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Effectiveness and Safety of Ustekinumab in Ulcerative Colitis: Real-world Evidence from the ENEIDA Registry

2021; Oxford University Press; Volume: 15; Issue: 11 Linguagem: Inglês

10.1093/ecco-jcc/jjab070

1876-4479

María Chaparro, A Garre, Marisa Iborra, Mónica Sierra‐Ausín, Manuel Barreiro‐de Acosta, A Fernández-Clotet, Luisa de Castro, Marta Maia Boscá-Watts, María José Casanova, Alicia López‐García, R Lorente, Cristina Rodríguez, Ana Yaiza Carbajo, M Arroyo, Ana Gutiérrez, Joaquín Hinojosa, Teresa Martínez-Pérez, Albert Villoría, Fernando Bermejo, David Busquets, Blau Camps, Fiorella Cañete, Noemí Manceñido, David Monfort, Mercè Navarro-Llavat, José Lázaro Pérez‐Calle, Laura Ramos, Montserrat Rivero, Teresa Angueira, Patricia Camo Monterde, Daniel Carpio, Irene García-de-la-Filia, Carlos González‐Muñoza, Luis Hernández, José María Huguet, V Morales, Beatriz Sicilia, Pablo Vega, Isabel Vera, Yamile Zabana, Pilar Nos, Patricia Suárez Álvarez, Cristina Suárez, Elena Ricart, Vicent Hernández, Miguel Mínguez, Lucía Márquez, Daniel Hervías Cruz, Saioa Rubio Iturria, Jesús Barrio, Carla J. Gargallo-Puyuelo, Rubén Francés, Esther Hinojosa, M Del Moral, Xavier Calvet, Alicia Algaba, Xavier Aldeguer, Jordi Guardiola, Míriam Mañosa, Ramón Pajares, Marta Piqueras, Orlando García-Bosch, Pilar López Serrano, Beatriz Castro, Alfredo J. Lucendo, Miguel Montoro, Elena Castro Ortiz, Francisco Mesonero, Esther García-Planella, David A Fuentes, Inmaculada Bort, Pedro Delgado‐Guillena, Lara Arias García, Águeda Iglesias, Marta Calvo, María Esteve, Eugeni Domènech, Javier P. Gisbert,

Diagnosis and treatment of tuberculosis

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.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.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.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.