Clinical Evaluation of the Use of Recombinant Human Interleukin-1 Receptor Antagonist Combines with Methotrexate for the Control the Inflammation of Rheumatoid Arthritis

Objective To evaluate the efficacy of using rhIL-1Ra for the treatment of active RA.Methods The study was based on the use of multi-center,randomized,double-blind,parallel-controlled clinical trial research.40 cases of active RA were obtained from Test Center of Nan-fang hospital.Based on the program 3:1 ratio,the patients were randomly divided into rhIL-1Ra group(treatment group) and the MTX group(control group).30 cases of treatment group were treated with rhIL-1Ra combined with MTX;10 cases of the control group were treated with MTX for 24 weeks.The main evaluation index was the comparison of the proportion of patients reached ACR20 after 12 weeks and 24 weeks to the baseline.The secondary evaluation was the comparison of the proportion of patients reached ACR50,ACR70 after 12 weeks and 24 weeks to the baseline.The index are duration of morning stiffness,joint swelling and joint tenderness count,VAS score,health assessment questionnaire(HAQ),the level of acute phase reactants(ESR,CRP),and the sharp score of dual wrist imaging at week 24.Results 30 cases of treatment group treated with rhIL-1Ra plus MTX,10 cases of the control group to MTX treatment,and follow-up observation,treatment of After the first 12 weeks of treatment the treatment group ACR20 reached 73%,ACR50 37%,and ACR70 13%,while the control group ACR20 reached 10%,ACR50 10%,and ACR70 0%(P = 0.000);after 24 weeks the treatment group ACR20 reached 87%,ACR50 50%,ACR70 37%,while for the control group ACR20 reached 50%,ACR50 10% and ACR70 0%(P = 0.000).The other indicators also reflects the effect of similar extent and trend of improvement(P = 0.000).The sharp score of dual wrist joint for(1) the treatment group:the average joint erosion score at week 0 was 2.33 and at week 24 was 2.23(P = 0.795);the average joint narrow score at week 0 was 1.70 and at 24 weeks was 1.43(P = 0.343),(2) the control group:the average joint erosion score at week 0 was 2.60 and at 24 weeks was 3.60(P = 0.024);the average joints narrow score at week 0 was 1.70 and at 24 weeks was 2.50(P = 0.019).Conclusion The efficacy of rhIL-1Ra combined with MTX was better than MTX alone.The treatment can significantly control the course of RA and prevent the progress of RA.