Clinical characteristics and prognosis of liver injury in patients receiving immune checkpoint inhibitor-based therapy: a real-world retrospective study

Aims This study aimed to examine the clinical characteristics, injury patterns and 6-month recovery of liver injury in patients receiving immune checkpoint inhibitor -based therapy. Methods We conducted a retrospective study of patients receiving ICIs at Tianjin Union Medical Center (The First Affiliated Hospital of Nankai University) between January 2020 and June 2024, with follow-up censored December 2024 and a minimum 6 months. We analysed the clinical characteristics, severity, dynamic changes in liver function, and recovery factors of patients with ICI-based therapy-related liver injury (ICI-LI). Results Of 682 patients, 83 (12.17%) developed ICI-LI (cholestatic 73.49%, mixed 20.48%, hepatocellular 6.02%). Among 83 patients, baseline alkaline phosphatase (ALP), gamma-glutamyl transferase, and total bilirubin, and peak alanine aminotransferase (ALT) and aspartate aminotransferase (AST) trend to be higher with greater liver injury severity. The rate of change in liver function parameters differed by subtype: hepatocellular injury showed rapid ALT/AST increases, cholestatic injury a marked but slower ALP increase, and mixed injury features of both. In univariate analysis, age, peak ALT, and neutrophil-to-lymphocyte ratio (NLR) > 3 were associated with poor 6-month recovery ( P < 0.05); in multivariate analysis, only NLR >3 remained associated (OR = 10.917, 95% CI 1.552-76.817, P = 0.016). ROC analysis yielded AUCs of 0.702 for continuous NLR (cut-off 2.955, rounded to 3) and 0.694 for NLR >3. Conclusion Cholestatic injury was the predominant subtype with PD-1/PD-L1 inhibitor-containing therapy. Changes in liver function parameters varied according to the clinical pattern. NLR >3 warrants further investigation as a potential exploratory biomarker for poor recovery in ICI-LI.