Prescrire Int. 2004 Oct;13(73):171-5.
(1) There is no agreed treatment for patients with rheumatoid arthritis in whom first-line options, including methotrexate, have failed. Recent slow-acting antirheumatic drugs have not been compared with one another, but they seem to have similar risk-benefit ratios. Etanercept, a TNF-alpha antagonist, is the most convenient to use. (2) Adalimumab is the third TNF-alpha antagonist to be marketed in France for use in rheumatoid arthritis, after etanercept and infliximab. (3) The clinical evaluation dossier mentions no data from comparative trials with other slow-acting antirheumatic drugs used in refractory rheumatoid arthritis. (4) Placebo-controlled trials show that adalimumab alone has very modest efficacy. The best results are obtained when adalimumab is combined with methotrexate. On the basis of the least demanding criterion (ACR 20%), about two-third of patients are improved by this combination. (5) Clinical trials show that it is pointless to continue treatment with adalimumab for more than three months if efficacy is inadequate. (6) Adalimumab, like other TNF-alpha antagonists, can have potentially serious adverse effects, linked mainly to its immunosuppressive action. Opportunistic infections and cases of tuberculosis have been reported, even during short treatment periods. Many questions remain regarding long-term treatment effects, such as the risk of lymphoma, autoimmune disorders, and onset or aggravation of demyelinising diseases. (7) Adalimumab is given once every two weeks, subcutaneously, while etanercept 25 mg is given as two subcutaneous injections per week, and infliximab is given as an intravenous infusion every 8 weeks. (8) In practice, for patients with rheumatoid arthritis who do not respond to methotrexate and to other classical slow-acting antirheumatic drugs, etanercept is the best choice among recent slow-acting antirheumatic drugs.
（1）对于类风湿关节炎患者，若包括甲氨蝶呤在内的一线治疗方案均告失败，则尚无公认的治疗方法。近期的慢作用抗风湿药物尚未相互比较，但它们的风险效益比似乎相似。肿瘤坏死因子-α拮抗剂依那西普使用起来最为便捷。（2）阿达木单抗是继依那西普和英夫利昔单抗之后，在法国上市用于治疗类风湿关节炎的第三种肿瘤坏死因子-α拮抗剂。（3）临床评估档案中未提及与用于难治性类风湿关节炎的其他慢作用抗风湿药物进行对比试验的数据。（4）安慰剂对照试验表明，单独使用阿达木单抗疗效甚微。阿达木单抗与甲氨蝶呤联合使用时效果最佳。根据最宽松的标准（美国风湿病学会20%改善标准），约三分之二的患者经此联合治疗后病情有所改善。（5）临床试验表明，如果疗效不佳，继续使用阿达木单抗治疗超过三个月毫无意义。（6）与其他肿瘤坏死因子-α拮抗剂一样，阿达木单抗可能会产生潜在的严重不良反应，主要与其免疫抑制作用有关。即使在短疗程治疗期间，也有机会性感染和结核病病例的报告。关于长期治疗效果仍有许多问题，例如淋巴瘤风险、自身免疫性疾病以及脱髓鞘疾病的发生或加重。（7）阿达木单抗每两周皮下注射一次，而依那西普25毫克每周皮下注射两次，英夫利昔单抗每8周静脉输注一次。（8）实际上，对于对甲氨蝶呤和其他传统慢作用抗风湿药物无反应的类风湿关节炎患者，在近期的慢作用抗风湿药物中，依那西普是最佳选择。
