Real-World Effectiveness and Safety of Ozanimod: 1-Year Follow-up From a Large Tertiary Center

Real-world data pertaining to ozanimod outcomes in patients with UC are limited. To address this knowledge gap, a real-world study of ozanimod in patients with UC was conducted.¹ The prospective, observational cohort study included consecutive patients treated with ozanimod at a single center. Patients were followed for up to 1 year. Clinical response was defined as a decrease from baseline of at least 3 points in the Simple Clinical Colitis Activity Index (SCCAI) score. Clinical remission was defined as an SCCAI score of 2 or lower.

Among the 45 included patients, 34 had clinically active disease at enrollment; 11 patients were in clinical remission but had active disease by endoscopy. Patients had a median age of 35 years and a median duration of disease of 6 years; 58% were male, 51% had extensive colitis, and 29% were on corticosteroid therapy at baseline. At week 10 of ozanimod therapy, among the patients who had clinically active disease at baseline, the rate of clinical response was 58% and the rate of clinical remission was 48%. At week 52, among 24 patients, the rate of clinical response as well as of clinical remission was 29%. Rates of relapse-free survival were similar regardless of exposure to prior advanced therapy, including when stratified by the number of prior advanced therapies and specifically in patients with prior exposure to vedolizumab. An AE of any grade was experienced by 13 patients, and 2 patients with AEs required discontinuation of ozanimod: hypertensive crisis in 1 patient with a history of hypertension and fatigue in 1 patient. Both AEs resolved after drug discontinuation. Symptomatic bradycardia was not observed.

Another interim analysis was conducted of 131 patients in the True North trial who received continuous ozanimod during the induction and maintenance phases, achieved a clinical response at week 52, and were enrolled in the OLE study.^2,3 Endoscopic improvement was defined as an endoscopy subscore of 1 or lower, histologic remission as a Geboes score of less than 2, and mucosal healing as an endoscopy subscore of 1 or lower and a Geboes score of less than 2. Data were evaluated by observed case analysis and nonresponder imputation analysis. There were 94 patients (72%) who completed the induction, maintenance, and OLE portions of the study. The 131 patients had a median age of 44.3 years, and 51.9% were female. The mean age at diagnosis was 36.1 ± 13.4 years, the mean time since diagnosis was 8.5 ± 7.3 years, and 32.1% had extensive UC. Of the 131 patients who demonstrated a clinical response at week 52, most achieved endoscopic improvement (77.9% and 73.3%), histologic remission (72.3% and 67.3%), and mucosal healing (60.2% and 56.3%) at OLE weeks 46 and 94, respectively (Figure 1). Ozanimod therapy was associated with a reduction in the mean Mayo endoscopic subscore from 2.5 ± 0.5 at baseline to 1.0 ± 0.9 at OLE week 52, to 0.9 ± 0.9 at OLE week 46, and to 1.0 ± 1.0 at OLE week 94. The data suggest that long-term ozanimod therapy yields sustained endoscopic and histologic improvement in patients with moderately to severely active UC.

Figure 1.

The efficacy of ozanimod at OLE weeks 46 and 94 in patients with a clinical response at OLE entry at week 52 (98 and 146 weeks of continuous treatment, respectively; OC analysis). OC, observed case; OLE, open-label extension. Adapted from Abreu et al. Abstract Tu1725. Presented at: DDW 2023; May 6-9, 2023; Chicago, Illinois.²