The phase Ⅱ clinical trial of leflunomide in treatment of rheumatoid arthritis
Shuai Zongwen, Liu Shuang, Sun Guihua et al (Dept of Rheumatology & Immunology, The First Affiliated Hospital of Anhui Medical University, Hefei 230022)
Objective To investigate the efficacy and safety of leflunomide(LFM) in comparison with methotrexate( MTX) in treating rheumatoid arthritis(RA). Methods By the randomised, double-blind, double-simulated and MTX-controlled method,80 patients with active RA were equally divided to receive LFM 20 mg daily or MTX 15 mg weekly for 24 weeks and their effects and adverse events(AEs) were observed. Results The total effective rate for LFM and MTX were 77.5% and 72.5% respectively after 12 week therapy, and 86.5% and 83.3% respectively 24 weeks later. There were no significant differences between them. The incidence of AEs for LFM and MTX were 13.5% and 25.1% respectively, also no significant difference was found, but the AEs related to LFM showed to be more moderate. Conclusion LFM is an effective agent in treatment of RA, and is well tolerated.