Prescrire Int. 2004 Apr;13(70):43-5.
(1) There is no consensus on the best treatment option for rheumatoid arthritis when a first-line agent fails (most often methotrexate). Among the recent immunosuppressants, etanercept should be used before infliximab. (2) Anakinra, an interleukin-1 type 1 receptor antagonist, was recently authorised in the European Union as a second-line treatment for rheumatoid arthritis in combination with methotrexate. (3) There are no published trials comparing anakinra with other slow-acting antirheumatic drugs (especially infliximab and etanercept). In one clinical trial in patients who did not respond adequately to methotrexate, the combination anakinra + methotrexate was more effective than methotrexate + placebo on ACR 20%, ACR 50% and ACR 70% criteria, but the clinical relevance of these results is doubtful. (4) An indirect comparison suggests that etanercept is more effective than anakinra + methotrexate. (5) In a placebo-controlled trial of anakinra, 75% of patients had reactions at the injection site. Serious infections, neutropenia and anti-anakinra antibodies were also reported. There is no evidence that anakinra is any safer than etanercept. (6) Anakinra + etanercept offers no gains in efficacy, just an increased risk of severe infections. (7) Subcutaneous injections of anakinra are required daily (twice-weekly subcutaneous injections for etanercept). (8) In short, there is no argument for using anakinra as a second-line treatment for rheumatoid arthritis; it does not improve disease management.
(1)当一线药物(最常见的是甲氨蝶呤)治疗类风湿关节炎失败时,对于最佳治疗方案尚无共识。在最近的免疫抑制剂中,应在英夫利昔单抗之前使用依那西普。(2)阿那白滞素,一种白细胞介素-1Ⅰ型受体拮抗剂,最近在欧盟被批准作为类风湿关节炎的二线治疗药物,与甲氨蝶呤联合使用。(3)尚无已发表的试验比较阿那白滞素与其他慢作用抗风湿药物(尤其是英夫利昔单抗和依那西普)。在一项对甲氨蝶呤反应不佳的患者的临床试验中,阿那白滞素+甲氨蝶呤联合用药在达到美国风湿病学会(ACR)20%、ACR50%和ACR70%标准方面比甲氨蝶呤+安慰剂更有效,但这些结果的临床相关性存疑。(4)一项间接比较表明,依那西普比阿那白滞素+甲氨蝶呤更有效。(5)在一项阿那白滞素的安慰剂对照试验中,75%的患者在注射部位出现反应。还报告了严重感染、中性粒细胞减少和抗阿那白滞素抗体。没有证据表明阿那白滞素比依那西普更安全。(6)阿那白滞素+依那西普在疗效上没有优势,只是严重感染的风险增加。(7)阿那白滞素需要每日皮下注射(依那西普为每周两次皮下注射)。(8)简而言之,没有理由将阿那白滞素用作类风湿关节炎的二线治疗药物;它并不能改善疾病管理。