Development and validation of a nomogram model for predicting immune-mediated hepatitis in cancer patients treated with immune checkpoint inhibitors.

Abstract

Immune checkpoint inhibitors (ICIs) have been widely used in various types of cancer, but they have also led to a significant number of adverse events, including ICI-induced immune-mediated hepatitis (IMH). This study aimed to explore the risk factors for IMH in patients treated with ICIs and to develop and validate a new nomogram model to predict the risk of IMH. Detailed information was collected between January 1, 2020, and December 31, 2023. Univariate logistic regression analysis was used to assess the impact of each clinical variable on the occurrence of IMH, followed by stepwise multivariate logistic regression analysis to determine independent risk factors for IMH. A nomogram model was constructed based on the results of the multivariate analysis. The performance of the nomogram model was evaluated via the area under the receiver operating characteristic curve (AUC), calibration curves, decision curve analysis (DCA), and clinical impact curve (CIC) analysis. A total of 216 (8.82%) patients developed IMH. According to stepwise multivariate logistic analysis, hepatic metastasis, the TNM stage, the WBC count, LYM, ALT, TBIL, ALB, GLB, and ADA were identified as risk factors for IMH. The AUC for the nomogram model was 0.817 in the training set and 0.737 in the validation set. The calibration curves, DCA results, and CIC results indicated that the nomogram model had good predictive accuracy and clinical utility. The nomogram model is intuitive and straightforward, making it highly suitable for rapid assessment of the risk of IMH in patients receiving ICI therapy in clinical practice. Implementing this model enables early adoption of preventive and therapeutic strategies, ultimately reducing the likelihood of immune-related adverse events (IRAEs), and especially IMH.