March 26, 2009 — Adding etanercept to methotrexate may improve patient-reported outcomes (PROs) and remission in active early rheumatoid arthritis (RA), according to the results of a double-blind, randomized clinical trial reported in the March 16 Online First issue of the Annals of the Rheumatic Diseases.
"The COMET (Combination of methotrexate [MTX] and etanercept [ETN] in active early rheumatoid arthritis) trial, which enrolled moderate-to-severe RA patients with disease duration from three months to two years inclusive, found that early intervention with ETN+MTX combination therapy prevented further joint damage with half the patients reaching clinical remission at the end of the study's first year," write J. Kekow, from University of Magdeburg, in Magdeburg, Germany, and colleagues from The COMET trial. "Objectives of the present study were to examine the effects of combination therapy with ETN+MTX versus MTX alone on HRQoL [health-related quality of life], using PROs in COMET trial patients and to assess the relationship between remission and PRO improvement."
In COMET, patients were randomly assigned to receive etanercept, 50 mg once weekly plus methotrexate, or methotrexate alone. PROs included the Health Assessment Questionnaire (HAQ), EuroQoL health status, fatigue and pain visual analog scales, Hospital Anxiety and Depression Scale, and Medical Outcomes Short Form-36 (SF-36). This study includes results from week 52, with mean changes from baseline analyzed by analysis of covariance with use of last observation carried forward.
Compared with methotrexate alone, the etanercept plus methotrexate group had significantly greater improvements in most PROs, including physical functioning, pain, fatigue, and overall health status. Improvement in HAQ score was significantly greater in the etanercept plus methotrexate group vs the methotrexate-alone group (–1.02 vs –0.72; P < .001), as was the proportion reaching the minimal clinically important difference of 0.22 (88% vs 78%; P < .006). The association between PRO score and clinical status showed that patients achieving remission had the greatest improvement.
Limitations of this study include use of the last observation carried forward method for missing PRO data, which could introduce bias if scores change with time; and use of the single-item fatigue visual analog scale, lacking the ability to measure multiple aspects of fatigue.
"Early treatment with ETN+MTX leads to significantly greater improvements in multiple dimensions of PROs than MTX alone," the study authors write. "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."
Wyeth Research, USA supported this study and employs 5 of the study authors. The journal article was prepared with the assistance of BioMedCom Consultants Inc, Montreal, Canada.
Ann Rheum Dis. Published online March 16, 2009.
Lynn- I was wondering. Have you come across any articles relating to how often side effects really happen when people use these biologics?