Patient-reported outcomes improve with etanercept plus methotrexate in active
early rheumatoid arthritis and the improvement is strongly associated with
remission: the COMET trial.
Author(s): Kekow J, Moots RJ, Emery P, Durez P, Koenig A, Singh A, Pedersen R, Robertson D,
Freundlich B, Sato R.
Affiliation(s): Clinic of Rheumatology, Vogelsang-Gommern, and University of Magdeburg, Germany.
Publication date & source: 2010, Ann Rheum Dis. , 69(1):222-5
OBJECTIVES: To compare the 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, randomised 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 analysed by analysis of
covariance using the last observation carried forward method. 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. A significantly greater improvement in HAQ score was observed in the
ETN+MTX than the MTX group (-1.02 vs -0.72; p<0.001) and a greater proportion
reached the minimal clinically important difference of 0.22 (88% vs 78%;
p<0.006). 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 maximise the chance of restoring
normal functioning and HRQoL.
Ann Rheum Dis. 2011 Aug;70(8):1519.