Thaler Kylie, Chandiramani Divya V, Hansen Richard A, Gartlehner Gerald
Department for Evidence-based Medicine and Clinical Epidemiology, Danube University Krems, Krems, Austria.
Biologics. 2009;3:485-98. doi: 10.2147/btt.2009.3755. Epub 2009 Dec 29.
To systematically review the general and comparative efficacy and safety of anakinra for rheumatoid arthritis.
We searched MEDLINE((R)), Embase, The Cochrane Library, and the International Pharmaceutical Abstracts from 1980 to April 2009. We manually searched reference lists of pertinent review articles and explored the Center for Drug Evaluation and Research database. For efficacy we included randomized controlled trials (RCTs) comparing anakinra with placebo or other biologics. For safety both experimental and observational studies were eligible. Two persons independently reviewed abstracts and full text articles and extracted relevant data.
We included data from 3 RCTs comparing anakinra with placebo for rheumatoid arthritis (RA). The pooled relative risk (RR) of an ACR50 (American College of Rheumatology) response for anakinra compared with placebo is 2.28 (95% CI 1.41 to 3.67). Adjusted indirect comparisons of ACR50 response rates of anakinra and anti-TNF agents showed a RR of 0.67 (95% CI 0.38 to 1.17) favoring the anti-TNF drugs. This result did not reach statistical significance. For safety, we included 9 experimental and observational studies of 24 weeks to 3 years duration. Up to 30% of patients withdrew from the studies due to adverse events. 67.2% (95% CI 38.7 to 95.7) of patients experienced an injection site reaction.
Anakinra is an effective drug for treating RA. Indirect comparisons with adalimumab, etanercept and infliximab, however, showed a trend towards greater efficacy for the anti-TNF drugs. Anakinra also seems to be associated with comparably high rates of injection site reactions. These results should be taken into account when considering biologic therapy for patients with RA.
系统评价阿那白滞素治疗类风湿关节炎的总体疗效、安全性及其与其他药物的比较。
检索1980年至2009年4月期间的MEDLINE((R))、Embase、Cochrane图书馆及国际药学文摘数据库。人工检索相关综述文章的参考文献列表，并查阅药品评价和研究中心数据库。疗效方面纳入比较阿那白滞素与安慰剂或其他生物制剂的随机对照试验（RCT）。安全性方面，实验性和观察性研究均符合要求。两名研究人员独立审阅摘要和全文并提取相关数据。
纳入3项比较阿那白滞素与安慰剂治疗类风湿关节炎（RA）的RCT数据。与安慰剂相比，阿那白滞素达到美国风湿病学会（ACR）50%改善标准（ACR50）反应的合并相对危险度（RR）为2.28（95%可信区间[CI] 1.41至3.67）。阿那白滞素与抗TNF药物ACR50反应率的校正间接比较显示RR为0.67（95%CI 0.38至1.17），抗TNF药物更具优势，但该结果未达到统计学显著性。安全性方面，纳入9项持续时间为24周-3年的实验性和观察性研究。高达30%的患者因不良事件退出研究。67.2%（95%CI为38.7至95.7）的患者出现注射部位反应。
阿那白滞素是治疗RA的有效药物。然而，与阿达木单抗、依那西普和英夫利昔单抗的间接比较显示，抗TNF药物疗效更佳。阿那白滞素似乎也与较高的注射部位反应发生率相关。在考虑对RA患者进行生物治疗时应考虑这些结果。
