How long does it take Zeposia (ozanimod) to work?
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.
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References
- Ozanimod 09/2020 Drugs.com. https://www.drugs.com/ppa/ozanimod.html
- Zeposia (ozanimod). Zeposia.com https://www.zeposia.com/
- FDA Approves Bristol Myers Squibb’s Zeposia (ozanimod), an Oral Treatment for Adults with Moderately to Severely Active Ulcerative Colitis May 27th 2021 https://www.drugs.com/newdrugs/fda-approves-bristol-myers-squibb-s-zeposia-ozanimod-oral-adults-moderately-severely-active-5539.html
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