Comparative Study of the Effectiveness of Vedolizumab Versus Ustekinumab After Anti-TNF Failure in Crohn's Disease (Versus-CD): Data from the ENEIDA Registry

• Published in: Journal of Crohn's and colitis 2024-01, Vol.18 (1), p.65-74
• Main Authors: García, María José, Rivero, Montserrat, Fernández-Clotet, Agnès, de Francisco, Ruth, Sicilia, Beatriz, Mesonero, Francisco, de Castro, María Luisa, Casanova, María José, Bertoletti, Federico, García-Alonso, Francisco Javier, López-García, Alicia, Vicente, Raquel, Calvet, Xavier, Barreiro-de Acosta, Manuel, Ferrer Rosique, Juan, Varela Trastoy, Pilar, Nuñez, Alejandro, Ricart, Elena, Riestra, Sabino, Arias García, Lara, Rodríguez, María, Arranz, Laura, Pajares, Ramón, Mena, Raquel, Calafat, Margalida, Camo, Patricia, Bermejo, Fernando, Ponferrada, Ángel, Madrigal, Rosa Eva, Llaó, Jordina, Sesé, Eva, Sánchez, Eugenia, Pineda Mariño, Juan Ramón, González Muñoza, Carlos, Carbajo López, Ana Yaiza, Julián, Ana Belén, Villoria Ferrer, Albert, Baston-Rey, Iria, Jara, Lorena, Almela, Pedro, Codesido, Laura, de la Maza, Saioa, Leal, Carles, Caballol, Berta, Pérez-Martínez, Isabel, Vinuesa Campo, Raquel, Crespo, Javier, Domènech, Eugeni, Chaparro, María, Gisbert, Javier P
• Format: Article
• Language: English
• Subjects: Antibodies, Monoclonal, Humanized; Crohn Disease - drug therapy; Humans; Registries; Remission Induction; Retrospective Studies; Treatment Outcome; Tumor Necrosis Factor Inhibitors - therapeutic use; Tumor Necrosis Factor-alpha; Ustekinumab - therapeutic use
• ISSN: 1873-9946; 1876-4479
• DOI: 10.1093/ecco-jcc/jjad124

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