The University of Toledo Translation Journal of Medical Sciences 
Haematology and Oncology Abstract, Department of Medicine Research Symposium UTJMS 2023 May 5; 11(1):e1-e1 

Immune Checkpoint Inhibitor Induced Hepatitis Injury: 
Risk Factors, Outcomes, and Impact on Survival 

Abdul Miah1*, Gabriel Tinoco, Songzhu Zhao, Lai Wei, Dwight H Owen, Danae M . Hamouda1 

1Division of Haemtology and Oncology , Department of Medicine, The University of 
Toledo, Toledo, OH 43614 

*Corresponding author: danae.hamouda@utoledo.edu

Published: 05 May 2023 

Purpose: Immune checkpoint inhibitors (ICIs) are associated with a unique set of immune-related 
adverse events (irAEs). Few studies have evaluated risk factors and outcomes of patients who develop 
ICI-induced hepatitis (ICIH).  

Methods: We utilized an institutional database of patients with advanced cancers treated with ICI to 
identify patients with ICIH. irAEs were graded using the Common Terminology Criteria for Adverse 
Events v4. Overall survival (OS) was calculated from the date of ICI to death from any cause or the date 
of the last follow-up. OS with 95% confidence intervals were estimated using the Kaplan–Meier method 
and stratified by occurrence of ICIH.  

Results: We identified 1,096 patients treated with ICI . The most common ICIs were PD1/L1 (n=774) 
and CTLA-4 inhibitors (n=195). ICIH occurred among 64 (6%) patients: severity was < grade 3 in 30 
and ≥ grade 3 in 24 patients (3.1% overall). Median time to ICIH was 63 days. ICIH was more frequent 
in women (p=0.038), in patients treated with combination ICIs (p<0.001), and when given as first line 
therapy (p=0.018). Occurrence of ICIH was associated with significantly longer OS, median 37.0 
months (95% CI 21.4, NR) compared to 11.3 months (95% CI 10, 13, p<0.001); there was no difference 
in OS between patients with ≥ grade 3 ICIH vs grade 1-2.  

Conclusion: Female sex, combination immunotherapy, and first line of immunotherapy were associated 
with ICIH. Patients with ICIH had improved clinical survival compared to those that did not develop 
ICIH. 

https://dx.doi.org/10.46570/utjms.vol11-2023-736 

https://dx.doi.org/10.46570/utjms.vol11-2023-736
mailto:danae.hamouda@utoledo.edu