Objective: To evaluate the responsiveness of patient reported outcomes (PROs) including fatigue, sleep, activity limitation, and quality of life in rheumatoid arthritis (RA) patients.
Methods: Data were considered from a randomized controlled trial comparing abatacept (n=258) to placebo (n=133) on a background of DMARD therapy in RA patients who were anti-TNF therapy inadequate responders (ATTAIN study). PROs assessed included SF-36, activity limitation, fatigue and sleep. For each outcome the treatment difference, relative percent improvement, standardized resonse mean (SRM) and relative efficiency (RE) for assessing an outcome's ability to detect a treatment effect relative to tender joint count (TJC) were calculated. A RE >1 suggests a measure is more efficient than TJC in detecting treatment effect.
Results: Moderate to large SRMs (≥ 0.6) were observed for the PRO measures. In particular, SRMs (95% CI) were: physician global 0.72 (0.51, 0.94); HAQ 0.63 (0.42, 0.85); SF36 physical component score 0.62 (0.40, 0.83); SF36 bodily pain 0.68 (0.46, 0.90); and fatigue 0.59 (0.38, 0.81). REs for physician global (1.6), SF36 bodily pain domain (1.4), pain intensity (1.4), HAQ (1.2), SF36 physical component score (1.2), fatigue (1.1) and patient global assessment (1.04) were all more responsive than TJC. The SF36 mental component score (0.3), swollen joint count (0.6), activity limitation (0.8), sleep (0.7) and CRP (0.9) were less responsive.
Conclusions: Using PROs for evaluating therapies for RA patients can detect improvements and will identify changes that are important to patients. In general, physical assessments are more responsive to an effective treatment than mental assessments.
- Patient Reported Outcomes
- Quality of Life
- Rheumatoid Arthritis