Drug updated on 4/17/2024
| Dosage Form | Capsule (oral: 0.23 mg, 0.46 mg, 0.92 mg) |
| Drug Class | Sphingosine 1-phosphate receptor modulators |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
- For treating moderately to severely active ulcerative colitis (UC) in adults.
Summary
- Ozanimod (Zeposia) is used for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. It is also indicated for treating moderately to severely active ulcerative colitis (UC) in adults.
- According to a systematic review with frequentist network meta-analysis, ozanimod was associated with fewer adverse events compared to other high-efficacy disease-modifying therapies such as natalizumab, fingolimod, alemtuzumab, cladribine and ocrelizumab among adult patients with relapsing-remitting MS.
- A Bayesian network meta-analysis found that monoclonal antibody therapies were more efficacious than newer treatments like ozanimod for reducing annualised relapse rate and time to confirmed disability progression in patients with RMS.
- In terms of safety outcomes among moderate-to-severe ulcerative colitis patients treated by biologics or small molecule drugs like ozanimod; vedolizumab ranked lowest while upadacitinib had the highest ranking based on surface under the cumulative ranking probabilities from a systematic review and network meta-analysis study.
- The use of Sphongosine-1-phospate receptors modulators including Ozanimod increased cardiovascular adverse events risk by 1.21 times according to an analysis involving seventeen randomized controlled trials published through January 2021 which included over thirteen thousand participants suffering from MS.
- From a total number of seven Systematic Reviews / Meta-Analyses documents reviewed on Zeposia's efficacy against Multiple Sclerosis & Ulcerative Colitis, it was observed that Amiselimod emerged as most effective therapeutic strategy amongst all sphongosine-1-phosphate receptor modulators studied so far but further research is needed before confirming these findings.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Zeposia (ozanimod) Prescribing Information. | 2022 | Celgene Corporation, Summit, NJ |