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Review Article

生物仿制药治疗炎症性肠病的疗效、安全性和免疫原性：系统综述

卷 26, 期 2, 2019

页: [270 - 279] 页: 10

弟呕挨: 10.2174/0929867323666161014153346

价格: $65

摘要

背景：抗肿瘤坏死因子（anti-tnf）单克隆抗体已彻底改变炎症性肠病（ibd）的治疗。然而，由于它们的复杂性，它们的生产是昂贵的，这导致了它们的高价格。由于这些疗法的专利保护在几个国家已经过期，生物仿制药已经开发出来以降低医疗成本。本文旨在综述有关IBD中生物仿制药的安全性、有效性和免疫原性的文献。 方法：使用以下术语进行公开文献检索，直至2016年5月：“生物仿制药”、“CT-P13”、“英夫利昔单抗”、“克罗恩病”、“溃疡性结肠炎”、“炎性肠病”、“疗效”、“安全性”、“免疫原性”。此外，还审查了国际会议的摘要。 结果：11项对IBD患者的研究全部提供了有关IBD患者生物仿制药的疗效、安全性和免疫原性的真实证据。根据现有证据，CT-P13在现实生活中对IBD患者有效且耐受性良好。绝大多数研究只包括从未接受过生物治疗的IBD患者。关于CT-P13和它的始发者之间的互换性的信息目前正在NOR-SWITCH试验中进行研究。否则，CT-P13的免疫原性特征似乎与原始人相似。 结论：英夫利昔单抗生物仿制药与IBD的创始者具有相似的免疫原性，安全有效。需要大量的前瞻性上市后研究来评估CT-P13的长期安全性。使用英夫利昔单抗生物仿制药可能会节省大量医疗成本。

关键词: biosimilar P13，CT，英夫利昔单抗治疗，炎症性肠疾病、效能、安全、immunogenicity。

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