Abstract: Objective To explore the efficacy and safety of etanercept combined with methotrexate in treatment of patients with rheumatoid arthritis. Methods 54 outpatient patients with rheumatoid arthritis (RA) from September 2015 to January 2016 were recruited to the open observational study. The control group included 30 patients who received methotrexate (10 mg, po, qw), and the treatment group included 24 patients who received etanercept (25 mg, sc, qw) and methotrexate (10 mg, po, qw). We observed the tender and swollen joint counts, patient visual analogue score (VAS) on disease condition, physician VAS on disease condition, patient VAS on joint pain, patient health questionnaire (HAQ) and erythrocyte sedimentation rate (ESR) at 4, 8 and 12 weeks of follow-up.Therapeutic efficacy was evaluated by the American College of Rheumatism (ACR) efficacy evaluation criteria. Results At 4th week, tender and swollen joint counts and ESR had been significantly improved compared with baseline. All the observation indexes were significantly improved compared with baseline at 8th week, and were significantly improved compared with baseline and the control group at 12nd week. The remission rates of ACR20 at 8th week and ACR20, ACR50, ACR70 at 12nd week of the treatment group were higher than that of the control group in the same period, and the differences were statistically significant (P<0.05 or P<0.01). No serious adverse events were noted during the observation. There was no significant difference in incidence of adverse events between the treatment group and the control group (P>0.05). Conclusion Etanercept combined with methotrexate has better efficacy and higher remission rate than methotrexate used only in treatment of rheumatoid arthritis.

Key words: etanercept, methotrexate, rheumatoid arthritis, efficacy, safety