Adverse events associated with acute pancreatitis caused by immune checkpoint inhibitors: a pharmacovigilance analysis of the FDA adverse event reporting system (FAERS) database

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). Disproportionality analysis employing reporting odds ratios (RORs) was conducted to detect AP signals in ICI-treated patients compared to the entire FAERS database. 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. 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.