Abstract: Objective To analyze the clinical characteristics, treatment, and prognosis of the patients with ICI-induced immune-mediated hepatotoxicity (IMH). Methods A total 14 IMH patients were retrospectively recruited from Department of Infectious Diseases, Ruijin Hospital between September 2019 to September 2022. The characteristics of onset, clinical manifestations, treatment response and the prognosis of IMH patients were summarized and analyzed. Results The 14 patients (median age, 61 years) were mainly males, usually present with jaundice, malaise, and yellow color urine as the main symptoms. The mainly clinical pattern was cholestasis type in 8/12 (66.67%), and 10 patients had grade 3-4 liver injury. The patients were treated with diammonium glycyrrhetate or UDCA basically, and 10 patients were treated with steroids (4/10) or steroids combined with second line immunosuppressive treatment (Mycophenolate Mofetil, 6/10). After treatment, 5 of the 14 patients died or withdrawing treatment due to deterioration of the disease (excluding sudden unexpected death in 2 patients due to other diseases), and 7 patients recovered from IMH. The neutrophil-to-lymphocyte ratio (NLR) in the poor prognosis group was significantly higher than those in the good prognosis group (13.5 vs 3.3, P<0.05). Conclusion Cholestatic type is the main clinical pattern of IMH. Half of the patients recovered after the treatment. The overall prognosis is poor. NLR may be used as a clinical marker to evaluate the prognosis of IMH.

Key words: Immune-checkpoint inhibitors (ICIs), Immune-related adverse reactions, Hepatotoxicity