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Please use this identifier to cite or link to this item: http://hdl.handle.net/1843/62489
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dc.creatorRogério Serafim Parrapt_BR
dc.creatorBianca Loyo Pona Schiavetti da Silvapt_BR
dc.creatorMarcio Lubinipt_BR
dc.creatorMauro Bafuttopt_BR
dc.creatorCristina Florespt_BR
dc.creatorEduardo Garcia Vilelapt_BR
dc.creatorSandra Felice Borattopt_BR
dc.creatorNewton Luiz Tricarico Gasparetti Juniorpt_BR
dc.creatorFlavio Steinwurzpt_BR
dc.creatorNayara Salgado Carvalhopt_BR
dc.creatorOmar Férespt_BR
dc.creatorJúlio Maria Fonseca Cheblipt_BR
dc.creatorJosé Joaquim Ribeiro da Rochapt_BR
dc.creatorNatália Sousa Freitas Queirozpt_BR
dc.creatorAderson Omar Mourão Cintra Damiãopt_BR
dc.creatorMatheus Freitas Cardoso de Azevedopt_BR
dc.creatorLiliana Andrade Cheblipt_BR
dc.creatorErika Ruback Bertgespt_BR
dc.creatorAntonio José Tiburcio Alves Juniorpt_BR
dc.creatorOrlando Ambrogini Juniorpt_BR
dc.date.accessioned2024-01-08T20:00:28Z-
dc.date.available2024-01-08T20:00:28Z-
dc.date.issued2022-04-21-
dc.citation.volume22pt_BR
dc.citation.issue199pt_BR
dc.citation.spage1pt_BR
dc.citation.epage12pt_BR
dc.identifier.doihttps://doi.org/10.1186/s12876-022-02280-3pt_BR
dc.identifier.issn1471-230Xpt_BR
dc.identifier.urihttp://hdl.handle.net/1843/62489-
dc.description.resumoBackground The effectiveness of ustekinumab (UST) in the treatment of Crohn’s disease (CD) has been demonstrated in the pivotal Phase 3 UNITI 1 and 2 and IM-UNITI studies in both anti-TNF-naïve 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. Methods 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. Results Overall, 245 CD (mean age 39.9 [15–87]) 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 = 98/239), 64.0% (n = 153/239) and 39.3% (n = 94/239), 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-naïve 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. Conclusions 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.pt_BR
dc.format.mimetypepdfpt_BR
dc.languageengpt_BR
dc.publisherUniversidade Federal de Minas Geraispt_BR
dc.publisher.countryBrasilpt_BR
dc.publisher.departmentMED - DEPARTAMENTO DE CLÍNICA MÉDICApt_BR
dc.publisher.departmentMEDICINA - FACULDADE DE MEDICINApt_BR
dc.publisher.initialsUFMGpt_BR
dc.relation.ispartofBMC Gastroenterologypt_BR
dc.rightsAcesso Abertopt_BR
dc.subjectCrohn’s diseasept_BR
dc.subjectUstekinumabpt_BR
dc.subjectInfammatory bowel diseasept_BR
dc.subjectBiological therapypt_BR
dc.subject.otherDoença de Crohnpt_BR
dc.subject.otherUstekinumabpt_BR
dc.subject.otherInflamaçãopt_BR
dc.subject.otherTerapia Biológicapt_BR
dc.titleLong-term effectiveness and safety of ustekinumab in bio-naïve and bio-experienced anti-tumor necrosis factor patients with Crohn’s disease: a real-world multicenter Brazilian studypt_BR
dc.typeArtigo de Periódicopt_BR
dc.url.externahttps://bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-022-02280-3pt_BR
dc.identifier.orcidhttp://orcid.org/0000-0002-5566-9284pt_BR
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