Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry

Abstract Background: The development program (UNIFI) has shown promising results of ustekinumab in ulcerative colitis (UC) treatment that should be confirmed in clinical practice. Aims: To evaluate the durability, effectiveness and safety of ustekinumab in UC in real-life. Methods: Patients included...

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Detalles Bibliográficos
Autores: Chaparro, María, Garre, Ana, Iborra, Marisa, Sierra Ausín, Mónica, Barreiro de Acosta, Manuel, Fernández Clotet, Agnès, Castro, Luisa de, Boscá Watts, Maia, Casanova, María José, López García, Alicia, Lorente, Rufo, Rodríguez, Cristina, Carbajo, Ana Y., Arroyo, María Teresa, Gutiérrez, Ana, Hinojosa, Joaquín, Martínez Pérez, Teresa, Villoria, Albert, Bermejo, Fernando, Busquets, David, Camps, Blau, Cañete, Fiorella, Manceñido, Noemí, Monfort, David, Navarro Llavat, Mercè, Pérez Calle, José Lázaro, Ramos, Laura, Rivero, Montserrat, Angueira, Teresa, Camo Monterde, Patricia, Carpio, Daniel, García de la Filia, Irene, González Muñoza, Carlos, Hernández, Luís, Huguet, José María, Morales, Víctor J., Sicilia, Beatriz, Vega, Pablo, Vera, Isabel, Zabana Abdo, Yamile
Tipo de recurso: artículo
Estado:Versión aceptada para publicación
Fecha de publicación:2021
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:2445/181737
Acceso en línea:https://hdl.handle.net/2445/181737
Access Level:acceso abierto
Palabra clave:Colitis ulcerosa
Anticossos monoclonals
Ulcerative colitis
Monoclonal antibodies
Descripción
Sumario:Abstract Background: The development program (UNIFI) has shown promising results of ustekinumab in ulcerative colitis (UC) treatment that should be confirmed in clinical practice. Aims: 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. Thirty-six percent 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 both in 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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