{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T19:24:22Z","timestamp":1788809062004,"version":"build-2803163510"},"reference-count":27,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2025,4,4]],"date-time":"2025-04-04T00:00:00Z","timestamp":1743724800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,9,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Patient age can impact the safety and efficacy of ulcerative colitis (UC) treatments. Etrasimod is an oral, once daily (QD), selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to severely active UC. Here, we evaluate the impact of age on etrasimod safety and efficacy in patients with UC in the phase 3 ELEVATE UC clinical program.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Data were pooled from ELEVATE UC 52 and ELEVATE UC 12 in patients receiving etrasimod 2\u00a0mg QD or placebo. Proportions and incidence rates (IRs) per 100 patient-years of treatment-emergent adverse events (AEs) were stratified by age (&amp;lt;40, 40-59, and \u226560 years). With the same age stratifications, efficacy was evaluated in patients with baseline Modified Mayo scores of 5-9 and 4-9 for the primary efficacy endpoint (clinical remission) and secondary efficacy endpoints.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Overall, 787 patients were enrolled (&amp;lt;40 years, n\u2005=\u2005420 [53.4%]; 40-59 years, n\u2005=\u2005276 [35.1%]; and \u226560 years, n\u2005=\u200591 [11.6%]). Arthralgia, fatigue, and hypertension IRs were higher in older patients, irrespective of treatment. Serious AEs and AEs leading to treatment discontinuation were low and consistent across age groups. Significantly more patients receiving etrasimod 2\u00a0mg QD vs placebo achieved efficacy endpoints, regardless of age.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The safety profile of etrasimod 2\u00a0mg QD in the ELEVATE UC population was consistent across age groups, with no change in the incidence of AEs. Patients receiving etrasimod vs placebo showed significant clinical benefit, regardless of age.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>ClinicalTrials.gov<\/jats:title>\n                  <jats:p>NCT03945188; NCT03996369.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ibd\/izae308","type":"journal-article","created":{"date-parts":[[2025,4,4]],"date-time":"2025-04-04T15:30:54Z","timestamp":1743780654000},"page":"2352-2362","source":"Crossref","is-referenced-by-count":5,"title":["Assessment and Impact of Age on the Safety and Efficacy of Etrasimod in Patients With Ulcerative Colitis: A Post Hoc Analysis of Data From the ELEVATE UC Clinical Program"],"prefix":"10.1093","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0815-2044","authenticated-orcid":false,"given":"Gary R","family":"Lichtenstein","sequence":"first","affiliation":[{"name":"Division of Gastroenterology, Perelman School of Medicine at the University of Pennsylvania , Philadelphia, PA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3585-2425","authenticated-orcid":false,"given":"Jessica R","family":"Allegretti","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women\u2019s Hospital , Boston, MA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr.","given":"Edward V","family":"Loftus","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science , Rochester, MN ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter M","family":"Irving","sequence":"additional","affiliation":[{"name":"IBD Unit, Guy\u2019s and St Thomas\u2019 NHS Foundation Trust , London ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rupa","family":"Banerjee","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Asian Institute of Gastroenterology , Hyderabad ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aline","family":"Charabaty","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Johns Hopkins School of Medicine , Washington, DC ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanja","family":"Kuehbacher","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine\/Gastroenterology, St. Marien- and St. Annastift Hospital , Ludwigshafen am Rhein ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eustratios","family":"Bananis","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Collegeville, PA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John C","family":"Woolcott","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Collegeville, PA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexis B","family":"Dalam","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Manila ,","place":["Philippines"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krisztina","family":"Lazin","sequence":"additional","affiliation":[{"name":"Pfizer AG , Z\u00fcrich ,","place":["Switzerland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Keating","sequence":"additional","affiliation":[{"name":"Pfizer Inc , New York, NY ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aoibhinn","family":"McDonnell","sequence":"additional","affiliation":[{"name":"Pfizer Ltd , Sandwich ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7341-1351","authenticated-orcid":false,"given":"Silvio","family":"Danese","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital and Vita Salute San Raffaele University , Milan ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,4,4]]},"reference":[{"issue":"10080","key":"2025092307423385500_CIT0001","doi-asserted-by":"publisher","first-page":"1756","DOI":"10.1016\/S0140-6736(16)32126-2","article-title":"Ulcerative colitis","volume":"389","author":"Ungaro","year":"2017","journal-title":"Lancet."},{"issue":"4","key":"2025092307423385500_CIT0002","doi-asserted-by":"publisher","first-page":"441","DOI":"10.1111\/apt.13294","article-title":"Efficacy and safety of anti-TNF therapy in elderly patients with inflammatory bowel disease","volume":"42","author":"Lobat\u00f3n","year":"2015","journal-title":"Aliment Pharmacol Ther."},{"issue":"1","key":"2025092307423385500_CIT0003","doi-asserted-by":"publisher","first-page":"147","DOI":"10.1186\/s12876-020-01296-x","article-title":"Elderly-onset vs adult-onset ulcerative colitis: a different natural history","volume":"20","author":"Zammarchi","year":"2020","journal-title":"BMC Gastroenterol."},{"issue":"6","key":"2025092307423385500_CIT0004","doi-asserted-by":"publisher","first-page":"1425","DOI":"10.1097\/MIB.0000000000000738","article-title":"Epidemiology and long-term outcome of inflammatory bowel disease diagnosed at elderly age\u2014an increasing distinct entity","volume":"22","author":"Jeuring","year":"2016","journal-title":"Inflamm Bowel Dis."},{"key":"2025092307423385500_CIT0005","doi-asserted-by":"publisher","first-page":"105","DOI":"10.1159\/000503099","article-title":"Management of the elderly inflammatory bowel disease patient","volume":"101","author":"Hruz","year":"2020","journal-title":"Digestion."},{"issue":"6","key":"2025092307423385500_CIT0006","doi-asserted-by":"publisher","first-page":"441","DOI":"10.1007\/s40266-022-00943-0","article-title":"Ulcerative colitis in adulthood and in older patients: same disease, same outcome, same risks","volume":"39","author":"Fries","year":"2022","journal-title":"Drugs Aging."},{"key":"2025092307423385500_CIT0007","author":"Colby"},{"issue":"13","key":"2025092307423385500_CIT0008","doi-asserted-by":"publisher","first-page":"1722","DOI":"10.3390\/cells12131722","article-title":"Efficacy and safety of biological therapies and JAK inhibitors in older patients with inflammatory bowel disease","volume":"12","author":"Fries","year":"2023","journal-title":"Cells"},{"issue":"3","key":"2025092307423385500_CIT0009","doi-asserted-by":"publisher","first-page":"462","DOI":"10.1093\/ibd\/izz065","article-title":"Risk of infection and types of infection among elderly patients with inflammatory bowel disease: a retrospective database analysis","volume":"26","author":"Khan","year":"2020","journal-title":"Inflamm Bowel Dis."},{"issue":"5","key":"2025092307423385500_CIT0010","doi-asserted-by":"publisher","first-page":"914","DOI":"10.1093\/ibd\/izy311","article-title":"Herpes zoster incidence in inflammatory bowel disease patients: a population-based study","volume":"25","author":"C\u00f4t\u00e9-Daigneault","year":"2019","journal-title":"Inflamm Bowel Dis."},{"issue":"1","key":"2025092307423385500_CIT0011","doi-asserted-by":"publisher","first-page":"27","DOI":"10.1093\/ibd\/izac084","article-title":"Assessment of safety and efficacy of tofacitinib, stratified by age, in patients from the ulcerative colitis clinical program","volume":"29","author":"Lichtenstein","year":"2023","journal-title":"Inflamm Bowel Dis."},{"issue":"1","key":"2025092307423385500_CIT0012","doi-asserted-by":"publisher","first-page":"30","DOI":"10.1016\/j.cgh.2010.09.026","article-title":"Advanced age is an independent risk factor for severe infections and mortality in patients given anti-tumor necrosis factor therapy for inflammatory bowel disease","volume":"9","author":"Cottone","year":"2011","journal-title":"Clin Gastroenterol Hepatol."},{"issue":"10383","key":"2025092307423385500_CIT0013","doi-asserted-by":"publisher","first-page":"1159","DOI":"10.1016\/S0140-6736(23)00061-2","article-title":"Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies","volume":"401","author":"Sandborn","year":"2023","journal-title":"Lancet."},{"issue":"10","key":"2025092307423385500_CIT0014","first-page":"652","article-title":"Predictors of aggressive inflammatory bowel disease","volume":"7","author":"Yarur","year":"2011","journal-title":"Gastroenterol Hepatol (N Y)"},{"key":"2025092307423385500_CIT0015","doi-asserted-by":"publisher","first-page":"A106","DOI":"10.1136\/gutjnl-2023-BSG.172","article-title":"P100 Efficacy and safety of ozanimod in older patients with ulcerative colitis (UC): post hoc analysis of the True North study","volume":"72","author":"Sheikh","year":"2023","journal-title":"Gut."},{"issue":"9","key":"2025092307423385500_CIT0016","doi-asserted-by":"publisher","first-page":"672","DOI":"10.1212\/WNL.0b013e318248deea","article-title":"Fingolimod-associated macular edema: incidence, detection, and management","volume":"78","author":"Jain","year":"2012","journal-title":"Neurology."},{"issue":"5","key":"2025092307423385500_CIT0017","doi-asserted-by":"publisher","first-page":"495","DOI":"10.1016\/j.autrev.2017.03.007","article-title":"Modulation of sphingosine-1-phosphate in inflammatory bowel disease","volume":"16","author":"Peyrin-Biroulet","year":"2017","journal-title":"Autoimmun Rev."},{"key":"2025092307423385500_CIT0018","doi-asserted-by":"publisher","first-page":"S755","DOI":"10.1093\/ecco-jcc\/jjaa017","article-title":"JAK inhibitors safety in ulcerative colitis: practical implications","volume":"14","author":"Agrawal","year":"2020","journal-title":"J Crohns Colitis."},{"issue":"6","key":"2025092307423385500_CIT0019","doi-asserted-by":"publisher","first-page":"882","DOI":"10.1097\/MIB.0000000000001099","article-title":"Management of inflammatory bowel disease in the elderly patient: challenges and opportunities","volume":"23","author":"Ananthakrishnan","year":"2017","journal-title":"Inflamm Bowel Dis."},{"issue":"6","key":"2025092307423385500_CIT0020","doi-asserted-by":"publisher","first-page":"507","DOI":"10.1093\/ecco-jcc\/jjv059","article-title":"Inflammatory bowel disease and the elderly: a review","volume":"9","author":"Taleban","year":"2015","journal-title":"J Crohns Colitis."},{"issue":"1","key":"2025092307423385500_CIT0021","doi-asserted-by":"publisher","first-page":"51","DOI":"10.4292\/wjgpt.v7.i1.51","article-title":"Elderly patients and inflammatory bowel disease","volume":"7","author":"Nimmons","year":"2016","journal-title":"World J Gastrointest Pharmacol Ther"},{"issue":"9","key":"2025092307423385500_CIT0022","doi-asserted-by":"publisher","first-page":"1541","DOI":"10.1093\/ibd\/izab052","article-title":"Systematic review of inclusion and analysis of older adults in randomized controlled trials of medications used to treat inflammatory bowel diseases","volume":"27","author":"Kochar","year":"2021","journal-title":"Inflamm Bowel Dis."},{"issue":"7","key":"2025092307423385500_CIT0023","doi-asserted-by":"publisher","first-page":"160","DOI":"10.1007\/s11894-023-00874-9","article-title":"Indications and safety of newer IBD treatments in the older patient","volume":"25","author":"Clement","year":"2023","journal-title":"Curr Gastroenterol Rep."},{"issue":"4","key":"2025092307423385500_CIT0024","doi-asserted-by":"publisher","first-page":"1055","DOI":"10.1183\/09031936.00059814","article-title":"Ageing and the epidemiology of multimorbidity","volume":"44","author":"Divo","year":"2014","journal-title":"Eur Respir J."},{"issue":"2","key":"2025092307423385500_CIT0025","doi-asserted-by":"publisher","first-page":"99","DOI":"10.1002\/clc.23303","article-title":"Hypertension in older adults: assessment, management, and challenges","volume":"43","author":"Oliveros","year":"2020","journal-title":"Clin Cardiol."},{"key":"2025092307423385500_CIT0026","volume-title":"Velsipity Assessment Report","author":"EMA","year":"2023"},{"issue":"10","key":"2025092307423385500_CIT0027","doi-asserted-by":"publisher","first-page":"1596","DOI":"10.1093\/ecco-jcc\/jjae060","article-title":"Etrasimod for the treatment of ulcerative colitis: analysis of infection events from the ELEVATE UC clinical program","volume":"18","author":"Regueiro","year":"2024","journal-title":"J Crohns Colitis."}],"container-title":["Inflammatory Bowel Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/ibdjournal\/advance-article-pdf\/doi\/10.1093\/ibd\/izae308\/62871732\/izae308.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ibdjournal\/article-pdf\/31\/9\/2352\/62871732\/izae308.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ibdjournal\/article-pdf\/31\/9\/2352\/62871732\/izae308.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,23]],"date-time":"2025-09-23T11:45:44Z","timestamp":1758627944000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ibdjournal\/article\/31\/9\/2352\/8106483"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4,4]]},"references-count":27,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2025,4,4]]},"published-print":{"date-parts":[[2025,9,1]]}},"URL":"https:\/\/doi.org\/10.1093\/ibd\/izae308","relation":{},"ISSN":["1078-0998","1536-4844"],"issn-type":[{"value":"1078-0998","type":"print"},{"value":"1536-4844","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2025,9]]},"published":{"date-parts":[[2025,4,4]]}}}