{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,2]],"date-time":"2026-04-02T12:46:54Z","timestamp":1775134014502,"version":"3.50.1"},"reference-count":35,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2025,11,24]],"date-time":"2025-11-24T00:00:00Z","timestamp":1763942400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,11,24]],"date-time":"2025-11-24T00:00:00Z","timestamp":1763942400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Hepatology Research"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>Immune checkpoint inhibitor (ICI)\u2010associated cholangitis is a rare immune\u2010related adverse event (irAE). However, large\u2010scale clinical studies specifically investigating this toxicity are still lacking. The aim was to describe ICI\u2010associated cholangitis reported to the United States Food and Drug Administration Adverse Event Reporting System (FAERS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Reports of irAEs were extracted from the FAERS database (Q1 2011 to Q4 2024). Cases of ICI\u2010associated cholangitis were identified using the following Preferred Terms from the Medical Dictionary for Regulatory Activities (version 27.1): \u201ccholangitis,\u201d \u201csclerosing cholangitis,\u201d and \u201cimmune\u2010mediated cholangitis\u201d. Reporting odds ratio (ROR) method was performed to evaluate the association between cholangitis and different ICI therapies. Additionally, the clinical features of ICI\u2010associated cholangitis were characterized, and the time\u2010to\u2010onset (TTO) of cholangitis following ICI treatment was assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 1102 patients with ICI\u2010associated cholangitis were identified. Male patients (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0628, 56.99%) outnumbered females (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0334, 30.31%). Most patients were aged \u2265\u00a065\u00a0years (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0540, 49.00%). Hospitalization (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0454, 41.20%) was the most frequent clinical outcome. Programmed cell death protein 1 inhibitors showed the strongest risk association (ROR\u00a0=\u00a024.65 and 95% confidence interval [CI]: 22.84\u201326.59), followed by programmed death\u2010ligand 1 inhibitors (ROR\u00a0=\u00a019.03 and 95% CI: 16.41\u201322.08). In contrast, cytotoxic T\u2010lymphocyte\u2010associated protein 4 inhibitors showed no significant association (ROR\u00a0=\u00a02.08 and 95% CI: 0.93\u20134.64). The median TTO was 77\u00a0days (interquartile range: 31\u2013164\u00a0days).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>From a pharmacovigilance perspective, this study characterizes certain clinical features of ICI\u2010associated cholangitis, elucidates distinct risk profiles across ICI classes, and emphasized the importance of constant monitoring. However, further studies remain essential to fully understand this rare irAE.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/hepr.70082","type":"journal-article","created":{"date-parts":[[2025,11,24]],"date-time":"2025-11-24T16:33:07Z","timestamp":1764001987000},"page":"478-486","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["A Pharmacovigilance Study of Immune Checkpoint Inhibitor\u2010Associated Cholangitis: Insights From the FDA Adverse Event Reporting System"],"prefix":"10.1111","volume":"56","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-0754-3373","authenticated-orcid":false,"given":"Haowen","family":"Tan","sequence":"first","affiliation":[{"name":"Office of Good Clinical Practice Wuzhou Red Cross Hospital  Wuzhou China"},{"name":"Department of Pharmacy Wuzhou Red Cross Hospital  Wuzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xuan","family":"Ou","sequence":"additional","affiliation":[{"name":"Office of Good Clinical Practice Wuzhou Red Cross Hospital  Wuzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ying","family":"Chen","sequence":"additional","affiliation":[{"name":"Office of Good Clinical Practice Wuzhou Red Cross Hospital  Wuzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Weiwei","family":"Lan","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Wuzhou Red Cross Hospital  Wuzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-4641-2874","authenticated-orcid":false,"given":"Luping","family":"Luo","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Wuzhou Red Cross Hospital  Wuzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,11,24]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.aaa8172"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ccell.2015.03.001"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrc3239"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2407417"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41571\u2010024\u201000976\u2010x"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2312695"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1703481"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41571\u2010019\u20100218\u20100"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2022.10.001"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdw649"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10637\u2010017\u20100453\u20100"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2020.11.048"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2019.04.022"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1136\/esmoopen\u20102020\u2010000866"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.3390\/cancers15010240"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.intimp.2022.109015"},{"key":"e_1_2_11_18_1","unstructured":"\u201c21 CFR \u00a7 600.80\u2014Postmarketing Reporting of Adverse Experiences.\u201d Accessed 30 Aug 2025 https:\/\/www.govinfo.gov\/app\/details\/CFR\u20102023\u2010title21\u2010vol7\/CFR\u20102023\u2010title21\u2010vol7\u2010sec600\u201080\/context."},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1001"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1158\/2159\u20108290.CD\u201018\u20100367"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.2165\/11599740\u2010000000000\u201000000"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264\u2010013\u20100061\u20107"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/jcpt.13024"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1136\/esmoopen\u20102017\u2010000268"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1080\/08923973.2024.2402338"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21763"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2023.12.008"},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.1097\/PAS.0000000000000453"},{"key":"e_1_2_11_29_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v28.i28.3732"},{"key":"e_1_2_11_30_1","doi-asserted-by":"publisher","DOI":"10.1111\/liv.16163"},{"key":"e_1_2_11_31_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v26.i3.353"},{"key":"e_1_2_11_32_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtho.2017.10.007"},{"key":"e_1_2_11_33_1","doi-asserted-by":"publisher","DOI":"10.1111\/jgh.15797"},{"key":"e_1_2_11_34_1","doi-asserted-by":"publisher","DOI":"10.1055\/s\u20100044\u20101779520"},{"key":"e_1_2_11_35_1","doi-asserted-by":"publisher","DOI":"10.1042\/CS20110184"},{"key":"e_1_2_11_36_1","doi-asserted-by":"publisher","DOI":"10.1097\/MEG.0000000000002280"}],"container-title":["Hepatology Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hepr.70082","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/hepr.70082","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hepr.70082","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,2]],"date-time":"2026-04-02T11:45:12Z","timestamp":1775130312000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/hepr.70082"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,24]]},"references-count":35,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2026,4]]}},"alternative-id":["10.1111\/hepr.70082"],"URL":"https:\/\/doi.org\/10.1111\/hepr.70082","archive":["Portico"],"relation":{},"ISSN":["1386-6346","1872-034X"],"issn-type":[{"value":"1386-6346","type":"print"},{"value":"1872-034X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11,24]]},"assertion":[{"value":"2025-09-01","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-18","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-24","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}