Gastrointestinal adverse events associated with immune checkpoint inhibitors: a pharmacovigilance analysis of the EudraVigilance and VigiAccess databases.

IF 3 3区医学 Q2 PHARMACOLOGY & PHARMACY Expert Opinion on Drug Safety Pub Date : 2024-10-11 DOI:10.1080/14740338.2024.2416539

Syed Arman Rabbani, Atul Khurana, Mohamed El-Tanani, Mandeep Kumar Arora, Shrestha Sharma, Sathvik B Sridhar, Harikesh Dubey

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Abstract

Background: This study aimed to provide an overview of gastrointestinal (GI) adverse events associated with immune checkpoint inhibitors (ICIs) using two pharmacovigilance databases, EudraVigilance and VigiAccess.

Research design and methods: Data was collected from the date of ICI's marketing authorization until 30 November 2023. Reporting odds ratio (ROR) was used as a measure of ADR reporting disproportionality for signal detection.

Results: Overall, across both databases, EudraVigilance and VigiAccess, a total of 76,606 ADR reports were analyzed. In EudraVigilance, colitis (12,581) and diarrhea (12,108) were the most reported GI adverse events, with similar findings in VigiAccess. Furthermore, in both databases, the most ADR reports were associated with nivolumab and pembrolizumab. Durvalumab (ROR:3.96,95%CI:3.65-4.28), ipilimumab (ROR:1.95,95%CI:1.89-2.01), nivolumab (ROR:1.05,95%CI:1.02-1.07), and atezolizumab (ROR:1.04,95%CI:1.01-1.07) demonstrated higher risks of GI events compared to other ICIs. EudraVigilance analysis identified dysphagia, ascites, hematochezia, and gastroesophageal reflux disease as potential signals associated with ICI therapy. Majority of ADR reports (87.2%) comprised serious GI adverse events, a portion of which was associated with fatal outcomes (14.5%). Atezolizumab (14.9%) and pembrolizumab (11.9%) were linked to a higher incidence of fatal outcomes compared to other ICIs.

Conclusion: The differential risk profiles of ICIs-associated-GI adverse events underscore the importance of personalized therapy in oncology.

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与免疫检查点抑制剂相关的胃肠道不良事件：EudraVigilance 和 VigiAccess 数据库的药物警戒分析。

研究背景本研究旨在利用两个药物警戒数据库（EudraVigilance和VigiAccess）概述与免疫检查点抑制剂（ICIs）相关的胃肠道（GI）不良事件：数据收集时间为 ICI 获批上市之日起至 2023 年 11 月 30 日。报告几率比（ROR）被用来衡量ADR报告与信号检测的不相称性：总体而言，EudraVigilance 和 VigiAccess 两个数据库共分析了 76,606 份 ADR 报告。在 EudraVigilance 中，结肠炎（12,581 例）和腹泻（12,108 例）是报告最多的消化道不良事件，在 VigiAccess 中也有类似的结果。此外，在这两个数据库中，最多的 ADR 报告与 nivolumab 和 pembrolizumab 有关。与其他 ICIs 相比，Durvalumab（ROR:3.96,95%CI:3.65-4.28）、ipilimumab（ROR:1.95,95%CI:1.89-2.01）、nivolumab（ROR:1.05,95%CI:1.02-1.07）和 atezolizumab（ROR:1.04,95%CI:1.01-1.07）发生消化道事件的风险较高。EudraVigilance分析发现，吞咽困难、腹水、血尿和胃食管反流病是与ICI治疗相关的潜在信号。大部分 ADR 报告（87.2%）包括严重的消化道不良事件，其中一部分与死亡结果有关（14.5%）。与其他 ICIs 相比，Atezolizumab（14.9%）和 pembrolizumab（11.9%）的致命后果发生率更高：ICIs相关GI不良事件的不同风险特征凸显了肿瘤个性化治疗的重要性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Opinion on Drug Safety 医学-药学

CiteScore

5.90

自引率

3.20%

发文量

审稿时长

6-12 weeks

期刊介绍： Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.