英夫利昔单抗生物类似药治疗炎症性肠病的系统评价。
Infliximab Biosimilars in the Treatment of Inflammatory Bowel Diseases: A Systematic Review.
机构信息
Center of Research of Immunopathology and Rare Diseases-Coordinating Center of Piemonte and Valle d'Aosta Network for Rare Diseases, Department of Clinical and Biological Sciences, and SCDU Nephrology and Dialysis, S. Giovanni Bosco Hospital, Piazza del Donatore di Sangue 3, 10154, Turin, Italy.
Louise Coote Lupus Unit, Guy's and St Thomas' NHS Foundation Trust, London, UK.
出版信息
BioDrugs. 2017 Feb;31(1):37-49. doi: 10.1007/s40259-016-0206-1.
BACKGROUND
Biological therapies represent a fundamental innovation for the management of inflammatory bowel diseases (IBD). However, many biological originators have reached, or are about to reach, patent expiry and long-term therapy costs have become progressively unsustainable. CT-P13, a biosimilar of the anti-tumor necrosis factor (anti-TNF) monoclonal antibody infliximab, might represent a significant alternative to its originator, with the potential to decrease medical care costs and, therefore, become available to a large number of patients.
OBJECTIVES
In this systematic review, we analyzed the data from available clinical trials that recently investigated the validity of indication extrapolation of CT-P13 for the treatment of IBD in naïve patients and in patients who switched from its originator infliximab, focusing on clinical efficacy, safety and immunogenicity.
METHODS
A detailed literature search was developed a priori to identify articles that investigated the validity of indication extrapolation of CT-P13 for the treatment of IBD in TNF inhibitor treatment-naïve patients and in patients who switched from the originator infliximab. This was applied to Ovid MEDLINE, In-Process and Other Non-Indexed Citations, EMBASE, Cochrane Central Register of Controlled Trials, and Scopus for content from 2012 to September 2016.
RESULTS
We based our review on the available data from 11 studies that included a total of 1007 IBD patients: 570 patients suffering from Crohn's disease (294 switched and 276 naïve), 435 patients suffering from ulcerative colitis (127 switched and 308 naïve), and two IBD unclassified patients (switched). Overall, no significant difference in efficacy and safety between the originator infliximab and its biosimilar CT-P13 was observed. When assessing the safety of CT-P13, we found that 9.2% of patients experienced adverse effects (4.1% infusion-related reactions and 4.3% infections).
CONCLUSION
The analyzed studies did not report a significant difference in terms of efficacy, safety and immunogenicity when comparing the clinical experience with CT-P13 with the available literature data on the originator treatment in IBD. However, some debate is ongoing regarding interchangeability and immunogenicity.
背景
生物疗法代表了炎症性肠病（IBD）治疗的重大创新。然而，许多生物原创药物已经达到或即将达到专利期届满，长期治疗费用变得越来越难以承受。CT-P13 是一种抗肿瘤坏死因子（anti-TNF）单克隆抗体英夫利昔单抗的生物类似物，可能成为其原创药物的重要替代品，具有降低医疗费用的潜力，因此可以为大量患者提供。
目的
在这项系统评价中，我们分析了最近研究 CT-P13 在初治患者和从其原创药物英夫利昔单抗转换的患者中治疗 IBD 的适应证外推有效性的临床试验数据，重点关注临床疗效、安全性和免疫原性。
方法
我们预先进行了详细的文献检索，以确定研究 CT-P13 在 TNF 抑制剂初治患者和从原创药物英夫利昔单抗转换的患者中治疗 IBD 的适应证外推有效性的文章。该检索应用于 Ovid MEDLINE、In-Process 和其他非索引引文、EMBASE、Cochrane 对照试验中心注册库和 Scopus，内容时间为 2012 年至 2016 年 9 月。
结果
我们根据来自 11 项研究的现有数据进行了综述，这些研究共纳入了 1007 例 IBD 患者：570 例克罗恩病患者（294 例转换，276 例初治），435 例溃疡性结肠炎患者（127 例转换，308 例初治）和 2 例 IBD 未分类患者（转换）。总体而言，原创药物英夫利昔单抗和其生物类似物 CT-P13 的疗效和安全性无显著差异。在评估 CT-P13 的安全性时，我们发现 9.2%的患者出现不良反应（4.1%为输注相关反应，4.3%为感染）。
结论
在比较 CT-P13 的临床经验与 IBD 中原创药物的现有文献数据时，分析研究未报告在疗效、安全性和免疫原性方面有显著差异。然而，关于可互换性和免疫原性仍存在一些争议。
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