生物抗风湿药物治疗常规改善病情抗风湿药或抗肿瘤坏死因子药物治疗反应不佳的类风湿关节炎患者的疗效的间接比较：一项荟萃分析。
Indirect comparisons of the efficacy of biological antirheumatic agents in rheumatoid arthritis in patients with an inadequate response to conventional disease-modifying antirheumatic drugs or to an anti-tumour necrosis factor agent: a meta-analysis.
机构信息
Division of Rheumatology, Mount Sinai Hospital, University of Toronto, Toronto, Canada.
出版信息
Ann Rheum Dis. 2011 Feb;70(2):266-71. doi: 10.1136/ard.2010.132134. Epub 2010 Nov 19.
BACKGROUND
The availability of increasing numbers of biological agents for the treatment of rheumatoid arthritis (RA) offers several therapeutic options. While all biologicals have proven effective in trials, very limited direct comparisons are available. The objective of the present work was to compare the efficacy of biologicals (anti-tumour necrosis factor (TNF) agents, rituximab, abatacept, tocilizumab) in patients with RA with active disease and (i) an inadequate response (IR) to methotrexate (IR-MTX), (ii) an IR to anti-TNF agents (IR-anti-TNFs) using indirect comparisons.
METHODS
Randomised clinical trials were identified examining the efficacy of a biological agent in RA at 6 months in patients with an IR-MTX or with an IR-anti-TNF. To compare the relative efficacy of biologicals, adjusted indirect comparison meta-analytic methods to estimate the ORs of achieving a 50% improvement according to American College of Rheumatology criteria (ACR50) response at 6 months were used.
RESULTS
A total of 18 published trials and 1 abstract were included in the analyses. In IR-MTX, anti-TNFs had the same probability of reaching an ACR50 compared to 'non-anti-TNF biologicals' taken together (OR 1.30, 95 % CI 0.91 to 1.86). However, when compared to specific biological agents, anti-TNFs demonstrated a higher probability of reaching an ACR50 than abatacept (OR 1.52, 95 % CI 1.0 to 2.28), but not in comparison to rituximab and tocilizumab. In IR-anti-TNF, no significant differences existed between rituximab, tocilizumab, abatacept and golimumab. [corrected]
CONCLUSIONS
In a meta-analysis of randomised clinical trials of patients with IR-MTX, anti-TNFs demonstrated a higher probability of achieving an ACR50 response than abatacept. In IR-anti-TNF, no difference was found between rituximab, tocimizumab, abatacept and golimumab.
背景
越来越多的生物制剂可用于治疗类风湿关节炎（RA），这为治疗提供了多种选择。虽然所有生物制剂在临床试验中均已证实有效，但可供直接比较的非常有限。本研究旨在比较生物制剂（抗肿瘤坏死因子（TNF）制剂、利妥昔单抗、阿巴西普、托珠单抗）在患有活动性疾病且（i）对甲氨蝶呤（MTX）反应不足（IR-MTX）、（ii）对 TNF 拮抗剂反应不足（IR-anti-TNFs）的 RA 患者中的疗效，采用间接比较的方法。
方法
确定了评估生物制剂在 RA 患者中 6 个月疗效的随机临床试验，这些患者对 MTX 反应不足（IR-MTX）或对 TNF 拮抗剂反应不足（IR-anti-TNFs）。为了比较生物制剂的相对疗效，采用调整后的间接比较meta 分析方法，估计达到美国风湿病学会（ACR）50%缓解率的优势比（OR），6 个月时根据 ACR50 标准评估。
结果
共纳入 18 项已发表的试验和 1 项摘要。在 IR-MTX 中，与“非抗 TNF 生物制剂”联合相比，TNF 拮抗剂达到 ACR50 的概率相同（OR 1.30，95%CI 0.91 至 1.86）。然而，与特定的生物制剂相比，TNF 拮抗剂达到 ACR50 的概率高于阿巴西普（OR 1.52，95%CI 1.0 至 2.28），但与利妥昔单抗和托珠单抗相比并非如此。在 IR-anti-TNF 中，利妥昔单抗、托珠单抗、阿巴西普和戈利木单抗之间无显著差异。
结论
在对 IR-MTX 患者的随机临床试验进行的 meta 分析中，TNF 拮抗剂达到 ACR50 缓解率的概率高于阿巴西普。在 IR-anti-TNF 中，利妥昔单抗、托珠单抗、阿巴西普和戈利木单抗之间无差异。
Zotero 插件