Mapi Values the Netherlands, De Molen 84, 3995 AX Houten, The Netherlands.
Arthritis Res Ther. 2011;13(6):R204. doi: 10.1186/ar3537. Epub 2011 Dec 12.
The goal of this study was to compare the efficacy in terms of Health Assessment Questionnaire change from baseline (HAQ CFB), 50% improvement in American College of Rheumatology criterion (ACR-50) and Disease Activity Score in 28 joints (DAS28) defined remission (< 2.6) between abatacept and other biologic disease modifying anti-rheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA) who have inadequate response to methotrexate (MTX-IR).
A systematic literature review identified controlled trials investigating the efficacy of abatacept (three studies), etanercept (two studies), infliximab (two), adalimumab (two), certolizumab pegol (two) ritixumab (three), and tocilizumab (two) in MTX-IR patients with RA. The clinical trials included in this analysis were similar with respect to trial design, baseline patient characteristics and background therapy (MTX). The key clinical endpoints of interest were HAQ CFB, ACR-50 and DAS28 < 2.6 measured at 24 and 52 weeks. The results were analysed using network meta-analysis methods that enabled calculation of an estimate for expected relative effect of comparative treatments. Analysis results were expressed as the difference in HAQ CFB score and odds ratio (OR) of achieving an ACR-50 and DAS28 response and associated 95% credible intervals (CrI).
The analysis of HAQ CFB at 24 weeks and 52 weeks showed that abatacept in combination with MTX is expected to be more efficacious than MTX monotherapy and is expected to show a comparable efficacy relative to other biologic DMARDs in combination with MTX. Further, abatacept showed comparable ACR-50 and DAS28 < 2.6 response rates with other biologic DMARDs at 24 and 52 weeks, except for ACR-50 compared to certolizumab pegol at 52 weeks and for DAS28 < 2.6 compared to tocilizumab at 24 weeks. Sensitivity analyses confirmed the robustness of the findings.
Abatacept in combination with MTX is expected to result in a comparable change from baseline in HAQ score and comparable ACR-50 and DAS28 < 2.6 response rates in MTX-IR patients compared to other approved biologic agents.
本研究旨在比较阿巴西普与其他生物改善病情抗风湿药(DMARD)在甲氨蝶呤(MTX)治疗反应不足的类风湿关节炎(RA)患者中的疗效差异,评估其在健康评估问卷(HAQ)从基线的变化(HAQ CFB)、美国风湿病学会(ACR)50%改善标准(ACR-50)和 28 个关节疾病活动度评分(DAS28)缓解标准(<2.6)方面的疗效。
系统文献检索确定了评估阿巴西普(三项研究)、依那西普(两项研究)、英夫利昔单抗(两项研究)、阿达木单抗(两项研究)、培塞利珠单抗(两项研究)、利妥昔单抗(三项研究)和托珠单抗(两项研究)治疗 MTX 治疗反应不足的 RA 患者疗效的对照试验。本分析中纳入的临床试验在试验设计、基线患者特征和背景治疗(MTX)方面具有相似性。主要临床终点为 24 周和 52 周时 HAQ CFB、ACR-50 和 DAS28 <2.6。使用网络荟萃分析方法计算比较治疗的预期相对疗效估计值。分析结果表示为 HAQ CFB 评分差异和达到 ACR-50 和 DAS28 缓解的比值比(OR)以及相关的 95%可信区间(CrI)。
24 周和 52 周 HAQ CFB 分析表明,阿巴西普联合 MTX 治疗预计比 MTX 单药治疗更有效,且与 MTX 联合其他生物 DMARD 治疗的疗效相当。此外,阿巴西普与其他生物 DMARD 联合治疗在 24 周和 52 周时的 ACR-50 和 DAS28 <2.6 缓解率相似,但在 52 周时的 ACR-50 与培塞利珠单抗比较,以及在 24 周时的 DAS28 <2.6 与托珠单抗比较时除外。敏感性分析证实了研究结果的稳健性。
与其他已批准的生物制剂相比,阿巴西普联合 MTX 治疗预计在 MTX 治疗反应不足的 RA 患者中可使 HAQ 评分从基线有类似的变化,且 ACR-50 和 DAS28 <2.6 的缓解率也类似。