英夫利昔单抗生物类似药与其他生物药物治疗类风湿关节炎的疗效和安全性：一项混合治疗比较。
Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison.
机构信息
Department of Health Economics, Corvinus University of Budapest, Fővám tér 8., Budapest, 1093, Hungary,
出版信息
Eur J Health Econ. 2014 May;15 Suppl 1(Suppl 1):S53-64. doi: 10.1007/s10198-014-0594-4. Epub 2014 May 16.
OBJECTIVE
The aim of this meta-analysis was to compare the efficacy and safety of infliximab-biosimilar and other available biologicals for the treatment of rheumatoid arthritis (RA), namely abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab and tocilizumab.
METHODS
A systematic literature review of MEDLINE database until August 2013 was carried out to identify relevant randomized controlled trials (RCTs). Bayesian mixed treatment comparison method was applied for the pairwise comparison of treatments. Improvement rates by the American College of Rheumatology criteria (ACR20 and ACR50) at week 24 were used as efficacy endpoints, and the occurrence of serious adverse events was considered to assess the safety of the biologicals.
RESULTS
Thirty-six RCTs were included in the meta-analysis. All the biological agents proved to be superior to placebo. For ACR20 response, certolizumab pegol showed the highest odds ratio (OR) compared to placebo, OR 7.69 [95% CI 3.69-14.26], followed by abatacept OR 3.7 [95% CI 2.17-6.06], tocilizumab OR 3.69 [95% CI 1.87-6.62] and infliximab-biosimilar OR 3.47 [95% CI 0.85-9.7]. For ACR50 response, certolizumab pegol showed the highest OR compared to placebo OR 8.46 [3.74-16.82], followed by tocilizumab OR 5.57 [95% CI 2.77-10.09], and infliximab-biosimilar OR 4.06 [95% CI 1.01-11.54]. Regarding the occurrence of serious adverse events, the results show no statistically significant difference between infliximab-biosimilar and placebo, OR 1.87 [95% CI 0.74-3.84]. No significant difference regarding efficacy and safety was found between infliximab-biosimilar and the other biological treatments.
CONCLUSION
This is the first indirect meta-analysis in RA that compares the efficacy and safety of biosimilar-infliximab to the other biologicals indicated in RA. We found no significant difference between infliximab-biosimilar and other biological agents in terms of clinical efficacy and safety.
目的
本荟萃分析旨在比较英夫利昔单抗生物类似药与其他已上市的生物制剂（如阿巴西普、阿达木单抗、依那西普、戈利木单抗、英夫利昔单抗、利妥昔单抗和托珠单抗）治疗类风湿关节炎（RA）的疗效和安全性。
方法
对截至 2013 年 8 月 MEDLINE 数据库进行了系统文献检索，以确定相关的随机对照试验（RCT）。采用贝叶斯混合治疗比较法进行两两治疗比较。24 周时美国风湿病学会（ACR）标准（ACR20 和 ACR50）的改善率作为疗效终点，严重不良事件的发生情况作为评估生物制剂安全性的指标。
结果
36 项 RCT 纳入荟萃分析。所有生物制剂均优于安慰剂。在 ACR20 反应方面，与安慰剂相比，培塞利珠单抗的优势比（OR）最高，OR 为 7.69[95%CI3.69-14.26]，其次是阿巴西普 OR 为 3.7[95%CI2.17-6.06]、托珠单抗 OR 为 3.69[95%CI1.87-6.62]和英夫利昔单抗生物类似药 OR 为 3.47[95%CI0.85-9.7]。在 ACR50 反应方面，培塞利珠单抗与安慰剂相比 OR 最高，OR 为 8.46[3.74-16.82]，其次是托珠单抗 OR 为 5.57[95%CI2.77-10.09]和英夫利昔单抗生物类似药 OR 为 4.06[95%CI1.01-11.54]。关于严重不良事件的发生，英夫利昔单抗生物类似药与安慰剂相比结果显示无统计学差异，OR 为 1.87[95%CI0.74-3.84]。英夫利昔单抗生物类似药与其他生物制剂在疗效和安全性方面无显著差异。
结论
这是 RA 中首个比较英夫利昔单抗生物类似药与其他生物制剂疗效和安全性的间接荟萃分析。我们发现英夫利昔单抗生物类似药与其他生物制剂在临床疗效和安全性方面无显著差异。
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