Guyot Patricia, Taylor Peter C, Christensen Robin, Pericleous Louisa, Drost Pieter, Eijgelshoven Indra, Bergman Gert, Lebmeier Maximilian
Mapi Consultancy, Houten, The Netherlands.
J Rheumatol. 2012 Jun;39(6):1198-206. doi: 10.3899/jrheum.111345. Epub 2012 Apr 15.
To compare the efficacy of abatacept and alternative biologic disease-modifying antirheumatic drugs (DMARD) in patients with rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX) in the United Kingdom.
A systematic literature search identified 11 individual studies investigating the efficacy of abatacept, infliximab, adalimumab, etanercept, certolizumab pegol, and golimumab in adult patients with RA that did not respond to MTX. The clinical trials included in this analysis were similar in trial design, baseline patient characteristics, and background therapy (i.e., MTX). The key clinical endpoints of interest were the Health Assessment Questionnaire (HAQ) change from baseline (CFB) and the American College of Rheumatology (ACR) responses at 6 months (24-28 weeks). Results were analyzed using Bayesian network metaanalysis methods, and were expressed as differences in HAQ CFB and ACR20/50/70 relative risks, with 95% credible limits (CrL).
Analysis of HAQ CFB at 6 months showed that abatacept is more efficacious than placebo [mean difference in HAQ CFB: -0.30 (95% CrL -0.42; -0.16)] and comparable to all other biologic agents, in patients receiving MTX as background treatment. Abatacept is also expected to result in a higher proportion of ACR responders compared to placebo, with relative risks ranging from 1.90 (95% CrL 1.24; 2.57) for ACR20 to 3.72 (95% CrL 1.50; 10.52) for ACR70, and to result in comparable proportions of ACR responders as other biologic agents, at 6 months.
Abatacept is expected to result in improvement in functional status comparable to other recommended biologic agents in patients with RA who are unresponsive to MTX in the UK.
在英国,比较阿巴西普与其他改善病情的抗风湿生物制剂(DMARD)对类风湿关节炎(RA)患者且对甲氨蝶呤(MTX)反应不佳者的疗效。
一项系统文献检索确定了11项针对未对MTX产生反应的成年RA患者研究阿巴西普、英夫利昔单抗、阿达木单抗、依那西普、赛妥珠单抗和戈利木单抗疗效的独立研究。本分析纳入的临床试验在试验设计、基线患者特征和背景治疗(即MTX)方面相似。感兴趣的关键临床终点是健康评估问卷(HAQ)自基线的变化(CFB)以及6个月(24 - 28周)时美国风湿病学会(ACR)的反应。使用贝叶斯网络荟萃分析方法分析结果,并表示为HAQ CFB差异和ACR20/50/70相对风险,以及95%可信区间(CrL)。
对6个月时HAQ CFB的分析表明,在接受MTX作为背景治疗的患者中,阿巴西普比安慰剂更有效[HAQ CFB的平均差异:-0.30(95% CrL -0.42;-0.16)],且与所有其他生物制剂相当。与安慰剂相比,阿巴西普预计也会使ACR反应者比例更高,ACR20的相对风险范围为1.90(95% CrL 1.24;2.57)至ACR(_{70})的3.72(95% CrL 1.