12 | 1.1 days | Standard Deviation 4.8 |
| Adalimumab | Duration of Inpatient Hospitalizations in Past 6 Months | Month 24 | 0.8 days | Standard Deviation 3.5 |
| Adalimumab | Duration of Inpatient Hospitalizations in Past 6 Months | Month 36 | 0.7 days | Standard Deviation 3.1 |
| Adalimumab | Duration of Inpatient Hospitalizations in Past 6 Months | Month 60 | 0.5 days | Standard Deviation 2.4 |
Secondary
Duration of Morning Stiffness
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Duration of Morning Stiffness | Baseline | 65.3 minutes | Standard Deviation 72.8 |
| Adalimumab | Duration of Morning Stiffness | Month 3 | 34.6 minutes | Standard Deviation 55.6 |
| Adalimumab | Duration of Morning Stiffness | Month 6 | 27.4 minutes | Standard Deviation 44.3 |
| Adalimumab | Duration of Morning Stiffness | Month 12 | 24.2 minutes | Standard Deviation 43.5 |
| Adalimumab | Duration of Morning Stiffness | Month 24 | 20.9 minutes | Standard Deviation 39.8 |
| Adalimumab | Duration of Morning Stiffness | Month 36 | 19.0 minutes | Standard Deviation 41 |
| Adalimumab | Duration of Morning Stiffness | Month 48 | 15.0 minutes | Standard Deviation 29.8 |
| Adalimumab | Duration of Morning Stiffness | Month 60 | 15.2 minutes | Standard Deviation 32.7 |
Secondary
Number of Days With Impairment of Non-Occupational Activities in Past 6 Months
Patients reported the number of days that sickness affected non-occupational activities in four categories: household, child-rearing/parenting, education, and recreational (free-time). Participants with no impairment were considered to have 0 days.
Time frame: Baseline, 6, 12, 24, 36, 48, and 60 months
Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Child-rearing/parenting | 15.1 days | Standard Deviation 41.6 |
| Adalimumab | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Recreational | 59.1 days | Standard Deviation 65.6 |
| Adalimumab | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Household | 56.9 days | Standard Deviation 64.3 |
| Adalimumab | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Educational | 8.3 days | Standard Deviation 31.6 |
| Month 3 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Household | 27.7 days | Standard Deviation 50.6 |
| Month 3 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Educational | 2.5 days | Standard Deviation 17.1 |
| Month 3 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Child-rearing/parenting | 4.7 days | Standard Deviation 23.1 |
| Month 3 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Recreational | 28.3 days | Standard Deviation 50.9 |
| Month 6 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Child-rearing/parenting | 3.1 days | Standard Deviation 18.1 |
| Month 6 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Household | 22.4 days | Standard Deviation 46.1 |
| Month 6 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Educational | 1.6 days | Standard Deviation 13.3 |
| Month 6 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Recreational | 23.0 days | Standard Deviation 47.4 |
| Month 12 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Household | 20.6 days | Standard Deviation 46.3 |
| Month 12 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Educational | 1.1 days | Standard Deviation 10.1 |
| Month 12 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Child-rearing/parenting | 2.8 days | Standard Deviation 18.4 |
| Month 12 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Recreational | 19.5 days | Standard Deviation 45 |
| Month 24 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Educational | 1.0 days | Standard Deviation 10.1 |
| Month 24 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Recreational | 18.5 days | Standard Deviation 44.9 |
| Month 24 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Household | 18.2 days | Standard Deviation 43.7 |
| Month 24 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Child-rearing/parenting | 1.9 days | Standard Deviation 13.6 |
| Month 36 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Household | 19.2 days | Standard Deviation 46.1 |
| Month 36 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Child-rearing/parenting | 3.0 days | Standard Deviation 19.7 |
| Month 36 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Educational | 0.9 days | Standard Deviation 11.5 |
| Month 36 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Recreational | 19.1 days | Standard Deviation 46 |
| Month 48 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Recreational | 16.3 days | Standard Deviation 41.7 |
| Month 48 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Child-rearing/parenting | 1.6 days | Standard Deviation 8.2 |
| Month 48 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Educational | 1.4 days | Standard Deviation 12.6 |
| Month 48 | Number of Days With Impairment of Non-Occupational Activities in Past 6 Months | Household | 16.1 days | Standard Deviation 39.8 |
Secondary
Number of Inpatient Hospitalizations in Past 6 Months
Participants self-reported the number of hospitalizations they had in the past 6 months.
Time frame: Baseline, 6, 12, 24, 36, 48, and 60 months
Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Number of Inpatient Hospitalizations in Past 6 Months | Month 36 | 0.1 hospitalizations | Standard Deviation 0.4 |
| Adalimumab | Number of Inpatient Hospitalizations in Past 6 Months | Month 48 | 0.1 hospitalizations | Standard Deviation 0.7 |
| Adalimumab | Number of Inpatient Hospitalizations in Past 6 Months | Month 60 | 0.1 hospitalizations | Standard Deviation 0.4 |
| Adalimumab | Number of Inpatient Hospitalizations in Past 6 Months | Baseline | 0.4 hospitalizations | Standard Deviation 1.5 |
| Adalimumab | Number of Inpatient Hospitalizations in Past 6 Months | Month 6 | 0.2 hospitalizations | Standard Deviation 1 |
| Adalimumab | Number of Inpatient Hospitalizations in Past 6 Months | Month 12 | 0.2 hospitalizations | Standard Deviation 1 |
| Adalimumab | Number of Inpatient Hospitalizations in Past 6 Months | Month 24 | 0.1 hospitalizations | Standard Deviation 0.5 |
Secondary
Number of Physician Visits in Past 6 Months
Participants self-reported the number of physician visits they had in the past 6 months.
Time frame: Baseline, 6, 12, 24, 36, 48, and 60 months
Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Number of Physician Visits in Past 6 Months | General practitioner | 4.0 visits | Standard Deviation 4.6 |
| Adalimumab | Number of Physician Visits in Past 6 Months | Other specialists | 1.2 visits | Standard Deviation 2.4 |
| Adalimumab | Number of Physician Visits in Past 6 Months | Rheumatologist | 3.3 visits | Standard Deviation 3.1 |
| Adalimumab | Number of Physician Visits in Past 6 Months | Orthopedic specialist | 0.9 visits | Standard Deviation 2.2 |
| Month 3 | Number of Physician Visits in Past 6 Months | Other specialists | 0.9 visits | Standard Deviation 1.8 |
| Month 3 | Number of Physician Visits in Past 6 Months | General practitioner | 2.9 visits | Standard Deviation 4.4 |
| Month 3 | Number of Physician Visits in Past 6 Months | Rheumatologist | 2.5 visits | Standard Deviation 2.7 |
| Month 3 | Number of Physician Visits in Past 6 Months | Orthopedic specialist | 0.6 visits | Standard Deviation 1.9 |
| Month 6 | Number of Physician Visits in Past 6 Months | Orthopedic specialist | 0.7 visits | Standard Deviation 1.6 |
| Month 6 | Number of Physician Visits in Past 6 Months | Rheumatologist | 2.2 visits | Standard Deviation 2 |
| Month 6 | Number of Physician Visits in Past 6 Months | Other specialists | 0.9 visits | Standard Deviation 1.8 |
| Month 6 | Number of Physician Visits in Past 6 Months | General practitioner | 2.6 visits | Standard Deviation 3.2 |
| Month 12 | Number of Physician Visits in Past 6 Months | General practitioner | 2.1 visits | Standard Deviation 2.5 |
| Month 12 | Number of Physician Visits in Past 6 Months | Other specialists | 0.8 visits | Standard Deviation 1.4 |
| Month 12 | Number of Physician Visits in Past 6 Months | Rheumatologist | 1.9 visits | Standard Deviation 1.5 |
| Month 12 | Number of Physician Visits in Past 6 Months | Orthopedic specialist | 0.5 visits | Standard Deviation 1.3 |
| Month 24 | Number of Physician Visits in Past 6 Months | General practitioner | 2.1 visits | Standard Deviation 3 |
| Month 24 | Number of Physician Visits in Past 6 Months | Rheumatologist | 1.8 visits | Standard Deviation 1.4 |
| Month 24 | Number of Physician Visits in Past 6 Months | Orthopedic specialist | 0.5 visits | Standard Deviation 1.3 |
| Month 24 | Number of Physician Visits in Past 6 Months | Other specialists | 0.8 visits | Standard Deviation 1.5 |
| Month 36 | Number of Physician Visits in Past 6 Months | Other specialists | 0.8 visits | Standard Deviation 1.5 |
| Month 36 | Number of Physician Visits in Past 6 Months | General practitioner | 1.9 visits | Standard Deviation 2.4 |
| Month 36 | Number of Physician Visits in Past 6 Months | Orthopedic specialist | 0.5 visits | Standard Deviation 1 |
| Month 36 | Number of Physician Visits in Past 6 Months | Rheumatologist | 1.9 visits | Standard Deviation 1.4 |
| Month 48 | Number of Physician Visits in Past 6 Months | Orthopedic specialist | 0.5 visits | Standard Deviation 1.9 |
| Month 48 | Number of Physician Visits in Past 6 Months | Other specialists | 0.8 visits | Standard Deviation 1.5 |
| Month 48 | Number of Physician Visits in Past 6 Months | General practitioner | 1.8 visits | Standard Deviation 2.5 |
| Month 48 | Number of Physician Visits in Past 6 Months | Rheumatologist | 1.8 visits | Standard Deviation 1.6 |
Secondary
Participant's Assessment of Fatigue
Participants were asked to indicate how much they had suffered from abnormal exhaustion and fatigue during the past 7 days on a scale from 0 (none) to 10 (strongly).
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Participant's Assessment of Fatigue | Baseline | 5.8 units on a scale | Standard Deviation 2.7 |
| Adalimumab | Participant's Assessment of Fatigue | Month 3 | 4.4 units on a scale | Standard Deviation 2.7 |
| Adalimumab | Participant's Assessment of Fatigue | Month 6 | 4.2 units on a scale | Standard Deviation 2.7 |
| Adalimumab | Participant's Assessment of Fatigue | Month 12 | 4.0 units on a scale | Standard Deviation 2.7 |
| Adalimumab | Participant's Assessment of Fatigue | Month 24 | 3.8 units on a scale | Standard Deviation 2.7 |
| Adalimumab | Participant's Assessment of Fatigue | Month 36 | 3.5 units on a scale | Standard Deviation 2.6 |
| Adalimumab | Participant's Assessment of Fatigue | Month 48 | 3.5 units on a scale | Standard Deviation 2.6 |
| Adalimumab | Participant's Assessment of Fatigue | Month 60 | 3.4 units on a scale | Standard Deviation 2.7 |
Secondary
Participant's Assessment of Pain
Participants were asked to evaluate their level of pain in the past 7 days on a scale from 0 (no pain) to 10 (unbearable pain).
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Participant's Assessment of Pain | Baseline | 6.1 units on a scale | Standard Deviation 2.3 |
| Adalimumab | Participant's Assessment of Pain | Month 3 | 4.4 units on a scale | Standard Deviation 2.5 |
| Adalimumab | Participant's Assessment of Pain | Month 6 | 4.2 units on a scale | Standard Deviation 2.5 |
| Adalimumab | Participant's Assessment of Pain | Month 12 | 3.9 units on a scale | Standard Deviation 2.5 |
| Adalimumab | Participant's Assessment of Pain | Month 24 | 3.7 units on a scale | Standard Deviation 2.4 |
| Adalimumab | Participant's Assessment of Pain | Month 36 | 3.5 units on a scale | Standard Deviation 2.4 |
| Adalimumab | Participant's Assessment of Pain | Month 48 | 3.3 units on a scale | Standard Deviation 2.4 |
| Adalimumab | Participant's Assessment of Pain | Month 60 | 3.3 units on a scale | Standard Deviation 2.4 |
Secondary
Patient Assessment of Adalimumab Therapy
Participants were asked to rate therapy with adalimumab in comparison with other previous therapies according to the following response options: * Considerably better * Better * About the same * Worse * Noticeably worse
Time frame: Months 3, 6, 12, 24, 36, 48, and 60
Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab | Patient Assessment of Adalimumab Therapy | Considerably better | 35.6 percentage of participants |
| Adalimumab | Patient Assessment of Adalimumab Therapy | About the same | 19.2 percentage of participants |
| Adalimumab | Patient Assessment of Adalimumab Therapy | Noticeably worse | 1.6 percentage of participants |
| Adalimumab | Patient Assessment of Adalimumab Therapy | Worse | 6.9 percentage of participants |
| Adalimumab | Patient Assessment of Adalimumab Therapy | Better | 36.6 percentage of participants |
| Month 3 | Patient Assessment of Adalimumab Therapy | Better | 39.7 percentage of participants |
| Month 3 | Patient Assessment of Adalimumab Therapy | About the same | 14.9 percentage of participants |
| Month 3 | Patient Assessment of Adalimumab Therapy | Worse | 5.0 percentage of participants |
| Month 3 | Patient Assessment of Adalimumab Therapy | Considerably better | 39.6 percentage of participants |
| Month 3 | Patient Assessment of Adalimumab Therapy | Noticeably worse | 0.9 percentage of participants |
| Month 6 | Patient Assessment of Adalimumab Therapy | About the same | 12.2 percentage of participants |
| Month 6 | Patient Assessment of Adalimumab Therapy | Considerably better | 46.3 percentage of participants |
| Month 6 | Patient Assessment of Adalimumab Therapy | Better | 37.3 percentage of participants |
| Month 6 | Patient Assessment of Adalimumab Therapy | Worse | 3.8 percentage of participants |
| Month 6 | Patient Assessment of Adalimumab Therapy | Noticeably worse | 0.4 percentage of participants |
| Month 12 | Patient Assessment of Adalimumab Therapy | Considerably better | 51.6 percentage of participants |
| Month 12 | Patient Assessment of Adalimumab Therapy | Worse | 1.9 percentage of participants |
| Month 12 | Patient Assessment of Adalimumab Therapy | Noticeably worse | 0.3 percentage of participants |
| Month 12 | Patient Assessment of Adalimumab Therapy | Better | 37.1 percentage of participants |
| Month 12 | Patient Assessment of Adalimumab Therapy | About the same | 9.1 percentage of participants |
| Month 24 | Patient Assessment of Adalimumab Therapy | Better | 40.4 percentage of participants |
| Month 24 | Patient Assessment of Adalimumab Therapy | About the same | 6.7 percentage of participants |
| Month 24 | Patient Assessment of Adalimumab Therapy | Considerably better | 51.5 percentage of participants |
| Month 24 | Patient Assessment of Adalimumab Therapy | Worse | 1.3 percentage of participants |
| Month 24 | Patient Assessment of Adalimumab Therapy | Noticeably worse | 0.1 percentage of participants |
| Month 36 | Patient Assessment of Adalimumab Therapy | Better | 38.1 percentage of participants |
| Month 36 | Patient Assessment of Adalimumab Therapy | Worse | 0.5 percentage of participants |
| Month 36 | Patient Assessment of Adalimumab Therapy | About the same | 5.6 percentage of participants |
| Month 36 | Patient Assessment of Adalimumab Therapy | Noticeably worse | 0.3 percentage of participants |
| Month 36 | Patient Assessment of Adalimumab Therapy | Considerably better | 55.5 percentage of participants |
| Month 48 | Patient Assessment of Adalimumab Therapy | Noticeably worse | 0.8 percentage of participants |
| Month 48 | Patient Assessment of Adalimumab Therapy | Considerably better | 53.6 percentage of participants |
| Month 48 | Patient Assessment of Adalimumab Therapy | Worse | 1.1 percentage of participants |
| Month 48 | Patient Assessment of Adalimumab Therapy | About the same | 5.6 percentage of participants |
| Month 48 | Patient Assessment of Adalimumab Therapy | Better | 38.8 percentage of participants |
Secondary
Percentage of Participants Taking Concomitant RA Medications
Assessment of concomitant medications included disease-modifying antirheumatic drugs (DMARDs) (methotrexate, Leflunomid, sulfasalazine), systemic glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), Cox-2 inhibitors (coxibs), analgesics and others.
Time frame: Baseline to month 60
Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab | Percentage of Participants Taking Concomitant RA Medications | Analgesics | 10.9 percentage of participants |
| Adalimumab | Percentage of Participants Taking Concomitant RA Medications | NSAIDs or coxibs | 22.1 percentage of participants |
| Adalimumab | Percentage of Participants Taking Concomitant RA Medications | Sulfasalazine | 3.6 percentage of participants |
| Adalimumab | Percentage of Participants Taking Concomitant RA Medications | Systemic glucocorticoids | 68.1 percentage of participants |
| Adalimumab | Percentage of Participants Taking Concomitant RA Medications | Leflunomide | 12.0 percentage of participants |
| Adalimumab | Percentage of Participants Taking Concomitant RA Medications | Other | 3.8 percentage of participants |
| Adalimumab | Percentage of Participants Taking Concomitant RA Medications | Methotrexate | 53.4 percentage of participants |
| Month 3 | Percentage of Participants Taking Concomitant RA Medications | Other | 9.8 percentage of participants |
| Month 3 | Percentage of Participants Taking Concomitant RA Medications | Methotrexate | 58.6 percentage of participants |
| Month 3 | Percentage of Participants Taking Concomitant RA Medications | Leflunomide | 13.0 percentage of participants |
| Month 3 | Percentage of Participants Taking Concomitant RA Medications | Sulfasalazine | 4.1 percentage of participants |
| Month 3 | Percentage of Participants Taking Concomitant RA Medications | Analgesics | 12.5 percentage of participants |
| Month 3 | Percentage of Participants Taking Concomitant RA Medications | NSAIDs or coxibs | 24.2 percentage of participants |
| Month 3 | Percentage of Participants Taking Concomitant RA Medications | Systemic glucocorticoids | 73.4 percentage of participants |