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 Kekow1,
- R J Moots2,
- P Emery3,
- P Durez4,
- A Koenig5,
- A Singh5,
- R Pedersen5,
- D Robertson5,
- B Freundlich5,
- R Sato5
- 1Clinic of Rheumatology, Vogelsang-Gommern, and University of Magdeburg, Germany
- 2Inflammation Research Unit, School of Clinical Sciences, University of Liverpool, Liverpool, UK
- 3University of Leeds, Leeds, UK
- 4Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium
- 5Wyeth Research, Collegeville, Pennsylvania, USA
- Correspondence to Reiko Sato, Ph.D., Global Health Outcomes Assessment, Wyeth, 500 Arcola Road, E-Dock, Collegeville, PA 19426, USA; sator2{at}wyeth.com
- Accepted 1 March 2009
- Published Online First 16 March 2009
Abstract
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.
Footnotes
-
Funding This study was funded by Wyeth Research, USA. This article was prepared with the assistance of BioMedCom Consultants inc, Montreal, Canada.
-
Competing interests JK was an investigator for this trial. RM and PE has served as a consultant, received research grants from Wyeth, and were investigators for this trial. PD was an investigator for this trial and has received speaker's fee from Wyeth. DR, RP, AS, AK, BF and RS are employees of Wyeth.
-
Provenance and Peer review Not commissioned; externally peer reviewed.
