{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T15:34:58Z","timestamp":1791560098062,"version":"4.3.4"},"reference-count":38,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,4,21]],"date-time":"2022-04-21T00:00:00Z","timestamp":1650499200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,4,21]],"date-time":"2022-04-21T00:00:00Z","timestamp":1650499200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Gastroenterol"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The effectiveness of ustekinumab (UST) in the treatment of Crohn\u2019s disease (CD) has been demonstrated in the pivotal Phase 3 UNITI 1 and 2 and IM-UNITI studies in both anti-TNF-na\u00efve and anti-TNF-exposed patients. Given the selective nature of pivotal trial designs, real-world effectiveness and safety studies are warranted. We report our experience with UST treatment in a large, real-world multicenter cohort of Brazilian patients with CD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We performed a retrospective multicenter study including patients with CD, predominantly biologically refractory CD, who received UST. The primary endpoint was the proportion of patients in clinical remission at weeks 8, 24 and 56. Possible predictors of clinical and biological response\/remission and safety outcomes were also assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, 245 CD (mean age 39.9 [15\u201387]) patients were enrolled. Most patients (86.5%) had been previously exposed to biologics. According to nonresponder imputation analysis, the proportions of patients in clinical remission at weeks 8, 24 and 56 were 41.0% (n\u2009=\u200998\/239), 64.0% (n\u2009=\u2009153\/239) and 39.3% (n\u2009=\u200994\/239), respectively. A biological response was achieved in 55.4% of patients at week 8, and 59.3% were in steroid-free remission at the end of follow-up. No significant differences in either clinical or biological remission were noted between bio-na\u00efve and bio-experienced patients. Forty-eight patients (19.6%) presented 60 adverse events during the follow-up, of which 8 (13.3%) were considered serious adverse events (3.2% of 245 patients). Overall, a proximal disease location, younger age, perianal involvement, and smoking were associated with lower rates of clinical remission over time.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>UST therapy was effective and safe in the long term in this large real-life cohort of Brazilian patients with refractory CD, regardless of previous exposure to other biological agents.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12876-022-02280-3","type":"journal-article","created":{"date-parts":[[2022,4,21]],"date-time":"2022-04-21T13:04:43Z","timestamp":1650546283000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":25,"title":["Long-term effectiveness and safety of ustekinumab in bio-na\u00efve and bio-experienced anti-tumor necrosis factor patients with Crohn\u2019s disease: a real-world multicenter Brazilian study"],"prefix":"10.1186","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5566-9284","authenticated-orcid":false,"given":"Rog\u00e9rio Serafim","family":"Parra","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00falio Maria Fonseca","family":"Chebli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nat\u00e1lia Sousa Freitas","family":"Queiroz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aderson Omar Mour\u00e3o Cintra","family":"Dami\u00e3o","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matheus Freitas Cardoso","family":"de Azevedo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liliana Andrade","family":"Chebli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erika Ruback","family":"Bertges","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio Jos\u00e9 Tiburcio","family":"Alves Junior","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Orlando","family":"Ambrogini Junior","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bianca Loyo Pona Schiavetti","family":"da Silva","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcio","family":"Lubini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mauro","family":"Bafutto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Flores","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eduardo Garcia","family":"Vilela","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra Felice","family":"Boratto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Newton Luiz Tricarico","family":"Gasparetti Junior","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Flavio","family":"Steinwurz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nayara Salgado","family":"Carvalho","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Omar","family":"F\u00e9res","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 Joaquim Ribeiro","family":"da Rocha","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,4,21]]},"reference":[{"issue":"1","key":"2280_CR1","doi-asserted-by":"publisher","first-page":"22","DOI":"10.1038\/s41572-020-0156-2","volume":"6","author":"G Roda","year":"2020","unstructured":"Roda G, Chien Ng S, Kotze PG, Argollo M, Panaccione R, Spinelli A, et al. 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Smyrna, GA: UCB Inc; 2018."}],"container-title":["BMC Gastroenterology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12876-022-02280-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12876-022-02280-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12876-022-02280-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,4,21]],"date-time":"2022-04-21T13:07:18Z","timestamp":1650546438000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcgastroenterol.biomedcentral.com\/articles\/10.1186\/s12876-022-02280-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,4,21]]},"references-count":38,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2022,12]]}},"alternative-id":["2280"],"URL":"https:\/\/doi.org\/10.1186\/s12876-022-02280-3","relation":{},"ISSN":["1471-230X"],"issn-type":[{"value":"1471-230X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,4,21]]},"assertion":[{"value":"2 June 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 April 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"21 April 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The need for informed consent to participate was waived by the ethics committee of the Hospital das Cl\u00ednicas of the Ribeir\u00e3o Preto Medical School, University of S\u00e3o Paulo (HCFMRP-USP) due to retrospective and anonymous nature of the study. The study was approved by the ethics committee of the coordinating site (HCFMRP-USP, CAAE: 13436419.7.1001.5440; Ethics Committee Number: 3.335.068\/2019). All procedures were conducted in accordance with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Parra RS has received fees for serving as a speaker and\/or an advisory board member for AbbVie, Ferring Pharmaceuticals, Janssen, and Takeda. Chebli JMF has received fees for serving as a speaker and\/or an advisory board member for Abbott, AbbVie, Janssen, and Takeda. Queiroz NSF reports receiving consulting and lecture fees from Janssen, Takeda, and Abbvie. Damiao AOMC has received fees for serving as a speaker and\/or an advisory board member for Takeda, Abbvie, Pfizer, Janssen, Ferring, and Natulab. Azevedo MFC reports receiving consulting fees from Janssen, lecture fees from Janssen, Takeda, and Abbvie, and travel grant support from Takeda, Janssen, and Abbvie. Chebli LA has received fees for serving as a speaker for Janssen and Takeda. Alves Jr AJT received fees for serving as a speaker and\/or an advisory board member for Janssen, Takeda, Abbvie, Nestle and Apsen. Ambrogini Jr O has received fees for serving as a speaker and\/or an advisory board member for Janssen, Abbvie, Takeda, and UCB. Da Silva BLPS has received fees for serving as a speaker for Pfizer, Abbvie, Janssen, and Takeda. Flores C has received fees for serving as a speaker for Janssen, Abbvie, UCB Biopharma, and Takeda. Steinwurz F is speaker\/consultant\/researcher for Abbvie, Amgen, Ferring, Janssen, Novartis, Pfizer, Sandoz, Takeda, and UCB biopharma. Bertges ER, Lubini M, Bafutto M, Vilela EG, Boratto SDF, Gasparetti Jr NLT, Salgado NC, F\u00e9res O, and Rocha JJR report no conflict of interest.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"199"}}