Hepatobiliary Adverse Events Linked to Immune Checkpoint Inhibitors: A Real-World Pharmacovigilance Analysis Using FAERS Data.

ABSTRACT:

Background

Immune checkpoint inhibitors (ICIs) improve cancer outcomes but cause significant hepatobiliary toxicity (e.g., liver dysfunction, immune-mediated liver disease). Prior studies were limited to small samples or case reports. This study evaluated hepatobiliary toxicity, risk variations, and temporal trends for six ICIs (PD-1/PD-L1 inhibitors) via the FDA Adverse Event Reporting System (FAERS) to guide safer use.

Methods

We analyzed 18 640 061 FAERS reports (2004-2024). Disproportionality analyses (ROR, PRR, EBGM, BCPNN) detected hepatobiliary toxicity signals. A Weibull model analyzed AE timing. Logistic regression assessed effects of age, gender, and weight.

Results

PD-L1 inhibitors (Durvalumab, Atezolizumab) are associated more strongly with immune-mediated

SUBMITTER: Chen Y 

PROVIDER: S-EPMC12620246 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature