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

Nathaniel A. Cohen, David Choi, Nicole Garcia, Natalie K. Choi, Emma Picker, Noa Krugliak Cleveland, Russell D. Cohen, Sushila R. Dalal, Joel Pekow, David T. Rubin*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)579-587
Number of pages9
JournalDigestive Diseases and Sciences
Volume69
Issue number2
DOIs
StatePublished - Feb 2024
Externally publishedYes

Funding

FundersFunder number
Gastro-intestinal Research Foundation of Chicago
Maor Foundation
Gastro-Intestinal Research Foundation

    Keywords

    • Ozanimod
    • Real world evidence
    • Small molecule therapies
    • Ulcerative colitis

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