{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T18:07:28Z","timestamp":1785434848806,"version":"3.56.0"},"reference-count":27,"publisher":"Wiley","issue":"22","license":[{"start":{"date-parts":[[2025,11,16]],"date-time":"2025-11-16T00:00:00Z","timestamp":1763251200000},"content-version":"vor","delay-in-days":15,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Thoracic Cancer"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Immune checkpoint inhibitors (ICIs) improve cancer outcomes but cause significant hepatobiliary toxicity (e.g., liver dysfunction, immune\u2010mediated liver disease). Prior studies were limited to small samples or case reports. This study evaluated hepatobiliary toxicity, risk variations, and temporal trends for six ICIs (PD\u20101\/PD\u2010L1 inhibitors) via the FDA Adverse Event Reporting System (FAERS) to guide safer use.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We analyzed 18\u2009640\u2009061 FAERS reports (2004\u20132024). Disproportionality analyses (ROR, PRR, EBGM, BCPNN) detected hepatobiliary toxicity signals. A Weibull model analyzed AE timing. Logistic regression assessed effects of age, gender, and weight.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      PD\u2010L1 inhibitors (Durvalumab, Atezolizumab) are associated more strongly with immune\u2010mediated liver disease\/hepatic failure (ROR\u2009=\u20094.28\u20135.07). PD\u20101 inhibitors (Nivolumab, Pembrolizumab) are linked more to hepatitis\/liver abnormalities (ROR\u2009=\u20093.42\u20133.93). AE reports are common in males (53.32%) and patients &gt;\u200965\u2009years (43.43%), though demographics didn't alter risk (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&gt;\u20090.05). Median onset: 23\u2009days (Toripalimab liver injury) vs. 84\u2009days (Tislelizumab autoimmune hepatitis), supporting drug\u2010specific monitoring in the first three months.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Our FAERS analysis showed PD\u2010L1 inhibitors were more associated with immune\u2010mediated liver disease and hepatic failure, whereas PD\u20101 inhibitors were linked to hepatitis and liver abnormalities, underscoring the need for drug\u2010specific monitoring.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/1759-7714.70184","type":"journal-article","created":{"date-parts":[[2025,11,17]],"date-time":"2025-11-17T04:55:00Z","timestamp":1763355300000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Hepatobiliary Adverse Events Linked to Immune Checkpoint Inhibitors: A Real\u2010World Pharmacovigilance Analysis Using\n                    <scp>FAERS<\/scp>\n                    Data"],"prefix":"10.1111","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-6784-1907","authenticated-orcid":false,"given":"Yuzhu","family":"Chen","sequence":"first","affiliation":[{"name":"Department of Oncology, Beijing Chest Hospital Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute  Beijing China"},{"name":"Laboratory for Clinical Medicine Capital Medical University  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yixin","family":"Zeng","sequence":"additional","affiliation":[{"name":"Department of Oncology, Beijing Chest Hospital Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaisheng","family":"Zhang","sequence":"additional","affiliation":[{"name":"School of Medicine Shaoguan University  Shaoguan People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nand","family":"Lal","sequence":"additional","affiliation":[{"name":"Department of Physiology Harbin Medical University  Harbin Heilongjiang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuxiang","family":"Zhao","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine Fenyang College of Shanxi Medical University  Taiyuan Shanxi China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fei","family":"Qi","sequence":"additional","affiliation":[{"name":"Department of Oncology, Beijing Chest Hospital Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute  Beijing China"},{"name":"Laboratory for Clinical Medicine Capital Medical University  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tongmei","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Oncology, Beijing Chest Hospital Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute  Beijing China"},{"name":"Laboratory for Clinical Medicine Capital Medical University  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,11,16]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/HEP.0000000000000045"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1703481"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdx225"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41575-024-01019-7"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40360-025-00856-9"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1504627"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtocrr.2021.100225"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)01281-7"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1810865"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.31227"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)31046-2"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2018.3923"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-020-02903-2"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1126\/sciimmunol.aba2351"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.apsb.2021.10.003"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1080\/17425255.2019.1574744"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms241411694"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10637-021-01136-z"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12865-025-00682-y"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.3389\/fonc.2021.650292"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1136\/jitc-2020-000943"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41571-019-0218-0"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000003546"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1136\/jitc-2025-011545"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1177\/1078155217745144"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-015-0351-3"},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbspin.2006.09.002"}],"container-title":["Thoracic 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