Long-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 study

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dc.creatorRogério Serafim Parra
dc.creatorBianca Loyo Pona Schiavetti da Silva
dc.creatorMarcio Lubini
dc.creatorMauro Bafutto
dc.creatorCristina Flores
dc.creatorEduardo Garcia Vilela
dc.creatorSandra Felice Boratto
dc.creatorNewton Luiz Tricarico Gasparetti Junior
dc.creatorFlavio Steinwurz
dc.creatorNayara Salgado Carvalho
dc.creatorOmar Féres
dc.creatorJúlio Maria Fonseca Chebli
dc.creatorJosé Joaquim Ribeiro da Rocha
dc.creatorNatália Sousa Freitas Queiroz
dc.creatorAderson Omar Mourão Cintra Damião
dc.creatorMatheus Freitas Cardoso de Azevedo
dc.creatorLiliana Andrade Chebli
dc.creatorErika Ruback Bertges
dc.creatorAntonio José Tiburcio Alves Junior
dc.creatorOrlando Ambrogini Junior
dc.date.accessioned2024-01-08T20:00:28Z
dc.date.accessioned2025-09-08T23:37:36Z
dc.date.available2024-01-08T20:00:28Z
dc.date.issued2022-04-21
dc.format.mimetypepdf
dc.identifier.doihttps://doi.org/10.1186/s12876-022-02280-3
dc.identifier.issn1471-230X
dc.identifier.urihttps://hdl.handle.net/1843/62489
dc.languageeng
dc.publisherUniversidade Federal de Minas Gerais
dc.relation.ispartofBMC Gastroenterology
dc.rightsAcesso Aberto
dc.subjectDoença de Crohn
dc.subjectUstekinumab
dc.subjectInflamação
dc.subjectTerapia Biológica
dc.subject.otherCrohn’s disease
dc.subject.otherUstekinumab
dc.subject.otherInfammatory bowel disease
dc.subject.otherBiological therapy
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 study
dc.typeArtigo de periódico
local.citation.epage12
local.citation.issue199
local.citation.spage1
local.citation.volume22
local.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.
local.identifier.orcidhttp://orcid.org/0000-0002-5566-9284
local.publisher.countryBrasil
local.publisher.departmentMED - DEPARTAMENTO DE CLÍNICA MÉDICA
local.publisher.departmentMEDICINA - FACULDADE DE MEDICINA
local.publisher.initialsUFMG
local.url.externahttps://bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-022-02280-3

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