{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,6]],"date-time":"2026-04-06T18:52:39Z","timestamp":1775501559369,"version":"3.50.1"},"reference-count":22,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"6","license":[{"start":{"date-parts":[[2018,4,19]],"date-time":"2018-04-19T00:00:00Z","timestamp":1524096000000},"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":["Hepatology Communications"],"published-print":{"date-parts":[[2018,6]]},"abstract":"<jats:p>The GLOBAL Primary Biliary Cholangitis (PBC) Study Group and United Kingdom\u2010PBC (UK\u2010PBC) Consortium have demonstrated that dichotomous response criteria are not as accurate as continuous equations at predicting mortality or liver transplantation in PBC. The aim of this analysis was to assess the clinical utility of the GLOBE and UK\u2010PBC risk scores using data from POISE, a phase 3 trial investigating obeticholic acid (OCA) in patients with PBC. Data (N = 216) at baseline and month 12 were used to calculate the GLOBE and UK\u2010PBC risk scores to assess the projected change in risk with OCA versus placebo. Additionally, the benefit of OCA was assessed in patients not meeting the POISE primary endpoint. Both the GLOBE and UK\u2010PBC risk scores predicted a significant reduction in long\u2010term risk of death and liver transplantation after OCA treatment (<jats:italic toggle=\"yes\">P &lt;<\/jats:italic> 0.0001). The differences in the relative risk reduction from baseline in the 10\u2010year event risk after 1 year for OCA 10 mg versus placebo was 26% (GLOBE) and 37% (UK\u2010PBC). The scores also predicted a significantly decreased risk in patients treated with OCA who did not meet POISE response criteria after 1 year of treatment compared to an increased risk with placebo (<jats:italic toggle=\"yes\">P &lt;<\/jats:italic> 0.0001). <jats:italic toggle=\"yes\">Conclusion:<\/jats:italic> This analysis demonstrates the use of the GLOBE and UK\u2010PBC risk scores to assess risk reduction of a cohort treated with OCA. While validation of this risk reduction in studies with clinical outcomes is needed, this study highlights the potential use of these scores in individualizing risk prediction in PBC both in clinical practice and therapeutic trials. (<jats:italic toggle=\"yes\">Hepatology Communications<\/jats:italic> 2018;2:683\u2010692)<\/jats:p>","DOI":"10.1002\/hep4.1180","type":"journal-article","created":{"date-parts":[[2018,4,19]],"date-time":"2018-04-19T19:20:12Z","timestamp":1524165612000},"page":"683-692","source":"Crossref","is-referenced-by-count":25,"title":["Clinical application of the GLOBE and United Kingdom\u2010primary biliary cholangitis risk scores in a trial cohort of patients with primary biliary cholangitis"],"prefix":"10.1097","volume":"2","author":[{"given":"Marco","family":"Carbone","sequence":"first","affiliation":[{"name":"Academic Department of Medical Genetics,University of Cambridge,Cambridge,United Kingdom"},{"name":"Division of Gastroenterology,University of Milan\u2010Bicocca,Milan,Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maren H.","family":"Harms","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology,Erasmus University Medical Center,Rotterdam,the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Willem J.","family":"Lammers","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology,Erasmus University Medical Center,Rotterdam,the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tonya","family":"Marmon","sequence":"additional","affiliation":[{"name":"Intercept Pharmaceutical, Inc.,San Diego,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard","family":"Pencek","sequence":"additional","affiliation":[{"name":"Intercept Pharmaceutical, Inc.,San Diego,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Leigh","family":"MacConell","sequence":"additional","affiliation":[{"name":"Intercept Pharmaceutical, Inc.,San Diego,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Shapiro","sequence":"additional","affiliation":[{"name":"Intercept Pharmaceutical, Inc.,San Diego,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David E.","family":"Jones","sequence":"additional","affiliation":[{"name":"Institute of Cellular Medicine,Newcastle University,Newcastle,United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"George F.","family":"Mells","sequence":"additional","affiliation":[{"name":"Academic Department of Medical Genetics,University of Cambridge,Cambridge,United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bettina E.","family":"Hansen","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology,Erasmus University Medical Center,Rotterdam,the Netherlands"},{"name":"Toronto Centre for Liver Disease,Toronto General 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