EVALUATION OF THE EFFICACY AND SAFETY OF LEFLUNOMIDE VS METHOTREXATE IN KOREAN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS

초록

To compare the efficacy and safety of 16-week treatment of leflunomide (LEF) 20mg/day vs methotrexate (MTX) 7.5-15 mg/week in Korean patients with rheumatoid arthritis (RA). Methods: Study was conducted as a double blind, double dummy, parallel, randomized (1:1), comparative, multicenter trial. All patients fulfilled the 1987 ACR criteria for RA. Primary end point was the responder rate of ACR 20% improvement criteria (ACR20) and secondary end points include tender joint count (28 joints), assessment. Safety variables were evaluated. Results: A total of 149 patients were screened and 127 were randomized from 7 centers in Korea, during the period from Jan 2001 to Sep 2001. Among 127 patients, 10 patients were discontinued the study and 117 completed the study. Major protocol violation was detected in 23 of 65 patients treated with LEF and in 14 of 62 patients treated with MTX. Patient’s characteristics were not significantly different between the two groups. The ACR20 responder rate in the LEF group was 62.2% (28/54) compared to 47.2% (17/36) for MTX group (95% confidence interval: -6.6 ~ -36.6%). Among secondary end points, physician’s global assessment, and painontensity assessment were significantly improved in LEF group than in MTX group. Drug related adverse events were reported 15 of 65 subjects (23.1%) with LEF group and 3 of 62 increased ALT levels three times above normal ranges as serious adverse events, however, all patients were recovered without any sequelle. Conciusion: LEF had at least comparable or superior efficacy to MTX in the treatment of RA. Although some serious adverse effects were observed in patients with LEF, LEF could be considered as a new anti-rheumatic drug for treating RA