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

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 p...

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Autores: Chaparro, Maria, Garre, Ana, Iborra, Marisa, Sierra, Monica, Barreiro-de Acosta, Manuel, Fernandez-Clotet, Agnes, de Castro, Luisa, Bosca-Watts, Maia, Casanova, Maria Jose, Lopez-Garcia, Alicia, Lorente, Rufo, Rodriguez, Cristina, Carbajo, Ana Y, Arroyo, Maria Teresa, Gutierrez, Ana, Hinojosa, Joaquin, Martinez-Perez, Teresa, Villoria, Albert, Bermejo, Fernando, Busquets, David, Camps, Blau, Canete, Fiorella, Mancenido, Noemi, Monfort, David, Navarro-Llavat, Merce, Perez-Calle, Jose Lazaro, Ramos, Laura, Rivero, Montserrat, Angueira, Teresa, Camo, Patricia, Carpio, Daniel, Garcia-de-la-Filia, Irene, Gonzalez-Munoza, Carlos, Hernandez, Luis, Huguet, Jose M, Morales, Victor J, Sicilia, Beatriz, Vega, Pablo, Vera, Isabel, Zabana, Yamile, Nos, Pilar, Suarez Alvarez, Patricia, Calvino-Suarez, Cristina, Ricart, Elena, Hernandez, Vicent, Minguez, Miguel, Marquez, Lucia, Hervias Cruz, Daniel, Rubio Iturria, Saioa, Barrio, Jesus, Gargayo-Puyuelo, Carla, Frances, Ruben, Hinojosa, Esther, Del Moral, Maria, Calvet, Xavier, Algaba, Alicia, Aldeguer, Xavier, Guardiola, Jordi, Manosa, Miriam, Pajares, Ramon, Piqueras, Marta, Garcia-Bosch, Orlando, Lopez Serrano, Pilar, Castro, Beatriz, Lucendo, Alfredo J, Montoro, Miguel, Castro Ortiz, Elena, Mesonero, Francisco, Garcia-Planella, Esther, Fuentes, David A, Bort, Inmaculada, Delgado-Guillena, Pedro, Arias, Lara, Iglesias, Agueda, Calvo, Marta, Esteve, Maria, Domenech, Eugeni, Gisbert, Javier P
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Institución:INCLIVA
Repositorio:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
OAI Identifier:oai:incliva.fundanetsuite.com:p15678
Acceso en línea:https://incliva.portalinvestigacion.com/publicaciones/15678
Access Level:acceso abierto
Palabra clave:Ustekinumab
ulcerative colitis
response
remission
durability
real-world evidence
Descripción
Sumario: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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