Effectiveness and Safety of Ustekinumab in Ulcerative Colitis: Real-world Evidence from the ENEIDA Registry. (16th April 2021)

• Record Type: Journal Article
• Authors: Chaparro, María; Garre, Ana; Iborra, Marisa; Sierra-Ausín, Mónica; Barreiro-de Acosta, Manuel; Fernández-Clotet, Agnès; de Castro, Luisa; Boscá-Watts, Maia; Casanova, María José; López-García, Alicia; Lorente, Rufo; Rodríguez, Cristina; Carbajo, Ana Y; Arroyo, Maria 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, Luis; Huguet, José M; Morales, Víctor J; Sicilia, Beatriz; Vega, Pablo; Vera, Isabel; Zabana, Yamile; Nos, Pilar; Suárez Álvarez, Patricia; Calviño-Suárez, Cristina; Ricart, Elena; Hernández, Vicent; Mínguez, Miguel; Márquez, Lucía; Hervías Cruz, Daniel; Rubio Iturria, Saioa; Barrio, Jesús; Gargallo-Puyuelo, Carla; Francés, Rubén; Hinojosa, Esther; del Moral, María; Calvet, Xavier; Algaba, Alicia; Aldeguer, Xavier; Guardiola, Jordi; Mañosa, Miriam; Pajares, Ramón; Piqueras, Marta; García-Bosch, Orlando; López Serrano, Pilar; Castro, Beatriz; Lucendo, Alfredo J; Montoro, Miguel; Castro Ortiz, Elena; Mesonero, Francisco; García-Planella, Esther; Fuentes, David A; Bort, Inmaculada; Delgado-Guillena, Pedro; Arias, Lara; Iglesias, Agueda; Calvo, Marta; Esteve, Maria; Domènech, Eugeni; Gisbert, Javier P;
• Is Part Of: Journal of Crohn's and colitis. Volume 15:Number 11(2021)
• Page Start: 1846
• Page End: 1851
• Publication Date: 2021-04-16
• Subjects: Ustekinumab -- ulcerative colitis -- response -- remission -- durability -- real-world evidence; Inflammatory bowel diseases -- Periodicals; 616.344005
• DOI: 10.1093/ecco-jcc/jjab070
• Languages: English
• ISSNs: 1873-9946

Abstract

Abstract: Background and Aims: 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. 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; 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. Conclusions: 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.