{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T11:00:28Z","timestamp":1792839628648,"version":"4.5.0"},"reference-count":23,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2022,8,23]],"date-time":"2022-08-23T00:00:00Z","timestamp":1661212800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Liver International"],"published-print":{"date-parts":[[2022,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background &amp; Aims<\/jats:title>\n                    <jats:p>Obeticholic acid (OCA) has recently been restricted in patients with primary biliary cholangitis (PBC) with \u201cadvanced cirrhosis\u201d because of its narrow therapeutic index. We aimed to better define the predicting factors of hepatic serious adverse events (SAEs) and non\u2010response in cirrhotic patients undergoing OCA therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Safety and efficacy of treatment were evaluated in a cohort of consecutive PBC cirrhotic patients started with OCA. OCA response was evaluated according to the Poise criteria. Risk factors for hepatic SAEs and non\u2010response were reported as risk ratios (RR) with 95% confidence intervals (CIs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>One hundred PBC cirrhotics were included, 97 Child\u2010Pugh class A and 3 class B. Thirty\u2010one had oesophageal varices and 5 had a history of ascites. Thirty\u2010three per cent and 32% of patients achieved a biochemical response at 6 and 12\u2009months respectively. Male sex (adjusted\u2010RR 1.75, 95%CI 1.42\u20132.12), INR (1.37, 1.00\u20131.87), Child\u2010Pugh score (1.79, 1.28\u20132.50), MELD (1.17, 1.04\u20131.30) and bilirubin (1.83, 1.11\u20133.01) were independently associated with non\u2010response to OCA. Twenty\u2010two patients discontinued OCA within 12\u2009months: 10 for pruritus, 9 for hepatic SAEs (5 for jaundice and\/or ascitic decompensation; 4 for upper digestive bleeding). INR (adjusted\u2010RR 1.91, 95%CI 1.10\u20133.36), lower albumin levels (0.18, 0.06\u20130.51), Child\u2010Pugh score (2.43, 1.50\u20134.04), history of ascites (3.5, 1.85\u20136.5) and bilirubin (1.30, 1.05\u20131.56), were associated with hepatic SAEs. A total bilirubin\u22651.4\u00a0mg\/dl at baseline was the most accurate biochemical predictor of hepatic SAEs under OCA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>An accurate baseline assessment is crucial to select cirrhotic patients who can benefit from OCA. Although OCA is effective in one third of cirrhotics, bilirubin level\u2009\u22651.4\u00a0mg\/dl should discourage from its use.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/liv.15386","type":"journal-article","created":{"date-parts":[[2022,8,5]],"date-time":"2022-08-05T23:53:06Z","timestamp":1659743586000},"page":"2453-2465","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":30,"title":["Predictors of serious adverse events and non\u2010response in cirrhotic patients with primary biliary cholangitis treated with obeticholic acid"],"prefix":"10.1111","volume":"42","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0220-0500","authenticated-orcid":false,"given":"Antonio","family":"De Vincentis","sequence":"first","affiliation":[{"name":"Internal Medicine and Hepatology University Campus Bio\u2010Medico of Rome  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daphne","family":"D'Amato","sequence":"additional","affiliation":[{"name":"Gastroenterology Unit, Citt\u00e0 della salute e della scienza  Turin Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Cristoferi","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Centre for Autoimmune Liver Diseases, Department of Medicine and Surgery University of Milano\u2010Bicocca, European Reference Network on Hepatological Diseases (ERN RARE\u2010LIVER), San Gerardo Hospital  Monza Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessio","family":"Gerussi","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Centre for Autoimmune Liver Diseases, Department of Medicine and Surgery University of Milano\u2010Bicocca, European Reference Network on Hepatological Diseases (ERN RARE\u2010LIVER), San Gerardo Hospital  Monza Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federica","family":"Malinverno","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Centre for Autoimmune Liver Diseases, Department of Medicine and Surgery University of Milano\u2010Bicocca, European Reference Network on Hepatological Diseases (ERN RARE\u2010LIVER), San Gerardo Hospital  Monza Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0561-7902","authenticated-orcid":false,"given":"Ana","family":"Lleo","sequence":"additional","affiliation":[{"name":"Internal Medicine and Hepatology, Humanitas Clinical and Research Center IRCCS Humanitas University  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7520-744X","authenticated-orcid":false,"given":"Francesca","family":"Colapietro","sequence":"additional","affiliation":[{"name":"Internal Medicine and Hepatology, Humanitas Clinical and Research Center IRCCS Humanitas University  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8629-0878","authenticated-orcid":false,"given":"Fabio","family":"Marra","sequence":"additional","affiliation":[{"name":"Internal Medicine and Hepatology Unit, Department of Experimental and Clinical Medicine University of Firenze  Firenze Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Galli","sequence":"additional","affiliation":[{"name":"Department of Experimental and Clinical Biochemical Sciences University of Florence  Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cecilia","family":"Fiorini","sequence":"additional","affiliation":[{"name":"Department of Experimental and Clinical Biochemical Sciences University of Florence  Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Coco","sequence":"additional","affiliation":[{"name":"Hepatology Unit, University Hospital of Pisa  Pisa Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8364-9152","authenticated-orcid":false,"given":"Maurizia","family":"Brunetto","sequence":"additional","affiliation":[{"name":"Hepatology Unit, University Hospital of Pisa  Pisa Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Grazia Anna","family":"Niro","sequence":"additional","affiliation":[{"name":"Gastroenterology Unit, Fondazione Casa Sollievo Della Sofferenza IRCCS  San Giovanni Rotondo Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosa","family":"Cotugno","sequence":"additional","affiliation":[{"name":"Gastroenterology Unit, Fondazione Casa Sollievo Della Sofferenza IRCCS  San Giovanni Rotondo Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo","family":"Saitta","sequence":"additional","affiliation":[{"name":"Division of Medicine and Hepatology University Hospital of Messina \u201cPoliclinico G. 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