Introduction: Immune checkpoint-inhibitors (ICIs) improve the survival in certain cancers. However, side effects of ICIs might limit its use. Little is known about their biliary toxicity. Accordingly, we used a large database to investigate the epidemiology of ICI-induced cholangitis and describe underlying associations.
Methods: A multi-institutional database (Explorys Inc, Cleveland, OH, USA), an aggregate of electronic health record data from 26 US healthcare systems was surveyed. A cohort of patients who were on ICIs (nivolumab, pembrolizumab, ipilimumab and atezolizumab) between 2011 and 2022 was identified. Subsequently, patients who developed new Systematized Nomenclature of Medicine-Clinical Terms diagnosis of cholangitis after taking ICIs were selected. The prevalence of ICI-induced cholangitis as calculated, and underlying associations were described.
Results: There were 70,398,640 in the database of which 417,390 patients had a diagnosis of cholangitis. Among these patients, 260 patients had a prior history of ICI use. Compared to patients with history of ICI use who didn’t develop cholangitis (n=19,940), patients with ICI and cholangitis were more likely to be female [OR: 1.38; 95% CI 1.08–1.76]. There were no statistically significant age or race-based differences. Overall, patients who received any ICI had a significantly higher risk of cholangitis compared to the general population [OR: 1.28; 95% CI 1.13–1.45]. Patients who received Ipilimumab had the highest odds of developing ICI-induced cholangitis (Figure 1).
Discussion: In this large retrospective study, we found that patients taking ICI have a higher risk of cholangitis compared to the general population. Ipilimumab poses the greatest risk for ICI-induced for cholangitis. The risk of cholangitis should be discussed with all patients prior to initiating an ICI, as it may be a factor in choosing among ICIs.
