학술논문
Ustekinumab and vedolizumab for the prevention of postoperative recurrence of Crohn's disease: Results from the ENEIDA registry.
Document Type
Academic Journal
Author
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.; Fernández-Clotet A; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; Hospital Clínic de Barcelona, Barcelona, Spain.; Nos P; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; Hospital Politècnic La Fe, Valencia, Spain.; 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.; Manceñido N; Hospital Infanta Sofía, Madrid, Spain.; Carbajo A; Hospital Rio Hortega, Valladolid, Spain.; Hinojosa E; Hospital de Manises, Spain.; Hernández-Camba A; Hospital Nuestra Señora de la Candelaria, Tenerife, Spain.; Muñoz-Pérez R; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; Hospital General Universitario de Alicante, Alicante, Spain.; Boscá-Watts M; Hospital Clínico Universitario de Valencia, Valencia, Spain.; Calvo M; Hospital Puerta de Hierro, Madrid, Spain.; Sierra-Ausín M; Hospital Universitario de León, León, Spain.; Sánchez-Rodríguez E; Hospital Ramón y Cajal, Madrid, Spain.; Barreiro-de Acosta M; Hospital Clínico Universitario de Santiago de Compostela, Spain.; Núñez-Alonso A; Hospital Universitario de Salamanca, Spain.; Zabana Y; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; Hospital Mútua de Terrassa, Spain.; Márquez L; Hospital Parc de Mar, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.; 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.; Guardiola J; Hospital Universitari de Bellvitge - IDIBELL, Spain.; Sáinz E; Xarxa Assistencial Althaia, Manresa, Spain.; Delgado-Guillena P; Hospital General de Granollers, Granollers, Spain.; Busquets D; Hospital Universitari de Girona Dr. Josep Trueta, Girona, Spain.; van Domselaar M; Hospital de Torrejón, Torrejón de Ardoz, Spain.; Girona E; Hospital General Universitario de Elche, Elche, Spain.; Lorente R; Hospital de Ciudad Real, Ciudad Real, Spain.; Casas-Deza D; Instituto de Investigación Sanitaria de Aragón (IISA), Hospital Universitario Miguel Servet, Zaragoza, Spain.; Huguet JM; Hospital General Universitario de Valencia, Spain.; Maestro S; Complejo Asistencial Universitario de Palencia, Spain.; Cabello MJ; Hospital Virgen de las Nieves, Granada, Spain.; Castro J; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; Hospital Clínic de Barcelona, Barcelona, Spain.; Iborra M; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; Hospital Politècnic La Fe, Valencia, Spain.; 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.; 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.; 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.
Source
Publisher: Elsevier Country of Publication: Netherlands NLM ID: 100958385 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1878-3562 (Electronic) Linking ISSN: 15908658 NLM ISO Abbreviation: Dig Liver Dis Subsets: MEDLINE
Subject
Language
English
Abstract
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.
Competing Interests: 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.
(Copyright © 2022. Published by Elsevier Ltd.)
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.
Competing Interests: 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.
(Copyright © 2022. Published by Elsevier Ltd.)