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

Author:

García María José1ORCID,Rivero Montserrat1,Fernández-Clotet Agnès2ORCID,de Francisco Ruth3,Sicilia Beatriz4,Mesonero Francisco5ORCID,de Castro María Luisa6,Casanova María José7ORCID,Bertoletti Federico8,García-Alonso Francisco Javier9,López-García Alicia10,Vicente Raquel11,Calvet Xavier12,Barreiro-de Acosta Manuel13ORCID,Ferrer Rosique Juan14,Varela Trastoy Pilar15,Nuñez Alejandro16,Ricart Elena2,Riestra Sabino3ORCID,Arias García Lara4,Rodríguez María17,Arranz Laura18,Pajares Ramón19,Mena Raquel20,Calafat Margalida21,Camo Patricia22,Bermejo Fernando23ORCID,Ponferrada Ángel24,Madrigal Rosa Eva25,Llaó Jordina26,Sesé Eva27,Sánchez Eugenia5,Pineda Mariño Juan Ramón6,González Muñoza Carlos8ORCID,Carbajo López Ana Yaiza9,Julián Ana Belén11,Villoria Ferrer Albert12,Baston-Rey Iria13,Jara Lorena14,Almela Pedro28,Codesido Laura29,de la Maza Saioa30,Leal Carles31,Caballol Berta2,Pérez-Martínez Isabel3,Vinuesa Campo Raquel4,Crespo Javier1,Domènech Eugeni21ORCID,Chaparro María7ORCID,Gisbert Javier P7ORCID

Affiliation:

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

2. Inflammatory 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

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

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

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

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

7. Gastroenterology 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Abstract

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.

Funder

Spanish Working Group in Crohn’s Disease and Ulcerative Colitis

Publisher

Oxford University Press (OUP)

Subject

Gastroenterology,General Medicine

Reference38 articles.

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2. Long-term durability of infliximab treatment in Crohn’s disease and efficacy of dose ‘escalation’ in patients losing response;Chaparro;J Clin Gastroenterol,2011

3. Changes in the requirement for early surgery in inflammatory bowel disease in the era of biological agents;Guasch;J Gastroenterol Hepatol,2020

4. Effectiveness and safety of the sequential use of a second and third anti-TNF agent in patients with inflammatory bowel disease: Results from the Eneida Registry;Casanova;Inflamm Bowel Dis,2020

5. Review article: Managing the adverse events caused by anti-TNF therapy in inflammatory bowel disease;Shivaji;Aliment Pharmacol Ther,2019

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