{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,11]],"date-time":"2026-10-11T13:33:30Z","timestamp":1791725610615,"version":"4.3.4"},"reference-count":18,"publisher":"Springer Science and Business Media LLC","issue":"12","license":[{"start":{"date-parts":[[2025,9,22]],"date-time":"2025-09-22T00:00:00Z","timestamp":1758499200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,9,22]],"date-time":"2025-09-22T00:00:00Z","timestamp":1758499200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100016288","name":"Kissei Pharmaceutical Co., Ltd.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100016288","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100014421","name":"EA Pharma Co., Ltd.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014421","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Gastroenterol"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Carotegrast methyl is approved for treating patients with moderately active ulcerative colitis with inadequate response to 5-aminosalicylic acid agents. However, real-world evidence to guide optimal use is limited. This retrospective study aimed to characterise suitable patient profiles, identify biomarkers predictive of carotegrast methyl efficacy, and determine the appropriate timing for treatment evaluation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      We analysed data from 186 patients enrolled in a phase 3 trial of carotegrast methyl (96 carotegrast methyl, 90 placebo). We assessed biomarkers (leucine-rich\n                      <jats:italic>\u03b1<\/jats:italic>\n                      -2 glycoprotein, C-reactive protein, faecal calprotectin, and anti-integrin \u03b1v\u03b26 antibody titres) alongside clinical outcomes and assessed symptom diaries and maintenance therapies.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Low disease activity at baseline (partial Mayo score\u2009\u2264\u20095) was associated with higher remission rates (56.1 vs. 33.3%). Anti-integrin \u03b1v\u03b26 antibody titres of\u2009&lt;\u200944.6 U\/mL at baseline predicted higher clinical remission rates (49.1 vs. 26.8%). Symptom improvement was detectable from week 2. Faecal calprotectin correlated with the endoscopic subscore at the end of treatment (\n                      <jats:italic>\u03c1<\/jats:italic>\n                      \u2009=\u20090.566); a faecal calprotectin level of\u2009&lt;\u2009387.5 \u00b5g\/g predicted Mayo endoscopic subscore 0\/1. Most patients maintained remission with oral 5-aminosalicylic acid alone; the 1-year maintenance rate was 56.5%.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Carotegrast methyl appears most effective in patients with moderately active ulcerative colitis with low disease activity, with week 2 and beyond as an appropriate time point for assessing efficacy. Anti-integrin \u03b1v\u03b26 antibody titre shows promise in predicting response to carotegrast methyl. Faecal calprotectin may serve as a non-invasive surrogate for evaluating endoscopic healing.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00535-025-02299-9","type":"journal-article","created":{"date-parts":[[2025,9,22]],"date-time":"2025-09-22T07:12:10Z","timestamp":1758525130000},"page":"1523-1534","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Optimising carotegrast methyl use in ulcerative colitis: patient profiling, predictive biomarkers, and timing of efficacy evaluation (ASPECT study)"],"prefix":"10.1007","volume":"60","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2950-7660","authenticated-orcid":false,"given":"Katsuyoshi","family":"Matsuoka","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fumihito","family":"Hirai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenji","family":"Watanabe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryota","family":"Hokari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taku","family":"Kobayashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masayuki","family":"Saruta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Nakase","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takahiro","family":"Suzuki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gakuto","family":"Yamazaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshifumi","family":"Hibi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mamoru","family":"Watanabe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadakazu","family":"Hisamatsu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,9,22]]},"reference":[{"key":"2299_CR1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)32126-2","author":"R Ungaro","year":"2017","unstructured":"Ungaro R, Mehandru S, Allen PB, et al. 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Fumihito Hirai has served as a speaker for AbbVie, EA Pharma, Janssen, Mochida, Mitsubishi Tanabe, and Takeda, and has received research funding from AbbVie, Janssen, Eli Lilly, and MSD. Kenji Watanabe has served as a speaker for Mitsubishi Tanabe, Takeda, Mochida, EA Pharma, AbbVie, JIMRO, Kyorin, Janssen, Pfizer, and Kissei, is a consultant for EA Pharma, is a member of the Data Safety Monitoring Board for EA Pharma, is a member of the Advisory Board for Takeda, and has received research funding from EA Pharma and Takeda. Ryota Hokari has no conflicts of interest to declare. Taku Kobayashi has served as an advisory board member, consultant, or speaker for AbbVie, Alfresa Pharma, Alimentiv, Bristol Myers Squibb, Celltrion, Covidien, EA Pharma, Eli Lilly, Ferring, Galapagos, Gilead Sciences, Janssen, JIMRO, Kissei, Kyorin, Mitsubishi Tanabe, Mochida, MSD, Nippon Kayaku, Pfizer, Takeda, and Zeria, and has received research funding from AbbVie, Alfresa Pharma, Bristol Myers Squibb, EA Pharma, Gilead Sciences, Helmsley Charitable Trust, Kyorin, Miyarisan, Mochida, Nippon Kayaku, Otsuka Holdings, Pfizer, Sekisui Medical, Samsung, Takeda, Zeria, and JIMRO. Masayuki Saruta has served as a speaker for AbbVie, Janssen, Mitsubishi Tanabe, Takeda, EA Pharma, Gilead, Kissei, Mochida, Nobelpharma, and Viatris, and has received research funding from AbbVie, CMIC Corporation, Janssen, Mochida, and Zeria. Hiroshi Nakase has served as a speaker for AbbVie, Kissei, Kyorin, Mitsubishi Tanabe, Janssen, Takeda, Pfizer, EA Pharma, Mochida, Daiichi Sankyo, Gilead, Viatris, and JIMRO, is an advisory board member for Janssen and Pfizer, and has received research funding from Pentax Medical, Mitsubishi Tanabe, Mochida, AbbVie, Miyarisan, JIMRO, and Kyorin. Takahiro Suzuki is an employee of EA Pharma. Gakuto Yamazaki is an employee of Kissei. Toshifumi Hibi has served as a speaker for AbbVie, EA Pharma, JIMRO, Zeria, Mitsubishi Tanabe, Takeda, Janssen, Pfizer, and Mochida, is a consultant for Celltrion, JIMRO, AbbVie, Eli Lilly, Mitsubishi Tanabe, Mochida, Takeda, EA Pharma, and Janssen, and has received research funding from Alfresa Pharma, Kyorin, JIMRO, Zeria, Mochida, and Miyarisan. Mamoru Watanabe has served as a speaker for Mitsubishi Tanabe, Zeria, EA Pharma, Mochida, and Eli Lilly, is a consultant for EA Pharma, Kissei, Eli Lilly, and MSD, and has received research funding from Zeria, AbbVie, and Nippon Kayaku. Tadakazu Hisamatsu has served as a speaker for Mitsubishi Tanabe, Pfizer, AbbVie, EA Pharma, Janssen, and Takeda, and has received research funding from EA Pharma and Kissei.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}