{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T18:23:32Z","timestamp":1787163812500,"version":"build-2736575974"},"reference-count":16,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"9","license":[{"start":{"date-parts":[[2020,7,6]],"date-time":"2020-07-06T00:00:00Z","timestamp":1593993600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Hepatol Commun"],"published-print":{"date-parts":[[2020,9]]},"abstract":"<jats:p>\n                    Patients with primary biliary cholangitis (PBC) with incomplete response to ursodeoxycholic acid are at risk of disease progression and need additional therapy. Obeticholic acid (OCA) was approved in Canada in May 2017, but its effectiveness in a real\u2010world setting has not been described. We sought to describe our experience with OCA in a Canadian cohort. OCA\u2010naive patients treated at two Canadian centers were included. Clinical and biochemical data were collected at OCA initiation and during follow\u2010up. Primary outcomes were changes in serum alkaline phosphatase (ALP), gamma\u2010glutamyl transferase (GGT), and total bilirubin (TB) over the duration of therapy. Secondary outcomes were changes in alanine aminotransferase (ALT), aspartate aminotransferase (AST), immunoglobulin M (IgM), platelets, and albumin; and achievement of the primary endpoint of the original phase 3 study that led to OCA approval (A Placebo\u2010Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis [POISE]), dose reductions, discontinuations, and tolerability. Repeated\u2010measures models were used to assess changes in biochemistry over time. Sixty\u2010four patients were included; 4 carried a diagnosis of overlap with autoimmune hepatitis. Mean age was 54.6\u00a0years, median ALP was 250\u00a0U\/L, TB was 13\u00a0\u00b5mol\/L, platelet count was 225\u00a0\u00d7\u00a010\n                    <jats:sup>9<\/jats:sup>\n                    \/L, and 24% had liver stiffness measurements \u226516.9\u00a0kPa. There was a significant reduction in mean ALP of 55\u00a0U\/L (\n                    <jats:italic toggle=\"yes\">P<\/jats:italic>\n                    \u00a0&lt;\u00a00.001), GGT of 138\u00a0U\/L (\n                    <jats:italic toggle=\"yes\">P<\/jats:italic>\n                    \u00a0&lt;\u00a00.001), ALT of 11.9\u00a0U\/L (\n                    <jats:italic toggle=\"yes\">P<\/jats:italic>\n                    \u00a0&lt;\u00a00.001), AST of 5.7\u00a0U\/L (\n                    <jats:italic toggle=\"yes\">P<\/jats:italic>\n                    \u00a0&lt;\u00a00.05), and IgM of 0.70\u00a0g\/L (\n                    <jats:italic toggle=\"yes\">P<\/jats:italic>\n                    \u00a0&lt;\u00a00.001) over 12\u00a0months; TB remained stable (\n                    <jats:italic toggle=\"yes\">P<\/jats:italic>\n                    \u00a0=\u00a00.98). Forty\u2010four patients met POISE\u2010inclusion criteria, 39% (n\u00a0=\u00a017) of whom had 12\u2010month biochemical measurements. In this subset, 18% (n\u00a0=\u00a03\/17) met the 12\u2010month POISE primary endpoint, but considering follow\u2010up to 19\u00a0months, 43% achieved this target (n\u00a0=\u00a09\/21). Pruritus was the most commonly reported complaint.\n                    <jats:italic toggle=\"yes\">Conclusion<\/jats:italic>\n                    : Use of OCA was associated with improvement in biochemical surrogates of outcome in PBC in a real\u2010world setting.\n                  <\/jats:p>","DOI":"10.1002\/hep4.1518","type":"journal-article","created":{"date-parts":[[2020,7,6]],"date-time":"2020-07-06T21:13:41Z","timestamp":1594070021000},"page":"1332-1345","source":"Crossref","is-referenced-by-count":55,"title":["Real\u2010World Effectiveness of Obeticholic Acid in Patients with Primary Biliary Cholangitis"],"prefix":"10.1097","volume":"4","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8792-2240","authenticated-orcid":false,"given":"Surain B.","family":"Roberts","sequence":"first","affiliation":[{"name":"Toronto Centre for Liver Disease,Toronto General Hospital,University Health Network,Toronto,ON,Canada"},{"name":"Institute of Health Policy, Management and Evaluation,University of Toronto,Toronto,ON,Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marwa","family":"Ismail","sequence":"additional","affiliation":[{"name":"Toronto Centre for Liver Disease,Toronto General Hospital,University Health Network,Toronto,ON,Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gowthami","family":"Kanagalingam","sequence":"additional","affiliation":[{"name":"Toronto Centre for Liver Disease,Toronto General Hospital,University Health Network,Toronto,ON,Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew L.","family":"Mason","sequence":"additional","affiliation":[{"name":"Department of Medicine,University of Alberta,Edmonton,AB,Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark G.","family":"Swain","sequence":"additional","affiliation":[{"name":"Department of Medicine,University of Calgary,Calgary,AB,Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Vincent","sequence":"additional","affiliation":[{"name":"D\u00e9partement de M\u00e9decine,Universit\u00e9 de Montr\u00e9al,Montr\u00e9al,QC,Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric M.","family":"Yoshida","sequence":"additional","affiliation":[{"name":"Department of Medicine,University of British Columbia,Vancouver,BC,Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cynthia","family":"Tsien","sequence":"additional","affiliation":[{"name":"Department of Medicine,University of Ottawa,Ottawa,ON,Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer A.","family":"Flemming","sequence":"additional","affiliation":[{"name":"Department of Medicine,Queen\u2019s University,Kingston,ON,Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harry L.A.","family":"Janssen","sequence":"additional","affiliation":[{"name":"Toronto Centre for Liver Disease,Toronto General Hospital,University Health Network,Toronto,ON,Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gideon M.","family":"Hirschfield","sequence":"additional","affiliation":[{"name":"Toronto Centre for Liver Disease,Toronto General Hospital,University Health Network,Toronto,ON,Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bettina E.","family":"Hansen","sequence":"additional","affiliation":[{"name":"Toronto Centre for Liver Disease,Toronto General Hospital,University Health Network,Toronto,ON,Canada"},{"name":"Institute of Health Policy, Management and Evaluation,University of Toronto,Toronto,ON,Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aliya F.","family":"Gulamhusein","sequence":"additional","affiliation":[{"name":"Toronto Centre for Liver Disease,Toronto General Hospital,University Health Network,Toronto,ON,Canada"},{"name":"Institute of Health Policy, Management and Evaluation,University of Toronto,Toronto,ON,Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the Canadian Network for Autoimmune Liver Disease","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2020,7,6]]},"reference":[{"key":"hep41518-bib-0001-20240114","doi-asserted-by":"crossref","first-page":"E664","DOI":"10.9778\/cmajo.20180029","article-title":"Epidemiology and liver transplantation burden of primary biliary cholangitis: a retrospective cohort study","volume":"6","year":"2018","journal-title":"CMAJ Open"},{"key":"hep41518-bib-0002-20240114","doi-asserted-by":"crossref","first-page":"394","DOI":"10.1002\/hep.30145","article-title":"Primary biliary cholangitis: 2018 practice guidance from the American Association for the study of liver 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