Systematic review: effectiveness and safety of switching between originator infliximab and biosimilar infliximab in patients with inflammatory bowel disease.

IF 3.6 3区医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY

Expert Opinion on Biological Therapy Pub Date : 2024-07-01 Epub Date: 2024-07-18 DOI:10.1080/14712598.2024.2378090

Gary R Lichtenstein, Arif Soonasra, Mark Latymer, Sheena Singh, Brian G Feagan

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引用次数: 0

Abstract

Introduction: Infliximab (IFX) biosimilars are available to treat inflammatory bowel disease (IBD), offering cost reductions versus originator IFX in some jurisdictions. However, concerns remain regarding the efficacy and safety of originator-to-biosimilar switching. This systematic literature review evaluated safety and effectiveness of switching between IFX products in patients with IBD, including multiple switchers.

Methods: Embase, PubMed, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials were searched to capture studies (2012-2022) including patients with IBD who switched between approved IFX products. Effectiveness outcomes: disease activity; disease severity; response to treatment; patient-reported outcomes (PROs). Safety outcomes: incidence and rate of adverse events (AEs); discontinuations due to AEs, failure rate; hospitalizations; surgeries. Immunogenicity outcomes (n, %): anti-drug antibodies; patients receiving concomitant immunomodulatory medication.

Results: Data from 85 publications (81 observational, two randomized controlled trials) were included. Clinical effectiveness outcomes were consistent with the known profile of originator IFX with no difference after switching. There were no unexpected/serious AEs after switching, and rates of AEs were generally consistent with the known profile of IFX.

Conclusions: Most studies reported that clinical, PROs, and safety outcomes for originator-to-biosimilar switching were clinically equivalent to originator responses. Limited data are available regarding multiple switches.

Protocol registration: www.crd.york.ac.uk/prospero identifier is CRD42021289144.

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系统综述：炎症性肠病患者在原研英夫利昔单抗和生物仿制药英夫利昔单抗之间转换的有效性和安全性。

简介：英夫利西单抗（IFX）生物仿制药可用于治疗炎症性肠病（IBD），与原研药 IFX 相比，在某些地区可降低成本。然而，从原研药到生物仿制药转换的疗效和安全性仍然令人担忧。本系统性文献综述评估了IBD患者（包括多次转换者）转换IFX产品的安全性和有效性：方法：检索了Embase、PubMed、Cochrane系统综述数据库、Cochrane对照试验中央登记册，以获取包括在获批IFX产品之间转换的IBD患者的研究（2012-2022年）。疗效结果：疾病活动度、疾病严重程度、治疗反应、患者报告结果（PROs）。安全性结果：不良事件（AEs）的发生率和发生率；因AEs而停药，失败率；住院；手术。免疫原性结果（n，%）：抗药性抗体；同时接受免疫调节药物治疗的患者：结果：纳入了 85 篇文献（81 篇观察性文献，2 篇随机对照试验）的数据。临床疗效结果与原研 IFX 的已知情况一致，换药后无差异。换药后没有出现意外/严重的不良反应，不良反应发生率与 IFX 的已知情况基本一致：大多数研究报告称，从原研药到生物类似药转换的临床、PROs 和安全性结果与原研药的临床反应相当。关于多次转换的数据有限。协议注册：www.crd.york.ac.uk/prospero 识别码为 CRD42021289144。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Opinion on Biological Therapy 医学-生物工程与应用微生物

CiteScore

8.60

自引率

0.00%

发文量

审稿时长

3-8 weeks

期刊介绍： Expert Opinion on Biological Therapy (1471-2598; 1744-7682) is a MEDLINE-indexed, international journal publishing peer-reviewed research across all aspects of biological therapy. Each article is structured to incorporate the author’s own expert opinion on the impact of the topic on research and clinical practice and the scope for future development. The audience consists of scientists and managers in the healthcare and biopharmaceutical industries and others closely involved in the development and application of biological therapies for the treatment of human disease. The journal welcomes: Reviews covering therapeutic antibodies and vaccines, peptides and proteins, gene therapies and gene transfer technologies, cell-based therapies and regenerative medicine Drug evaluations reviewing the clinical data on a particular biological agent Original research papers reporting the results of clinical investigations on biological agents and biotherapeutic-based studies with a strong link to clinical practice Comprehensive coverage in each review is complemented by the unique Expert Collection format and includes the following sections: Expert Opinion – a personal view of the data presented in the article, a discussion on the developments that are likely to be important in the future, and the avenues of research likely to become exciting as further studies yield more detailed results; Article Highlights – an executive summary of the author’s most critical points.