Evaluation of the clinical and radiological.efficacy of recombinant human TNFR Ⅱ -Fc combined with methotrexate in the treatment of moderate and severe rheumatoid arthritis
10.3760/cma.j.issn.1007-7480.2011.10.004
- VernacularTitle:重组人肿瘤坏死因子受体Ⅱ一Fc融合蛋白联合甲氨蝶呤治疗中重度活动性类风湿关节炎的临床和放射学疗效评估
- Author:
Xiaoxiang CHEN
;
Qing DAI
;
Huaxiang WU
;
Dongbao ZHAO
;
Xingfu LI
;
Shaoxian HU
;
Nanping YANG
;
Yi TAO
;
Jianhua XU
;
Anbin HUANG
;
Lindi JIANG
;
Chunde BAO
- Publication Type:Journal Article
- Keywords:
Arthritis,rheumatoid;
Methotrexate;
TNFRⅡ-Fc
- From:
Chinese Journal of Rheumatology
2011;15(10):671-676
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the clinical and radiological efficacy of TNFR Ⅱ -Fc combined with methotrexate( MTX ) in treatment of patients with moderate and severe rheumatoid arthritis.MethodsThree hundred and ninty-six RA patients were randomized into the combined treatment group,the TNFR Ⅱ -Fc only group and MTX only group.All patients were treated for 24 weeks.ACR-N,ACR20,ACR50,ACR70,DAS28-ESR and Sharp score of both hands were measured for efficacy,and the side-effects were analyzed by one-way ANOVA.Results After 24-week therapy,the ACR-N of the combined treatment group [( 12.79±9.24)％-year] was significantly improved than that of the TNFR Ⅱ-Fc only group [(9.56±11.16)％-year,P＜0.05] and that of the MTX only group[(5.08±11.10)％-year,P＜0.05],and the TNFR Ⅱ-Fc group was significantly improved than that of the MTX group(P＜0.05).The ACR20 response rate of the combined group(80.4％) was significantly higher than that of the TNFR Ⅱ -Fc group(71.1％,P＜0.05) and the MTX group(56.7％,P＜0.01 ).The ACRS0 response rate of the combined group(53.6％) was significantly higher than that of the MTX group(30.8％,P＜0.01 ).The ACR70 response rate of the combined group was 27.7％,which was significantly different from that of the TNFR Ⅱ -Fc group (15.8％) and MTX group (7.7％,P＜0.05or P＜0.01 ).DAS28-ESR in the combination group was significantly reduced than those of the TNFR Ⅱ -Fc group and MTX group,and the DAS28-ESR of the TNFR Ⅱ -Fc group was significantly reduced than MTX group.The average total Sharp score of both hands,which demonstrated the radiographic changes,was significantly reduced in the combination group than the MTX group(P=0.03).The total adverse events in the combined group(40.9％) was significantly high than that of the MTX group(28.8％,P＜0.05).Conclusion TNFR Ⅱ -Fc combined with MTX can effectively control the activity of RA and radiological progress.
