{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T14:59:15Z","timestamp":1787497155179,"version":"build-2736575974"},"reference-count":21,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2024,8,4]],"date-time":"2024-08-04T00:00:00Z","timestamp":1722729600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100014421","name":"EA Pharma Co., Ltd.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014421","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100016288","name":"Kissei","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100016288","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Gastro and Hepatol"],"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aim<\/jats:title>\n                    <jats:p>Early treatment response of ulcerative colitis (UC) symptom resolution is desirable. This post hoc analysis evaluated efficacy outcomes, including endoscopic remission, by responder status and the influence of once\u2010daily (QD) versus twice\u2010daily (BID) budesonide foam dosing in patients with UC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Data were pooled from phase 2 and phase 3 clinical trials of budesonide rectal foam QD or BID or placebo for up to 12\u00a0weeks. Outcomes were evaluated by treatment and budesonide administration regimen and by responder group: early (rectal bleeding subscore [RBS] 0 from Week 2 through Week 6), delayed (RBS 0 at Week 6), and nonresponder (RBS\u00a0&gt;\u00a00 at Week 6).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The main analysis set included 55 (QD) and 120 (BID) budesonide\u2010treated patients and 116 placebo\u2010treated patients. At Week 6, the trend in early response rate was significant among treatment groups (BID, 45.3%; QD, 32.1%; placebo, 12.8%;\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0&lt;\u00a00.0001). Among BID recipients, trends for complete endoscopic remission rate (Mayo endoscopic score [MES]\u00a0=\u00a00) and endoscopic remission rate (MES\u00a0=\u00a00 or 1) were significant among responder status groups (early responder, 67.4% and 95.4%, respectively; delayed responder, 48.1% and 85.2%; nonresponder, 24.0% and 64.0%;\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0&lt;\u00a00.001 for both). Regardless of the administration regimen, most early responders achieved endoscopic remission at Week 6. Among responder status groups, early responders' cumulative non\u2010relapse period was greatest (\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a00.07).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>A BID budesonide administration regimen is preferred to increase the probability of early response and, following endoscopic remission, a better prognosis after stopping treatment.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/jgh.16692","type":"journal-article","created":{"date-parts":[[2024,8,4]],"date-time":"2024-08-04T23:00:06Z","timestamp":1722812406000},"page":"2367-2376","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Impact of twice\u2010daily budesonide foam administration on early clinical response and endoscopic remission in patients with ulcerative colitis: a post hoc analysis"],"prefix":"10.1111","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3781-4724","authenticated-orcid":false,"given":"Kenji","family":"Watanabe","sequence":"first","affiliation":[{"name":"Department of Internal Medicine for Inflammatory Bowel Disease Toyama University Hospital  Toyama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5493-5675","authenticated-orcid":false,"given":"Fumihito","family":"Hirai","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Faculty of Medicine Fukuoka University  Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4399-0940","authenticated-orcid":false,"given":"Kiyonori","family":"Kobayashi","sequence":"additional","affiliation":[{"name":"Research and Development Center for New Medical Frontiers Kitasato University  Sagamihara Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5103-5209","authenticated-orcid":false,"given":"Ken","family":"Takeuchi","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, IBD Center Tsujinaka Hospital Kashiwanoha  Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7085-3314","authenticated-orcid":false,"given":"Shinsuke","family":"Kurosu","sequence":"additional","affiliation":[{"name":"EA Pharma Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-9170-0494","authenticated-orcid":false,"given":"Katsutoshi","family":"Inagaki","sequence":"additional","affiliation":[{"name":"EA Pharma Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-0506-690X","authenticated-orcid":false,"given":"Ken\u2010ichi","family":"Iwayama","sequence":"additional","affiliation":[{"name":"Kissei Pharmaceutical Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4244-3243","authenticated-orcid":false,"given":"Makoto","family":"Naganuma","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Third Department of Internal Medicine Kansai Medical University  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,8,4]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)60150-0"},{"key":"e_1_2_7_3_1","first-page":"699","article-title":"Ulcerative colitis","volume":"87","author":"Adams SM","year":"2013","journal-title":"Am. Fam. Physician"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000000152"},{"key":"e_1_2_7_5_1","volume-title":"StatPearls","author":"Lynch WD","year":"2022"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/jgh.14872"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1515\/jbcpp-2016-0014"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM198712243172603"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1159\/000502205"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1155\/1990\/708916"},{"key":"e_1_2_7_11_1","doi-asserted-by":"crossref","first-page":"137","DOI":"10.1016\/S0090-9556(25)06497-9","article-title":"Budesonide is metabolized by cytochrome P450 3A (CYP3A) enzymes in human liver","volume":"23","author":"J\u00f6nsson G","year":"1995","journal-title":"Drug Metab. Dispos."},{"key":"e_1_2_7_12_1","first-page":"86","article-title":"Pharmacokinetics and metabolism of budesonide, a selective glucocorticoid","volume":"122","author":"Ryrfeldt A","year":"1982","journal-title":"Eur. J. Respir. Dis. Suppl."},{"key":"e_1_2_7_13_1","first-page":"9","article-title":"Oral budesonide","volume":"5","author":"Greenberg G","year":"2002","journal-title":"Clin. Persp. Gastro."},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjv208"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0220413"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00535-017-1376-4"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2007.03361.x"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/ueg2.12283"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000001987"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2020.12.031"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12876-022-02388-6"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.5217\/ir.2019.00064"}],"container-title":["Journal of Gastroenterology and Hepatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jgh.16692","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,9]],"date-time":"2025-04-09T22:46:17Z","timestamp":1744238777000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jgh.16692"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,8,4]]},"references-count":21,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2024,11]]}},"alternative-id":["10.1111\/jgh.16692"],"URL":"https:\/\/doi.org\/10.1111\/jgh.16692","archive":["Portico"],"relation":{},"ISSN":["0815-9319","1440-1746"],"issn-type":[{"value":"0815-9319","type":"print"},{"value":"1440-1746","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,8,4]]},"assertion":[{"value":"2024-03-26","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-07-13","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-08-04","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}