RESEARCH - Patient-reported outcomes improve with Enbrel plus MTX in active early RA: COMET

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Ann Rheum Dis. Published Online First: 16 March 2009.

doi:10.1136/ard.2008.102509

Concise Report

Patient-reported outcomes improve with etanercept plus methotrexate in

active early rheumatoid arthritis and the improvement is strongly

associated with remission: The COMET trial

J Kekow 1, R J Moots 2, P Emery 2, P Durez 3, A Koenig 4, A Singh 4, R

Pedersen 4, D on 4, B Freundlich 4 and R Sato 4*

1 Clinic of Rheumatology, Vogelsang-Gommern and University of Magdeburg, Germany

2 University of Leeds, United Kingdom

3 Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Belgium

4 Wyeth Research, Collegeville, United States

Abstract

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.

http://ard.bmj.com/cgi/content/abstract/ard.2008.102509v1

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