{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T18:12:33Z","timestamp":1787163153024,"version":"build-2736575974"},"reference-count":37,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2020,12,12]],"date-time":"2020-12-12T00:00:00Z","timestamp":1607731200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2021,2]]},"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Obeticholic acid (OCA) was recently approved as the only on\u2010label alternative for patients with primary biliary cholangitis (PBC) with intolerance or suboptimal response to ursodeoxycholic acid (UDCA). However, few data are available outside clinical trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To assess the effectiveness and safety of OCA in a real\u2010world cohort of patients with non\u2010effective UDCA therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Open\u2010label, prospective, real\u2010world, multicentre study, enrolling consecutive patients who did not meet Paris II criteria, from 18 institutions in Spain and Portugal. Effectiveness was assessed by the changes in GLOBE and UK\u2010PBC scores from baseline. POISE and Paris II criteria were evaluated after 12\u00a0months of OCA . Liver fibrosis was evaluated by FIB\u20104 and AST to platelet ratio index (APRI).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      One hundred and twenty patients were eligible, median time since PBC diagnosis 9.3 (4.0\u201013.8) years, 21.7% had cirrhosis, and 26.7% received had previous or concomitant treatment with fibrates. Seventy\u2010eight patients completed at least 1\u00a0year of OCA. The Globe\u2010PBC score decreased to 0.17 (95% CI 0.05 to 0.28;\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a00.005) and the UK\u2010PBC score decreased to 0.81 (95% CI \u22120.19 to 1.80;\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a00.11). There was a significant decrease in alkaline phosphatase of 81.3\u00a0U\/L (95% CI 42.5 to 120;\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0&lt;\u00a00.001), ALT 22.1\u00a0U\/L (95% CI 10.4 to 33.8;\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0&lt;\u00a00.001) and bilirubin 0.12\u00a0mg\/dL (95% CI 0 to 0.24;\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a00.044). FIB\u20104 and APRI remained stable. According to the POISE criteria, 29.5% (23 out of 78) achieved response. The adverse events rate was 35%; 11.67% discontinued (8.3% due to pruritus).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This study supports data from phase III trials with significant improvement of PBC\u2010Globe continuous prognostic marker score among OCA\u2010treated patients with good tolerability.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/apt.16181","type":"journal-article","created":{"date-parts":[[2023,9,3]],"date-time":"2023-09-03T01:35:30Z","timestamp":1693704930000},"page":"519-530","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":38,"title":["Effectiveness and safety of obeticholic acid in a Southern European multicentre cohort of patients with primary biliary cholangitis and suboptimal response to ursodeoxycholic acid"],"prefix":"10.1111","volume":"53","author":[{"given":"Elena","family":"Gomez","sequence":"first","affiliation":[{"name":"Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luisa","family":"Garcia Buey","sequence":"additional","affiliation":[{"name":"Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Esther","family":"Molina","sequence":"additional","affiliation":[{"name":"Santiago Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marta","family":"Casado","sequence":"additional","affiliation":[{"name":"Almeria Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabel","family":"Conde","sequence":"additional","affiliation":[{"name":"Valencia Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marina","family":"Berenguer","sequence":"additional","affiliation":[{"name":"Valencia 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