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

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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

Journal of Crohns & Colitis  OXFORD UNIV PRESS

Tipo:
Article
Páginas:
1846-1851
PubMed:
33860795

Citas Recibidas en Web of Science: 60

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Keywords

  • Ustekinumab; ulcerative colitis; response; remission; durability; real-world evidence

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