{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T00:19:20Z","timestamp":1788826760886,"version":"build-2803163510"},"reference-count":35,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2024,12,13]],"date-time":"2024-12-13T00:00:00Z","timestamp":1734048000000},"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":[[2025,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Etrasimod is an oral, once daily (QD), selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). We assessed the benefit of etrasimod monotherapy and the impact of concomitant corticosteroids (CS) and\/or 5-aminosalicylates (5-ASA) therapy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In ELEVATE UC 52 and ELEVATE UC 12, patients with moderately to severely active UC were randomized 2:1 to etrasimod 2 mg QD or placebo for 52 and 12 weeks, respectively. Oral CS or 5-ASA were allowed at baseline. Patients in the monotherapy subgroup received etrasimod or placebo without concomitant CS and\/or 5-ASA at baseline. Predefined primary (clinical remission) and key secondary efficacy endpoints aligned with those from both trials and were assessed at Week 12 and Week 52. Safety was assessed up to Week 52.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Clinical remission rates at Weeks 12 and 52 were significantly higher for etrasimod compared with placebo in patients receiving monotherapy (Week 12: 26.2% vs 4.8%; Week 52: 35.7% vs 4.0%). Differences vs placebo were statistically significant for all predefined endpoints at both time points in patients receiving monotherapy or etrasimod with concomitant 5-ASA only (all P\u2005&amp;lt;\u2005.05); numerical differences, due to small sample sizes, vs placebo were observed for all endpoints in the CS only and CS + 5-ASA subgroups. Safety was consistent with the overall population.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Etrasimod monotherapy showed consistent efficacy and safety vs placebo; no apparent benefit was observed with concomitant CS and\/or 5-ASA in patients receiving etrasimod.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical trial registration<\/jats:title>\n                  <jats:p>NCT03945188; NCT03996369.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ibd\/izae288","type":"journal-article","created":{"date-parts":[[2024,12,13]],"date-time":"2024-12-13T17:05:31Z","timestamp":1734109531000},"page":"2144-2153","source":"Crossref","is-referenced-by-count":3,"title":["Etrasimod as a Monotherapy or With Concomitant Use of Corticosteroids and\/or Aminosalicylates: Results From the ELEVATE UC Clinical Program"],"prefix":"10.1093","volume":"31","author":[{"given":"Andres J","family":"Yarur","sequence":"first","affiliation":[{"name":"Inflammatory Bowel Disease Institute and Division of Gastroenterology and Hepatology, Cedars-Sinai Medical Center , Los Angeles, CA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael V","family":"Chiorean","sequence":"additional","affiliation":[{"name":"Inflammatory Bowel Disease Center, Swedish Medical Center , Seattle, WA ,","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, Harvard Medical School , Boston, MA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raymond K","family":"Cross","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Melissa L. Posner Institute for Digestive Health and Liver Diseases at Mercy Medical Center , Baltimore, MD ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3897-7370","authenticated-orcid":false,"given":"Christina","family":"Ha","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Mayo Clinic Arizona , Scottsdale, AZ ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martina","family":"Goetsch","sequence":"additional","affiliation":[{"name":"Pfizer AG , Z\u00fcrich ,","place":["Switzerland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aoibhinn","family":"McDonnell","sequence":"additional","affiliation":[{"name":"Pfizer Ltd , Sandwich, Kent ,","place":["UK"]}],"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":"Joseph","family":"Wu","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Cambridge, MA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A","family":"Blanco","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Collegeville, PA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-7998-1770","authenticated-orcid":false,"given":"Arcangelo M","family":"Abbatemarco","sequence":"additional","affiliation":[{"name":"Pfizer Inc , New York, NY ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julian","family":"Pan\u00e9s","sequence":"additional","affiliation":[{"name":"Formerly Department of Gastroenterology, Hospital Cl\u00ednic de Barcelona, IDIBAPS, CIBERehd , Barcelona ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,12,13]]},"reference":[{"issue":"10080","key":"2025081217435172300_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":"3","key":"2025081217435172300_CIT0002","doi-asserted-by":"publisher","first-page":"384","DOI":"10.14309\/ajg.0000000000000152","article-title":"ACG clinical guideline: ulcerative colitis in adults","volume":"114","author":"Rubin","year":"2019","journal-title":"Am J Gastroenterol."},{"issue":"6","key":"2025081217435172300_CIT0003","doi-asserted-by":"publisher","first-page":"557","DOI":"10.1080\/17474124.2019.1604219","article-title":"A current overview of corticosteroid use in active ulcerative colitis","volume":"13","author":"Salice","year":"2019","journal-title":"Expert Rev Gastroenterol Hepatol"},{"issue":"7","key":"2025081217435172300_CIT0004","doi-asserted-by":"publisher","first-page":"769","DOI":"10.1093\/ecco-jcc\/jjx009","article-title":"Third European evidence-based consensus on diagnosis and management of ulcerative colitis. 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