Ozanimod in Patients with Ulcerative Colitis - Prospective Real-World Evidence from the Dutch ICC Registry

Abstract Background Ozanimod, a sphingosine-1-phosphate receptor modulator, was approved for ulcerative colitis [UC] in 2021 but has not been widely adopted in routine clinical practice. As real-world evidence on ozanimod remains scarce, this study evaluated real-world ozanimod use in the Netherlands. Methods Data were retrieved from the Dutch ICC Registry, a multicenter, nationwide cohort prospectively collecting data of patients initiating advanced therapies for inflammatory bowel diseases [IBD]. Patients aged ≥ 16 years with UC or IBD-unclassified who initiated ozanimod in routine care were included. The primary outcome was clinical remission (Simple Clinical Colitis Activity Index ≤ 2) at week 24 among patients with clinically active disease at baseline. Effectiveness was assessed through week 104 using modified non-responder imputation (mNRI) and observed-case analyses. Treatment persistence and safety were assessed in all patients. Results Forty-two patients were followed for a median duration of 133.0 weeks (Q1, Q3: 80.2, 180.0). Among patients with clinically active disease at baseline, 28.6% (6/21, 95%CI [9.2, 47.9]) achieved clinical remission at week 24 using mNRI, compared with 54.5% (6/11, 95%CI [25.1, 84.0]) using observed-case analysis. The same rates were observed for clinical response. Twenty-seven patients discontinued ozanimod after a median treatment duration of 25.0 weeks (Q1, Q3: 7.5, 51.0). No serious adverse events were reported. Conclusions These findings suggest that ozanimod can induce and maintain remission in selected patients with UC, including those with difficult-to-treat IBD, and support its favorable safety profile.