Effectiveness and Safety of Ustekinumab in Ulcerative Colitis: Real-world Evidence from the ENEIDA Registry
Por:
Chaparro, M, Garre, A, Iborra, M, Sierra-Ausin, M, Barreiro-de Acosta, M, Fernandez-Clotet, A, de Castro, L, Bosca-Watts, M, Casanova, M, Lopez-Garcia, A, Lorente, R, Rodriguez, C, Carbajo, A, Arroyo, M, 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, J, Ramos, L, Rivero, M, Angueira, T, Monterde, P, Carpio, D, Garcia-de-la-Filia, I, Gonzalez-Munoza, C, Hernandez, L, Huguet, J, Morales, V, Sicilia, B, Vega, P, Vera, I, Zabana, Y, Nos, P, Alvarez, P, Calvino-Suarez, C, Ricart, E, Hernandez, V, Minguez, M, Marquez, L, Cruz, D, Iturria, S, 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, P, Castro, B, Lucendo, A, Montoro, M, Ortiz, E, Mesonero, F, Garcia-Planella, E, Fuentes, D, Bort, I, Delgado-Guillena, P, Arias, L, Iglesias, A, Calvo, M, Esteve, M, Domenech, E and Gisbert, J
Publicada:
1 nov 2021
Ahead of Print:
1 abr 2021
Resumen:
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.
Green Published
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