生物制剂在炎症性肠病中的真实世界安全性和有效性：一项在卡拉布里亚地区进行的上市后一年药物警戒观察性研究。
Real‑world safety and efficacy of biological agents in inflammatory bowel disease: a one-year post-marketing pharmacovigilance observational study in the Calabria region.
作者信息
Fabiano Antonio, De Sarro Caterina, Frajia Domenico, Bosco Francesca, Guarnieri Lorenza, Ruga Stefano, Rodinò Stefano, Sebkova Ladislava, Ciliberto Enrico, Buoncompagni Isidoro, Costantino Laura, Leo Antonio, Marcianò Gianmarco, Rania Vincenzo, Citraro Rita, Michael Ashour, De Sarro Giovambattista
机构信息
Department of Health Sciences, Magna Graecia University of Catanzaro, Catanzaro, 88100, Italy.
Science of Health Department, School of Medicine, System and Applied Pharmacology@University Magna Grecia, Magna Graecia University of Catanzaro, Catanzaro, 88100, Italy.
出版信息
Pharmacol Rep. 2025 Aug 19. doi: 10.1007/s43440-025-00774-x.
BACKGROUND
The use of immune-modifying biological agents has markedly changed the clinical course and the management of inflammatory bowel diseases (IBDs). Active post-marketing surveillance programs are essential for the early recognition of both expected and unexpected adverse events (AEs), providing a powerful tool for better defining the safety profiles of biologics in a real-world setting.
METHODS
Patients diagnosed with IBDs and treated with biologic drugs at two gastroenterology units in Calabria, Italy, were monitored during the period from 2023 to 2024. AEs and drug switches or swaps were recorded. The primary objective was to assess the safety profile of biological therapies in real-world practice, as measured by the occurrence of AEs. Secondary objectives focused on assessing treatment effectiveness by monitoring rates of therapeutic ineffectiveness and rigorously analyzing necessary modifications to therapy (swaps/switches) in response to treatment failure.
RESULTS
A total of 214 patients were enrolled, including 85 with Crohn's disease (CD) and 120 with ulcerative colitis (UC). Among biologics, vedolizumab (VDZ) was the most prescribed drug (50.3%), followed by ustekinumab (UST, 33.6%). Among biosimilars, infliximab (IFX) was the most administered (70%), followed by adalimumab (ADA) (63.3%). 96 patients experienced AEs, though no serious adverse events (SAEs) were reported. The highest number of AEs was reported with VDZ (n = 31; 32.3%), followed by IFX (n = 22, 23.0%), ADA and UST (n = 17, 17.7%), and golimumab (GOL) (n = 7; 7.3%). The biological drugs associated with the fewest AEs were upadacitinib (UPA) and tofacitinib (TFC) (n = 1; 1.0%).
CONCLUSIONS
This study confirms the importance of pharmacovigilance in monitoring the safety of biologics in IBDs. The results offer useful insights into the actual use of monoclonals in gastroenterology and support more targeted prescribing.
CLINICAL TRIAL NUMBER
Not applicable.
背景
免疫调节生物制剂的使用显著改变了炎症性肠病（IBD）的临床病程和治疗方式。积极的上市后监测计划对于早期识别预期和非预期不良事件（AE）至关重要，为在现实环境中更好地界定生物制剂的安全性提供了有力工具。
方法
2023年至2024年期间，对意大利卡拉布里亚两个胃肠病科被诊断为IBD并接受生物药物治疗的患者进行监测。记录不良事件以及药物更换情况。主要目标是通过不良事件的发生情况评估生物治疗在现实世界实践中的安全性。次要目标集中在通过监测治疗无效的发生率以及严格分析因治疗失败而对治疗（更换/替换）进行的必要调整来评估治疗效果。
结果
共纳入214例患者，其中85例为克罗恩病（CD），120例为溃疡性结肠炎（UC）。在生物制剂中，维多珠单抗（VDZ）是最常处方的药物（50.3%），其次是乌司奴单抗（UST，33.6%）。在生物类似药中，英夫利昔单抗（IFX）使用最多（70%），其次是阿达木单抗（ADA）（63.3%）。96例患者发生不良事件，但未报告严重不良事件（SAE）。报告不良事件最多的是VDZ（n = 31；32.3%），其次是IFX（n = 22，23.0%）、ADA和UST（n = 17，17.7%）以及戈利木单抗（GOL）（n = 7；7.3%）。不良事件最少的生物药物是乌帕替尼（UPA）和托法替布（TFC）（n = 1；1.0%）。
结论
本研究证实了药物警戒在监测IBD生物制剂安全性方面的重要性。研究结果为单克隆抗体在胃肠病学中的实际应用提供了有用见解，并支持更有针对性的处方。
临床试验编号
不适用。
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