Comparative Efficacy of Vedolizumab and Adalimumab in Ulcerative Colitis Patients Previously Treated With Infliximab.


Journal

Inflammatory bowel diseases
ISSN: 1536-4844
Titre abrégé: Inflamm Bowel Dis
Pays: England
ID NLM: 9508162

Informations de publication

Date de publication:
18 10 2019
Historique:
received: 23 01 2019
pubmed: 2 4 2019
medline: 30 5 2020
entrez: 2 4 2019
Statut: ppublish

Résumé

Adalimumab (ADA) and vedolizumab (VDZ) have shown efficacy in moderate to severe ulcerative colitis (UC) patients who failed infliximab (IFX). Although, a comparative efficacy evaluation of ADA and VDZ in this clinical setting is currently missing. The aim of this study is to compare the efficacy of ADA and VDZ in patients affected by UC who failed IFX. Clinical records of UC patients from 8 Italian IBD referral centers who failed IFX and were candidates to receive either ADA or VDZ were retrospectively reviewed. The primary end point was therapeutic failure at week 52. Secondary end points included therapy discontinuation at weeks 8, 24 and 52, the discontinuation-free survival, and safety. One hundred sixty-one UC patients, 15 (9.2%) primary, 83 (51.6%) secondary IFX failures, and 63 (39.2%) IFX intolerants were included. Sixty-four (40%) patients received ADA and 97 (60%) VDZ as second line therapy. At week 52, 37.5% and 28.9% of patients on ADA and VDZ, respectively, had therapeutic failure (P = 0.302). However, the failure rate was significantly higher in the ADA group as compared with VDZ group among IFX secondary failures (48.0% ADA vs 22.4%VDZ, P = 0.035). The therapy discontinuation-free survival was significantly higher in the group of IFX secondary failures who received VDZ as compared with ADA at both the univariate (P = 0.007) and multivariate survival analysis (OR 2.79; 95% CI, 1.23-6.34; P = 0.014). No difference in the failure and biologic discontinuation-free survival was observed in the IFX primary failure and intolerant subgroups. Vedolizumab might be the therapy of choice in those UC patients who showed secondary failure to IFX.

Sections du résumé

BACKGROUND
Adalimumab (ADA) and vedolizumab (VDZ) have shown efficacy in moderate to severe ulcerative colitis (UC) patients who failed infliximab (IFX). Although, a comparative efficacy evaluation of ADA and VDZ in this clinical setting is currently missing.
AIM
The aim of this study is to compare the efficacy of ADA and VDZ in patients affected by UC who failed IFX.
METHODS
Clinical records of UC patients from 8 Italian IBD referral centers who failed IFX and were candidates to receive either ADA or VDZ were retrospectively reviewed. The primary end point was therapeutic failure at week 52. Secondary end points included therapy discontinuation at weeks 8, 24 and 52, the discontinuation-free survival, and safety.
RESULTS
One hundred sixty-one UC patients, 15 (9.2%) primary, 83 (51.6%) secondary IFX failures, and 63 (39.2%) IFX intolerants were included. Sixty-four (40%) patients received ADA and 97 (60%) VDZ as second line therapy. At week 52, 37.5% and 28.9% of patients on ADA and VDZ, respectively, had therapeutic failure (P = 0.302). However, the failure rate was significantly higher in the ADA group as compared with VDZ group among IFX secondary failures (48.0% ADA vs 22.4%VDZ, P = 0.035). The therapy discontinuation-free survival was significantly higher in the group of IFX secondary failures who received VDZ as compared with ADA at both the univariate (P = 0.007) and multivariate survival analysis (OR 2.79; 95% CI, 1.23-6.34; P = 0.014). No difference in the failure and biologic discontinuation-free survival was observed in the IFX primary failure and intolerant subgroups.
CONCLUSION
Vedolizumab might be the therapy of choice in those UC patients who showed secondary failure to IFX.

Identifiants

pubmed: 30931477
pii: 5424157
doi: 10.1093/ibd/izz057
doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0
Gastrointestinal Agents 0
vedolizumab 9RV78Q2002
Infliximab B72HH48FLU
Adalimumab FYS6T7F842

Types de publication

Comparative Study Journal Article Multicenter Study Observational Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

1805-1812

Informations de copyright

© 2019 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Auteurs

Agnese Favale (A)

Dep. of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy.

Sara Onali (S)

Dep. of Biomedicine and Prevention, University of Rome "Tor Vergata", Rome, Italy.

Flavio Caprioli (F)

IRCCS "Cà Grada" Foundation, "Ospedale Maggiore" hospital, University of Milan, Milan, Italy.

Daniela Pugliese (D)

"IRCCS Policlinico Agostino Gemelli", Holy Heart Catholic University, Rome, Italy.

Alessandro Armuzzi (A)

"IRCCS Policlinico Agostino Gemelli", Holy Heart Catholic University, Rome, Italy.

Fabio Salvatore Macaluso (FS)

United Hospitals "Villa Sofia-Cervello", Palermo, Italy.

Ambrogio Orlando (A)

United Hospitals "Villa Sofia-Cervello", Palermo, Italy.

Anna Viola (A)

Dep. of Clinical Medicine, University of Messina, Messina, Italy.

Walter Fries (W)

Dep. of Clinical Medicine, University of Messina, Messina, Italy.

Antonio Rispo (A)

Dep. of Clinical Medicine and Surgery, University of Naples "Federico II", Naples, Italy.

Fabiana Castiglione (F)

Dep. of Clinical Medicine and Surgery, University of Naples "Federico II", Naples, Italy.

Giammarco Mocci (G)

"Brotzu" Hospital, Cagliari, Italy.

Fabio Chicco (F)

University of Cagliari, Cagliari, Italy.

Paolo Usai (P)

University of Cagliari, Cagliari, Italy.

Emma Calabrese (E)

Dep. of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy.

Livia Biancone (L)

Dep. of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy.

Giovanni Monteleone (G)

Dep. of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy.

Massimo Claudio Fantini (MC)

Dep. of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy.

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