{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T05:38:31Z","timestamp":1791005911169,"version":"4.1.0"},"reference-count":40,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2025,9,30]],"date-time":"2025-09-30T00:00:00Z","timestamp":1759190400000},"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":["J of Gastro and Hepatol"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Obeticholic acid (OCA) was conditionally approved in 2016 as a second\u2010line therapy for patients with primary biliary cholangitis (PBC) and incomplete response to ursodeoxycholic acid (UDCA) monotherapy. We aimed to evaluate the impact of OCA add\u2010on therapy on biochemical outcomes and safety in those patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We systematically searched MEDLINE, Embase, and Cochrane CENTRAL for papers published up to October 29, 2024, evaluating OCA in patients with PBC at the 12\u2010month timepoint. Pooled analyses of liver enzymes were performed using the standard mean difference (SMD) and 95% confidence interval (CI) from the OCA baseline. Side effects and the achievement of criteria for adequate response are presented in percentages (95% CI).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      We included 1285 patients from 10 studies, two of which were RCTs. The addition of OCA significantly reduced alkaline phosphatase (ALP) (SMD \u22120.86; \u22121.15 to \u22120.56;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001) and total bilirubin (SMD \u22120.29; \u22120.43 to \u22120.15;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001). Overall, 37.23% of the patients (95% CI 31.47\u201343.39) responded to OCA (POISE criteria). The response rate was greater in the POISE trial results compared with real\u2010world data (46.15% vs. 30.54%, respectively;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.0089). Pruritus was the most common adverse event (40.23%; 24.65\u201358.07). Approximately one\u2010fifth of the patients stopped OCA (18.05%; 12.72\u201324.99), with pruritus being the main reason for discontinuation (47.70%; 34.15\u201361.60).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Adding OCA improves ALP, bilirubin, and biochemical remission rates in patients with PBC who did not respond well to UDCA monotherapy. Real\u2010world data show an attenuated response. Pruritus is the most common side effect and the leading cause of drug discontinuation.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/jgh.70094","type":"journal-article","created":{"date-parts":[[2025,9,30]],"date-time":"2025-09-30T10:16:48Z","timestamp":1759227408000},"page":"2820-2829","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Efficacy and Safety of Obeticholic Acid as Second\u2010Line Therapy in Primary Biliary Cholangitis: Systematic Review and Meta\u2010Analysis"],"prefix":"10.1111","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8398-3553","authenticated-orcid":false,"given":"Eliabe\u00a0S.","family":"Abreu","sequence":"first","affiliation":[{"name":"Division of Gastroenterology &amp; Hepatology Mayo Clinic  Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriel\u00a0Prusch","family":"Fernandes","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology &amp; Hepatology Mayo Clinic  Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henrique\u00a0de\u00a0Carvalho","family":"Lacerda","sequence":"additional","affiliation":[{"name":"Universidade Federal de Minas Gerais  Belo Horizonte Minas Gerais Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pedro\u00a0Henrique","family":"Reginato","sequence":"additional","affiliation":[{"name":"Universidade Federal do Paran\u00e1  Curitiba Paran\u00e1 Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henrique\u00a0Alexsander","family":"Ferreira\u00a0Neves","sequence":"additional","affiliation":[{"name":"Universidade Federal do Paran\u00e1  Curitiba Paran\u00e1 Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlos\u00a0Danilo","family":"Sanchez\u00a0Gonzalez","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology &amp; Hepatology Mayo Clinic  Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John\u00a0E.","family":"Eaton","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology &amp; Hepatology Mayo Clinic  Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7824-2152","authenticated-orcid":false,"given":"Guilherme\u00a0Grossi\u00a0Lopes","family":"Can\u00e7ado","sequence":"additional","affiliation":[{"name":"Hospital das Cl\u00ednicas da Universidade Federal de Minas Gerais  Belo Horizonte Minas Gerais Brazil"},{"name":"Hospital da Pol\u00edcia Militar de Minas Gerais  Belo Horizonte Minas Gerais Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,9,30]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.30145"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00535-013-0903-1"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2019.04.001"},{"key":"e_1_2_10_5_1","first-page":"174A","article-title":"Reductions in Abnormal Direct Bilirubin With Obeticholic Acid in Patients With Primary Biliary Cholangitis","volume":"66","author":"Pares A.","year":"2017","journal-title":"Hepatology"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1509840"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(19)30094-9"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.31017"},{"key":"e_1_2_10_9_1","unstructured":"U.S. Food & Drug Administration.Ocaliva (Obeticholic Acid) by Intercept Pharmaceuticals: Drug Safety Communication\u2014Serious Liver Injury Being Observed in Patients Without Cirrhosis [Internet].2024[cited 2025 Jan 4]. Available from:https:\/\/www.fda.gov\/safety\/medical\u2010product\u2010safety\u2010information\/ocaliva\u2010obeticholic\u2010acid\u2010intercept\u2010pharmaceuticals\u2010drug\u2010safety\u2010communication\u2010serious\u2010liver\u2010injury."},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000003029"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2022.08.054"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1097\/HEP.0000000000001166"},{"key":"e_1_2_10_13_1","unstructured":"European Medicines Agency.EMA Recommends Revoking Conditional Marketing Authorisation for Ocaliva [Internet].2024. Available from:https:\/\/www.ema.europa.eu\/en\/news\/ema\u2010recommends\u2010revoking\u2010conditional\u2010marketing\u2010authorisation\u2010ocaliva."},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2011.02.031"},{"key":"e_1_2_10_15_1","unstructured":"IND Safety Reporting [Internet]. Code of Federal Regulations. Sect. \u00a7 312.32 Aug 4 2025. Available from:https:\/\/www.ecfr.gov\/current\/title\u201021\/chapter\u2010I\/subchapter\u2010D\/part\u2010312\/subpart\u2010B\/section\u2010312.32. 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