{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T18:29:17Z","timestamp":1793212157959,"version":"4.5.0"},"reference-count":26,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2025,1,13]],"date-time":"2025-01-13T00:00:00Z","timestamp":1736726400000},"content-version":"vor","delay-in-days":12,"URL":"https:\/\/creativecommons.org\/licenses\/by\/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":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,1,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aims<\/jats:title>\n                    <jats:p>Treating ulcerative colitis (UC) in patients with prior advanced therapy (AT) exposure may be challenging. We report the efficacy and safety of risankizumab, a monoclonal interleukin 23p19 antibody, in patients with UC and prior inadequate response or intolerance to AT (AT-IR).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In the 12-week phase 3 INSPIRE induction study, patients were randomized to intravenous risankizumab 1200\u00a0mg or placebo. Clinical responders were randomized to subcutaneous risankizumab 180\u00a0mg, risankizumab 360\u00a0mg, or placebo (risankizumab withdrawal) in the 52-week phase 3 COMMAND maintenance study. This post hoc analysis assessed outcomes by AT-IR status, number, and mechanism of action. AT included biologics, Janus kinase inhibitors, and sphingosine-1-phosphate receptor modulators.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Efficacy analyses included 472 non-AT-IR and 503 AT-IR patients (induction), and 137 non-AT-IR and 411 AT-IR patients (maintenance). More patients achieved clinical remission per Adapted Mayo score with risankizumab 1200\u00a0mg versus placebo at induction week 12 (non-AT-IR, 29.7% versus 8.4%, nominal P\u2005&amp;lt;\u2005.0001; AT-IR, 11.4% versus 4.3%, nominal P\u2005=\u2005.0083); consistent with risankizumab 180\u00a0mg or risankizumab 360\u00a0mg versus placebo (withdrawal) at maintenance week 52 (non-AT-IR, 50.9% or 61.7% versus 31.1%, nominal P\u2005=\u2005.057 or P\u2005=\u2005.0033, respectively; AT-IR, 36.6% or 29.5% versus 23.2%, nominal P\u2005=\u2005.0159 or P\u2005=\u2005.2334, respectively). Risankizumab had increased efficacy over placebo, regardless of AT-IR number or mechanism of action, with higher efficacy rates for non-AT-IR compared to AT-IR. Safety results in non-AT-IR and AT-IR patients were generally comparable in both induction and maintenance.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Risankizumab was effective and well tolerated, regardless of prior AT-IR status.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration numbers<\/jats:title>\n                    <jats:p>INSPIRE [NCT03398148], COMMAND [NCT03398135].<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ecco-jcc\/jjaf005","type":"journal-article","created":{"date-parts":[[2025,1,10]],"date-time":"2025-01-10T15:18:51Z","timestamp":1736522331000},"source":"Crossref","is-referenced-by-count":18,"title":["Risankizumab efficacy and safety based on prior inadequate response or intolerance to advanced therapy: post hoc analysis of the INSPIRE and COMMAND phase 3 studies"],"prefix":"10.1093","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5247-940X","authenticated-orcid":false,"given":"Remo","family":"Panaccione","sequence":"first","affiliation":[{"name":"Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary , Calgary, Alberta,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edouard","family":"Louis","sequence":"additional","affiliation":[{"name":"Hepato-Gastroenterology and Digestive Oncology Department, University Hospital CHU of Li\u00e8ge , Li\u00e8ge,","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,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2784-4046","authenticated-orcid":false,"given":"Geert","family":"D\u2019Haens","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Amsterdam University Medical Centres , Amsterdam,","place":["The Netherlands"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Peyrin-Biroulet","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, INFINY Institute, INSERM NGERE, CHRU Nancy , Vand\u0153uvre-l\u00e8s-Nancy,","place":["France"]},{"name":"Groupe Hospitalier priv\u00e9 Ambroise Par\u00e9 - Hartmann, Paris IBD Center , Neuilly sur Seine,","place":["France"]},{"name":"Division of Gastroenterology and Hepatology, McGill University Health Centre , Montreal, Quebec,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marla","family":"Dubinsky","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Inflammatory Bowel Disease Center, Icahn School of Medicine at Mount Sinai , New York, NY,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ken","family":"Takeuchi","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, IBD Center, Tsujinaka Hospital Kashiwanoha , Kashiwa, Chiba,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5647-1723","authenticated-orcid":false,"given":"David T","family":"Rubin","sequence":"additional","affiliation":[{"name":"University of Chicago Medicine Inflammatory Bowel Disease Center , Chicago, IL,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jasmina","family":"Kalabic","sequence":"additional","affiliation":[{"name":"AbbVie Deutschland GmbH & Co. KG , Ludwigshafen,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen B","family":"Chien","sequence":"additional","affiliation":[{"name":"AbbVie Inc , North Chicago, IL,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Su","family":"Chen","sequence":"additional","affiliation":[{"name":"AbbVie Inc , North Chicago, IL,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ling","family":"Cheng","sequence":"additional","affiliation":[{"name":"AbbVie Inc , North Chicago, IL,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yafei","family":"Zhang","sequence":"additional","affiliation":[{"name":"AbbVie Inc , North Chicago, IL,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W Rachel","family":"Duan","sequence":"additional","affiliation":[{"name":"AbbVie Inc , North Chicago, IL,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramona","family":"Vladea","sequence":"additional","affiliation":[{"name":"AbbVie Inc , North Chicago, IL,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick M","family":"Hecht","sequence":"additional","affiliation":[{"name":"AbbVie Inc , North Chicago, IL,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre","family":"Morisset","sequence":"additional","affiliation":[{"name":"AbbVie Inc , North Chicago, IL,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Schreiber","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, University Hospital Schleswig-Holstein, Kiel University , 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