J Crohns Colitis. 2024 Jan 27;18(1):65-74. doi: 10.1093/ecco-jcc/jjad124.

María José García ¹, Montserrat Rivero ¹, Agnès Fernández-Clotet ², Ruth de Francisco ³, Beatriz Sicilia ⁴, Francisco Mesonero ⁵, María Luisa de Castro ⁶, María José Casanova ⁷, Federico Bertoletti ⁸, Francisco Javier García-Alonso ⁹, Alicia López-García ¹⁰, Raquel Vicente ¹¹, Xavier Calvet ¹², Manuel Barreiro-de Acosta ¹³, Juan Ferrer Rosique ¹⁴, Pilar Varela Trastoy ¹⁵, Alejandro Nuñez ¹⁶, Elena Ricart ², Sabino Riestra ³, Lara Arias García ⁴, María Rodríguez ¹⁷, Laura Arranz ¹⁸, Ramón Pajares ¹⁹, Raquel Mena ²⁰, Margalida Calafat ²¹, Patricia Camo ²², Fernando Bermejo ²³, Ángel Ponferrada ²⁴, Rosa Eva Madrigal ²⁵, Jordina Llaó ²⁶, Eva Sesé ²⁷, Eugenia Sánchez ⁵, Juan Ramón Pineda Mariño ⁶, Carlos González Muñoza ⁸, Ana Yaiza Carbajo López ⁹, Ana Belén Julián ¹¹, Albert Villoria Ferrer ¹², Iria Baston-Rey ¹³, Lorena Jara ¹⁴, Pedro Almela ²⁸, Laura Codesido ²⁹, Saioa de la Maza ³⁰, Carles Leal ³¹, Berta Caballol ², Isabel Pérez-Martínez ³, Raquel Vinuesa Campo ⁴, Javier Crespo ¹, Eugeni Domènech ²¹, María Chaparro ⁷, Javier P Gisbert ⁷

Author information

¹Gastroenterology and Hepatology Department, Hospital Universitario Marqués de Valdecilla, Universidad de Cantabria, Instituto de Investigación Valdecilla (IDIVAL), Universidad de Cantabria, Santander, Spain.

²Inflammatory Bowel Disease Unit, Gastroenterology Department, Hospital Clinic of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, Spain.

³Gastroenterology Department, Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain.

⁴IBD Unit, Gastroenterology Department, Hospital Universitario de Burgos, Burgos, Spain.

⁵Gastroenterology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain.

⁶Gastroenterology Department, Hospital Álvaro Cunqueiro, Vigo, Spain.

⁷Gastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.

⁸Gastroenterology Department, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain.

⁹Gastroenterology Department, Hospital Universitario Río Hortega, Valladolid, Spain.

¹⁰Gastroenterology Department, Hospital del Mar, Barcelona, Barcelona, Spain.

¹¹Gastroenterology Department, Hospital Universitario Miguel Servet, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Zaragoza, Spain.

¹²Gastroenterology Department, Consorci Corporació Sanitària Parc Taulí, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Sabadell, Spain.

¹³Gastroenterology Department, Hospital Universitario Clínico de Santiago, Santiago de Compostela, Spain.

¹⁴Gastroenterology Department, Hospital Universitario Fundación de Alcorcón, Alcorcón, Spain.

¹⁵Gastroenterology Department, Hospital Universitario de Cabueñes, Gijón, Spain.

¹⁶Gastroenterology Department, Hospital Universitario de Salamanca, Salamanca, Spain.

¹⁷Gastroenterology Department, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.

¹⁸Gastroenterology Department, Hospital Universitario Nuestra Señora de Candelaria, Tenerife, Spain.

¹⁹Gastroenterology Department, Hospital Universitario Infanta Sofía, Madrid, Spain.

²⁰Gastroenterology Department, Consorci Sanitari de Terrasa, Barcelona, Spain.

²¹Gastroenterology Department, Hospital Universitari Germans Trias i Pujol, Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas (CIBERehd), Badalona, Spain.

²²Gastroenterology Department, Hospital General San Jorge, Huesca, Spain.

²³Gastroenterology Department, Hospital Universitario de Fuenlabrada, Madrid, Spain.

²⁴Gastroenterology Department, Hospital Universitario Infanta Leonor, Madrid, Spain.

²⁵Gastroenterology Department, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.

²⁶Gastroenterology Department, Althaia Xarxa Assistencial Universitària de Manresa, Manresa, Spain.

²⁷Gastroenterology Department, Hospital Universitario Arnau de Vilanova de Lleida, Lleida, Spain.

²⁸Gastroenterology Department, Hospital General Universitario de Castellón, Castellón, Spain.

²⁹Gastroenterology Department, Complexo Hospitalario Universitario de Ourense, Ourense, Spain.

³⁰Gastroenterology Department, Hospital Universitario de Basurto, Bilbao, Spain.

³¹Gastroenterology Department, Consorci Hospitalari de Vic, Vic, Spain.

Abstract

Background: Both vedolizumab and ustekinumab are approved for the management of Crohn's disease [CD]. Data on which one would be the most beneficial option when anti-tumour necrosis factor [anti-TNF] agents fail are limited.

Aims: To compare the durability, effectiveness, and safety of vedolizumab and ustekinumab after anti-TNF failure or intolerance in CD.

Methods: CD patients from the ENEIDA registry who received vedolizumab or ustekinumab after anti-TNF failure or intolerance were included. Durability and effectiveness were evaluated in both the short and the long term. Effectiveness was defined according to the Harvey-Bradshaw index [HBI]. The safety profile was compared between the two treatments. The propensity score was calculated by the inverse probability weighting method to balance confounder factors.

Results: A total of 835 patients from 30 centres were included, 207 treated with vedolizumab and 628 with ustekinumab. Dose intensification was performed in 295 patients. Vedolizumab [vs ustekinumab] was associated with a higher risk of treatment discontinuation (hazard ratio [HR] 2.55, 95% confidence interval [CI]: 2.02-3.21), adjusted by corticosteroids at baseline [HR 1.27; 95% CI: 1.00-1.62], moderate-severe activity in HBI [HR 1.79; 95% CI: 1.20-2.48], and high levels of C-reactive protein at baseline [HR 1.06; 95% CI: 1.02-1.10]. The inverse probability weighting method confirmed these results. Clinical response, remission, and corticosteroid-free clinical remission were higher with ustekinumab than with vedolizumab. Both drugs had a low risk of adverse events with no differences between them.

Conclusion: In CD patients who have failed anti-TNF agents, ustekinumab seems to be superior to vedolizumab in terms of durability and effectiveness in clinical practice. The safety profile is good and similar for both treatments.