{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,2]],"date-time":"2026-11-02T19:15:21Z","timestamp":1793646921872,"version":"4.5.1"},"reference-count":28,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2024,1,1]],"date-time":"2024-01-01T00:00:00Z","timestamp":1704067200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Shire ViroPharma, Inc., a member of the Takeda group of companies"},{"name":"Takeda Pharmaceuticals USA, Inc."}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therap Adv Gastroenterol"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Relapse after corticosteroid withdrawal in eosinophilic esophagitis is not well understood.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>Budesonide oral suspension (BOS) 2.0\u2009mg twice daily (b.i.d.) was evaluated in two consecutive phase III studies (12 and 36\u2009weeks, respectively). For clinicopathologic responders after 12\u2009weeks of BOS treatment, we assessed randomized treatment withdrawal for up to 36\u2009weeks of therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>Post hoc analysis of a phase III, double-blind, randomized withdrawal study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Clinicopathologic responders (\u2a7d6 eosinophils per high-power field (eos\/hpf) and \u2a7e30% reduction in Dysphagia Symptom Questionnaire (DSQ) score from baseline) after 12\u2009weeks of BOS were randomized to continue BOS 2.0\u2009mg b.i.d. (BOS\u2013BOS) or withdraw to placebo (PBO; BOS\u2013PBO) for up to 36\u2009weeks. Relapsers (\u2a7e15 eos\/hpf (\u2a7e2 esophageal regions) and \u2a7e4\u2009days of dysphagia (DSQ)) could reinitiate BOS 2.0\u2009mg b.i.d. This post hoc analysis assessed a more clinically relevant relapse definition (\u2a7e15 eos\/hpf (\u2a7e1 esophageal region) and \u2a7e4\u2009days of dysphagia (DSQ)) for BOS\u2013BOS versus BOS\u2013PBO patients over 36\u2009weeks. To account for BOS\u2013PBO patients who reinitiated BOS before week 36, patients\u2019 last observations before reinitiating BOS were carried forward (last observation carried forward (LOCF)) for histologic, symptom, and endoscopic efficacy endpoints (at weeks 12 and 36).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Of 48 patients included (BOS\u2013BOS, n\u2009=\u200925; BOS\u2013PBO, n\u2009=\u200923), significantly more BOS\u2013PBO than BOS\u2013BOS patients relapsed over 36\u2009weeks using this post hoc relapse definition (60.9% vs 28.0%; p\u2009=\u20090.022). More BOS\u2013BOS than BOS\u2013PBO patients maintained histologic responses (all thresholds) and showed improvements in symptom and endoscopic efficacy endpoints.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>More BOS\u2013PBO than BOS\u2013BOS patients relapsed, determined by a more clinically relevant post hoc relapse definition. Using LOCF, more BOS\u2013BOS than BOS\u2013PBO patients also maintained or had improvements in efficacy endpoints.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration:<\/jats:title>\n                    <jats:p>ClinicalTrials.gov identifiers ( https:\/\/clinicaltrials.gov\/ ): NCT02605837, NCT02736409.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17562848241307602","type":"journal-article","created":{"date-parts":[[2024,12,24]],"date-time":"2024-12-24T00:55:02Z","timestamp":1735001702000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":8,"title":["Effect of randomized treatment withdrawal of budesonide oral suspension on clinically relevant efficacy outcomes in patients with eosinophilic esophagitis: a post hoc analysis"],"prefix":"10.1177","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1167-1101","authenticated-orcid":false,"given":"Evan S.","family":"Dellon","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Medicine, Center for Esophageal Diseases and Swallowing, University of North Carolina at Chapel Hill, 130 Mason Farm Road, Bioinformatics Building, Chapel Hill, NC 27599-7080, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margaret H.","family":"Collins","sequence":"additional","affiliation":[{"name":"Division of Pathology and Laboratory Medicine, Department of Pediatrics, Cincinnati Children\u2019s Hospital Medical Center, Department of Pathology & Laboratory Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A.","family":"Katzka","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Columbia University Medical Center, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincent A.","family":"Mukkada","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Hepatology and Nutrition, Cincinnati Children\u2019s Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary W.","family":"Falk","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenwen","family":"Zhang","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc., Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bridgett","family":"Goodwin","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc., Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Terreri","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals USA, Inc., Lexington, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mena","family":"Boules","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals USA, Inc., Lexington, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nirav K.","family":"Desai","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc., Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ikuo","family":"Hirano","sequence":"additional","affiliation":[{"name":"Kenneth C. Griffin Esophageal Center, Division of Gastroenterology and Hepatology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,12,23]]},"reference":[{"key":"bibr1-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2018.07.009"},{"key":"bibr2-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2020.02.038"},{"key":"bibr3-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1177\/2050640616689525"},{"key":"bibr4-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2021.06.020"},{"key":"bibr5-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2014.05.021"},{"key":"bibr6-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.11.021"},{"key":"bibr7-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2018.05.051"},{"key":"bibr8-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2021.04.022"},{"key":"bibr9-17562848241307602","unstructured":"Takeda Pharmaceuticals America, Inc. EOHILIA (budesonide oral suspension) prescribing information. US Food and Drug Administration, https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2024\/213976s000lbl.pdf (2024, accessed 22 February 2024)."},{"key":"bibr10-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2018.07.038"},{"key":"bibr11-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1186\/s41687-017-0006-5"},{"key":"bibr12-17562848241307602","unstructured":"Equator Network. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials, https:\/\/www.equator-network.org\/reporting-guidelines\/consort\/ (2010, accessed 3 May 2024)."},{"key":"bibr13-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2011-301817"},{"key":"bibr14-17562848241307602","first-page":"1","volume":"30","author":"Collins MH","year":"2017","journal-title":"Dis Esophagus"},{"key":"bibr15-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2011.02.040"},{"key":"bibr16-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2013.71"},{"key":"bibr17-17562848241307602","first-page":"2526","volume":"10","author":"Arnim UV","year":"2022","journal-title":"Clin Gastroenterol Hepatol"},{"key":"bibr18-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2020.07.039"},{"key":"bibr19-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2019.08.050"},{"key":"bibr20-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2020.08.027"},{"key":"bibr21-17562848241307602","unstructured":"ClinicalTrials.gov. Continuation study with budesonide oral suspension (BOS) for adolescent and adult participants with eosinophilic esophagitis (EoE), https:\/\/clinicaltrials.gov\/study\/NCT03245840 (2022, accessed 14 November 2023)."},{"key":"bibr22-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1177\/1740774515602688"},{"key":"bibr23-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2019.03.025"},{"key":"bibr24-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1002\/ueg2.12220"},{"key":"bibr25-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2019.09.042"},{"key":"bibr26-17562848241307602","volume":"9","author":"Hatter L","year":"2022","journal-title":"BMJ Open Respir Res"},{"key":"bibr27-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1016\/j.chest.2022.01.071"},{"key":"bibr28-17562848241307602","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2021.07.001"}],"container-title":["Therapeutic Advances in Gastroenterology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17562848241307602","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/17562848241307602","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17562848241307602","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,2]],"date-time":"2025-03-02T16:47:02Z","timestamp":1740934022000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/17562848241307602"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1]]},"references-count":28,"alternative-id":["10.1177\/17562848241307602"],"URL":"https:\/\/doi.org\/10.1177\/17562848241307602","relation":{},"ISSN":["1756-2848","1756-2848"],"issn-type":[{"value":"1756-2848","type":"print"},{"value":"1756-2848","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,1]]},"article-number":"17562848241307602"}}