Ipilimumab and nivolumab for cancer treatment: a pharmacovigilance study based on the FDA adverse event reporting system database.
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BACKGROUND: Cancer remains one of the leading is associated with of death globally. This study analyzed adverse drug event (ADE) signals and potential factors associated with reporting in ipilimumab and nivolumab-treated cancer data from the Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) database. METHODS: This study collected ADEs associated with ipilimumab, nivolumab, and their combination therapy for all cancers from the first quarter of 2004 to the fourth quarter of 2024 through the FAERS database. It investigated the basic information of all adverse reaction reports, analyzed the cumulative trends of ADE onset time across different age groups, and mined safety signals significantly associated with the three drug groups via disproportionality analysis. Additionally, the study explored potential factors associated with reporting of these adverse reactions. RESULTS: A total of 21,712,563 reports were included in this study as research subjects, among which there were 4,600, 36,556, and 10,862 adverse reaction reports for ipilimumab, nivolumab, and ipilimumab/nivolumab, respectively. Separate analysis of these three groups of drugs showed that the onset time of adverse reactions mostly exhibited a bimodal pattern characterized by "early concentrated outbreak + long-term persistent risk", which was related to age. These three groups of drugs showed a stronger associated with colitis, adrenal insufficiency, malignant neoplasm progression, death, and intentional product use issues. Age and weight were identified as potential factors associated with reporting of adverse reactions related to these three groups of drugs. CONCLUSION: Based on the FAERS database, this study identifies significant pharmacovigilance signals and potential reporting-associated factors for ipilimumab, nivolumab, and their combination. Importantly, these findings represent hypothesis-generating signal detections rather than definitive causal risk estimations, underscoring the absolute necessity for heightened clinical vigilance and routine endocrinological monitoring. These findings inform clinical monitoring strategies and provide a foundation for future research into the molecular potential mechanisms underlying irAEs.