{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T15:35:01Z","timestamp":1791560101577,"version":"4.3.4"},"reference-count":16,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2024,7,20]],"date-time":"2024-07-20T00:00:00Z","timestamp":1721433600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"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>The ileum is the most commonly affected segment of the gastrointestinal tract in Crohn\u2019s disease [CD]. We aimed to determine whether disease location affects response to filgotinib, a Janus kinase [JAK] inhibitor, in patients with moderately-to-severely active Crohn\u2019s disease [CD] and applying appropriate methods to account for differences in measuring disease activity in the ileum compared with the colon.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This post-hoc analysis of data from the FITZROY phase 2 trial [NCT02048618] compared changes in the Crohn\u2019s Disease Activity Index [CDAI] and Simple Endoscopic Score for Crohn\u2019s Disease [SES-CD] among patients with ileal-dominant and isolated colonic CD treated with 10 weeks of filgotinib 200\u00a0mg daily or placebo. A mixed effects model for repeated measures was used to test whether ileal disease responded differently when compared with colonic disease, by evaluating for effect modification using the interaction term of treatment assignment-by-disease location.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Numerically greater proportions of patients with isolated colonic disease compared to ileal-dominant CD achieved clinical remission [CDAI\u2005&amp;lt;\u2005150, 75.9% vs 41.6%] and endoscopic response [SES-CD reduction by 50%, 52.5% vs 15.5%] at Week 10. However, after adjusting for baseline disease activity by disease location and within-patient clustering effects, there was no significant difference in treatment response by disease location [mean difference in \u0394CDAI between ileal-dominant vs isolated colonic disease\u2005+\u20059.24 [95% CI: -87.19,\u2005+105.67], p\u2005=\u20050.85; mean difference in \u0394SES-CD -1.93 [95% CI: -7.03,\u2005+3.44], p\u2005=\u20050.48.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Filgotinib demonstrated similar efficacy in ileal-dominant and isolated colonic CD when controlling for baseline disease activity and clustering effects.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ecco-jcc\/jjae113","type":"journal-article","created":{"date-parts":[[2024,7,20]],"date-time":"2024-07-20T10:43:05Z","timestamp":1721472185000},"source":"Crossref","is-referenced-by-count":4,"title":["Re-evaluating Methods for Assessing Differences in Response in Ileal vs Colonic Crohn\u2019s Disease: A Post-hoc Analysis of the FITZROY Trial"],"prefix":"10.1093","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4698-9948","authenticated-orcid":false,"given":"Christopher","family":"Ma","sequence":"first","affiliation":[{"name":"Division of Gastroenterology & Hepatology, University of Calgary , Calgary, AB ,","place":["Canada"]},{"name":"Department of Community Health Sciences, University of Calgary , Calgary, AB ,","place":["Canada"]},{"name":"Medical Research & Development,\u00a0Alimentiv Inc. , London, ON ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian G","family":"Feagan","sequence":"additional","affiliation":[{"name":"Medical Research & Development,\u00a0Alimentiv Inc. , London, ON ,","place":["Canada"]},{"name":"Division of Gastroenterology, Schulich School of Medicine & Dentistry, Western University , London, ON ,","place":["Canada"]},{"name":"Department of Epidemiology & Biostatistics, Western University , London, ON ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhongya","family":"Wang","sequence":"additional","affiliation":[{"name":"Medical Research & Development,\u00a0Alimentiv Inc. , London, ON ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guangyong","family":"Zou","sequence":"additional","affiliation":[{"name":"Medical Research & Development,\u00a0Alimentiv Inc. , London, ON ,","place":["Canada"]},{"name":"Department of Epidemiology & Biostatistics, Western University , London, ON ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle I","family":"Smith","sequence":"additional","affiliation":[{"name":"Medical Research & Development,\u00a0Alimentiv Inc. , London, ON ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa M","family":"Shackelton","sequence":"additional","affiliation":[{"name":"Medical Research & Development,\u00a0Alimentiv Inc. , London, ON ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce E","family":"Sands","sequence":"additional","affiliation":[{"name":"Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai , New York, NY ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5247-940X","authenticated-orcid":false,"given":"Remo","family":"Panaccione","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology & Hepatology, University of Calgary , Calgary, AB ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2784-4046","authenticated-orcid":false,"given":"Geert R","family":"D\u2019Haens","sequence":"additional","affiliation":[{"name":"Medical Research & Development,\u00a0Alimentiv Inc. , London, ON ,","place":["Canada"]},{"name":"IBD Unit, Division of Gastroenterology, Amsterdam University Medical Centers , Amsterdam ,","place":["The 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