Effectiveness and Safety of Ustekinumab in Ulcerative Colitis: Real-world Evidence from the ENEIDA Registry
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 
Published: April 2021

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]&gt;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.