Long-term effectiveness and safety of ustekinumab in bio-naive and bio-experienced anti-tumor necrosis factor patients with Crohn's disease: a real-world multicenter Brazilian study

被引：16

作者：

Parra, Rogerio Serafim ^{[1
]}

Fonseca Chebli, Julio Maria ^{[2
]}

Freitas Queiroz, Natalia Sousa ^{[3
]}

Mourao Cintra Damiao, Aderson Omar ^{[3
]}

Cardoso de Azevedo, Matheus Freitas ^{[3
]}

Chebli, Liliana Andrade ^{[2
]}

Bertges, Erika Ruback ^{[2
]}

Tiburcio Alves Junior, Antonio Jose ^{[4
]}

Ambrogini Junior, Orlando ^{[5
]}

Pona Schiavetti da Silva, Bianca Loyo ^{[6
]}

Lubini, Marcio ^{[7
]}

Bafutto, Mauro ^{[8
]}

Flores, Cristina ^{[9
]}

Vilela, Eduardo Garcia ^{[10
]}

Boratto, Sandra Felice ^{[11
]}

Tricarico Gasparetti Junior, Newton Luiz ^{[12
]}

Steinwurz, Flavio ^{[13
]}

Carvalho, Nayara Salgado ^{[13
]}

Feres, Omar ^{[1
]}

Ribeiro da Rocha, Jose Joaquim ^{[1
]}

机构：

[1] Univ Sao Paulo, Ribeirao Preto Med Sch, Dept Surg & Anat, Av Bandeirantes 3900, BR-14048900 Ribeirao Preto, SP, Brazil

[2] Univ Fed Juiz de Fora, Juiz De Fora, Brazil

[3] Univ Sao Paulo, Sao Paulo, Brazil

[4] Pontificia Univ Catolica, Campinas, Brazil

[5] Univ Fed Sao Paulo, Sao Paulo, Brazil

[6] Prefeitura Municipal Santos, Santos, SP, Brazil

[7] Univ Passo Fundo, Passo Fundo, RS, Brazil

[8] Univ Fed Goias, Goiania, Go, Brazil

[9] Univ Fed Rio Grande do Sul, Porto Alegre, RS, Brazil

[10] Univ Fed Minas Gerais, Belo Horizonte, MG, Brazil

[11] Ctr Univ Saude ABC, Santo Andre, SP, Brazil

[12] Hosp Vivalle Rede DOr, Sao Jose Dos Campos, Brazil

[13] Hosp Israelita Albert Einstein, Sao Paulo, Brazil

来源：

BMC GASTROENTEROLOGY | 2022年 / 22卷 / 01期

关键词：

Ustekinumab; Crohn's disease; Inflammatory bowel disease; Biological therapy; INFLAMMATORY-BOWEL-DISEASE; INTENSIFICATION; INFLIXIMAB; THERAPY; LIFE; CARE;

D O I：

10.1186/s12876-022-02280-3

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

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-naive 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-naive 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.

引用

页数：12