{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T05:19:26Z","timestamp":1790140766680,"version":"4.0.1"},"reference-count":24,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2025,6,26]],"date-time":"2025-06-26T00:00:00Z","timestamp":1750896000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004331","name":"Johnson and Johnson","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004331","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":[[2025,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background and Aim<\/jats:title><jats:p>The global QUASAR (NCT04033445) clinical program demonstrated the efficacy and safety of guselkumab, a dual\u2010acting interleukin\u201023 p19 subunit inhibitor, as induction and maintenance therapy in participants with moderate to severely active ulcerative colitis (UC). We report a subgroup analysis in East Asian participants.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The QUASAR program included two randomized, placebo\u2010controlled, 12\u2010week induction studies of guselkumab 200\u2009mg (and 400\u2009mg, Phase 2b) IV every 4\u2009weeks (q4w) in adults with baseline modified Mayo scores of 5\u20139 and inadequate response\/intolerance to conventional and\/or advanced UC therapy. Clinical responders to guselkumab induction were re\u2010randomized (1:1:1) at maintenance study baseline to SC guselkumab 200\u2009mg q4w, 100\u2009mg q8w, or placebo. Primary endpoints were clinical response (Phase 2b) or clinical remission (Phase 3) at induction Week 12 (I\u201012) and clinical remission at maintenance Week 44 (M\u201044). Subgroup analyses included participants from sites in China, Japan, Korea, and Taiwan region.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Data were from 71 (Phase 2b) and 135 (Phase 3) East Asians in the induction studies and 106 in the maintenance study. At Week I\u201012, 45.5%\u201358.8% of guselkumab versus 25.5%\u201329.2% of placebo participants achieved clinical response and 16.0%\u201323.8% versus 4.2%\u20135.5%, respectively, achieved clinical remission. At Week M\u201044, 37.1%\u201346.3% of guselkumab versus 13.3% of placebo participants achieved clinical remission. The adverse event profile was generally consistent with the global QUASAR population.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Results support the efficacy and safety of guselkumab induction and maintenance in East Asians with moderately to severely active UC, consistent with findings from the global QUASAR studies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:ext-link>, NCT04033445; EudraCT, 2018\u2013004002\u201025<\/jats:p><\/jats:sec>","DOI":"10.1111\/jgh.17036","type":"journal-article","created":{"date-parts":[[2025,6,27]],"date-time":"2025-06-27T02:44:01Z","timestamp":1750992241000},"page":"2197-2208","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Guselkumab in East Asians With Moderate\u2010to\u2010Severe Ulcerative Colitis: Subgroup Analysis of the QUASAR Induction and Maintenance Studies"],"prefix":"10.1111","volume":"40","author":[{"given":"Baili","family":"Chen","sequence":"first","affiliation":[{"name":"The First Affiliated Hospital Sun Yat\u2010Sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6647-6325","authenticated-orcid":false,"given":"Byong\u00a0Duk","family":"Ye","sequence":"additional","affiliation":[{"name":"University of Ulsan College of Medicine Asan Medical Center  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qian","family":"Cao","sequence":"additional","affiliation":[{"name":"Sir Run Run Shaw Hospital, School of Medicine Zhejiang University  Hangzhou China"}],"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 and Medicine Fukuoka University Faculty of Medicine  Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8172-3240","authenticated-orcid":false,"given":"Masayuki","family":"Saruta","sequence":"additional","affiliation":[{"name":"The Jikei University School of Medicine  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Minhu","family":"Chen","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital Sun Yat\u2010Sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Pelak","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole","family":"Shipitofsky","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ye","family":"Miao","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1322-6407","authenticated-orcid":false,"given":"Keira","family":"Herr","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bryan","family":"Wahking","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianmin","family":"Zhuo","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1178-3536","authenticated-orcid":false,"given":"Tadakazu","family":"Hisamatsu","sequence":"additional","affiliation":[{"name":"Kyorin University School of Medicine  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,6,26]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.mayocp.2019.01.018"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.5217\/ir.2021.00115"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v30.i9.1154"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-024-08518-2"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/jgh.14872"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00384-023-04417-6"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.5217\/ir.2021.00104"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2019-319699"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cyto.2024.156743"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/ibd\/izaa033"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41588-023-01384-0"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00535-021-01784-1"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/jgh.15185"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.5217\/ir.2023.00050"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2020.12.031"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2020.1773430"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjab178"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjad100"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.5217\/ir.2018.16.1.4"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.13851"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.5217\/ir.2023.00013"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2025.1532852"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2023.08.038"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(24)01927-5"}],"container-title":["Journal of Gastroenterology and Hepatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jgh.17036","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T10:13:37Z","timestamp":1756721617000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jgh.17036"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6,26]]},"references-count":24,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2025,9]]}},"alternative-id":["10.1111\/jgh.17036"],"URL":"https:\/\/doi.org\/10.1111\/jgh.17036","archive":["Portico"],"relation":{},"ISSN":["0815-9319","1440-1746"],"issn-type":[{"value":"0815-9319","type":"print"},{"value":"1440-1746","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,6,26]]},"assertion":[{"value":"2025-03-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-06-08","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-06-26","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}