1. Long-term benefit of ustekinumab in ulcerative colitis in clinical practice: ULISES study.
- Author
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Chaparro M, Hermida S, Acosta D, Fernández-Clotet A, Barreiro-de Acosta M, Hernández Martínez Á, Arroyo M, Bosca-Watts MM, Diz-Lois Palomares MT, Menchén L, Martínez Cadilla J, Leo-Carnerero E, Muñoz Villafranca C, Sierra-Ausín M, González-Lama Y, Riestra S, Sendra Rumbeu P, Cabello Tapia MJ, García de la Filia I, Vicente R, Ceballos D, Pajares Villarroya R, Ramírez de la Piscina P, Martín-Arranz MD, Ramos L, Ruiz-Cerulla A, Martínez-Pérez TJ, San Miguel Amelivia E, Calvet X, Huguet JM, Keco-Huerga A, Lorente Poyatos RH, Muñoz JF, Ponferrada-Díaz Á, Sicilia B, Delgado-Guillena P, Gómez Delgado E, Rancel-Medina FJ, Alonso-Galán H, Herreros B, Rivero M, Varela P, Bermejo F, García Sepulcre M, Gimeno-Pitarch L, Kolle-Casso L, Márquez-Mosquera L, Martínez Tirado P, Ramírez C, Sesé Abizanda E, Dueñas Sadornil C, Fernández Rosáenz H, Gutiérrez Casbas A, Madrigal Domínguez RE, Nantes Castillejo Ó, Ber Nieto Y, Botella Mateu B, Frago Larramona S, López Serrano P, Rubio Mateos JM, Torrá Alsina S, Iyo E, Fernández Forcelledo JL, Hernández L, Rodríguez-Grau MC, Monfort Miquel D, Van Domselaar M, López Ramos C, Ruiz Barcia MJ, and Gisbert JP
- Subjects
- Humans, Male, Female, Retrospective Studies, Adult, Middle Aged, Treatment Outcome, Remission Induction, Severity of Illness Index, Ustekinumab therapeutic use, Colitis, Ulcerative drug therapy
- Abstract
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., (© 2024 The Author(s). Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.)
- Published
- 2024
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