Effect of Acid Suppressants on Adverse Events of Immune Checkpoint Inhibitors Using Real-world Databases.

IF 1.7 4区医学 Q4 ONCOLOGY

Anticancer research Pub Date : 2025-08-01 DOI:10.21873/anticanres.17689

Keisuke Okamoto, Juri Takizawa, Hinata Ueda, Katsuya Narumi, Masaki Kobayashi

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引用次数: 0

Abstract

Background/aim: Immune checkpoint inhibitors (ICIs) cause immune-related adverse events (irAEs) in various organs. Although many studies have suggested that acid suppressants (ASs) may affect irAEs, limited sample sizes have hindered detailed evaluations. Therefore, this study aimed to assess the impact of ASs on individual irAEs using large real-world databases, the Japanese Adverse Drug Event Report database (JADER) and the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

Materials and methods: We analyzed adverse event (AE) reports from the JADER and FAERS databases to assess the impact of ASs on ICI-related AEs. Reporting odds ratios (RORs) and 95% confidence intervals (95%CI) were calculated. Drug-drug interaction signals were defined by non-overlapping 95%CIs between ICIs alone and their combination use.

Results: Co-administration with ASs or proton pump inhibitors (PPIs) was associated with an increased risk of acute kidney injury (AKI) in both datasets, while H2-receptor antagonists (H2RAs) showed weaker or no signals. The incidence of endocrine-related AEs tended to decrease with ASs. The colitis results differed between the two datasets, with a decreased incidence in the JADER and an increased incidence in FAERS. Other ICI-related AEs showed consistent trends across datasets. Subgroup analyses of individual PPIs revealed varying results for AKI and colitis between the JADER and FAERS databases, with no consistent trends across PPIs.

Conclusion: ASs have diverse effects on ICI-induced AEs and their characteristics may differ between PPIs and H2RAs.

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酸抑制剂对免疫检查点抑制剂不良事件的影响

背景/目的：免疫检查点抑制剂（ICIs）在多个器官中引起免疫相关不良事件（irAEs）。尽管许多研究表明抑酸剂（ASs）可能影响irae，但有限的样本量阻碍了详细的评估。因此，本研究旨在利用大型真实世界数据库、日本不良药物事件报告数据库（JADER）和美国食品和药物管理局不良事件报告系统（FAERS）来评估asa对个体irae的影响。材料和方法：我们分析了来自JADER和FAERS数据库的不良事件（AE）报告，以评估ASs对ici相关AE的影响。计算报告优势比（RORs）和95%置信区间（95% ci）。药物-药物相互作用信号定义为单独使用ICIs和联合使用ICIs之间不重叠的95% ci。结果：在两个数据集中，与as或质子泵抑制剂（PPIs）共同给药与急性肾损伤（AKI）的风险增加相关，而h2受体拮抗剂（H2RAs）显示较弱或没有信号。内分泌相关ae的发生率倾向于随ASs而降低。结肠炎结果在两个数据集之间存在差异，JADER组发生率降低，FAERS组发生率增加。其他与ci相关的ae在数据集上显示出一致的趋势。单个ppi的亚组分析显示，在JADER和FAERS数据库中，AKI和结肠炎的结果不同，ppi之间没有一致的趋势。结论：as对ici诱导的ae有不同的作用，其作用特征在PPIs和H2RAs之间可能存在差异。

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

Anticancer research 医学-肿瘤学

CiteScore

3.70

自引率

10.00%

发文量

566

审稿时长

2 months

期刊介绍： ANTICANCER RESEARCH is an independent international peer-reviewed journal devoted to the rapid publication of high quality original articles and reviews on all aspects of experimental and clinical oncology. Prompt evaluation of all submitted articles in confidence and rapid publication within 1-2 months of acceptance are guaranteed. ANTICANCER RESEARCH was established in 1981 and is published monthly (bimonthly until the end of 2008). Each annual volume contains twelve issues and index. Each issue may be divided into three parts (A: Reviews, B: Experimental studies, and C: Clinical and Epidemiological studies). Special issues, presenting the proceedings of meetings or groups of papers on topics of significant progress, will also be included in each volume. There is no limitation to the number of pages per issue.