Hepatic failure associated with immune checkpoint inhibitors: An analysis of the Food and Drug Administration Adverse Event Reporting System database

• DOI: 10.1002/cam4.5655
• Publication Date: 2023-02-03T11:19:38Z
• Authors: Ye Xu; Cilin Yan; Ying Zhao; Dandan Li; Mingxing Guo; Xiangli Cui
• Keywords: Atezolizumab

Abstract Background Hepatic failure induced by immune checkpoint inhibitors (ICIs) has been reported in only a few case series and reports. Objective We aimed to explore the association between ICIs hepatic characterize clinical features of ICI‐associated pharmacovigilance database. Methods Data from first quarter (Q1) 2015 fourth (Q4) 2021 US Food Drug Administration Adverse Event Reporting System (FAERS) database were retrieved for disproportionality Bayesian analysis. odds ratios (ROR) information component (IC) used evaluate correlations failure. Results occurred 0.19% (18,454/9,647,655) all cases FAERS database, which 654 associated with ICIs. The overall median time initiation onset was 38 days, 72.3% adverse events within 3 months, 68.65% died after developing In general, strong signal shown (ROR 025 = 2.70, IC 1.39). For three categories ICIs, programmed cell death 1 ligand 3.09, 1.57) had higher risk than protein cytotoxic T lymphocyte‐associated 4 inhibitors. monotherapy, atezolizumab showed strongest 4.07, 1.90). combination nivolumab ipilimumab stronger signals compared or alone (nivolumab + vs. ipilimumab: ROR 1.40, 0.16; nivolumab: 1.24, 0.34). Considering concomitant agents majority these regimens ICI such as acetaminophen (ICIs ICIs: 1.06, 0.32). Conclusions possible failure, most months poor outcomes, should attract attention.