The effectiveness of ustekinumab and vedolizumab as third-line biologic therapy in patients with Crohn's disease.


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:
04 2023
Historique:
received: 21 06 2022
revised: 04 08 2022
accepted: 16 08 2022
medline: 28 3 2023
pubmed: 21 9 2022
entrez: 20 9 2022
Statut: ppublish

Résumé

The effectiveness of Ustekinumab (UST) and Vedolizumab (VDZ) in patients with Crohn's disease (CD) as third-line biologic therapies is unclear. We performed a multicentre, real-world assessment of the effectiveness of UST and VDZ among highly-refractory patients with CD. Data of consecutive patients with CD treated with UST and VDZ as third-line biologic therapy until December 2021 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). 143 patients (UST: n = 113; VDZ: n = 30) were included. At the end of induction, the rates of clinical response (CR) were 61.9% for UST and 60.0% for VDZ (p = 1.00), with steroid-free clinical remission (SFCR) achieved in 38.1% of patients in the UST group and 43.3% of patients in the VDZ group (p = 0.75). After 52 weeks of observation, the rates of CR were 65.9% for UST and 71.4% for VDZ (p = 0.77), while the rates of SFCR were 51.8% for UST and 57.1% for VDZ (p = 0.78). At multiple Cox proportional hazard regression model, age (HR 0.98; p = 0.04) and need for systemic steroids at baseline (HR 3.29; p = 0.003) were found to be independent predictors of treatment discontinuation. Both VDZ and UST showed high effectiveness as third-line biologic therapy in CD, without significant differences between them.

Sections du résumé

BACKGROUND
The effectiveness of Ustekinumab (UST) and Vedolizumab (VDZ) in patients with Crohn's disease (CD) as third-line biologic therapies is unclear.
AIMS
We performed a multicentre, real-world assessment of the effectiveness of UST and VDZ among highly-refractory patients with CD.
METHODS
Data of consecutive patients with CD treated with UST and VDZ as third-line biologic therapy until December 2021 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease (SN-IBD).
RESULTS
143 patients (UST: n = 113; VDZ: n = 30) were included. At the end of induction, the rates of clinical response (CR) were 61.9% for UST and 60.0% for VDZ (p = 1.00), with steroid-free clinical remission (SFCR) achieved in 38.1% of patients in the UST group and 43.3% of patients in the VDZ group (p = 0.75). After 52 weeks of observation, the rates of CR were 65.9% for UST and 71.4% for VDZ (p = 0.77), while the rates of SFCR were 51.8% for UST and 57.1% for VDZ (p = 0.78). At multiple Cox proportional hazard regression model, age (HR 0.98; p = 0.04) and need for systemic steroids at baseline (HR 3.29; p = 0.003) were found to be independent predictors of treatment discontinuation.
CONCLUSIONS
Both VDZ and UST showed high effectiveness as third-line biologic therapy in CD, without significant differences between them.

Identifiants

pubmed: 36127230
pii: S1590-8658(22)00653-3
doi: 10.1016/j.dld.2022.08.028
pii:
doi:

Substances chimiques

Ustekinumab FU77B4U5Z0
vedolizumab 9RV78Q2002
Gastrointestinal Agents 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

471-477

Informations de copyright

Copyright © 2022. Published by Elsevier Ltd.

Auteurs

Fabio Salvatore Macaluso (FS)

IBD Unit, "Villa Sofia-Cervello" Hospital, Viale Strasburgo 233, 90146 Palermo, Italy. Electronic address: fsmacaluso@gmail.com.

Mauro Grova (M)

IBD Unit, "Villa Sofia-Cervello" Hospital, Viale Strasburgo 233, 90146 Palermo, Italy.

Marica Saladino (M)

Gastroenterology and Hepatology Section, PROMISE, University of Palermo, Italy.

Maria Cappello (M)

Gastroenterology and Hepatology Section, PROMISE, University of Palermo, Italy.

Maria Giulia Demarzo (MG)

IBD Unit, A.O.U. Policlinico "G. Martino", Messina, Italy.

Antonino Carlo Privitera (AC)

IBD Unit, "Cannizzaro" Hospital, Catania, Italy.

Emiliano Giangreco (E)

Gastroenterology Unit, A.O. "Guzzardi", Vittoria, Italy.

Serena Garufi (S)

Gastroenterology Unit, A.R.N.A.S. "Garibaldi", Catania, Italy.

Sara Renna (S)

IBD Unit, "Villa Sofia-Cervello" Hospital, Viale Strasburgo 233, 90146 Palermo, Italy.

Angelo Casà (A)

IBD Unit, "Villa Sofia-Cervello" Hospital, Viale Strasburgo 233, 90146 Palermo, Italy.

Marco Ventimiglia (M)

Directorate General of Medical Device and Pharmaceutical Service, Italian Ministry of Health, Rome, Italy.

Walter Fries (W)

IBD Unit, A.O.U. Policlinico "G. Martino", Messina, Italy.

Ambrogio Orlando (A)

IBD Unit, "Villa Sofia-Cervello" Hospital, Viale Strasburgo 233, 90146 Palermo, Italy.

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