Objectives: To compare effects of etanercept (ETN) 50-mg once-weekly plus methotrexate (MTX) versus MTX alone on patient-reported outcomes (PROs) and the relationship between remission and PRO improvement.
Methods: In this double-blind, randomized clinical trial (COMET), PROs included: the Health Assessment Questionnaire (HAQ), EuroQoL health status, fatigue and pain visual analogue scales, Hospital Anxiety and Depression Scale, and Medical Outcomes Short-Form-36. Mean changes from baseline were analyzed by analysis of covariance using last observation carried forward. Results from week-52 are presented.
Results: Most PROs demonstrated significantly greater improvements with ETN+MTX than MTX alone including physical functioning, pain, fatigue, and overall health status. Significantly greater improvement in HAQ score was observed in the ETN+MTX than the MTX group ( 1.02 vs -0.72; P<.001) and a greater proportion reached the minimal clinically important difference of 0.22 (88% vs 78%; P<.006). The relationship between PRO score and clinical status indicated that improvement was greatest among patients achieving remission.
Conclusions: Early treatment with ETN+MTX leads to significantly greater improvements in multiple dimensions of PROs than MTX alone. The close relationship between disease activity and PRO improvement suggests that early treatment, with remission as a goal, should maximize the chance of restoring normal functioning and HRQoL.