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These products are associated with a broad array of immune\u2010related toxicities affecting a variety of organs, including the liver. <jats:styled-content style=\"fixed-case\">ICI<\/jats:styled-content>\u2010associated immune\u2010mediated hepatitis (<jats:styled-content style=\"fixed-case\">IMH<\/jats:styled-content>) ranges in severity between mild and life\u2010threatening and is marked by findings that bear both similarities as well as differences with idiopathic autoimmune hepatitis. Hepatotoxic events are often detected in clinical trials of <jats:styled-content style=\"fixed-case\">ICI<\/jats:styled-content>s that are powered for efficacy. Risk levels for <jats:styled-content style=\"fixed-case\">ICI<\/jats:styled-content>\u2010induced liver injury may be impacted by the specific checkpoint molecule targeted for treatment, the <jats:styled-content style=\"fixed-case\">ICI<\/jats:styled-content> dose levels, and the presence of a pre\u2010existing autoimmune diathesis, chronic infection or tumour cells which infiltrate the liver parenchyma. When patients develop liver injury during <jats:styled-content style=\"fixed-case\">ICI<\/jats:styled-content> treatment, a prompt assessment of the cause of injury, in conjunction with the application of measures to optimally manage the adverse event, should be made. Strategies to manage the risk of IMH include the performance of pretreatment liver tests with regular monitoring during and after <jats:styled-content style=\"fixed-case\">ICI<\/jats:styled-content> treatment and patient education. Using Common Terminology Criteria for Adverse Events developed at the National Cancer Institute to measure the severity level of liver injury, recommended actions may include continued <jats:styled-content style=\"fixed-case\">ICI<\/jats:styled-content> treatment with close patient monitoring, <jats:styled-content style=\"fixed-case\">ICI<\/jats:styled-content> treatment suspension or discontinuation and\/or administration of corticosteroids or, when necessary, a non\u2010steroidal immunosuppressive agent. The elucidation of reliable predictors of tumour\u2010specific <jats:styled-content style=\"fixed-case\">ICI<\/jats:styled-content> treatment responses, as well as an increased susceptibility for clinically serious immune\u2010related adverse events, would help optimize treatment decisions for individual patients.<\/jats:p>","DOI":"10.1111\/liv.13746","type":"journal-article","created":{"date-parts":[[2018,3,31]],"date-time":"2018-03-31T10:22:31Z","timestamp":1522491751000},"page":"976-987","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":189,"title":["Hepatotoxicity of immune checkpoint inhibitors: An evolving picture of risk associated with a vital class of immunotherapy agents"],"prefix":"10.1111","volume":"38","author":[{"given":"Daniel L.","family":"Suzman","sequence":"first","affiliation":[{"name":"Office of Hematology and Oncology Products Center for Drug Evaluation and Research US Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lorraine","family":"Pelosof","sequence":"additional","affiliation":[{"name":"Office of Hematology and Oncology Products Center for Drug Evaluation and Research US Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy","family":"Rosenberg","sequence":"additional","affiliation":[{"name":"Office of Biotechnology Products Center for Drug Evaluation and Research US Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark I.","family":"Avigan","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology Center for Drug Evaluation and Research US Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,4,24]]},"reference":[{"key":"e_1_2_14_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ccell.2015.03.007"},{"key":"e_1_2_14_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrclinonc.2016.25"},{"key":"e_1_2_14_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2017.01.035"},{"key":"e_1_2_14_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/imr.12531"},{"key":"e_1_2_14_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2015.02.018"},{"key":"e_1_2_14_7_1","doi-asserted-by":"publisher","DOI":"10.1189\/jlb.5RI0116-013RR"},{"key":"e_1_2_14_8_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.aaa8172"},{"key":"e_1_2_14_9_1","doi-asserted-by":"publisher","DOI":"10.1155\/2016\/4683607"},{"key":"e_1_2_14_10_1","unstructured":"US Food & Drug Administration.Drugs.2018;https:\/\/www.fda.gov\/Drugs\/default.htm. 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