Clinical Electrophysiology -> SVT/AVNRT/WPW/AT: -> Epidemiology of Cardiac Arrhythmias/ Epidemiology D-PO01 - Featured Poster Session (ID 11) Poster

D-PO01-034 - Immune Checkpoint Inhibitors And The Risk Of Sudden Cardiac Death Or Ventricular Arrhythmias: A Cardio-oncology Pharmacovigilance Analysis (ID 53)

Disclosure
 M. Mirabel: Nothing relevant to disclose.

Abstract

Background: Cancer immunotherapies (or Immune checkpoint inhibitors (ICI)) have recently been reported to induce fulminant cardiotoxic effects such as myocarditis and pericarditis.
Objective: To estimate the risk of sudden death (SD) and ventricular arrhythmias in patients receiving ICI using the World Health Organization individual case safety report (ICSR) database, Vigibase.
Methods: An extraction of VigiBase, which contains WHO individual case safety reports (ICSRs), was performed. All ICSRs with the following terms: accelerated idioventricular rythm, sudden cardiac death, cardiac arrest, cardiac death, cardiac fibrillation, cardio-respiratory arrest, parasystole, rhythm idioventricular, sudden death, torsade de pointes, ventricular arrhythmias (named as SD events) from Nov 1967 to Nov 2019. We used the ATC code L01 which regroups 219 antineoplastic agents including ICI avelumab (anti-PDL1), ipilimumab (anti CTLA4), nivolumab (anti-PD1) and pembrolizumab (anti-PD1). A disproportionality analysis was performed via VigiLyze to estimate of Reporting Odds Ratio (ROR). Signals were considered significant when the lower boundary of the 95% confidence interval (ROR0.25) was greater or equal to 1 and the number of cases was greater than 3. A disproportionality analysis was performed to estimate Reporting Odds Ratio (ROR). Signals were considered significant when the lower boundary of the 95% confidence interval (ROR0.25) was greater or equal to 1 and the number of cases was greater than 3.
Results: We found that avelumab was significantly associated with SD events (ROR0.25=1.7). This overreporting was not observed for other ICIs. Avelumab was associated with 12 cases of cardiac arrest (n=11) or sudden death (n=1), which were reported since 2017 as the drug became available. There were however no signals regarding other terms including ventricular arrhythmias.
Conclusion: ICI do not appear as associated with the occurrence of sudden death or life-threatening arrhythmias, with the exception of avelumab (anti-PDL1), one of the latest developed ICI, indicated in metastatic Merkel cell carcinoma and advanced renal cell carcinoma. Further attention is warranted to confirm this signal that may vary from one drug to another among ICI therapies.
Collapse