Objective:To examine the impact of added abatacept treatment on health related quality of life (HRQoL) in rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX).
Methods:The impact of abatacept therapy on HRQoL was examined in a longitudinal, randomized double-blind, placebo-controlled clinical trial. Effects of treatment on HRQoL were examined using repeated measures ANCOVA and comparing rates of change in HRQoL across treatment groups. We also examined the relationship of ACR clinical markers and disease duration with changes in HRQoL indicators. Finally, a responder analysis was used to examine the percentage of patients who improved by 0.5SD in 12 months or who reached normative levels observed in the US general population.
Results:Statistically significant improvements in the abatacept group relative to controls were observed across a range of HRQoL measures, including physical function, fatigue, all 8 domains of the SF-36 and the physical and mental component summaries (PCS and MCS). Improvements were observed as early as Day 29 for fatigue and 5 out of 8 SF-36 domains. By Day 169, all HRQoL measures were significantly better than placebo. HRQoL gains were associated with greater ACR clinical improvement, and the effects were consistent for patients with different disease duration. A significantly greater percentage of patients treated with abatacept reached normative levels of PCS, MCS, physical functioning, and fatigue compared to patients treated with MTX alone.
Conclusion:Combined abatacept and MTX therapy produces significant improvements across a wide range of HRQOL domains in RA patients.
- patient-reported outcomes
- quality of life
- rheumatoid arthritis