Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, 20 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, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
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Summary
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- Ponesimod demonstrated a significant reduction in relapses over 24 months with a relative risk (RR) of 0.58 (95% confidence interval (CI) (rate ratio (RR): 0.47; 95% CI: 0.39-0.58) 0.48 to 0.70), indicating a 42% reduction in relapse risk for patients with relapsing multiple sclerosis. This is comparable to other drugs like Fingolimod (RR 0.54) and Dimethyl fumarate (RR 0.62).
- Ponesimod reduced annualized relapse rates (ARR) by 53% (RR: 0.47; 95% CI: 0.39-0.58) and also significantly reduced 12-week confirmed disability accumulation by 39% (hazard ratio (HR): 0.61; 95% CI: 0.45-0.82), supporting its effectiveness in managing relapse and progression in relapsing multiple sclerosis.
- Ponesimod's effectiveness is comparable to other disease-modifying therapies like Alemtuzumab and Natalizumab for relapse rate reduction and disability accumulation, positioning it as an effective option among sphingosine 1-phosphate (S1P) (RMS) receptor modulators for multiple sclerosis treatment.
- Ponesimod was ranked worst among S1P receptor modulators for treatment acceptability, with a surface under the cumulative ranking (SUCRA) (SUCRA 90.5%) score of 96.0%, indicating a higher likelihood of treatment discontinuation due to adverse events compared to other drugs.
- There is no specific mention of serious adverse events (SAEs) for Ponesimod in the provided data. However, other drugs like Interferon beta-1b showed a possible trivial reduction in SAEs compared to placebo (odds ratio (OR) (depending on the confirmed disability progression (CDP) definition used for included ofatumumab trials) 0.92, 95% CI 0.55 to 1.54).
- The systematic review and network meta-analysis included 36,541 participants with relapsing-remitting multiple sclerosis (RRMS), of which 68.6% were female. No specific subgroup analyses were provided for Ponesimod, but a smaller relative treatment effect was noted in trials with a higher proportion of patients with prior disease-modifying therapy (DMT) usage.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Ponvory (ponesimod) Prescribing Information. | 2023 | Janssen Pharmaceuticals, Inc. Titusville, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis | 2024 | The Cochrane Database of Systematic Reviews |
| Comparative efficacy of therapies for relapsing multiple sclerosis: a systematic review and network meta-analysis | 2023 | Journal of Comparative Effectiveness Research |
| Comparative Efficacy of Relapsing Multiple Sclerosis Therapies: Model-Based Meta-Analyses for Confirmed Disability Accumulation and Annualized Relapse Rate | 2022 | Multiple Sclerosis and Related Disorders |
| Efficacy and acceptability of the S1P receptor in the treatment of multiple sclerosis: a meta-analysis | 2021 | Neurological Sciences |