Long-term benefit of ustekinumab in ulcerative colitis in clinical practice: ULISES study

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  • dc.contributor.author Chaparro, María
  • dc.contributor.author Márquez-Mosquera, Lucía
  • dc.contributor.author ULISES study group
  • dc.date.accessioned 2025-09-19T07:39:16Z
  • dc.date.available 2025-09-19T07:39:16Z
  • dc.date.issued 2024
  • dc.description.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.
  • dc.format.mimetype application/pdf
  • dc.identifier.citation Chaparro M, Hermida S, Acosta D, Fernández-Clotet A, Barreiro-de Acosta M, Hernández Martínez Á, et al. Long-term benefit of ustekinumab in ulcerative colitis in clinical practice: ULISES study. Aliment Pharmacol Ther. 2024 Nov;60(10):1325-38. DOI: 10.1111/apt.18230
  • dc.identifier.doi http://dx.doi.org/10.1111/apt.18230
  • dc.identifier.issn 0269-2813
  • dc.identifier.uri http://hdl.handle.net/10230/71237
  • dc.language.iso eng
  • dc.publisher Wiley
  • dc.relation.ispartof Aliment Pharmacol Ther. 2024 Nov;60(10):1325-38
  • dc.rights © 2024 The Author(s). Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
  • dc.rights.accessRights info:eu-repo/semantics/openAccess
  • dc.rights.uri http://creativecommons.org/licenses/by-nc-nd/4.0/
  • dc.subject.other Colitis ulcerosa
  • dc.title Long-term benefit of ustekinumab in ulcerative colitis in clinical practice: ULISES study
  • dc.type info:eu-repo/semantics/article
  • dc.type.version info:eu-repo/semantics/publishedVersion

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