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

• Autor(a) principal: Rogério Serafim Parra
• Data de Publicação: 2022
• Outros Autores: Bianca Loyo Pona Schiavetti da Silva, Marcio Lubini, Mauro Bafutto, Cristina Flores, Eduardo Garcia Vilela, Sandra Felice Boratto, Newton Luiz Tricarico Gasparetti Junior, Flavio Steinwurz, Nayara Salgado Carvalho, Omar Féres, Júlio Maria Fonseca Chebli, José Joaquim Ribeiro da Rocha, Natália Sousa Freitas Queiroz, Aderson Omar Mourão Cintra Damião, Matheus Freitas Cardoso de Azevedo, Liliana Andrade Chebli, Erika Ruback Bertges, Antonio José Tiburcio Alves Junior, Orlando Ambrogini Junior
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Repositório Institucional da UFMG
• Texto Completo: https://doi.org/10.1186/s12876-022-02280-3; http://hdl.handle.net/1843/62489; http://orcid.org/0000-0002-5566-9284
• topic: Crohn’s disease; Ustekinumab; Infammatory bowel disease; Biological therapy; Doença de Crohn; Ustekinumab; Inflamação; Terapia Biológica

Background 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.