Long‐term benefit of ustekinumab in ulcerative colitis in clinical practice: ULISES study
Authors: Chaparro María , Hermida Sandra , Acosta Diana , Fernández‐Clotet Agnès , Barreiro‐de Acosta Manuel , Hernández Martínez Álvaro , Arroyo Maite , Bosca‐Watts Marta Maia , Diz‐Lois Palomares M. Teresa , Menchén Luis , Martínez Cadilla Jesús , Leo‐Carnerero Eduardo , Muñoz Villafranca Carmen , Sierra‐Ausín Mónica , González‐Lama Yago , Riestra Sabino , Sendra Rumbeu Pau , Cabello Tapia M. José , García de la Filia Irene , Vicente Raquel , Ceballos Daniel , Pajares Villarroya Ramón , Ramírez de la Piscina Patricia , Martín‐Arranz María Dolores , Ramos Laura , Ruiz‐Cerulla Alexandra , Martínez‐Pérez Teresa de Jesús , San Miguel Amelivia Elena , Calvet Xavier , Huguet José María , Keco‐Huerga Alma , Lorente Poyatos Rufo H. , Muñoz José Fernando , Ponferrada‐Díaz Ángel , Sicilia Beatriz , Delgado‐Guillena Pedro , Gómez Delgado Elena , Rancel‐Medina Francisco J. , Alonso‐Galán Horacio , Herreros Belén , Rivero Montserrat , Varela Pilar , Bermejo Fernando , García Sepulcre Marifé , Gimeno‐Pitarch Leticia , Kolle‐Casso Lilyan , Márquez‐Mosquera Lucía , Martínez Tirado Pilar , Ramírez Cynthia , Sesé Abizanda Eva , Dueñas Sadornil Carmen , Fernández Rosáenz Hipólito , Gutiérrez Casbas Ana , Madrigal Domínguez Rosa Eva , Nantes Castillejo Óscar , Ber Nieto Yolanda , Botella Mateu Belén , Frago Larramona Santiago , López Serrano Pilar , Rubio Mateos José María , Torrá Alsina Sandra , Iyo Eduardo , Fernández Forcelledo José Luis , Hernández Luis , Rodríguez‐Grau María Carmen , Monfort Miquel David , Van Domselaar Manuel , López Ramos Carmen , Ruiz Barcia M. Jesús , Gisbert Javier P. ,   the ULISES study group
Published: September 2024

Background

Ustekinumab is approved for ulcerative colitis (UC).

Aims

To assess the durability of ustekinumab in patients with UC and its short‐term effectiveness, durability and tolerability in clinical practice.

Methods

Retrospective, multicentre study of patients who had received their first ustekinumab dose at least 16 weeks before inclusion. Patients were followed until treatment discontinuation or last visit. Only patients with active disease at the start of ustekinumab treatment were considered in the effectiveness analysis. Patients who stopped ustekinumab before their last visit were considered not to be in subsequent remission.

Results

We included 620 patients; 155 (25%) discontinued ustekinumab during follow‐up (median 12 months). Rate of discontinuation was 20% per patient‐year of follow‐up. Anaemia at baseline (hazard ratio, HR 1.5; 95% confidence interval [CI] 1.1–2.1), steroids at baseline (HR 1.5; 95% CI 1.06–2.08) and more severe clinical activity at baseline (HR 1.5; 95% CI 1.09–2.06) were associated with higher risk of discontinuation. At the end of induction, 226 (40%) patients were in steroid‐free clinical remission. Moderate–severe vs mild disease activity at baseline (odds ratio [OR] 0.3; 95% CI 0.2–0.5), male sex (OR 0.5; 95% CI 0.4–0.8), and increased number of previous biologics (OR 0.6; 95% CI 0.6–0.8) were associated with lower likelihood of steroid‐free clinical remission at week 16. One hundred and seventy‐six patients (28%) had at least one adverse event. We observed no negative impact of ustekinumab on extraintestinal manifestations and/or immune‐mediated diseases.

Conclusions

Ustekinumab durability in UC was relatively high, and treatment was effective in highly refractory patients. The safety profile was consistent with previous studies.