Drug updated on 4/18/2024
| Dosage Form | Tablet (oral; 0.25 mg, 1 mg, 2 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.
Summary
- Siponimod (Mayzent) is indicated for the treatment of relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It targets sphingosine-1-phosphate receptors and requires prior testing for CYP2C9 genotype to adjust the dose accordingly.
- Seven systematic reviews/meta-analyses were analyzed to gather information about the safety and effectiveness of siponimod compared to other drugs used in treating similar conditions.
- Among Disease Modifying Therapies (DMTs), siponimod was found to be superior in controlling disease progression, alongside mitoxantrone and ocrelizumab. It demonstrated a significant impact on neuroimaging markers, such as changes in total volume of lesions visible through T2-weighted image contrast.
- Siponimod showed strong efficacy in reducing the annualized relapse rate compared with 19 other DMTs for relapsing forms of MS and was identified as superior to placebo in preventing clinical relapses.
- The risk profile associated with siponimod varies depending on individual factors and potential genetic predispositions like CYP2C9 genotypes, which may affect tolerability. While detailed data comparing adverse events between siponimod and other drugs were not provided, the varying degrees of risk associated with different DMTs must be considered.
- Comparisons within the class effect group involving another S1P receptor modulator, Fingolimod, revealed increased cardiovascular risks that necessitate rigorous monitoring during treatment. This highlights the importance of considering patient-specific factors in treatments like siponimod that affect cardiovascular health.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Mayzent (siponimod) Prescribing Information. | 2023 | Novartis Pharmaceuticals Corporation, East Hanover, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Treatment optimization in multiple sclerosis: Canadian MS Working Group recommendations. | 2020 | The Canadian Journal of Neurological Sciences |