Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial
Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial
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DOI：
10.1016/s0140-6736(04)15640-7
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发表时间：
2004-02-28
期刊：
影响因子：
168.9
通讯作者：
Sanda, M
中科院分区：
文献类型：
--
作者：
Klareskog, L;van der Heijde, D;Sanda, M
背景依那西普和甲氨蝶呤在治疗类风湿性关节炎中是有效的，但没有数据表明联合用药或同时使用与单用任何一种药物相比。我们的目的是评估联合治疗依那西普和甲氨蝶呤与单一疗法在类风湿关节炎patients with rheumatoid arthritis.Methods在一项双盲，随机，临床疗效，安全性和放射学研究，686例活动性类风湿关节炎患者随机分配到治疗依那西普25毫克（皮下注射每周两次），口服甲氨蝶呤（每周高达20毫克），或组合。根据美国风湿病学会（ACR）的标准评估临床反应。主要疗效终点是前24周内ACR反应（ACR-N）曲线下面积（AUC）的数字指数。主要影像学终点是总关节损伤从基线至第52周的变化，并采用改良的Sharp评分进行评估。分析的意图treat.Findings四例患者没有收到任何药物，因此682进行了研究。与依那西普单药和甲氨蝶呤单药相比，联合用药组24周时的ACR-N AUC更大（18.3%-年[95%CI 17.1-19.6] vs 14.7%-年[13.5-16.0]，p
Background Etanercept and methotrexate are effective in the treatment of rheumatoid arthritis but no data exist on concurrent initiation or use of the combination compared with either drug alone. We aimed to assess combination treatment with etanercept and methotrexate versus the monotherapies in patients with rheumatoid arthritis.Methods In a double-blind, randomised, clinical efficacy, safety, and radiographic study, 686 patients with active rheumatoid arthritis were randomly allocated to treatment with etanercept 25 mg (subcutaneously twice a week), oral methotrexate (up to 20 mg every week), or the combination. Clinical response was assessed by criteria of the American College of Rheumatology (ACR). The primary efficacy endpoint was the numeric index of the ACR response (ACR-N) area under the curve (AUC) over the first 24 weeks. The primary radiographic endpoint was change from baseline to week 52 in total joint damage and was assessed with the modified Sharp score. Analysis was by intention to treat.Findings Four patients did not receive any drug; thus 682 were studied. ACR-N AUC at 24 weeks was greater for the combination group compared with etanercept alone and methotrexate alone (18.3% years [95% CI 17.1-19.6] vs 14.7%-years [13.5-16.0], p