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

March 25, 2009

Ann Rheum Dis. 2009 Mar 16.

Patient-reported outcomes improve with etanercept plus methotrexate in

active early rheumatoid arthritis and the improvement is strongly

associated with remission: The COMET trial.

Kekow J, Moots RJ, Emery P, Durez P, Koenig A, Singh A, Pedersen R,

on D, Freundlich B, Sato R.

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

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.

PMID: 19293160

Not an MD

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