Abstract 16689: Stress Cardiomypoathy in the Patient on Immune Checkpoint Inhibitors; a Pharmacovigilance Study From 2013-2023 FAERS Database

Introduction: Immune checkpoint inhibitors (ICIs) are a form of immunotherapy widely used in the treatment of different cancers. These inhibitors function by blocking specific proteins, such as PD-1 (programmed cell death protein 1) or CTLA-4 (cytotoxic T-lymphocyte-associated protein 4), which regulate the immune response. While ICIs have demonstrated significant benefits, they can also lead to immune-related adverse drug reactions (ADRs). Although rare, cardiac immune-related ADRs are associated with high mortality rates.

Hypothesis: The aim of this study to investigate the potential association between stress cardiomyopathy and the use of immune checkpoint inhibitors.

Methods: We conducted an analysis using individual case safety reports obtained from the FDA Adverse Event Reporting System (FAERS) Database. These reports encompassed the period from the marketing authorization of each specific ICIs (ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, and cemiplimab) up until March 2023. The synthesized data was further examined based on outcome severity, age, and gender.

Results: Among 9,772 individual cardiac adverse events associated with immune checkpoint inhibitors, 121 cases (1.2%) of stress cardiomyopathy were reported from 2013 to 2023. The highest occurrence of stress cardiomyopathy adverse events (57.8%) was observed in the age group of 65-85 , compared to 26.4% in the age group of 14-64. Females were more frequently affected, accounting for 55.3% of the cases, while males constituted 41.3%. The three most commonly reported ICIs associated with stress cardiomyopathy were pembrolizumab (39.6%), nivolumab (33.8%), and ipilimumab (16.5%). Among the 121 cases, 19% resulted in mortality, while 26.5% had life-threatening outcomes. Additionally, 79.3% of cases required hospitalization, 5.7% experienced disability, and 57.8% had outcomes that were not characterized.

Conclusions: Immune checkpoint inhibitor-induced cardiac ADRs, specifically stress cardiomyopathy, were found to be serious and associated with unfavorable outcomes. Physicians should remain vigilant regarding cardiac symptoms in patients receiving immune checkpoint inhibitors, as early detection can improve overall outcomes.