Chinese Hepatolgy ›› 2025, Vol. 30 ›› Issue (7): 967-971.

• Drug Induced Liver Injury • Previous Articles     Next Articles

Analysis of clinical characteristics of liver injury associated with immune checkpoint inhibitors

ZHAO Meng-yu1, WANG Yan1, LIU Li-wei2, CHEN Wei3, ZHAO Xin-yan1   

  1. 1. Liver Research Center, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Diseases, Beijing 100050, China;
    2. Fourth Department of Liver Disease, Beijing You’an Hospital, Capital Medical University, Beijing 100069, China;
    3. Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
  • Received:2024-11-20 Online:2025-07-31 Published:2025-08-11
  • Contact: ZHAO Xin-yan, Email: zhao_xinyan@ccmu.edu.cn

Abstract: Objective To explore the clinical characteristics of patients with immune-mediated liver injury induced by immune checkpoint inhibitors (ICIs). Methods A retrospective analysis was conducted on patients with malignant tumors who were hospitalized at Beijing Friendship Hospital, Capital Medical University, and received ICIs from April 2016 to December 2022. The clinical characteristics of patients with ICIs-related liver injury and non-ICIs-related liver injury were compared. Results A total of 1,355 patients with malignant tumors treated with ICIs were included in the study, among whom 66 cases (4.9%) developed ICIs-related liver injury, while 1,289 cases (95.1%) did not develop ICIs-related liver injury. There were no statistically significant difference between the two groups in age, gender, tumor location, number of ICIs cycles, type of ICIs, type of ICIs drug, and other systemic immune-related adverse events (irAEs). The baseline levels of alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) in the ICIs-related liver injury group were significantly lower than those in the non-ICIs-related liver injury group (87 vs. 98, P=0.025; 37.5 vs. 49, P=0.003), while the peak levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), GGT, and total bilirubin (TBil) were significantly higher in the ICIs-related liver injury group than in the non-ICIs-related liver injury group (122 vs. 24,P<0.01; 133 vs. 29,P<0.01; 189 vs. 97,P=0.04; 23.9 vs. 16.4, P<0.01). The mortality rate within twelve months was not statistically different between the ICIs-related liver injury group and the non-ICIs-related liver injury group (7.6% vs. 3.0%, P=0.065). There was also no statistically significant difference in mortality rate between patients who received corticosteroids and those who did not (8.3% vs. 10.7%, P=0.85). Conclusion The incidence of ICIs-related liver injury in patients with malignant tumors treated with ICIs was 4.9%. ICIs-related liver injury mainly manifested as elevated ALT and AST levels, with increased GGT and TBil levels. Most cases were mild, and deaths due to ICIs-related liver injury were rare, indicating a relatively better prognosis.

Key words: Immune checkpoint inhibitors, Liver injury, Prognosis