Drug updated on 5/17/2024
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
- Indicated 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.
- Indicated for treating moderately to severely active ulcerative colitis (UC) in adults.
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Summary
- Ozanimod (Zeposia) is indicated for the treatment of relapsing forms of multiple sclerosis (MS) and moderately to severely active ulcerative colitis (UC) in adults. It significantly reduces the annualized relapse rate and the number of new or enlarging T2 lesions, highlighting its efficacy.
- Eleven systematic reviews/meta-analyses provided insights into the safety, efficacy, and comparison of Ozanimod with other drugs across different populations and subgroups.
- In terms of cardiovascular safety, Ozanimod presents an increased risk compared to placebo, but may have a more favorable profile than similar agents like fingolimod, suggesting careful consideration of its use.
- For treating ulcerative colitis, Ozanimod has proven to be effective without leading to a significantly higher increase in adverse events, making it a viable option for induction therapy.
- Compared to classic immunosuppressants such as alemtuzumab for the treatment of RRMS, Ozanimod offers better safety while maintaining reasonable efficacy levels, thus presenting itself as an attractive alternative where high-efficacy treatments pose significant risks.
- When used for treating ulcerative colitis patients who are not responding well enough or are intolerant towards traditional biologics or newer small molecule options, Ozanimod can serve as an effective induction therapy with a manageable side effects profile.
- Subgroup considerations suggest that Ozanimod might be preferable among patients where cardiovascular risk factors exist, due to its relatively moderate impact on heart rate and blood pressure compared to other S1PR modulators.
- Ozanimod's balance between effectiveness at reducing disease activity and managing side effect profiles makes it competitive within both the MS and UC therapeutic landscapes. However, further direct comparisons within specific population groups would help elucidate optimal use cases.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Zeposia (ozanimod) Prescribing Information. | 2023 | Celgene Corporation, Summit, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Clinician's guide to using ozanimod for the treatment of ulcerative colitis. | 2023 | Journal of Crohn's & Colitis |