Intermountain Healthcare Pharmacy Services, Taylorsville, UT, USA.
Department of Pharmacy Systems, Outcomes and Policy, College of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA.
Am J Health Syst Pharm. 2021 Mar 31;78(8):697-704. doi: 10.1093/ajhp/zxab042.
This article assesses the relative efficacy and safety of infliximab biosimilars in treatment of patients with rheumatoid arthritis (RA).
A frequentist, random-effects network meta-analysis was performed to evaluate evidence from randomized controlled trials that examined the use of infliximab biosimilars for treatment of patients with RA. PubMed/MEDLINE and other sources were searched for reports evaluating rates of response to treatment with the reference product (infliximab) vs an infliximab biosimilar. The primary efficacy outcome of interest was the rate of attainment of ACR20 (ie, 20% improvement in American College of Rheumatology core measures). The primary safety outcome was the rate of treatment-related serious adverse events (SAEs). Data were extracted by the primary author, and an assessment for risks of methodological bias was performed for each evaluated study.
Five studies that enrolled a total of 2,499 patients were included. Overall comparisons using odds ratios and 95% confidence intervals (CIs) did not indicate statistically significant differences in response to treatment with biosimilar agents relative to each other or the infliximab reference product. ORs for ACR20 response for biosimilars vs infliximab were as follows: 1.475 (95% CI, 0.940-2.315) for infliximab-axxq, 1.259 (95% CI, 0.854-1.855) for infliximab-dyyb, 0.865 (95% CI, 0.5511.358) for infliximab-qbtx, and 0.832 (95% CI, 0.506-1.367) for infliximab-abda. Similar findings were observed in reported SAE rates among patients treated with the various biosimilars.
ACR20 response appears to be comparable and nonsignificantly different between infliximab biosimilars. In the absence of any meaningful differences in safety or efficacy, biosimilar cost may be the deciding factor in choosing a treatment or agent for formulary inclusion.
本文评估英夫利昔单抗生物类似药治疗类风湿关节炎(RA)患者的相对疗效和安全性。
采用固定效应网络荟萃分析评估了英夫利昔单抗生物类似药治疗 RA 患者的随机对照试验证据。检索了 PubMed/MEDLINE 和其他来源的报告,评估了参考产品(英夫利昔单抗)与英夫利昔单抗生物类似药治疗的应答率。主要疗效结局是 ACR20 达标率(即美国风湿病学会核心指标改善 20%)。主要安全性结局是治疗相关严重不良事件(SAE)的发生率。主要作者提取数据,并对每项评估研究进行了方法学偏倚风险评估。
纳入了 5 项共纳入 2499 例患者的研究。使用优势比(OR)和 95%置信区间(CI)的总体比较并未表明生物类似药之间或与英夫利昔单抗参考产品相比,治疗应答存在统计学显著差异。生物类似药与英夫利昔单抗相比,ACR20 应答的 OR 如下:英夫利昔单抗-axxq 为 1.475(95%CI,0.940-2.315),英夫利昔单抗-dyyb 为 1.259(95%CI,0.854-1.855),英夫利昔单抗-qbtx 为 0.865(95%CI,0.551-1.358),英夫利昔单抗-abda 为 0.832(95%CI,0.506-1.367)。在报告的接受各种生物类似药治疗的患者 SAE 发生率方面也观察到了类似的结果。
英夫利昔单抗生物类似药的 ACR20 应答似乎相似且无统计学差异。在安全性或疗效方面没有任何明显差异的情况下,生物类似药的成本可能是选择治疗药物或纳入药物的决定因素。