Ustekinumab in bio-naïve and bio-failure Crohn's disease patients: Results from a « real-life » monocentric cohort.
Biologics
Crohn's disease
Inflammatory bowel disease
Real-life data
Ustekinumab
Journal
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
ISSN: 1878-3562
Titre abrégé: Dig Liver Dis
Pays: Netherlands
ID NLM: 100958385
Informations de publication
Date de publication:
01 2021
01 2021
Historique:
received:
21
08
2020
revised:
29
10
2020
accepted:
31
10
2020
pubmed:
23
11
2020
medline:
18
12
2021
entrez:
22
11
2020
Statut:
ppublish
Résumé
The pivotal clinical trials have largely demonstrated the efficacy and safety of ustekinumab in Crohn's disease. Real-life cohorts published so far only include very few bio-naïve patients. This study assesses effectiveness and safety of ustekinumab in bio-naïve and bio-failure patients treated with ustekinumab in routine practice and look for predictors of response. We performed a retrospective monocentric study. Initial response was assessed by maintenance therapy beyond week 16. Sustained response was assessed by the continuation or cessation of therapy over time for another reason than stopping in sustained remission. Treatment persistence was assessed by Kaplan Meier curves and predictors of treatment persistence were studied by univariate and multivariate Cox model. Out of 156 recorded patients, three patients were still in their induction phase at time of analysis and 5 patients were lost to follow-up, leaving 148 patients for clinical effectiveness analyses, including 35 bio-naïve when starting ustekinumab. A maintenance therapy was initiated in 79.7%. At one year, the probability to be still treated with ustekinumab was 73.8%. Treatment cessation increased with smoking in multivariate analysis. Previous biologic failure (as a whole), CRP and fecal calprotectin baseline levels did not influence initial response and treatment persistence. A large proportion of CD patients initially respond to ustekinumab and continue this treatment beyond one year. Treatment persistence is as high in bio-failure as in bio-naïve patients.
Sections du résumé
BACKGROUND
The pivotal clinical trials have largely demonstrated the efficacy and safety of ustekinumab in Crohn's disease. Real-life cohorts published so far only include very few bio-naïve patients. This study assesses effectiveness and safety of ustekinumab in bio-naïve and bio-failure patients treated with ustekinumab in routine practice and look for predictors of response.
METHODS
We performed a retrospective monocentric study. Initial response was assessed by maintenance therapy beyond week 16. Sustained response was assessed by the continuation or cessation of therapy over time for another reason than stopping in sustained remission. Treatment persistence was assessed by Kaplan Meier curves and predictors of treatment persistence were studied by univariate and multivariate Cox model.
RESULTS
Out of 156 recorded patients, three patients were still in their induction phase at time of analysis and 5 patients were lost to follow-up, leaving 148 patients for clinical effectiveness analyses, including 35 bio-naïve when starting ustekinumab. A maintenance therapy was initiated in 79.7%. At one year, the probability to be still treated with ustekinumab was 73.8%. Treatment cessation increased with smoking in multivariate analysis. Previous biologic failure (as a whole), CRP and fecal calprotectin baseline levels did not influence initial response and treatment persistence.
CONCLUSION
A large proportion of CD patients initially respond to ustekinumab and continue this treatment beyond one year. Treatment persistence is as high in bio-failure as in bio-naïve patients.
Identifiants
pubmed: 33221330
pii: S1590-8658(20)30996-8
doi: 10.1016/j.dld.2020.10.040
pii:
doi:
Substances chimiques
Biological Products
0
Ustekinumab
FU77B4U5Z0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
72-78Informations de copyright
Copyright © 2020 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest E Louis has received fees for: Research Grant: Takeda, Pfizer; Educational Grant: Abbvie, Takeda, Janssen; Speaker Fees: Abbvie, Ferring, MSD, Falk, Takeda, Hospira, Janssen, Pfizer, Celgene; Advisory Board: Abbvie, Ferring, MSD, Takeda, Celgene, Hospira, Janssen; Consultant: Abbvie.