Eshelman School of Pharmacy, University of North Carolina at Chapel Hill.
Biologics and Biosimilars Collective Intelligence Consortium, Alexandria, VA.
J Manag Care Spec Pharm. 2023 Sep;29(9):985-998. doi: 10.18553/jmcp.2023.29.9.985.
Infliximab (IFX) was one of the first tumor necrosis factor inhibitors developed to treat rheumatoid arthritis (RA) and has transformed the treatment and management of many chronic inflammatory diseases. Large-scale studies in the real-world setting on the utilization patterns of IFX biosimilars are limited. To conduct a scoping review of observational studies investigating the switching and discontinuation outcomes of the IFX biosimilars in patients with RA. A comprehensive literature search was conducted in 3 databases (ie, PubMed, Embase, and Web of Science). This review identified observational studies that examined switching and/or discontinuation outcomes of IFX biosimilar products in adult patients with RA. Studies published in English between 2015 and 2020 were included. Studies that did not include either switching or discontinuation patterns of IFX biosimilars, had a pooled result for biologics, or were nonobservational were excluded. Extracted data were summarized using descriptive statistics. The initial literature search yielded 1,130 studies. With 244 duplicate articles removed and 779 excluded after title and abstract screening, the search resulted in 107 studies for full-text screening. 18 articles were included in this review. 13 countries were represented in the included studies, with most studies originating in a European country and only one article from the United States. Discontinuation rates of IFX biosimilars were reported by 14 studies and varied substantially from 8.3% to 87.0%. 4 studies (22%) directly compared discontinuation rates between IFX reference and biosimilar. Switching rates, similarly, had a great variance from 4% to 81.5%; only 4 articles described rates specifically in patients with RA. The most common causes of discontinuation were ineffectiveness and adverse effects. The growing market of biologic products necessitates more large-scale studies examining the real-world treatment patterns of these therapy options to provide reassurance to and build trust among patients and clinicians. Our findings suggest the inconclusiveness of current literature on the real-world implications of IFX biosimilars discontinuation and product switching. This review captures the heterogeneity in reported data and identifies areas for future research to provide clarity to the value of IFX biosimilars.
英夫利昔单抗(IFX)是最早开发用于治疗类风湿关节炎(RA)的肿瘤坏死因子抑制剂之一,它改变了许多慢性炎症性疾病的治疗和管理方式。在真实环境中,关于 IFX 生物仿制药利用模式的大规模研究有限。本研究旨在对评估 IFX 生物仿制药在 RA 患者中转换和停药结局的观察性研究进行综述。在 3 个数据库(即 PubMed、Embase 和 Web of Science)中进行了全面的文献检索。本综述纳入了评估 RA 成年患者 IFX 生物仿制药转换和/或停药结局的观察性研究。纳入了 2015 年至 2020 年期间发表的英文研究。排除了未纳入 IFX 生物仿制药转换或停药模式、汇总了生物制剂结果或非观察性研究的研究。提取的数据采用描述性统计进行总结。初始文献检索得到 1130 项研究。去除 244 篇重复文章,经标题和摘要筛选排除 779 篇后,对 107 篇全文进行了筛选。本综述纳入了 18 篇文章。纳入的研究来自 13 个国家,其中大多数研究来自欧洲国家,仅有 1 篇来自美国。14 项研究报告了 IFX 生物仿制药的停药率,从 8.3%到 87.0%不等。4 项研究(22%)直接比较了 IFX 参比药物和生物仿制药的停药率。转换率也有很大差异,从 4%到 81.5%不等;只有 4 篇文章专门描述了 RA 患者的转换率。停药的最常见原因是无效和不良反应。生物制品市场的不断增长需要更多的大规模研究来检查这些治疗方案的实际治疗模式,以向患者和临床医生提供保证并建立信任。我们的研究结果表明,目前关于 IFX 生物仿制药停药和产品转换对实际影响的文献结论并不明确。本综述捕捉到了报告数据的异质性,并确定了未来研究的领域,以阐明 IFX 生物仿制药的价值。