Ozanimod (Zeposia) is approved to treat multiple sclerosis and moderately to severely active ulcerative colitis.
Ozanimod works quickly in multiple sclerosis (MS), within a few months, although it may take up to a year for the full effects of significantly less disease progression, fewer relapses, and less brain atrophy than standard care to be seen.
- Research has shown that there was a trend towards a reduction in disease progression with ozanimod Vs interferon-beta-1a within 3 months of administration (7.6% of ozanimod patients had disease progression Vs 7.8% of patients assigned interferon, although this difference was not statistically significant)
- After one year of treatment, 78% of patients taking ozanimod were relapse-free, compared with 66% of patients taking interferon-beta-1a. After 2 years 76% of patients taking ozanimod remained relapse-free compared with 64% of those taking interferon
- The number of new or enlarging T2 hyperintense lesions seen on MRI was significantly lower with one year of ozanimod treatment compared to the number seen with interferon (a 48% relative reduction). The number of GdE lesions was also statistically significantly lower with ozanimod compared to interferon (a 63% relative reduction).
- In two year studies, these significant results persisted, although the relative reductions were slightly less (46% for T2 lesions and 53% for GdE lesions).
Ozanimod is an oral prescription medicine that is approved to treat relapsing forms of multiple sclerosis (MS) in adults including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
For people with moderately to severely active ulcerative colitis (UC), decreases in rectal bleeding and stool frequency were seen as early as week 2 and significant differences in clinical remission, clinical response, and endoscopic improvement compared to placebo were noted within 10 weeks of starting ozanimod (Zeposia).
- In True North, a phase 3 trial that compared ozanimod to placebo in adult patients with moderately to severely active UC, the primary endpoint of clinical remission was met by week 10 with 18% of people taking ozanimod in remission compared to only 6% of those taking placebo. Secondary endpoints were also met, including clinical response (48% versus 26%), endoscopic improvement (27% versus 12%), and endoscopic-histologic mucosal improvement (13% versus 4%) for ozanimod versus placebo, respectively.
- In the maintenance part of the trial the primary endpoint of clinical remission (37% versus 19%) as well as key secondary endpoints, including clinical response (60% versus 41%), endoscopic improvement (46% versus 26%), corticosteroid-free clinical remission (32% versus 17%) and endoscopic-histologic mucosal improvement (30% versus 14%) for ozanimod versus placebo, respectively, were maintained at week 52.