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 / 中华风湿病学杂志
Chinese Journal of Rheumatology
; (12): 671-676, 2011.
Article
in Zh
| WPRIM
| ID: wpr-422663
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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.
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Index:
WPRIM
Type of study:
Clinical_trials
Language:
Zh
Journal:
Chinese Journal of Rheumatology
Year:
2011
Type:
Article