Parigi Tommaso Lorenzo, D'Amico Ferdinando, Peyrin-Biroulet Laurent, Danese Silvio
Department of Biomedical Sciences, Humanitas University , Milan, Italy.
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele , Milan, Italy.
Expert Opin Biol Ther. 2021 Jan;21(1):37-46. doi: 10.1080/14712598.2020.1811849. Epub 2020 Aug 31.
Biologic drugs have significantly improved the treatment of ulcerative colitis (UC) and Crohn's disease (CD). However, the availability of these drugs is limited by their high cost. Infliximab was the first biologic to be approved for inflammatory bowel diseases (IBD). After its patent expired other manufactures developed biosimilar versions, among which CT-P13, and licensed them thorough an expedite process.
The aim of this review is to summarize the available evidence on CT-P13 use in IBD, with particular interest in the phase II trials of a subcutaneous version of CT-P13.
Biosimilars, such as CT-P13, are an important resource for health-care systems. Although CT-P13 approval in IBD was based on extrapolation, subsequent studies confirmed its clinical equivalence to originator infliximab. A new subcutaneous formulation of CT-P13 showed promising results in phase I and II trials in both CD and UC. Clinical efficacy and safety were comparable and interestingly serum drug doses appeared to be more stable than conventional intravenous CT-P13. If these preliminary results will be confirmed, the first sub-cutaneous version of infliximab could soon be available for IBD.
生物药物显著改善了溃疡性结肠炎（UC）和克罗恩病（CD）的治疗。然而，这些药物的可及性受到其高成本的限制。英夫利昔单抗是首个被批准用于治疗炎症性肠病（IBD）的生物药物。其专利到期后，其他制造商开发了生物类似药版本，其中包括CT-P13，并通过快速程序对其进行了许可。
本综述的目的是总结CT-P13用于IBD的现有证据，尤其关注CT-P13皮下注射剂型的II期试验。
生物类似药，如CT-P13，是医疗保健系统的重要资源。尽管CT-P13在IBD中的批准是基于外推法，但后续研究证实了其与原研英夫利昔单抗的临床等效性。CT-P13的一种新的皮下注射剂型在CD和UC的I期和II期试验中显示出了有前景的结果。临床疗效和安全性相当，有趣的是，血清药物剂量似乎比传统静脉注射的CT-P13更稳定。如果这些初步结果得到证实，首个皮下注射剂型的英夫利昔单抗可能很快就能用于IBD的治疗。
