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Patient-reported outcomes improve with etanercept plus methotrexate in active early rheumatoid arthritis and the improvement is strongly associated with remission: The COMET trial
  1. J Kekow
  1. Clinic of Rheumatology, Vogelsang-Gommern and University of Magdeburg, Germany
    1. R J Moots
    1. University of Leeds, United Kingdom
      1. P Emery
      1. University of Leeds, United Kingdom
        1. P Durez
        1. Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Belgium
          1. A Koenig
          1. Wyeth Research, Collegeville, United States
            1. A Singh
            1. Wyeth Research, Collegeville, United States
              1. R Pedersen
              1. Wyeth Research, Collegeville, United States
                1. D Robertson
                1. Wyeth Research, Collegeville, United States
                  1. B Freundlich
                  1. Wyeth Research, Collegeville, United States
                    1. R Sato (sator2{at}wyeth.com)
                    1. 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.

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