| アブストラクト | BACKGROUND: The precise incidence of immune-related adverse events (irAEs) remains unclear. This pharmacovigilance study investigated acute pancreatitis (AP) associated with immune checkpoint inhibitors (ICIs) using real-world data from the FDA Adverse Event Reporting System (FAERS). RESEARCH DESIGN AND METHODS: Disproportionality analysis employing reporting odds ratios (RORs) was conducted to detect AP signals in ICI-treated patients compared to the entire FAERS database. RESULTS: A total of 152,042 individual patients were included in the dataset from which we identified a cohort of 921 acute pancreatitis adverse events (AEs). The severe outcome of acute pancreatitis was death, with a rate of 13.6% (125/921). Immune checkpoint inhibitor (ICI)-related acute pancreatitis AEs were classified into two categories (pancreatitis and immune-mediated pancreatitis) based on the type of adverse event observed. ICI treatments were significantly correlated with the risk of ICIs-induced acute pancreatitis (AP) but varied among different drugs. The median time to AP onset was 57 days, with events occurring throughout the first year post-ICI initiation. CONCLUSIONS: Our findings provide an enhanced understanding of potential acute pancreatitis related adverse events and provide actionable insights for the early detection and management of ICI related pancreatic adverse events. |
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| ジャーナル名 | Expert opinion on drug safety |
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| Pubmed追加日 | 2025/3/28 |
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| 投稿者 | Tong, Lihua; Yuan, Yanling; He, Wanming; Yang, Wen; Pan, Xingxi |
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| 組織名 | Department of Oncology, The Sixth Affiliated Hospital, School of Medicine, South;China University of Technology, Guangdong, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40152025/ |
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