Drug updated on 9/4/2024
| 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
- Ponvory (ponesimod) is indicated for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- Relapse Prevention: Alemtuzumab was the most effective in preventing relapses in RRMS within the first 24 months (RR vs. placebo 0.46), followed by mitoxantrone (RR 0.47), natalizumab (RR 0.56), and fingolimod (RR 0.72).
- Disability Progression: Mitoxantrone, alemtuzumab, and natalizumab were the most effective in preventing disability worsening, with RR values of 0.20, 0.35, and 0.64, respectively. Alemtuzumab, ofatumumab, and ublituximab showed the highest efficacy for ARR, while alemtuzumab, ocrelizumab, and ofatumumab were most effective for 3mCDP.
- Alemtuzumab demonstrated higher rates of adverse events (AEs) and infections compared to other high-efficacy disease-modifying therapies (DMTs), with a notable increase in serious infections, including urinary tract infections.
- Ponesimod exhibited a higher rate of discontinuations due to AEs (10.1%) compared to alemtuzumab (3.0%) and placebo (4.2%), with the lowest acceptability (SUCRA 96.0%) among S1P receptor modulators.
- There is no population types or subgroups information available in the reviewed studies.
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 safety of high-efficacy disease-modifying therapies in relapsing–remitting multiple sclerosis: a systematic review and network meta-analysis. | 2022 | Neurological Sciences |
| Efficacy and acceptability of the S1P receptor in the treatment of multiple sclerosis: a meta-analysis. | 2021 | Neurological Sciences |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Sphingosine 1-phosphate receptor modulators in multiple sclerosis treatment: a practical review. | 2024 | Annals of Clinical and Translational Neurology |