Clinical Application Of Combination Therapy With Etanercept Plus Methotrexate In Active Rheumatoid Arthritis

Objective: To observe the efficacy and safety of recombinant human tumor necrosis factor receptor-Fc fusion protein (etanercept) plus methotrexate for treatment of active rheumatoid arthritis and the affect to the levels of tumor necrosis factor-α(TNF-α) and interleukin -1β(IL-1β) in serum.Methods: 60 patients with active RA were randomly divided into control group and trial group. 30 patients in trial group were treated with twice-weekly subcutaneous etanercept (25mg) puls weekly oral methotrexate (10mg) ; the other 30 patients in control group were treated with daily oral leflunomide (20mg) or third-daily oral sulfasalazine (0.5g) puls weekly oral methotrexate (10mg) , the couse of treatment was 12 weeks. the clinical and laboratory index were Observed at weeks 4, 8, 12. Clinical assessments using the American College of Rheumatology (ACR) criteria and Disease activity score (DAS) 28; The levels of TNF-αand IL-1βin serum were determined by Enzyme-Linked Immunosorbent Assay (ELISA) .Results:①A total of 59 of 60 patients finished the study. At weeks 4, the ACR20, ACR50 responses of the trial group was significantly better than the control group (P<0.05) , one patient achieve ACR70 in trial group; At weeks 8, the ACR50 and ACR70 responses of the trial group were both significantly better than the control group, respectively (P<0.05 ) ; At weeks 12, the ACR50 responses was significantly better than the control group (P<0.05 ) .②At weeks 4, 8, 12, The DAS28 had a significant improvement of the both two groups. The mean DAS among patients in trial group was significantly better than the patients in the control group (P<0.05) ; at weeks 12, significantly more patients in trial group than in control group had achieved remission (DAS < 2.6) .③12 weeks later, The level of TNF-αin trial group was significantly decreased than control group (respectively, P<0.05) .④3 patients in trial group developed rash, one of the patients stopped the treatment after 4 weeks because of serious systemic urticaria and anhelation. the other two were Injection site reaction, with no special treatment. 1 patient in control group occurred a transient white blood cell decrease, 1 patient occurred a transient increase in transaminase and 2 patient occurred gastrointestinal tract reaction, the two groups did not develop significantly damage of the liver and kidney function.Conclusion: Compared with traditional DMARDs, etanercept puls MTX had significant efficacy in patients with active RA, It acted more rapidly and can decrease the levels of TNF-αin RA patients' serum, with a nice tolerance and safety.