The efficacy and safety of etanercept in patients with active rheumatoid arthritis receiving methotrexate / 대한내과학회지

ABSTRACT

BACKGROUND: This study was performed to investigate the efficacy and safety of etanercept in active rheumatoid arthritis patients with stable dose of methotrexate in Korean. METHODS: In a 12 week, single arm, open trial, we assigned 76 patients with active rheumatoid arthritis who had an inadequate response to disease-modifying antirheumatic drugs. Patients received twice-weekly subcutaneous injections of etanercept 25 mg while continuing to receive methotrexate at a stable dose of 7.5~25 mg per week. The clinical response was defined as the percent improvement in disease activity according to the criteria of the American College of Rheumatology (ACR) at 12 weeks. RESULTS: Etanercept led to significant improvements in disease activity and was safe and well tolerated. At 12 week, 84.4% of the patients receiving 25 mg of etanercept achieved a 20% ACR response, and 53.1% of those receiving etanercept achieved a 50% ACR response. The most common adverse event was injection-site reaction. Other adverse events were upper respiratory infection, nausea, and facial edema, but there were no serious adverse events associated with etanercept. CONCLUSION: In active rheumatoid arthritis patients, etanercept was safe, well tolerated, and provided rapid clinical improvements.