Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry.
Fecha de publicación:
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Autores de INCLIVA
Participantes ajenos a INCLIVA
- Chaparro, Maria
- Garre, Ana
- Iborra, Marisa
- Sierra, Monica
- Barreiro-de Acosta, Manuel
- Fernandez-Clotet, Agnes
- de Castro, Luisa
- 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
- 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
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.
© The Author(s) 2021. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved
Datos de la publicación
- ISSN/ISSNe:
- 1873-9946, 1876-4479
- Tipo:
- Article
- Páginas:
- 1846-1851
- PubMed:
- 33860795
Journal of Crohns & Colitis OXFORD UNIV PRESS
Citas Recibidas en Web of Science: 60
Documentos
Filiaciones
Keywords
- Ustekinumab; ulcerative colitis; response; remission; durability; real-world evidence
Cita
Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry. Chaparro M, Garre A, Iborra M, Sierra M, Barreiro M, Fernandez A, de Castro L et al. Journal of Crohns & Colitis. 2021 abril 16. 15 (11):1846-1851. DOI:10.1093/ecco-jcc/jjab070. PMID:33860795.
Portal de investigación