{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T19:23:19Z","timestamp":1788808999552,"version":"build-2803163510"},"reference-count":28,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2025,11,20]],"date-time":"2025-11-20T00:00:00Z","timestamp":1763596800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,1,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aims<\/jats:title>\n                    <jats:p>Upadacitinib (UPA)\u2014an oral, reversible selective Janus kinase inhibitor\u2014has a favorable benefit\u2013risk profile for patients with Crohn\u2019s disease (CD) and ulcerative colitis (UC). We evaluated the benefit\u2013risk of UPA in select subgroups with CD or UC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients were randomized to UPA 45\u2009mg (UPA45) once daily (QD) or placebo (PBO) induction for 12 (CD: U-EXCEED, U-EXCEL) or 8\u2009weeks (UC: U-ACHIEVE, U-ACCOMPLISH). Clinical responders were re-randomized to QD UPA 15\u2009mg (UPA15), UPA 30\u2009mg (UPA30), or PBO for 52-week maintenance (CD: U-ENDURE; UC: U-ACHIEVE). This exploratory post hoc analysis assessed efficacy and safety outcomes (adverse events of special interest [AESIs]: serious infections, major adverse cardiovascular [CV] events, malignancies, and venous thromboembolic events) by CV risk, prior treatment failure, and age.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>This analysis included 1021 patients with CD and 1097 with UC during induction, and 673 with CD and 746 with UC during maintenance. Improved efficacy outcomes comparable to the overall study populations were observed with UPA versus PBO across subgroups. Patients receiving UPA30 generally showed numerically higher rates of improvements versus UPA15. AESI rates were generally comparable between UPA and PBO across subgroups except for numerically higher rates of herpes zoster and serious infections in CD with UPA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>UPA resulted in consistent benefit versus placebo across CV risk, prior treatment failure, and age subgroups. No treatment differences were seen in AESIs across subgroups except herpes zoster and serious infections, reinforcing the favorable benefit\u2013risk profile for UPA in CD and UC seen in the overall study populations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial numbers<\/jats:title>\n                    <jats:p>NCT02819635, NCT03653026, NCT03345836, NCT03345849, NCT03345823<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ecco-jcc\/jjaf198","type":"journal-article","created":{"date-parts":[[2025,11,19]],"date-time":"2025-11-19T13:10:29Z","timestamp":1763557829000},"source":"Crossref","is-referenced-by-count":4,"title":["Benefit\u2013risk profile of upadacitinib: exploratory post hoc analysis of phase 2b\/3 studies in patients with moderately to severely active ulcerative colitis or Crohn\u2019s disease"],"prefix":"10.1093","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9942-3019","authenticated-orcid":false,"given":"Severine","family":"Vermeire","sequence":"first","affiliation":[{"name":"Department of Gastroenterology and Hepatology, University Hospitals of Leuven , Leuven 3000,","place":["Belgium"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Frederic","family":"Colombel","sequence":"additional","affiliation":[{"name":"Henry D. Janowitz Division of Gastroenterology, Department of Medicine, Icahn School of Medicine at Mount Sinai , New York, NY 10029,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7341-1351","authenticated-orcid":false,"given":"Silvio","family":"Danese","sequence":"additional","affiliation":[{"name":"Gastroenterology and Endoscopy Unit, IRCCS Ospedale San Raffaele , Milan 20132,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5247-940X","authenticated-orcid":false,"given":"Remo","family":"Panaccione","sequence":"additional","affiliation":[{"name":"Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary , Calgary, Alberta AB T2N 1N4,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Peyrin-Biroulet","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, CHRU Nancy, INSERM NGERE, Universit\u00e9 de Lorraine , Vand\u0153uvre-l\u00e8s-Nancy F-54500,","place":["France"]},{"name":"Division of Gastroenterology and Hepatology, McGill University Health Centre , Montreal, Quebec, QC H4A 0B1,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kendall","family":"Beck","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Medicine, University of California , San Francisco, CA 94143,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9275-4242","authenticated-orcid":false,"given":"Mar\u00eda","family":"Chaparro","sequence":"additional","affiliation":[{"name":"Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigaci\u00f3n Sanitaria Princesa (IIS-Princesa), Universidad Aut\u00f3noma de Madrid (UAM), Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Enfermedades Hep\u00e1ticas y Digestivas (CIBEREHD) , Madrid 28006,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2090-3445","authenticated-orcid":false,"given":"Javier P","family":"Gisbert","sequence":"additional","affiliation":[{"name":"Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigaci\u00f3n Sanitaria Princesa (IIS-Princesa), Universidad Aut\u00f3noma de Madrid (UAM), Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Enfermedades Hep\u00e1ticas y Digestivas (CIBEREHD) , Madrid 28006,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Dubcenco","sequence":"additional","affiliation":[{"name":"AbbVie Inc. , North Chicago, IL 60044,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justin","family":"Klaff","sequence":"additional","affiliation":[{"name":"AbbVie Inc. , North Chicago, IL 60044,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Grace","family":"Naling","sequence":"additional","affiliation":[{"name":"AbbVie Inc. , North Chicago, IL 60044,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sharanya","family":"Ford","sequence":"additional","affiliation":[{"name":"AbbVie Inc. , North Chicago, IL 60044,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valencia","family":"Remple","sequence":"additional","affiliation":[{"name":"AbbVie Inc. , North Chicago, IL 60044,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Namita","family":"Joshi","sequence":"additional","affiliation":[{"name":"AbbVie Inc. , North Chicago, IL 60044,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Smitha","family":"Suravaram","sequence":"additional","affiliation":[{"name":"AbbVie Inc. , North Chicago, IL 60044,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin","family":"Duncan","sequence":"additional","affiliation":[{"name":"AbbVie Inc. , North Chicago, IL 60044,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yibo","family":"Wang","sequence":"additional","affiliation":[{"name":"AbbVie Inc. , North Chicago, IL 60044,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bettina","family":"Wick-Urban","sequence":"additional","affiliation":[{"name":"AbbVie Deutschland GmbH & Co. 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