Real World Clinical Effectiveness and Safety of Ozanimod in the Treatment of Ulcerative Colitis: 1-Year Follow-Up from a Tertiary Center.

Autor: Cohen NA; Inflammatory Bowel Disease Center, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA., Choi D; Inflammatory Bowel Disease Center, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA., Garcia N; Inflammatory Bowel Disease Center, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA., Choi NK; Inflammatory Bowel Disease Center, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA., Picker E; Inflammatory Bowel Disease Center, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA., Krugliak Cleveland N; Inflammatory Bowel Disease Center, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA., Cohen RD; Inflammatory Bowel Disease Center, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA., Dalal SR; Inflammatory Bowel Disease Center, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA., Pekow J; Inflammatory Bowel Disease Center, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA., Rubin DT; Inflammatory Bowel Disease Center, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA. drubin@bsd.uchicago.edu.
Jazyk: angličtina
Zdroj: Digestive diseases and sciences [Dig Dis Sci] 2024 Feb; Vol. 69 (2), pp. 579-587. Date of Electronic Publication: 2023 Dec 12.
DOI: 10.1007/s10620-023-08178-8
Abstrakt: Background: Ozanimod is a first-in-class Sphingosine-1-phosphate (S1P) receptor modulator approved for the treatment of moderately to severely active ulcerative colitis (UC). Real world data describing use of ozanimod are limited.
Aim: To provide 1-year follow-up results of our UC patient cohort treated with ozanimod.
Methods: This prospective, observational cohort study includes consecutive patients who initiated ozanimod at the University of Chicago IBD Center between 5/2021 and 12/2022. We collected demographic, clinical, and laboratory data. Clinical disease activity was prospectively assessed using the Simple Clinical Colitis Activity Index.
Results: Forty-five patients with UC initiated ozanimod therapy and were included in the effectiveness analysis. The median age was 35 years (interquartile range (IQR) 28-52), median disease duration of 6 years (IQR 3-13), 26 (58%) were male, 23 (51%) had extensive colitis, 34 (76%) had previous advanced therapy exposure. Thirty-four patients had clinically active UC at the time of ozanimod initiation; week 10 clinical response and remission rates were 58% and 53%, respectively. By week 52, the rates were 25% for both clinical response and remission. In the 12 (39%) patients with a > 75% reduction in absolute lymphocyte count, numerically greater induction clinical response and remission rates were observed (80% vs 54%, p = 0.4 and 75% vs 53%, p = 0.4, respectively). There were no episodes of symptomatic bradycardia and no other new safety signals.
Conclusion: Ozanimod effectively induced clinical response and remission patients with largely treatment refractory UC, however, had modest long-term effectiveness. The safety profile was favorable with no new signals.
(© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
Databáze: MEDLINE
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