{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T15:02:01Z","timestamp":1790262121246,"version":"4.1.0"},"reference-count":48,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,7,14]],"date-time":"2026-07-14T00:00:00Z","timestamp":1783987200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,7,14]],"date-time":"2026-07-14T00:00:00Z","timestamp":1783987200000},"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":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Obeticholic acid (OCA) has been evaluated in patients with primary biliary cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (UDCA) in the 12\u2010month, double\u2010blind, phase 3 POISE trial. A 3\u2010year interim analysis of the open\u2010label extension (OLE) demonstrated a favourable safety profile with sustained improvements in liver biochemistries.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To present the final long\u2010term safety and efficacy data from the 5\u2010year POISE OLE.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      All patients who entered the OLE (\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u2009193) were started on OCA 5\u2009mg daily for a minimum of 3\u2009months, after which the dose could be increased. Safety and efficacy were evaluated in the overall OLE population. Additional analyses censored data points following OCA titration &gt;\u200910\u2009mg to align with the prescribing label.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      POISE was terminated after it was determined that the OLE had achieved its study objectives of sustained efficacy with no unexpected safety findings. With censoring of data points following OCA titration to &gt;\u200910\u2009mg, the most common treatment\u2010emergent adverse event (TEAE) was pruritus (70%); serious hepatic\u2010related TEAEs were reported in five patients (3%). The serious hepatic\u2010related TEAEs and deaths (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20092, 1%) were assessed by the Investigators as unrelated to OCA. Liver biochemistries improved throughout the OLE; the response rate for the POISE primary endpoint was 63% at Month 72. Liver stiffness, as measured by transient elastography, was stable over the study duration.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Findings from the POISE OLE support the safety and efficacy profile of long\u2010term OCA treatment for patients with PBC with inadequate response or intolerance to UDCA (NCT01473524).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>\n                      Phase 3 study of obeticholic acid in patients with primary biliary cirrhosis (POISE)\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      identifier: NCT01473524\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/apt.70832","type":"journal-article","created":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T03:26:02Z","timestamp":1784085962000},"page":"1083-1096","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Long\u2010Term Safety and Efficacy of Obeticholic Acid in Patients With Primary Biliary Cholangitis: Final Results of the\n                    <scp>POISE<\/scp>\n                    Long\u2010Term Safety Extension"],"prefix":"10.1111","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3906-6811","authenticated-orcid":false,"given":"Christopher L.","family":"Bowlus","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology University of California Davis School of Medicine  Sacramento California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frederik","family":"Nevens","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology University Hospital KU Leuven  Leuven Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kris V.","family":"Kowdley","sequence":"additional","affiliation":[{"name":"Liver Institute Northwest and Elon S. Floyd College of Medicine Washington State University  Seattle Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6821-0416","authenticated-orcid":false,"given":"Alan","family":"Bonder","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Beth Israel Deaconess Medical Center, Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Capozza","sequence":"additional","affiliation":[{"name":"Intercept Pharmaceuticals Inc.  Morristown New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Li","sequence":"additional","affiliation":[{"name":"Intercept Pharmaceuticals Inc.  Morristown New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Radhika","family":"Nair","sequence":"additional","affiliation":[{"name":"Intercept Pharmaceuticals Inc.  Morristown New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Trauner","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Medicine III Medical University of Vienna  Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David E.","family":"Jones","sequence":"additional","affiliation":[{"name":"Translational and Clinical Research Institute Newcastle University  Newcastle\u2010upon\u2010Tyne UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,14]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.30145"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2022.06.017"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)00154-3"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2022.08.054"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2017.03.022"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2017-315259"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.dld.2017.05.001"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.17226"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2014.08.029"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000000557"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2020.08.006"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.70120"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1509840"},{"key":"e_1_2_12_15_1","volume-title":"Ocaliva (Obeticholic Acid). 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