{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,5]],"date-time":"2026-11-05T21:00:54Z","timestamp":1793912454414,"version":"4.8.0"},"reference-count":26,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2025,7,24]],"date-time":"2025-07-24T00:00:00Z","timestamp":1753315200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"U-ENDURE","award":["NCT03345823"],"award-info":[{"award-number":["NCT03345823"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,9,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background and Aims<\/jats:title>\n                  <jats:p>The long-term efficacy and safety of upadacitinib in patients with moderate to severe Crohn\u2019s disease (CD) were evaluated in the U-ENDURE Long-Term Extension (LTE) study. Here we report the results after 2\u2009years of total maintenance treatment.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>U-ENDURE is an ongoing 240-week LTE study conducted at 243 sites across 43 countries (first patient enrolled in LTE 21 March 2019). Patients who completed the 52-week maintenance study continued their previously assigned treatment, once-daily upadacitinib 15\u2009mg or upadacitinib 30\u2009mg. Efficacy was analyzed at week 48 of the LTE; safety was analyzed in the cumulative study population (combined 52 week maintenance and 48 week LTE) and the LTE study population only (cutoff date: 19 December 2023).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>From LTE week 0 to week 48, as-observed efficacy rates for clinical remission (per stool frequency\/abdominal pain score, upadacitinib 15\u2009mg: 78.3% to 82.9%; upadacitinib 30\u2009mg: 84.7% to 76.6%; per CD Activity Index, upadacitinib 15\u2009mg: 81.3% to 83.1%; upadacitinib 30\u2009mg: 86.1% to 86.8%), endoscopic response (upadacitinib 15\u2009mg: 59.6% to 67.1%; upadacitinib 30\u2009mg: 71.2% to 69.6%), inflammatory biomarkers, and quality-of-life outcomes remained stable. The safety profile of the cumulative maintenance population observed through LTE week 48 was consistent with previous trials in the upadacitinib CD program. Treatment-emergent adverse event rates for the cumulative maintenance population were 283.1 and 273.4 events\/100 patient-years for upadacitinib 15\u2009mg and upadacitinib 30\u2009mg, respectively. Event rates of serious treatment-\u00ademergent adverse events were 16.0 events\/100 patient-years for upadacitinib 15\u2009mg and 14.6 events\/100 patient-years for upadacitinib 30\u2009mg. The most common adverse events of special interest (\u2265 5.0 events\/100 patient-years) were hepatic disorder, lymphopenia, creatine phosphokinase elevation, herpes zoster, and anemia. There was 1 treatment-emergent adverse event of suicide leading to death.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Sustained clinical, endoscopic, quality-of-life, and biomarker outcomes were observed in patients who were initial responders to upadacitinib and completed 2\u2009years of maintenance therapy, with no new safety signals identified.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical trial identifier<\/jats:title>\n                  <jats:p>U-ENDURE; ClinicalTrials.gov number, NCT03345823.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ecco-jcc\/jjaf138","type":"journal-article","created":{"date-parts":[[2025,7,24]],"date-time":"2025-07-24T11:52:04Z","timestamp":1753357924000},"source":"Crossref","is-referenced-by-count":13,"title":["Efficacy and safety of upadacitinib maintenance therapy in patients with moderately to severely active Crohn\u2019s disease: 2-year results from the U-ENDURE Long-Term Extension study"],"prefix":"10.1093","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7199-6851","authenticated-orcid":false,"given":"Edward V","family":"Loftus, Jr","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science , Rochester, MN,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geert","family":"D\u2019Haens","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Amsterdam University Medical Centre , Amsterdam,","place":["The Netherlands"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edouard","family":"Louis","sequence":"additional","affiliation":[{"name":"Department of Hepato-Gastroenterology and Digestive Oncology, University Hospital CHU of Li\u00e8ge , Li\u00e8ge,","place":["Belgium"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7681-8111","authenticated-orcid":false,"given":"Miguel","family":"Regueiro","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Cleveland Clinic Foundation , Cleveland, OH,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1092-0033","authenticated-orcid":false,"given":"Vipul","family":"Jairath","sequence":"additional","affiliation":[{"name":"Department of Medicine, Western University , London, ON,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2634-9668","authenticated-orcid":false,"given":"Fernando","family":"Magro","sequence":"additional","affiliation":[{"name":"Unit of Pharmacology and Therapeutics, Department of Biomedicine and Medicine , Porto,","place":["Portugal"]},{"name":"Department of Gastroenterology, S\u00e3o Jo\u00e3o University Hospital Center , Porto,","place":["Portugal"]},{"name":"CINTESIS@RISE, Department of Medicine, University of Porto , Porto,","place":["Portugal"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2848-6586","authenticated-orcid":false,"given":"Hiroshi","family":"Nakase","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine , Sapporo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Dubcenco","sequence":"additional","affiliation":[{"name":"AbbVie, Inc , North Chicago, IL,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana Paula","family":"Lacerda","sequence":"additional","affiliation":[{"name":"AbbVie, Inc , North Chicago, IL,","place":["United 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