Evaluation of time to onset and outcome of cardiac adverse events
related to pembrolizumab using post-marketing surveillance
Abstract
Aim: The present study aimed to evaluate time to onset,
incidence rates, and outcomes for pembrolizumab-induced cardiac adverse
events (AEs) in patients with cancer using the Japanese Adverse Drug
Event Report database. Methods: We analysed data for the period
from April 2004 to March 2022. Data on cardiac AEs were extracted and
relative risks of AEs were estimated using the reporting odds ratio.
Results: We analysed 2,021,907 reports and identified 15,306
reports of AEs caused by pembrolizumab. Of these, 399 cardiac AEs were
associated with pembrolizumab. Signals were detected for six cardiac
AEs: myocarditis, immune-mediated myocarditis, pericardial effusion,
cardiac tamponade, pericarditis, and pericarditis malignant. A histogram
of median times to onset showed occurrence from 33 to 138 days, but some
cases occurred even more than 1 year after the start of administration.
Among these, myocarditis was the most frequently reported (27.1%), with
fatal cases also reported. Conclusion: This study focused on
cardiac AEs caused by pembrolizumab as post-marketing AEs. Some cases
could potentially involve serious outcomes, so patients should be
monitored for signs of onset of these AEs not only at the start of
administration, but also over an extended period, especially for
myocarditis.