Effectiveness and Safety of Ustekinumab in Ulcerative Colitis: Real-world Evidence from the ENEIDA Registry

Background and Aims: The development programm UNIFI has shown promising results of ustekinumab in ulcerative colitis [UC] treatment which should be confirmed in clinical practice. We aimed to evaluate the durability, effectiveness, and safety of ustekinumab in UC in real life. Methods: Patients incl...

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Authors: Chaparro, M, Garre, A, Iborra, M, Sierra-Ausin, M, Barreiro-de Acosta, M, Fernandez-Clotet, A, de Castro, L, Bosca-Watts, M, Casanova, MJ, Lopez-Garcia, A, Lorente, R, Rodriguez, C, Carbajo, AY, Arroyo, MT, Gutierrez, A, Hinojosa, J, Martinez-Perez, T, Villoria, A, Bermejo, F, Busquets, D, Camps, B, Canete, F, Mancenido, N, Monfort, D, Navarro-Llavat, M, Perez-Calle, JL, Ramos, L, Rivero, M, Angueira, T, Monterde, PC, Carpio, D, Garcia-de-la-Filia, I, Gonzalez-Munoza, C, Hernandez, L, Huguet, JM, Morales, VJ, Sicilia, B, Vega, P, Vera, I, Zabana, Y, Nos, P, Alvarez, PS, Calvino-Suarez, C, Ricart, E, Hernandez, V, Minguez, M, Marquez, L, Cruz, DH, Iturria, SR, Barrio, J, Gargallo-Puyuelo, C, Frances, R, Hinojosa, E, del Moral, M, Calvet, X, Algaba, A, Aldeguer, X, Guardiola, J, Manosa, M, Pajares, R, Piqueras, M, Garcia-Bosch, O, Serrano, PL, Castro, B, Lucendo, AJ, Montoro, M, Ortiz, EC, Mesonero, F, Garcia-Planella, E, Fuentes, DA, Bort, I, Delgado-Guillena, P, Arias, L, Iglesias, A, Calvo, M, Esteve, M, Domenech, E, Gisbert, JP
Format: article
Status:Published version
Publication Date:2021
Country:España
Institution:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
Repository:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
OAI Identifier:oai:iibsantpau.fundanetsuite.com:p5198
Online Access:https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=5198
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8083263
Access Level:Open access
Keyword:Ustekinumab
ulcerative colitis
response
remission
durability
real-world evidence
Description
Summary:Background and Aims: The development programm UNIFI has shown promising results of ustekinumab in ulcerative colitis [UC] treatment which should be confirmed in clinical practice. We aimed to evaluate the durability, effectiveness, and safety of ustekinumab in UC in real life. Methods: Patients included in the prospectively maintained ENEIDA registry, who received at least one intravenous dose of ustekinumab due to active UC [Partial Mayo Score [PMS]>2], were included. Clinical activity and effectiveness were defined based on PMS. Short-term response was assessed at Week 16. Results: A total of 95 patients were included. At Week 16, 53% of patients had response [including 35% of patients in remission]. In the multivariate analysis, elevated serum C-reactive protein was the only variable significantly associated with lower likelihood of achieving remission. Remission was achieved in 39% and 33% of patients at Weeks 24 and 52, respectively; 36% of patients discontinued the treatment with ustekinumab during a median follow-up of 31 weeks. The probability of maintaining ustekinumab treatment was 87% at Week 16, 63% at Week 56, and 59% at Week 72; primary failure was the main reason for ustekinumab discontinuation. No variable was associated with risk of discontinuation. Three patients reported adverse events; one of them had a fatal severe SARS-CoV-2 infection. Conclusions: Ustekinumab is effective in both the short and the long term in real life, even in a highly refractory cohort. Higher inflammatory burden at baseline correlated with lower probability of achieving remission. Safety was consistent with the known profile of ustekinumab.

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