Pharmacovigilance and Risk Management Strategies Conference

It is critical to detect the hepatotoxic potential of drugs and to identify susceptible individuals at risk for both predictive and idiosyncratic liver toxicities. This is particularly important as immuno-oncology (IO) agents, e.g., checkpoint inhibitors, known to cause immune-mediated hepatitis, are used in increasingly broad populations as first-line treatment of malignancies and there is increasing understanding of drug-induced liver injury (DILI) in the setting of chronic liver disease. Recent advances in knowledge of immune-mediated hepatotoxicity secondary to IO agents and DILI application to classical will be reviewed. This will be followed by a discussion on DILI in patients with underlying liver disease, focusing on NASH. A panel discussion will conclude the session addressing points to consider in the pragmatic causality assessment of liver injury in the setting of exposure to IO agents.