Efficiency and safety of etanercept in patients with rheumatoid arthritis:an open-label controlled trial

Objective: To determine the effect of recombinant human tumor necrosis factor receptor-Fc fusion protein(rhTNFR:Fc,etanercept)treatment in active rheumatoid arthritis(RA).Methods: Thirty patients with active RA were enrolled.15 patients were treated with methotrexate(10~15 mg,once a week)as monotherapy.Other 15 patients were treated with methotrexate(10~15 mg,once a week)and etanercept(25 mg,twice a week)as combined therapy.The percentage of patients achieving a 20 percent ACR criteria for improvement was recorded at 2-week and 12-week.The adverse events were monitored throughout the trial.Results: As compared with patients who received methotrexate,patients who received the 25-mg dose of etanercept had a more rapid rate of improvement,with significantly more patients having 20 percent improvement(ACR core set)in disease activity during the first 6 weeks(ACR20,MTX 21.4% vs etanercept plus MTX 42.8%,P0.001.ACR50,MTX 0% vs etanercept plus MTX 14.3%,P0.001) and 12 weeks(ACR20,MTX 50.0% vs etanercept plus MTX 71.4%,P=0.003.ACR50,MTX 0% vs etanercept plus MTX 42.9%,P0.001). The adverse events associated with etanercept were mild injection-site reactions.Conclusion: Compared with oral methotrexate,subcutaneous etanercept can safely provide rapid,significant,and sustained benefit in patients with active rheumatoid arthritis.