{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,5]],"date-time":"2026-06-05T11:10:03Z","timestamp":1780657803086,"version":"3.54.1"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2024,4,11]],"date-time":"2024-04-11T00:00:00Z","timestamp":1712793600000},"content-version":"vor","delay-in-days":10,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,4,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Real-world data on the effectiveness and safety of ustekinumab (UST) in ulcerative colitis (UC) are lacking in Latin America. In this study, we aimed to describe the effectiveness and safety of UST in a real-world multicenter cohort of Brazilian patients with UC.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We conducted a multicenter retrospective observational cohort study, including patients with moderate-to-severe UC (total Mayo score 6\u201312, with an endoscopic subscore of 2 or 3) who received UST. The co-primary endpoints were clinical remission, defined as a total Mayo score \u22642 at 1 year, with a combined rectal bleeding and stool frequency subscore of \u22641, and endoscopic remission (endoscopic Mayo subscore of 0) within 1 year from baseline. Secondary endpoints included clinical response between weeks 12 and 16, endoscopic response within 1 year of starting UST, steroid-free clinical remission at week 52, and biochemical remission at week 52. We also evaluated UST treatment persistence and safety.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 50 patients were included (female, n\u2005=\u200536, 72.0%), with a median disease duration of 9.2 years (1\u201327). Most patients had extensive colitis (n\u2005=\u200538, 76.0%), and 43 (86.0%) were steroid dependent at baseline. Forty patients (80.0%) were previously exposed to biologics (anti-TNF drugs, n\u2005=\u200531; vedolizumab [VDZ], n\u2005=\u200527). The co-primary endpoints of clinical remission at 1 year and endoscopic remission within 1 year were achieved by 50.0% and 36.0% of patients, respectively. Clinical response at weeks 12\u201316 was 56.0%, and endoscopic response, steroid-free clinical remission, and biochemical remission at week 52 were 68.0%, 46.5%, and 50.0%, respectively. The UST treatment persistence rate at 24 months was 73.7%. During the follow-up, 10 patients (20.0%) were hospitalized, mostly due to disease progression, and 3 patients required colectomy. Nine patients (18.0%) discontinued the drug mainly due to a lack of effectiveness. Twenty-seven adverse events (AEs) were reported, 16 of which were considered as serious AEs.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>In this real-world cohort of difficult-to-treat UC patients, UST was associated with improvements in clinical, biochemical, and endoscopic outcomes. The safety profile was favorable, consistent with the known profile of UST.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/crocol\/otae023","type":"journal-article","created":{"date-parts":[[2024,4,11]],"date-time":"2024-04-11T14:12:04Z","timestamp":1712844724000},"source":"Crossref","is-referenced-by-count":9,"title":["Effectiveness and Safety of Ustekinumab for Ulcerative Colitis: A Brazilian Multicentric Observational Study"],"prefix":"10.1093","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5566-9284","authenticated-orcid":false,"given":"Rog\u00e9rio Serafim","family":"Parra","sequence":"first","affiliation":[{"name":"Department of Surgery and Anatomy, Ribeir\u00e3o Preto Medical School, University of S\u00e3o Paulo , Ribeir\u00e3o Preto, S\u00e3o Paulo , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1527-0663","authenticated-orcid":false,"given":"J\u00falio Maria Fonseca","family":"Chebli","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Medicine, Inflammatory Bowel Disease Center, Federal University of Juiz de Fora , Juiz de Fora, Minas Gerais , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5487-9418","authenticated-orcid":false,"given":"Matheus Freitas Cardoso","family":"de Azevedo","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, University of S\u00e3o Paulo School of Medicine , S\u00e3o Paulo , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7875-1475","authenticated-orcid":false,"given":"Liliana Andrade","family":"Chebli","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Medicine, Inflammatory Bowel Disease Center, Federal University of Juiz de Fora , Juiz de Fora, Minas Gerais , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1253-4945","authenticated-orcid":false,"given":"Gilmara Pandolfo","family":"Zabot","sequence":"additional","affiliation":[{"name":"Department of Colon and Rectum Surgery, Moinhos de Vento Hospital, Feevale University , Porto Alegre , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0867-6593","authenticated-orcid":false,"given":"Ornella Sari","family":"Cassol","sequence":"additional","affiliation":[{"name":"Department of Colorectal Surgery, Hospital de Cl\u00ednicas de Passo Fundo, Atitus Medical School , Rio Grande do Sul , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3256-4698","authenticated-orcid":false,"given":"Renata","family":"de S\u00e1 Brito Fr\u00f3es","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Endoscopy, Gastromed , Rio de Janeiro , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5936-9791","authenticated-orcid":false,"given":"Genoile Oliveira","family":"Santana","sequence":"additional","affiliation":[{"name":"Department of Life Sciences, State University of Bahia , Salvador, Bahia , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2779-7841","authenticated-orcid":false,"given":"M\u00e1rcio","family":"Lubini","sequence":"additional","affiliation":[{"name":"Department of Surgery, Passo Fundo University , Rio Grande do Sul , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8180-6254","authenticated-orcid":false,"given":"Daniela Oliveira","family":"Magro","sequence":"additional","affiliation":[{"name":"Department of Surgery, State University of Campinas (UNICAMP) , Campinas, S\u00e3o Paulo , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5397-0084","authenticated-orcid":false,"given":"Marcello","family":"Imbrizi","sequence":"additional","affiliation":[{"name":"Department of Surgery, State University of Campinas (UNICAMP) , Campinas, S\u00e3o Paulo , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5533-5401","authenticated-orcid":false,"given":"Antonio Carlos da Silva","family":"Moraes","sequence":"additional","affiliation":[{"name":"Internal Medicine Department, Hospital Copa D\u00b4Or , Rio de Janeiro , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8915-7279","authenticated-orcid":false,"given":"Fabio Vieira","family":"Teixeira","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology,\u00a0Gastrosa\u00fade Clinic , Marilia, S\u00e3o Paulo , 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School, University of S\u00e3o Paulo , Ribeir\u00e3o Preto, S\u00e3o Paulo , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2857-0825","authenticated-orcid":false,"given":"Nat\u00e1lia Sousa Freitas","family":"Queiroz","sequence":"additional","affiliation":[{"name":"Health Sciences Graduate Program, Pontif\u00edcia Universidade Cat\u00f3lica do Paran\u00e1 (PUCPR) , Curitiba , Brazil"},{"name":"IBD Center, Santa Cruz Hospital , Curitiba , Brazil"},{"name":"Internal Medicine Department, Hospital Copa D\u00b4Or , Rio de Janeiro , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9632-6691","authenticated-orcid":false,"given":"Paulo Gustavo","family":"Kotze","sequence":"additional","affiliation":[{"name":"Health Sciences Graduate Program, Pontif\u00edcia Universidade Cat\u00f3lica do Paran\u00e1 (PUCPR) , Curitiba , Brazil"},{"name":"Department of Colorectal Surgery, Hospital de 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