比较英夫利昔单抗生物类似药 CPT-13 与参比英夫利昔单抗在炎症性肠病中的有效性和药物生存情况：一项回顾性队列研究。

Comparative effectiveness and drug survival of biosimilar infliximab CPT-13 vs. reference infliximab in inflammatory bowel disease: A retrospective cohort study.

机构信息

Department of Gastroenterology, Reina Sofia Hospital of Murcia, Spain; Biomedical Research Institute of Murcia (IMIB-Pascual Parrilla), University Clinical Hospital Virgen de la Arrixaca, Murcia, Spain.

Department of Hospital Pharmacy, Reina Sofia Hospital of Murcia, Spain; Biomedical Research Institute of Murcia (IMIB-Pascual Parrilla), University Clinical Hospital Virgen de la Arrixaca, Murcia, Spain.

出版信息

Gastroenterol Hepatol. 2024 Jun-Jul;47(6):553-561. doi: 10.1016/j.gastrohep.2023.08.004. Epub 2023 Aug 18.

DOI:10.1016/j.gastrohep.2023.08.004

PMID:37597745

Abstract

BACKGROUND

Studies have investigated the efficacy and safety of switching to the biosimilar infliximab (CT-P13) in patients with inflammatory bowel disease (IBD). However, there is limited research directly comparing the effectiveness, drug survival, and pharmacokinetic profiles of the reference infliximab (IFX) and CT-P13 in real clinical settings.

OBJECTIVE

To compare the effectiveness and drug survival of CPT-13 and reference IFX at weeks 26 and 52, and to determine the pharmacokinetic profiles and safety profile in real-world settings.

METHODS

A retrospective observational cohort analysis was conducted at a single center. The study compared the proportion of patients achieving clinical remission and experiencing poor clinical outcomes at weeks 26 and 52. The drug survival rate of CT-P13 and reference infliximab was also assessed during the follow-up period.

RESULTS

A total of 153 patients were included in the study, 39.2% receiving CPT-13 and 60.8% reference IFX. At week 26, clinical remission rates were 66.7% (CPT-13: 74.4% vs. reference IFX: 62.3%, p=0.178), and at week 52, they were 64% (CPT-13: 85.4% vs. reference IFX: 63.0%, p=0.012). Subgroup analysis with therapeutic drug monitoring (TDM) found no significant differences at week 26 (CPT-13: 74.4% vs. reference IFX: 58.8%, p=0.235) or at week 52 (CPT-13: 85.4% vs. reference IFX: 68.8%, p=0.153).

CONCLUSION

Our study demonstrates comparable efficacy, drug survival, pharmacokinetic profiles, and incidence of immunogenicity between both drugs in a real clinical setting. Further studies with greater statistical power are needed to validate these findings.

摘要

背景

已有研究调查了炎症性肠病（IBD）患者转换为生物类似物英夫利昔单抗（CT-P13）的疗效和安全性。然而，在真实临床环境中，直接比较参考英夫利昔单抗（IFX）和 CT-P13 的有效性、药物存活率和药代动力学特征的研究有限。

目的

比较 CT-P13 和参考 IFX 在第 26 周和第 52 周的疗效和药物存活率，并确定真实环境中的药代动力学特征和安全性特征。

方法

在一家单中心进行回顾性观察队列分析。该研究比较了第 26 周和第 52 周时达到临床缓解和出现不良临床结局的患者比例。还评估了 CT-P13 和参考英夫利昔单抗在随访期间的药物存活率。

结果

共纳入 153 例患者，其中 39.2%接受 CT-P13 治疗，60.8%接受参考 IFX 治疗。第 26 周时，临床缓解率分别为 66.7%（CT-P13：74.4% vs. 参考 IFX：62.3%，p=0.178），第 52 周时为 64%（CT-P13：85.4% vs. 参考 IFX：63.0%，p=0.012）。治疗药物监测（TDM）的亚组分析发现，第 26 周时差异无统计学意义（CT-P13：74.4% vs. 参考 IFX：58.8%，p=0.235），第 52 周时也无统计学意义（CT-P13：85.4% vs. 参考 IFX：68.8%，p=0.153）。