Rheumatoid Arthritis
Conditions
Keywords
Quality of life (QOL), Rheumatoid arthritis (RA), Work productivity, Adalimumab
Brief summary
The objective of this study was to assess the effectiveness of adalimumab on health and disability outcomes in participants with rheumatoid arthritis (RA) in China.
Detailed description
This was a prospective, multicenter, observational study to assess the effectiveness of adalimumab on health-related quality of life (QoL) and work productivity in participants with rheumatoid arthritis (RA) in routine clinical practice in China. The decision to prescribe adalimumab for RA was based on clinical practice criteria without taking participation in this study into account. Participants were included in the study after a physician's decision of initiating adalimumab treatment. Participants were followed for 24 weeks, with scheduled study visits at baseline, Week 12 and Week 24.
Interventions
BIOLOGICALAdalimumab
Pre-filled syringe, administered by subcutaneous injection
Sponsors
AbbVie
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant had a diagnosis of rheumatoid arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) classification criteria and/or the ACR/the European League against Rheumatism (EULAR) 2010 classification criteria (any duration since diagnosis) * Participants with moderate to severe RA defined as a Disease Activity Score in 28 Joints (DAS28) Erythrocyte Sedimentation Rate (ESR) or DAS28 C-Reactive Protein (CRP) score \>3.2 * Biologically treatment naïve and initiated adalimumab at baseline visit, as per standard daily clinical practice * Availability of clinical data of the previous 12 weeks prior to baseline * Ability to self-complete participant questionnaires. * Participants had signed the authorization (or informed consent where applicable) to disclose and use personal health information after having been prescribed adalimumab
Exclusion criteria
* Participants who were pregnant or breastfeeding at enrollment or wished to become pregnant in the next 24 weeks. * Participation in any RA-related clinical trial at the time of enrollment, at baseline, or at any point during the past 24 weeks prior to baseline * Participants, who in the clinician's view, may not have been able to accurately report their quality of life (QoL) or prior resource utilization * Participants, who in the clinician's view, may not have been able to adhere to adalimumab therapy over 24 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 24 | Baseline and Week 24 | The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past 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 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative median indicates improvement from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Change From Baseline in Short Form 36-Item Health Survey (SF-36) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Scores at Weeks 12 and 24 | Baseline, Week 12, and Week 24 | The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 PCS and MCS scores range from 1-100: higher scores indicate a better state of health and an increase from baseline represents improvement. |
| Median Change From Baseline in EuroQol 5-dimension, 3-level Quality of Life Questionnaire (EQ-5D-3L) Index | Baseline, Week 12, and Week 24 | The EQ-5D-3L measures the participant's overall health state in a descriptive system of health-related quality of life (QoL) states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which has three response choices. The responses record three levels of severity ('no problems', 'having some or moderate problems', and 'being unable to do/extreme problems') within a particular EQ-5D-3L dimension. In addition, a 20 cm visual analogue scale (VAS) measures the participant's self-rated current health state on a scale from 0-100, from 0 (worst imaginable health state) to 100 ('best imaginable health state). The EQ-5D-3L results were converted into a weighted health state index with scores ranging from approximately 0 (death) to 1 (full health). A positive change from baseline indicates improvement. |
| Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Overall Work Impairment Score | Baseline, Week 12, and Week 24 | The Work Productivity and Activity Impairment Questionnaire (WPAI) is a participant-reported questionnaire to measure work and activity impairment during the past seven days. The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the participant's rheumatoid arthritis impair the productivity while working past seven days from visit). Data were calculated using the formula Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\] and converted to percent, with higher numbers indicating greater impairment and less productivity. Negative values indicate improvement from baseline. |
| Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 12 | Baseline and Week 12 | The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past 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 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative median indicates improvement from baseline. |
| Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score | Baseline, Week 12, and Week 24 | The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past 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 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22. |
| Percentage of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score | Baseline, Week 12, and Week 24 | The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past 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 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22. |
| Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Activity Impairment Score | Baseline, Week 12, and Week 24 | The Work Productivity and Activity Impairment Questionnaire (WPAI) is a participant-reported questionnaire to measure work and activity impairment during the past seven days. Activity impairment was calculated via WPAI question 6, the participant's rating of how much rheumatoid arthritis affected their ability to do regular daily activities, other than working at a job (0 = no effect; 10 = completely impacted productivity) / 10 \* 100. Negative values indicate improvement from baseline. |
Participant flow
Pre-assignment details
All participants who received at least one dose of adalimumab during the study
Participants by arm
| Arm | Count |
|---|---|
| Participants With RA Receiving Adalimumab 40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 13 |
| Overall Study | Other, not specified | 1 |
Baseline characteristics
| Characteristic | Participants With RA Receiving Adalimumab | — |
|---|---|---|
| Age, Continuous | 50.0 years STANDARD_DEVIATION 13.4 | — |
| Mean Baseline DAS28 score | 6.0 units on a scale STANDARD_DEVIATION 1.4 | — |
| Medical insurance type Employer benefits | 1 Participants | — |
| Medical insurance type National/Public insurance | 45 Participants | — |
| Medical insurance type National/Public insurance and private insurance | 1 Participants | — |
| Medical insurance type No insurance | 1 Participants | — |
| Medical insurance type Other | 5 Participants | — |
| Medical insurance type Private insurance | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 43 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 17 / 55 |
| serious Total, serious adverse events | 2 / 55 |
Outcome results
Primary
Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 24
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past 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 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative median indicates improvement from baseline.
Time frame: Baseline and Week 24
Population: Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With RA Receiving Adalimumab | Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 24 | -0.3 units on a scale |
p-value: =0.0002Wilcoxon signed-rank test
Secondary
Median Change From Baseline in EuroQol 5-dimension, 3-level Quality of Life Questionnaire (EQ-5D-3L) Index
The EQ-5D-3L measures the participant's overall health state in a descriptive system of health-related quality of life (QoL) states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which has three response choices. The responses record three levels of severity ('no problems', 'having some or moderate problems', and 'being unable to do/extreme problems') within a particular EQ-5D-3L dimension. In addition, a 20 cm visual analogue scale (VAS) measures the participant's self-rated current health state on a scale from 0-100, from 0 (worst imaginable health state) to 100 ('best imaginable health state). The EQ-5D-3L results were converted into a weighted health state index with scores ranging from approximately 0 (death) to 1 (full health). A positive change from baseline indicates improvement.
Time frame: Baseline, Week 12, and Week 24
Population: Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Participants With RA Receiving Adalimumab | Median Change From Baseline in EuroQol 5-dimension, 3-level Quality of Life Questionnaire (EQ-5D-3L) Index | Week 12 | 0.11 units on a scale |
| Participants With RA Receiving Adalimumab | Median Change From Baseline in EuroQol 5-dimension, 3-level Quality of Life Questionnaire (EQ-5D-3L) Index | Week 24 | 0.19 units on a scale |
Comparison: Median Change From Baseline in EQ-5D-3L Index Score at Week 12p-value: <0.0001Wilcoxon signed-rank test
Comparison: Median Change From Baseline in EQ-5D-3L Index Score at Week 24p-value: <0.0001Wilcoxon signed-rank test
Secondary
Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 12
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past 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 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative median indicates improvement from baseline.
Time frame: Baseline and Week 12
Population: Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With RA Receiving Adalimumab | Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 12 | -0.2 units on a scale |
p-value: =0.0006Wilcoxon signed-rank test
Secondary
Median Change From Baseline in Short Form 36-Item Health Survey (SF-36) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Scores at Weeks 12 and 24
The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 PCS and MCS scores range from 1-100: higher scores indicate a better state of health and an increase from baseline represents improvement.
Time frame: Baseline, Week 12, and Week 24
Population: Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Participants With RA Receiving Adalimumab | Median Change From Baseline in Short Form 36-Item Health Survey (SF-36) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Scores at Weeks 12 and 24 | PCS T-Score Week 12 | 6.50 units on a scale |
| Participants With RA Receiving Adalimumab | Median Change From Baseline in Short Form 36-Item Health Survey (SF-36) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Scores at Weeks 12 and 24 | MCS T-Score Week 12 | 0.44 units on a scale |
| Participants With RA Receiving Adalimumab | Median Change From Baseline in Short Form 36-Item Health Survey (SF-36) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Scores at Weeks 12 and 24 | PCS T-Score Week 24 | 4.90 units on a scale |
| Participants With RA Receiving Adalimumab | Median Change From Baseline in Short Form 36-Item Health Survey (SF-36) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Scores at Weeks 12 and 24 | MCS T-Score Week 24 | 6.01 units on a scale |
Comparison: Median change from baseline in PCS T-score at Week 12p-value: <0.0001Wilcoxon signed-rank test
Comparison: Median change from baseline in MCS T-score at Week 12p-value: =0.1233Wilcoxon signed-rank test
Comparison: Median change from baseline in PCS T-score at Week 24p-value: <0.001Wilcoxon signed-rank test
Comparison: Median change from baseline in MCS T-score at Week 24p-value: =0.001Wilcoxon signed-rank test
Secondary
Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Activity Impairment Score
The Work Productivity and Activity Impairment Questionnaire (WPAI) is a participant-reported questionnaire to measure work and activity impairment during the past seven days. Activity impairment was calculated via WPAI question 6, the participant's rating of how much rheumatoid arthritis affected their ability to do regular daily activities, other than working at a job (0 = no effect; 10 = completely impacted productivity) / 10 \* 100. Negative values indicate improvement from baseline.
Time frame: Baseline, Week 12, and Week 24
Population: Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Participants With RA Receiving Adalimumab | Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Activity Impairment Score | Week 12 | -10.0 percent impairment |
| Participants With RA Receiving Adalimumab | Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Activity Impairment Score | Week 24 | -20.0 percent impairment |
Comparison: Median Change from Baseline in WPAI Activity Impairment Score at Week 12p-value: =0.0026Wilcoxon signed-rank test
Comparison: Median Change from Baseline in WPAI Activity Impairment Score at Week 24p-value: =0.0001Wilcoxon signed-rank test
Secondary
Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Overall Work Impairment Score
The Work Productivity and Activity Impairment Questionnaire (WPAI) is a participant-reported questionnaire to measure work and activity impairment during the past seven days. The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the participant's rheumatoid arthritis impair the productivity while working past seven days from visit). Data were calculated using the formula Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\] and converted to percent, with higher numbers indicating greater impairment and less productivity. Negative values indicate improvement from baseline.
Time frame: Baseline, Week 12, and Week 24
Population: Observed population: participants continuing adalimumab treatment after the baseline visit who had at least Baseline data for this endpoint
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Participants With RA Receiving Adalimumab | Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Overall Work Impairment Score | Week 12 | -58.4 percent impairment |
| Participants With RA Receiving Adalimumab | Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Overall Work Impairment Score | Week 24 | -20.0 percent impairment |
Comparison: Median Change from Baseline in WPAI Overall Work Impairment Score at Week 12p-value: =0.0137Wilcoxon signed-rank test
Comparison: Median Change from Baseline in Overall Work Impairment Score at Week 24p-value: =0.0607Wilcoxon signed-rank test
Secondary
Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past 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 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22.
Time frame: Baseline, Week 12, and Week 24
Population: Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With RA Receiving Adalimumab | Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score | Week 12 | 23 Participants |
| Participants With RA Receiving Adalimumab | Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score | Week 24 | 20 Participants |
Secondary
Percentage of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past 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 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22.
Time frame: Baseline, Week 12, and Week 24
Population: Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With RA Receiving Adalimumab | Percentage of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score | Week 12 | 50.0 percentage of participants |
| Participants With RA Receiving Adalimumab | Percentage of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score | Week 24 | 51.3 percentage of participants |