{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T17:35:39Z","timestamp":1791394539020,"version":"4.3.3"},"reference-count":22,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T00:00:00Z","timestamp":1789689600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"EA Pharma Co.","id":[{"id":"https:\/\/ror.org\/04cjrna85","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Kissei Pharmaceutical Co.","id":[{"id":"https:\/\/ror.org\/028gkfr23","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,10,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The first multicenter, prospective post-marketing surveillance (PMS) in Japan was conducted to confirm the safety and effectiveness of carotegrast methyl (hereafter referred to as carotegrast) in the routine clinical practice for ulcerative colitis (UC) in Japan. Here, we report the results of the interim analysis of PMS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The ongoing PMS was initiated in June 2022 and will be continued until May 2028. Study patients are individuals with moderately active UC who were refractory or intolerant to 5-aminosalicylic acid, and who started carotegrast therapy for the first time. An interim analysis was conducted based on the data cut-off (March 27, 2025).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Safety and effectiveness analysis sets included 296 and 290 patients, respectively. In the safety analysis set, 36.8% of patients received carotegrast for &amp;lt;8 weeks and 63.2% for \u22658 weeks. The most common reason for treatment discontinuation was inadequate effectiveness in 44.0% of patients who received carotegrast for &amp;lt;8 weeks, and symptom improvement in 66.8% for \u22658 weeks. Adverse drug reactions (ADRs) were reported in 25 patients (8.45%). No serious ADRs, ADRs relevant to progressive multifocal leukoencephalopathy, and central nervous system-related ADRs were reported. No pregnancies were reported. One patient (0.34%) experienced an ADR of pyelonephritis related to infections. The proportions of patients with clinical response, clinical remission and rectal bleeding disappearance (defined by using partial Mayo score) were 146\/185 (78.9%), 133\/189 (70.4%) and 137\/190 (72.1%) after 8 weeks carotegrast administration, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>No new safety and effectiveness concerns were identified in the interim analysis for PMS.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/crocol\/otag105","type":"journal-article","created":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T19:16:11Z","timestamp":1789672571000},"source":"Crossref","is-referenced-by-count":0,"title":["Safety and effectiveness of carotegrast methyl in patients with ulcerative colitis: an interim report of post-marketing surveillance in Japan"],"prefix":"10.1093","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8172-3240","authenticated-orcid":false,"given":"Masayuki","family":"Saruta","sequence":"first","affiliation":[{"name":"Department of Internal Medicine, Division of Gastroenterology and Hepatology, The Jikei University School of Medicine , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-0235-0305","authenticated-orcid":false,"given":"Yoshiharu","family":"Miura","sequence":"additional","affiliation":[{"name":"Department of Neurology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-8225-6790","authenticated-orcid":false,"given":"Mie","family":"Iwaida","sequence":"additional","affiliation":[{"name":"Medical Department, EA Pharma Co., Ltd , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-0601-1674","authenticated-orcid":false,"given":"Minami","family":"Umeyama","sequence":"additional","affiliation":[{"name":"Medical Department, EA Pharma Co., Ltd , Tokyo,","place":["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":"Pharmaceutical Development Department, EA Pharma Co., Ltd , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-6567-162X","authenticated-orcid":false,"given":"Kiyotoshi","family":"Kuramoto","sequence":"additional","affiliation":[{"name":"Department of Post-Marketing Surveillance Pharmacovigilance & Post-Marketing Surveillance, Kissei Pharmaceutical Co., Ltd , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3781-4724","authenticated-orcid":false,"given":"Kenji","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Internal Medicine for Inflammatory Bowel Disease, Toyama University Hospital , Toyama,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,9,18]]},"reference":[{"key":"2026100711065225200_otag105-B1","doi-asserted-by":"crossref","first-page":"571","DOI":"10.1016\/S0140-6736(23)00966-2","article-title":"Ulcerative colitis","volume":"402","author":"Le Berre","year":"2023","journal-title":"Lancet"},{"key":"2026100711065225200_otag105-B2","doi-asserted-by":"crossref","first-page":"951","DOI":"10.1001\/jama.2023.15389","article-title":"Ulcerative colitis in adults: a review","volume":"330","author":"Gros","year":"2023","journal-title":"JAMA"},{"key":"2026100711065225200_otag105-B3","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1038\/s41575-022-00738-z","article-title":"Improving IBD outcomes in the era of many treatment options","volume":"20","author":"Kobayashi","year":"2023","journal-title":"Nat Rev Gastroenterol Hepatol"},{"key":"2026100711065225200_otag105-B4","doi-asserted-by":"crossref","first-page":"1011","DOI":"10.1007\/s40265-022-01732-0","article-title":"Carotegrast methyl: first approval","volume":"82","author":"Dhillon","year":"2022","journal-title":"Drugs"},{"key":"2026100711065225200_otag105-B5","author":"Hisamatsu Group"},{"key":"2026100711065225200_otag105-B6","doi-asserted-by":"crossref","first-page":"e533-e542","DOI":"10.1016\/j.crohns.2013.03.014","article-title":"Oral treatment with a novel small molecule alpha 4 integrin antagonist, AJM300, prevents the development of experimental colitis in mice","volume":"7","author":"Sugiura","year":"2013","journal-title":"J Crohns Colitis"},{"key":"2026100711065225200_otag105-B7","doi-asserted-by":"crossref","first-page":"1775","DOI":"10.1053\/j.gastro.2015.08.044","article-title":"Safety and efficacy of AJM300, an oral antagonist of \u03b14 integrin, in induction therapy for patients with active ulcerative colitis","volume":"149","author":"Yoshimura","year":"2015","journal-title":"Gastroenterology"},{"key":"2026100711065225200_otag105-B8","doi-asserted-by":"crossref","first-page":"648","DOI":"10.1016\/S2468-1253(22)00022-X","article-title":"AJM300 (carotegrast methyl), an oral antagonist of \u03b14-integrin, as induction therapy for patients with moderately active ulcerative colitis: a multicentre, randomised, double-blind, placebo-controlled, phase 3 study","volume":"7","author":"Matsuoka","year":"2022","journal-title":"Lancet Gastroenterol Hepatol"},{"key":"2026100711065225200_otag105-B9","doi-asserted-by":"crossref","first-page":"1870","DOI":"10.1056\/NEJMoa1107829","article-title":"Risk of natalizumab-associated progressive multifocal leukoencephalopathy","volume":"366","author":"Bloomgren","year":"2012","journal-title":"N Engl J Med"},{"key":"2026100711065225200_otag105-B10","doi-asserted-by":"crossref","first-page":"1660","DOI":"10.1002\/ibd.20520","article-title":"Use of the noninvasive components of the Mayo score to assess clinical response in ulcerative colitis","volume":"14","author":"Lewis","year":"2008","journal-title":"Inflamm Bowel Dis"},{"key":"2026100711065225200_otag105-B11","doi-asserted-by":"crossref","first-page":"271","DOI":"10.1159\/000541663","article-title":"Real-world effectiveness and safety of carotegrast methyl in Japanese patients with moderately active ulcerative colitis","volume":"9","author":"Ohmori","year":"2024","journal-title":"Inflamm Intest Dis"},{"key":"2026100711065225200_otag105-B12","doi-asserted-by":"crossref","first-page":"306","DOI":"10.5217\/ir.2025.00046","article-title":"Efficacy and safety of carotegrast methyl in active ulcerative colitis: a real-world prospective cohort study","volume":"24","author":"Shimoyama","year":"2026","journal-title":"Intest Res"},{"key":"2026100711065225200_otag105-B13","doi-asserted-by":"crossref","first-page":"316","DOI":"10.5217\/ir.2025.00066","article-title":"Real-world effectiveness and safety of carotegrast methyl in patients with ulcerative colitis: a multicenter retrospective cohort study","volume":"24","author":"Koshiba","year":"2026","journal-title":"Intest Res"},{"key":"2026100711065225200_otag105-B14","author":"EA Pharma Co., Ltd","year":"2026"},{"key":"2026100711065225200_otag105-B15","doi-asserted-by":"crossref","first-page":"1839","DOI":"10.1111\/jgh.14263","article-title":"Clinical differences between elderly-onset ulcerative colitis and non-elderly-onset ulcerative colitis: a nationwide survey data in Japan","volume":"33","author":"Komoto","year":"2018","journal-title":"J Gastroenterol Hepatol"},{"key":"2026100711065225200_otag105-B16","doi-asserted-by":"crossref","first-page":"1001","DOI":"10.1016\/j.dld.2022.12.024","article-title":"Management of inflammatory bowel disease in the elderly: a review","volume":"55","author":"Sousa","year":"2023","journal-title":"Dig Liver Dis"},{"key":"2026100711065225200_otag105-B17","doi-asserted-by":"crossref","first-page":"318","DOI":"10.5217\/ir.2024.00101","article-title":"Patient preferences for advanced therapies in ulcerative colitis using conjoint analysis","volume":"23","author":"Kobayashi","year":"2025","journal-title":"Intest Res"},{"key":"2026100711065225200_otag105-B18","doi-asserted-by":"crossref","first-page":"otaf014","DOI":"10.1093\/crocol\/otaf014","article-title":"Questionnaire survey of Japanese patients with inflammatory bowel disease and physicians on shared decision-making in advanced therapy: a web-based PAIR survey","volume":"7","author":"Hirai","year":"2025","journal-title":"Crohns Colitis 360"},{"key":"2026100711065225200_otag105-B19","doi-asserted-by":"crossref","first-page":"174","DOI":"10.1159\/000539738","article-title":"Patients\u2019 preference on advanced therapy and follow-up procedure for inflammatory bowel disease in Japan: a web-based 3A survey","volume":"9","author":"Morishita","year":"2024","journal-title":"Inflamm Intest Dis"},{"key":"2026100711065225200_otag105-B20","doi-asserted-by":"crossref","first-page":"otad069","DOI":"10.1093\/crocol\/otad069","article-title":"Questionnaire survey for inflammatory bowel disease patients in Japan; a web-based Japan, Crohn\u2019s disease, ulcerative colitis, patients survey","volume":"5","author":"Matsumoto","year":"2023","journal-title":"Crohns Colitis 360"},{"key":"2026100711065225200_otag105-B21","doi-asserted-by":"crossref","first-page":"166","DOI":"10.1111\/j.1365-2036.2007.03555.x","article-title":"Risk factors for non-adherence to medication in inflammatory bowel disease patients","volume":"27","author":"D\u2019Inc\u00e0","year":"2008","journal-title":"Aliment Pharmacol Ther"},{"key":"2026100711065225200_otag105-B22","doi-asserted-by":"crossref","first-page":"39","DOI":"10.1016\/S0002-9343(02)01383-9","article-title":"Medication nonadherence and the outcomes of patients with quiescent ulcerative colitis","volume":"114","author":"Kane","year":"2003","journal-title":"Am J Med"}],"container-title":["Crohn\u2019s &amp; Colitis 360"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/crohnscolitis360\/article-pdf\/8\/4\/otag105\/71225699\/otag105.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/crohnscolitis360\/article-pdf\/8\/4\/otag105\/71225699\/otag105.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T15:06:59Z","timestamp":1791385619000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/crohnscolitis360\/article\/doi\/10.1093\/crocol\/otag105\/8817229"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,18]]},"references-count":22,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2026,10,5]]}},"URL":"https:\/\/doi.org\/10.1093\/crocol\/otag105","relation":{},"ISSN":["2631-827X"],"issn-type":[{"value":"2631-827X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,10]]},"published":{"date-parts":[[2026,9,18]]},"article-number":"otag105"}}