Abstract
Purpose
The aim of this study was to evaluate hepatobiliary disorders adverse events
associated with pembrolizumab by using the Food and Drug Administration
Adverse Event Reporting System (FAERS).
Methods
We collected FAERS data from the first quarter of 2009 to the third quarter
of 2024 and used reporting odds ratio (ROR) to detect
pembrolizumab-associated hepatobiliary adverse events (AEs). A signal was
considered significant when the lower limit of the 95% confidence interval
(CI) of the ROR exceeded 1, and≥5 AEs were reported. Serious and nonserious
cases were compared by statistical analysis, and signals were further
prioritized using a rating scale.
Results
A total of 20,225,379 AEs were reported in the FAERS database, of which
45,774 AEs listed pembrolizumab as the ‘primary suspected’ drug.
Pembrolizumab treatment was significantly associated with hepatobiliary
disorders. Among these AEs, 101 signals were detected at the preferred term
(PT) levels, and 56 of them were identified as significant signals by using
disproportionality analyses. The median time-to-onset (TTO) was 63 days.
Notably, most hepatobiliary AEs occurred within three months after
pembrolizumab therapy.
Conclusion
Based on pharmacovigilance data from FAERS, different hepatobiliary AEs
should be closely monitored and managed according to the indications for
which pembrolizumab is used.
Keywords
pembrolizumab - FAERS - disproportionality analyses - hepatobiliary disorders - safety
