{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T01:18:41Z","timestamp":1792718321969,"version":"4.5.0"},"reference-count":16,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2023,11,27]],"date-time":"2023-11-27T00:00:00Z","timestamp":1701043200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Upadacitinib is an oral, selective Janus kinase inhibitor.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To assess the efficacy and safety of upadacitinib in patients with moderate\u2010to\u2010severe ulcerative colitis following 16\u2010week extended induction therapy, and 52\u2010week maintenance therapy in patients achieving clinical response after 16\u2010week extended induction therapy<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients without clinical response to 8\u2009weeks' upadacitinib 45\u2009mg once daily induction therapy in two induction trials were eligible for an additional 8\u2009weeks of therapy. Patients achieving clinical response at Week 16 were subsequently re\u2010randomised (1:1) to upadacitinib 15 or 30\u2009mg once daily for 52\u2010week maintenance therapy. Efficacy was assessed at induction Week 16 (integrated) and maintenance Week 52; safety was assessed throughout.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 127\/663 (19.2%) patients did not achieve clinical response to upadacitinib 45\u2009mg at Week 8 and received an additional 8\u2009weeks of therapy; 75\/127 (59.1%) subsequently achieved clinical response at Week 16 and entered the maintenance trial. At Week 52, 26.5% of patients receiving upadacitinib 15\u2009mg, and 43.6% receiving 30\u2009mg, achieved clinical remission; efficacy was observed across all other endpoints with both doses. Herpes zoster rates increased with longer duration (16\u2009weeks) of exposure to upadacitinib 45\u2009mg during induction compared with the same population during the first 8\u2009weeks. No other new safety signals were observed, and results are otherwise consistent with the known safety profile of upadacitinib.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Patients without clinical response after 8\u2009weeks' upadacitinib 45\u2009mg induction therapy, may benefit from an additional 8\u2009weeks of therapy.<\/jats:p><jats:p><jats:bold>Clinical trial registration:<\/jats:bold> NCT02819635; NCT03653026<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.17816","type":"journal-article","created":{"date-parts":[[2023,11,28]],"date-time":"2023-11-28T01:07:43Z","timestamp":1701133663000},"page":"393-408","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":32,"title":["Efficacy and safety of upadacitinib for 16\u2010week extended induction and 52\u2010week maintenance therapy in patients with moderately to severely active ulcerative colitis"],"prefix":"10.1111","volume":"59","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5247-940X","authenticated-orcid":false,"given":"Remo","family":"Panaccione","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology University of Calgary  Calgary Alberta Canada"}],"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 IRCCS Ospedale San Raffaele, University Vita\u2010Salute San Raffaele  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wen","family":"Zhou","sequence":"additional","affiliation":[{"name":"AbbVie Inc  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justin","family":"Klaff","sequence":"additional","affiliation":[{"name":"AbbVie Inc  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dapo","family":"Ilo","sequence":"additional","affiliation":[{"name":"AbbVie Inc  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xuan","family":"Yao","sequence":"additional","affiliation":[{"name":"AbbVie Inc  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gweneth","family":"Levy","sequence":"additional","affiliation":[{"name":"AbbVie Inc  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter D. R.","family":"Higgins","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Division of Gastroenterology University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7199-6851","authenticated-orcid":false,"suffix":"Jr","given":"Edward V.","family":"Loftus","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Mayo Clinic College of Medicine and Science  Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Su","family":"Chen","sequence":"additional","affiliation":[{"name":"AbbVie Inc  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuri Sanchez","family":"Gonzalez","sequence":"additional","affiliation":[{"name":"AbbVie Inc  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolyn","family":"Leonard","sequence":"additional","affiliation":[{"name":"AbbVie Inc  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xavier","family":"H\u00e9buterne","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Clinical Nutrition, CHU de Nice Universit\u00e9 C\u00f4te d'Azur  Nice France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James O.","family":"Lindsay","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology The Royal London Hospital, Barts Health NHS Trust  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qian","family":"Cao","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Sir Run Run Shaw Hospital, Zhejiang University School of Medicine  Hangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Nakase","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Sapporo Medical University School of Medicine  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6472-249X","authenticated-orcid":false,"given":"Jean\u2010Fr\u00e9d\u00e9ric","family":"Colombel","sequence":"additional","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S\u00e9verine","family":"Vermeire","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology University Hospital Leuven  Leuven Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,11,27]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1186\/s41927-018-0031-x"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen-2022-002735"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(22)00581-5"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(23)00208-X"},{"key":"e_1_2_11_6_1","unstructured":"RINVOQ (upadacitinib) prescribing information.US FDAhttps:\/\/www.rxabbvie.com\/pdf\/rinvoq_pi.pdf. 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