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阿巴西普治疗类风湿关节炎:一项 Cochrane 系统评价。

Abatacept for rheumatoid arthritis: a Cochrane systematic review.

机构信息

Institute of Population Health, University of Ottawa, Ontario, Canada.

出版信息

J Rheumatol. 2010 Feb;37(2):234-45. doi: 10.3899/jrheum.091066. Epub 2010 Jan 15.

Abstract

OBJECTIVE

To perform a systematic review of efficacy and safety of abatacept in patients with rheumatoid arthritis (RA).

METHODS

We searched the Cochrane Library, MEDLINE, EMBASE, ACP Journal Club, and Biosis Previews for randomized controlled trials (RCT) comparing abatacept alone or in combination with disease modifying antirheumatic drugs (DMARD)/biologics to placebo or other DMARD/biologics in patients with RA. Two reviewers independently assessed search results, risk of bias, and extracted data.

RESULTS

Seven trials with 2908 patients were included. Compared with placebo, patients with RA treated with abatacept were 2.2 times more likely to achieve an American College of Rheumatology 50% response (ACR50) at one year (relative risk 2.21, 95% CI 1.73, 2.82) with a 21% (95% CI 16%, 27%) absolute risk difference between groups. The number needed to treat to achieve an ACR50 response was 5 (95% CI 4, 7). Significantly greater improvements in physical function, disease activity, pain, and radiographic progression were noted in abatacept-treated patients compared to placebo. Total adverse events (AE) were greater in the abatacept group (RR 1.05, 95% CI 1.01, 1.08). Other harm outcomes were not significant, with the exception of serious infections at 12 months, which were more common in the abatacept group versus control group (Peto odds ratio 1.91, 95% CI 1.07, 3.42). Serious AE were more numerous in the abatacept + etanercept group versus the placebo + etanercept group (RR 2.30, 95% CI 1.15, 4.62).

CONCLUSION

Abatacept seems to be efficacious and safe in the treatment of RA. Abatacept should not be used in combination with other biologics to treat RA. Further longterm studies and postmarketing surveillance are required to assess for longer-term harms and sustained efficacy.

摘要

目的

系统评价阿巴西普治疗类风湿关节炎(RA)患者的疗效和安全性。

方法

我们检索了 Cochrane 图书馆、MEDLINE、EMBASE、ACP 期刊俱乐部和 Biosis Previews,以寻找比较阿巴西普单药或联合改善病情抗风湿药(DMARD)/生物制剂与安慰剂或其他 DMARD/生物制剂治疗 RA 患者的随机对照试验(RCT)。两名审查员独立评估了检索结果、偏倚风险和提取数据。

结果

纳入了 7 项共 2908 名患者的试验。与安慰剂相比,阿巴西普治疗的 RA 患者在一年时达到美国风湿病学会 50%缓解(ACR50)的可能性高 2.2 倍(相对风险 2.21,95%CI 1.73,2.82),两组之间的绝对风险差异为 21%(95%CI 16%,27%)。实现 ACR50 缓解的治疗需要数为 5(95%CI 4,7)。与安慰剂相比,阿巴西普治疗的患者在身体功能、疾病活动度、疼痛和放射学进展方面有显著改善。阿巴西普组的总不良事件(AE)更多(RR 1.05,95%CI 1.01,1.08)。其他危害结局无显著差异,但 12 个月时严重感染更为常见,阿巴西普组与对照组相比(Peto 比值比 1.91,95%CI 1.07,3.42)。阿巴西普+依那西普组与安慰剂+依那西普组相比,严重 AE 更为常见(RR 2.30,95%CI 1.15,4.62)。

结论

阿巴西普治疗 RA 似乎有效且安全。阿巴西普不应与其他生物制剂联合用于治疗 RA。需要进一步的长期研究和上市后监测,以评估长期危害和持续疗效。

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