Farkas Klaudia, Molnár Tamás
1st Department of Medicine, University of Szeged, Szeged, Hungary.
Immunotherapy. 2018 Feb;10(2):107-117. doi: 10.2217/imt-2017-0107. Epub 2017 Nov 10.
The introduction of biological agents has led to significant changes in the treatment of inflammatory bowel disease (IBD). The relatively high price of infliximab (IFX) and the expiration of the patents led to the introduction of biosimilar agents. CT-P13 was the first IFX biosimilar approved in the same indications as the reference product; however, the approval was based on randomized clinical trials conducted in patients with rheumatoid arthritis and ankylosing spondylitis. In the past 2-3 years, new findings from prospective observational studies supported the short-, medium- and long-term clinical efficacy and safety of CT-P13 in patients with IBD. This review summarized the clinical use and efficacy of the first biosimilar IFX, CT-P13, in the treatment of IBD.
生物制剂的引入给炎症性肠病(IBD)的治疗带来了重大变革。英夫利昔单抗(IFX)相对较高的价格以及专利到期促使了生物类似药的出现。CT-P13是首个在与参比产品相同适应症上获批的IFX生物类似药;然而,其获批是基于在类风湿关节炎和强直性脊柱炎患者中开展的随机临床试验。在过去两到三年里,前瞻性观察性研究的新发现支持了CT-P13在IBD患者中的短期、中期和长期临床疗效及安全性。本综述总结了首个IFX生物类似药CT-P13在IBD治疗中的临床应用及疗效。