Ustekinumab and vedolizumab for the prevention of postoperative recurrence of Crohn's disease: Results from the ENEIDA registry.


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 2023
Historique:
received: 06 04 2022
revised: 14 07 2022
accepted: 19 07 2022
pubmed: 11 8 2022
medline: 31 12 2022
entrez: 10 8 2022
Statut: ppublish

Résumé

Anti-TNF agents are the only effective biological agents for the prevention of postoperative recurrence (POR) in Crohn's disease (CD). However, they are contraindicated or have been shown to fail in some patients. Although ustekinumab and vedolizumab were licensed for CD some years ago, data in this setting are scarce. All CD patients in whom ustekinumab or vedolizumab was prescribed for the prevention of POR within three months of ileocolonic resection with anastomosis were identified from the ENEIDA registry. The development of endoscopic, clinical and surgical POR was registered. Forty patients were treated for the prevention of POR with ustekinumab and 25 were treated with vedolizumab. Eighty per cent had at least one risk factor for POR (prior resections, active smoking, perianal disease or penetrating disease behaviour). All the patients had been exposed to anti-TNF therapy. After a median follow-up of 17 and 26 months, the cumulative probability of clinical POR at 12 months after surgery was 32% and 30% for ustekinumab and vedolizumab, respectively. Endoscopic assessment within the first 18 months after surgery was available for 80% of the patients on ustekinumab and 70% for those on vedolizumab. The rate of endoscopic POR was 42% for ustekinumab and 40% for vedolizumab. One patient treated with ustekinumab and two with vedolizumab underwent a new intestinal resection. Ustekinumab and vedolizumab seem to be effective in the prevention of POR in patients at high risk. Our results warrant controlled trials comparing these drugs with conventional therapies.

Sections du résumé

BACKGROUND
Anti-TNF agents are the only effective biological agents for the prevention of postoperative recurrence (POR) in Crohn's disease (CD). However, they are contraindicated or have been shown to fail in some patients. Although ustekinumab and vedolizumab were licensed for CD some years ago, data in this setting are scarce.
METHODS
All CD patients in whom ustekinumab or vedolizumab was prescribed for the prevention of POR within three months of ileocolonic resection with anastomosis were identified from the ENEIDA registry. The development of endoscopic, clinical and surgical POR was registered.
RESULTS
Forty patients were treated for the prevention of POR with ustekinumab and 25 were treated with vedolizumab. Eighty per cent had at least one risk factor for POR (prior resections, active smoking, perianal disease or penetrating disease behaviour). All the patients had been exposed to anti-TNF therapy. After a median follow-up of 17 and 26 months, the cumulative probability of clinical POR at 12 months after surgery was 32% and 30% for ustekinumab and vedolizumab, respectively. Endoscopic assessment within the first 18 months after surgery was available for 80% of the patients on ustekinumab and 70% for those on vedolizumab. The rate of endoscopic POR was 42% for ustekinumab and 40% for vedolizumab. One patient treated with ustekinumab and two with vedolizumab underwent a new intestinal resection.
CONCLUSIONS
Ustekinumab and vedolizumab seem to be effective in the prevention of POR in patients at high risk. Our results warrant controlled trials comparing these drugs with conventional therapies.

Identifiants

pubmed: 35948459
pii: S1590-8658(22)00618-1
doi: 10.1016/j.dld.2022.07.013
pii:
doi:

Substances chimiques

Ustekinumab FU77B4U5Z0
vedolizumab 9RV78Q2002
Tumor Necrosis Factor Inhibitors 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

46-52

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2022. Published by Elsevier Ltd.

Déclaration de conflit d'intérêts

Declaration of Competing Interest MM has served as a speaker, consultant and advisory member for or has received research funding from AbbVie, Gilead, Janssen, MSD, Pfizer, Shire Pharmaceuticals, Faes, Takeda, Tillots; PN has served as a speaker, consultant and advisory member for or has received research funding from MSD, Abbvie, Janssen, Takeda, Roche, Sandoz, Ferring, Adacyte, Faes Farma, Kern Pharma, Pfizer, Shire Pharmaceuticals, Vifor Pharma, Chiesi and Tillots; MDM-A has served as a speaker, consultant and advisory member for or has received research funding from MSD, AbbVie, Hospira, Pfizer, Takeda, Janssen, Shire Pharmaceuticals, Tillotts Pharma, FaesPharma; MB-W has served as a speaker, consultant and advisory member for or has received research funding from MSD, Ferring, Abbvie, Janssen, Biogen and Takeda; MC has served as a speaker, consultant and advisory member for or has received research funding from MSD, Abbvie, Takeda, Jannsen, Pfizer, Otsuka Pharmaceutical, Chiesi, Ferring, Shire Pharmaceuticals and Dr. Falk Pharma; MS-A has served as a speaker, consultant and advisory member for or has received research funding from Takeda, Janssen, MSD, Abbvie, Ferring, Chiesi, Tillots and Pfizer; MBA has served as a speaker, consultant and advisory member for or has received research funding from MSD, AbbVie, Janssen, Kern Pharma, Celltrion, Takeda, Gillead, Celgene, Pfizer, Sandoz, Biogen, Fresenius, Ferring, Faes Farma, Dr. Falk Pharma, Chiesi, Gebro Pharma, Adacyte and Vifor Pharma; YZ has served as a speaker, consultant and advisory member for or has received research funding from MSD, AbbVie, Janssen, Takeda, Kern Pharma, Biogen; JPG has served as a speaker, consultant and advisory member for or has received research funding from MSD, Abbvie, Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz, Celgene, Gilead, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, and Vifor Pharma; JG has served as a speaker, consultant and advisory member for or has received research funding from Roche, MSD, Abbvie, Kern Pharma, Takeda, Janssen, Pfizer, Ferring, Chiesi and GE Healthcare; DB has served as a speaker, consultant and advisory member for or has received research funding from Abbvie, Janssen, Ferring, Pfizer, and Takeda; DC-D has served as a speaker, consultant and advisory member for or has received research funding from MSD, Ferring, Abbvie, Janssen, Faes Farma, Pfizer, Tillots and Takeda; SM has served as a speaker, consultant and advisory member for or has received research funding from MSD, Ferring, Abbvie, Janssen, Pfizer and Takeda; LM has served as a speaker and advisory member for or has received research funding from MSD, Takeda, Janssen, Abbvie and Pfizer; FC has served as a speaker, consultant and advisory member for or has received research funding from Takeda, Janssen, MSD, and Ferring; MC has served as a speaker, consultant and advisory member for or has received research funding from Takeda, Janssen, Faes Farma, and MSD; ED has served as a speaker, consultant and advisory member for or has received research funding from AbbVie, Adacyte Therapeutics, Celltrion, Gilead, Janssen, Kern Pharma, MSD, Pfizer, Roche, Samsung, Takeda, Tillots, Ferring, and Thermofisher; the remaining authors have no potential conflicts to declare.

Auteurs

Míriam Mañosa (M)

Department of Gastroenterology, Hospital Universitari Germans Trias i Pujol, Carretera del Canyet s/n, Badalona, Catalonia 08916 Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain. Electronic address: mmanosa.germanstrias@gencat.cat.

Agnès Fernández-Clotet (A)

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; Hospital Clínic de Barcelona, Barcelona, Spain.

Pilar Nos (P)

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; Hospital Politècnic La Fe, Valencia, Spain.

María Dolores Martín-Arranz (MD)

Department of Gastroenterology, and Innate Immunity Group, IdiPAZ Institute for Health Research, La Paz Hospital, Madrid, Spain; Universidad Autónoma de Madrid, Spain.

Noemí Manceñido (N)

Hospital Infanta Sofía, Madrid, Spain.

Ana Carbajo (A)

Hospital Rio Hortega, Valladolid, Spain.

Esther Hinojosa (E)

Hospital de Manises, Spain.

Alejandro Hernández-Camba (A)

Hospital Nuestra Señora de la Candelaria, Tenerife, Spain.

Roser Muñoz-Pérez (R)

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; Hospital General Universitario de Alicante, Alicante, Spain.

Maia Boscá-Watts (M)

Hospital Clínico Universitario de Valencia, Valencia, Spain.

Marta Calvo (M)

Hospital Puerta de Hierro, Madrid, Spain.

Mónica Sierra-Ausín (M)

Hospital Universitario de León, León, Spain.

Eugenia Sánchez-Rodríguez (E)

Hospital Ramón y Cajal, Madrid, Spain.

Manuel Barreiro-de Acosta (M)

Hospital Clínico Universitario de Santiago de Compostela, Spain.

Alejandro Núñez-Alonso (A)

Hospital Universitario de Salamanca, Spain.

Yamile Zabana (Y)

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; Hospital Mútua de Terrassa, Spain.

Lucía Márquez (L)

Hospital Parc de Mar, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.

Javier P Gisbert (JP)

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid (UAM), Madrid, Spain.

Jordi Guardiola (J)

Hospital Universitari de Bellvitge - IDIBELL, Spain.

Empar Sáinz (E)

Xarxa Assistencial Althaia, Manresa, Spain.

Pedro Delgado-Guillena (P)

Hospital General de Granollers, Granollers, Spain.

David Busquets (D)

Hospital Universitari de Girona Dr. Josep Trueta, Girona, Spain.

Manuel van Domselaar (M)

Hospital de Torrejón, Torrejón de Ardoz, Spain.

Eva Girona (E)

Hospital General Universitario de Elche, Elche, Spain.

Rufo Lorente (R)

Hospital de Ciudad Real, Ciudad Real, Spain.

Diego Casas-Deza (D)

Instituto de Investigación Sanitaria de Aragón (IISA), Hospital Universitario Miguel Servet, Zaragoza, Spain.

José M Huguet (JM)

Hospital General Universitario de Valencia, Spain.

Sergio Maestro (S)

Complejo Asistencial Universitario de Palencia, Spain.

M José Cabello (MJ)

Hospital Virgen de las Nieves, Granada, Spain.

Jesús Castro (J)

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; Hospital Clínic de Barcelona, Barcelona, Spain.

Marisa Iborra (M)

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; Hospital Politècnic La Fe, Valencia, Spain.

Fiorella Cañete (F)

Department of Gastroenterology, Hospital Universitari Germans Trias i Pujol, Carretera del Canyet s/n, Badalona, Catalonia 08916 Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.

Margalida Calafat (M)

Department of Gastroenterology, Hospital Universitari Germans Trias i Pujol, Carretera del Canyet s/n, Badalona, Catalonia 08916 Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.

Eugeni Domènech (E)

Department of Gastroenterology, Hospital Universitari Germans Trias i Pujol, Carretera del Canyet s/n, Badalona, Catalonia 08916 Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.

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