Frontiers in cardiovascular medicine
Age-stratified reporting of immune checkpoint inhibitor-associated myocarditis: disproportionality is amplified in older adults, with implications for geriatric oncology
By Pehlivan M, Uyar A, Turhan O and 8 others.
Abstract
Background
Cardiovascular toxicity is the immune-related adverse event with the highest reported fatality proportion among immune checkpoint inhibitor (ICI) complications; myocarditis mortality reaches 50%. ICI use has expanded into older populations underrepresented in pivotal trials, but cardiotoxicity reporting in these patients has not been quantified.
Methods
ICI-associated cardiac adverse event records submitted to the FDA Adverse Event Reporting System (FAERS) between January 2011 and March 2026 were retrieved via openFDA. Six ICI agents (pembrolizumab, nivolumab, ipilimumab, atezolizumab, durvalumab, cemiplimab) were crossed with 18 MedDRA Preferred Terms across six cardiac event categories; myocarditis terms were combined at the unique-report level. Reporting odds ratios (RORs) for myocarditis were calculated against the full FAERS background and stratified by age (<65 vs. ≥65 years). RORs reflect reporting disproportionality and do not represent true clinical incidence.