Clinical study of recombinant human tumor necrosis factor receptor II :IgG Fc protein for injection and methotrexate in the treatment of rheumatoid arthritis

Abstract

Objective To evaluate and compare the efficacy and adverse effects of recombinant human tumor necrosis factor receptor Ⅱ : IgG Fc protein for injection (etanercept) and methotrexate ( MTX )regimens for rheumatoid arthritis (RA). Methods Forty-six patients were randomly divided into two groups by stratified sampling method:etanercept group,22 patients were treated with 12.5 mg of etanercept,twice times per week by subcutaneous injection;and MTX group,24 patients were treated with 5-10 mg of MTX,once per week by oral administration. The course of treatment lasted 24 weeks in both groups, so as to observe their ACR20, ACR50, ACR70 and adverse effects of the drugs. Results After treated for 24 weeks,ACR50,ACR70 respectively achieved 54.5％ (12/22),31.8％ (7/22) in etanercept group,which were significantly higher than those in MTX group [16.7％(4/24),4.2％( 1/24)]. The total efficacy was 86.4％ (19/22) in etanercept group, 20.8％ (5/24) in MTX group, the difference between the two groups was significant (P ＜ 0.05 ). The incidence of adverse effects was not significant between the two groups [22.7％(5/22) vs. 50.0％ (12/24)](P ＞ 0.05). Conclusion Etanercept has a good efficacy and safety for the treatment of active RA. Key words: Methotrexate; Treatment outcome; Arthritis,rheumatoid; Recombinant human tnmor necrosis factor receptor Ⅱ : IgG Fc protein for injection