Objective: To compare the effect of adalimumab plus methotrexate (MTX) versus MTX monotherapy on health-related quality of life (HRQOL) and work activities in patients with early rheumatoid arthritis (RA).
Methods: Patients in this PREMIER study subanalysis (n = 525) were randomized to adalimumab 40 mg every other week plus MTX or MTX monotherapy. Medical Outcome Study Short-Form 36 Health Survey (SF-36) scores of RA patients were compared with US population norms at Weeks 12, 52, and 104.
Results: Physical Component Summary (PCS) scores at Week 12 for both groups improved from baseline and were significantly lower than US population scores (43.5 combination, 39.4 MTX, 49.4 US norm; p< 0.001). At Week 52, PCS score for adalimumab plus MTX was similar to that of the US population (47.5 vs 48.3; p = 0.25), while the PCS score for MTX was not similar to that of the US population (44.2 vs 48.3; p < 0.001). Criterion- and content-based interpretations for between-treatment differences in PCS scores suggest that those receiving combination therapy had fewer employment difficulties than those receiving MTX.
Conclusion: After 2 years, HRQOL for patients with early RA treated with adalimumab plus MTX improved to US norms. Combination therapy had reduced the influence of RA on work activity.