The aim: This study was undertaken to determme whether the addition of etanwcert a soluble tumor necrosis factor receptor to methotrexate therapy would provide additional benefit. Patients and Methods: In a 12 week trial, the authors randomized assigned 36 patients with active rheumatoid arthtistis to receive etanercept (25mg) subcutaneously twice weekly while continuing to receive methotrexate and 36 patients receive methotrexat alone. Results: The addition of etanercept to methotrexate therapy resulted in rapid and sustained improvement. At 12 weeks, 64.4 percent of the patients receiving etanercept plus methotrexate and 41.6 percent of those receiving methotrexate met the ACR 20 criteria (P0.001)
25.2 percent of the patients receiving etanercept plus methotrexate and 5.6 percent of those receiving methotrexate met the ACR 50 criteria (P0.001). Patients receiving etanercept plus methotrexate had significantly better outcomes according to all measures of disease activity. The only adverse events associated with etanercept were mild injection-site reactions, and no patient withdrew from the study because of adverse events associated with etanercept. Conclusions: In patients with persistently active rheumatoid arthritis, the combination of etanercept and methotrexate was safe and well tolerated and provided significantly greater clinical benefit than methotrexate alone.