Immune checkpoint inhibitors-related myocarditis in patients with cancer: an analysis of international spontaneous reporting systems

Abstract Background Immune checkpoint inhibitors-induced myocarditis presents unique clinical challenges. Here, we assessed post-marketing safety of cytotoxic T-lymphocyte-associated protein-4 (CTLA-4), programmed cell death-1 (PD-1), and death-ligand 1 (PD-L1) inhibitors by mining the real-world data reported in two international pharmacovigilance databases. Methods We analyzed immune (ICIs)-associated fatal adverse drug events (ADEs) reports from US Food Drug Administration (FDA) Adverse Event Reporting System (FAERS) collected July 1, 2014 to December 31, 2019 EudraVigilance (EV) database accessed on February 29, 2020. Three different approaches were used detect signal caused ICIs. Results Based 7613 ICIs-related ADEs EV 5786 ICIs-associated submitted FAERS database, most frequently ADE was ipilimumab-related colitis. For myocarditis, nivolumab-associated common. Among five toxic effects associated with ICIs, lethality rate highest. Therefore, further ICI-associated found that elderly patients male more likely develop myocarditis. The results detection showed risk avelumab-related detected reporting odds ratio (ROR) method proportional ratios (PRR) highest, whereas strength Bayesian confidence propagation neural networks (BCPNN) strongest. Conclusion findings this study indicated potential issues developing when using which consistent previous trials could provide a reference for workers