Hepatotoxicity in immune checkpoint inhibitors: A pharmacovigilance study from 2014–2021

Adverse events(AEs) related to hepatotoxicity have been reported in
patients treated with immune checkpoint inhibitors (ICIs). As the number
of adverse events increases, it is necessary to assess the differences in
each immune checkpoint inhibitor regimen. The purpose of this study was to
examine the relationship between ICIs and hepatotoxicity in a scientific
and systematic manner. Data were obtained from the FDA Adverse Event
Reporting System database (FAERS) and included data from the first quarter
of 2014 to the fourth quarter of 2021. Disproportionality analysis
assessed the association between drugs and adverse reactions based on the
reporting odds ratio (ROR) and information components (IC). 9,806 liver
adverse events were reported in the FAERS database. A strong signal was
detected in older patients (≥65 years) associated with ICIs. Hepatic
adverse events were most frequently reported with Nivolumab (36.17%).
Abnormal liver function, hepatitis, and autoimmune hepatitis were most
frequently reported, and hepatitis and immune-mediated hepatitis signals
were generated in all regimens. In clinical use, patients should be alert
to these adverse effects, especially in elderly patients, who may be
aggravated by the use of ICI.