Drug updated on 9/4/2024
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
- Zeposia (ozanimod) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults; and for treating moderately to severely active ulcerative colitis (UC) in adults.
- This summary is based on the review of 11 systematic review(s)/meta-analysis(es). [1-11]
- Annualized Relapse Rate (ARR) in RRMS: Ozanimod significantly reduced ARR compared to placebo and teriflunomide (rate ratio: 0.73; 95% CI: 0.62-0.84). Monoclonal antibody therapies (e.g., alemtuzumab, ofatumumab, ublituximab) were more effective than ozanimod in reducing ARR.
- Disability Progression in RRMS: Ozanimod showed a significant improvement in 3-month confirmed disability progression (3mCDP) compared to teriflunomide (hazard ratio: 0.78; 95% CI: 0.66-0.92), but not in 6-month confirmed disability progression (6mCDP) (hazard ratio: 0.78; 95% CI: 0.60-1.01). Monoclonal antibody therapies were superior to ozanimod for both 3mCDP and 6mCDP.
- MRI Lesion Activity in RRMS: Ozanimod was associated with a reduction in gadolinium-enhancing lesions (RR, -0.20; 95% CI, -0.34, -0.06) and new or enlarging T2 lesions (RR, -1.12; 95% CI, -1.52, -0.71) during the treatment period.
- Clinical Remission in Ulcerative Colitis: Upadacitinib was superior to ozanimod in inducing clinical remission in patients with moderate-to-severe ulcerative colitis.
- Adverse Events (AEs): Ozanimod showed a lower rate of overall AEs compared to teriflunomide (OR: 0.35; 95% CI: 0.29-0.43) and dimethyl fumarate (OR: 0.11; 95% CI: 0.08-0.16). However, it ranked highest for serious adverse events (SUCRA: 0.831) in moderate-to-severe ulcerative colitis.
- Specific Adverse Events: Ozanimod was associated with a higher risk of hypertension (RR: 1.76; 95% CI: 1.10-2.82) and an increased risk of cardiovascular AEs among S1PR modulators (RR: 2.21; 95% CI: 1.58-3.10). No increased risk of bradyarrhythmia was observed.
- Discontinuations Due to AEs: The rate of discontinuations due to AEs was lower with ozanimod compared to teriflunomide (OR: 0.14; 95% CI: 0.09-0.21) and dimethyl fumarate (OR: 0.11; 95% CI: 0.07-0.17).
- There is no population types or subgroups information available in the reviewed studies.
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 |