Mertens Marty, Singh Jasvinder A
Minneapolis VA Medical Center, Rheumatology (111R), One Veteran's Drive, Minneapolis, MN 55417, USA.
J Rheumatol. 2009 Jun;36(6):1118-25. doi: 10.3899/jrheum.090074. Epub 2009 May 15.
To perform a systematic review of clinical effectiveness and safety of anakinra in rheumatoid arthritis (RA).
We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, and the reference lists of included articles for randomized controlled trials comparing anakinra to placebo in adults with RA.
Five trials involving 2846 patients, 781 randomized to placebo and 2065 to anakinra, were included. There was a significant improvement in the number of participants achieving American College of Rheumatology (ACR)20 (38% vs 23%) treated with anakinra 50-150 mg daily versus placebo after 24 weeks. ACR50 (18% vs 7%), ACR70 (7% vs 2%), Health Assessment Questionnaire, visual analog scale for pain, Larsen radiographic scores, and erythrocyte sedimentation rate all demonstrated significant improvement with anakinra versus placebo as well. There were no statistically significant differences noted in the number of withdrawals, deaths, adverse events (total and serious), and infections (total and serious). An increase in incidence of serious infections in anakinra versus the placebo group (1.8% vs 0.6%) was noted that may be clinically significant. Injection site reactions were significantly increased, occurring in 71% of anakinra versus 28% of placebo group.
Anakinra is a relatively safe and modestly efficacious biologic therapy for RA. More studies are needed to evaluate safety and efficacy, especially in comparison to other therapies, and adverse event data for the longterm use of anakinra have yet to be assessed.
对阿那白滞素治疗类风湿关节炎(RA)的临床疗效和安全性进行系统评价。
我们检索了Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、EMBASE、CINAHL以及纳入文章的参考文献列表,以查找比较阿那白滞素与安慰剂治疗成年RA患者的随机对照试验。
纳入了5项试验,共2846例患者,其中781例随机分配至安慰剂组,2065例分配至阿那白滞素组。治疗24周后,每日使用50 - 150 mg阿那白滞素治疗的患者达到美国风湿病学会(ACR)20改善标准的人数显著多于安慰剂组(38% 对23%)。ACR50(18% 对7%)、ACR70(7% 对2%)、健康评估问卷、疼痛视觉模拟量表、Larsen放射学评分以及红细胞沉降率在阿那白滞素组与安慰剂组相比也均有显著改善。在撤药、死亡、不良事件(总体及严重)和感染(总体及严重)的数量上未观察到统计学显著差异。注意到阿那白滞素组严重感染的发生率高于安慰剂组(1.8% 对0.6%),这可能具有临床意义。注射部位反应显著增加,阿那白滞素组发生率为71%,而安慰剂组为28%。
阿那白滞素是一种治疗RA相对安全且疗效一般的生物疗法。需要更多研究来评估其安全性和疗效,尤其是与其他疗法相比,并且阿那白滞素长期使用的不良事件数据尚未得到评估。