Korean J Med.  2004 May;66(5):513-520.

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

• Choi BR
• Kang TY
• Joung CI
• Lee HS
• Uhm WS
• Kim TH
• Jun JB
• Yoo DH
• Bae SC

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.

Keyword

Etanercept; Rheumatoid arthritis; Methotrexate

MeSH Terms

Antirheumatic Agents
Arm
Arthritis, Rheumatoid*
Edema
Humans
Injections, Subcutaneous
Methotrexate*
Nausea
Rheumatology
Etanercept
Antirheumatic Agents
Methotrexate