{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:55:16Z","timestamp":1786978516354,"version":"build-2736575974"},"reference-count":34,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,2,1]],"date-time":"2025-02-01T00:00:00Z","timestamp":1738368000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/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":["UEG Journal"],"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Etrasimod is an oral, once\u2010daily (q.d.), selective sphingosine 1\u2010phosphate (S1P)\n                      <jats:sub>1,4,5<\/jats:sub>\n                      receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). Unlike the S1P receptor modulator ozanimod, etrasimod does not have a molecular structure to inhibit monoamine oxidase (MAO). Coadministration of drugs that inhibit MAO with opioids and antidepressants may increase the risk of adverse events (AEs).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>This post hoc analysis evaluated the incidence of AEs potentially related to serotonin syndrome in patients taking etrasimod and concomitant opioids or antidepressants in the Phase 3 ELEVATE UC 52 and ELEVATE UC 12 trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Safety data pooled from both trials were analysed in subgroups of patients receiving etrasimod 2\u00a0mg q.d. (up to 52\u00a0weeks of exposure) with\/without concomitant opioids or antidepressants. We report the proportions of patients who had\u00a0\u2265\u00a01 concurrent AE potentially associated with serotonin syndrome, including hypertension\u2010related events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 527 patients receiving etrasimod, 77 (14.6%) and 35 (6.6%) were taking concomitant opioids or antidepressants, respectively. The incidence of AEs potentially related to serotonin syndrome, including hypertension\u2010related AEs, was low (\u2264\u00a08.6%) and generally comparable in all subgroups. No reported AEs were serious or led to treatment discontinuation among patients taking these concomitant medications.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The incidence of AEs was low and comparable in patients receiving etrasimod with or without concomitant opioids or antidepressants. This analysis further supports the low likelihood of clinically relevant drug\u2013drug interactions between etrasimod and medications commonly prescribed to patients with UC, such as opioids or antidepressants.<\/jats:p>\n                    <jats:p>\n                      (\n                      <jats:bold>ClinicalTrials.gov<\/jats:bold>\n                      : NCT03945188; NCT03996369).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ueg2.12745","type":"journal-article","created":{"date-parts":[[2025,2,1]],"date-time":"2025-02-01T07:03:40Z","timestamp":1738393420000},"page":"719-727","source":"Crossref","is-referenced-by-count":1,"title":["Concomitant Use of Etrasimod With Opioids or Antidepressants in Patients With Ulcerative Colitis\u2014A Safety Analysis"],"prefix":"10.1002","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4397-9576","authenticated-orcid":false,"given":"Anita","family":"Afzali","sequence":"first","affiliation":[{"name":"Department of Internal Medicine Division of Digestive Diseases University of Cincinnati College of Medicine  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7681-8111","authenticated-orcid":false,"given":"Miguel","family":"Regueiro","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Hepatology and Nutrition Cleveland Clinic  Cleveland Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2293-5555","authenticated-orcid":false,"given":"Andres J.","family":"Yarur","sequence":"additional","affiliation":[{"name":"Inflammatory Bowel Disease Center and Division of Gastroenterology and Hepatology Cedars\u2010Sinai Medical Center  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4023-8868","authenticated-orcid":false,"given":"Yamile","family":"Zabana","sequence":"additional","affiliation":[{"name":"Deparment of Gastroenterology Hospital Universitari M\u00fatua Terrassa  Terrassa Spain"},{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red en Enfermedades Hep\u00e1ticas y Digestivas (CIBERehd)  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6850-4454","authenticated-orcid":false,"given":"Siew C.","family":"Ng","sequence":"additional","affiliation":[{"name":"Department of Medicine and Therapeutics Institute of Digestive Disease The Chinese University of Hong Kong  Hong Kong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sujatha","family":"Menon","sequence":"additional","affiliation":[{"name":"Pfizer Inc  Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2229-0382","authenticated-orcid":false,"given":"Aoibhinn","family":"McDonnell","sequence":"additional","affiliation":[{"name":"Pfizer Ltd  Sandwich UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krisztina","family":"Lazin","sequence":"additional","affiliation":[{"name":"Pfizer AG  Z\u00fcrich Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Keating","sequence":"additional","affiliation":[{"name":"Pfizer Inc  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1053-8408","authenticated-orcid":false,"given":"Abhishek","family":"Bhattacharjee","sequence":"additional","affiliation":[{"name":"Pfizer Healthcare India Pvt. 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