Drug updated on 9/4/2024
| Dosage Form | Capsule (oral; 0.25 mg, 0.5 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 patients 10 years of age and older.
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Summary
- Gilenya (fingolimod) 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 patients 10 years of age and older.
- This summary is based on the review of 17 systematic review(s)/meta-analysis(es). [1-17]
- Alemtuzumab (RR 0.46), mitoxantrone (RR 0.47), natalizumab (RR 0.56), and fingolimod (RR 0.72) were more effective than other drugs in preventing relapses in patients with RRMS over the first 24 months of treatment.
- Mitoxantrone (RR 0.20), alemtuzumab (RR 0.35), and natalizumab (RR 0.64) were the most effective in preventing disability worsening in RRMS over the first 24 months.
- Cladribine tablets were more effective than fingolimod, natalizumab, and alemtuzumab in achieving sustained disability improvement (SDI) and no evidence of disease activity (NEDA-3).
- Fingolimod demonstrated similar efficacy to interferons in controlling relapse rates and disability, with mixed results for alternate dosing effectiveness and safety.
- Fingolimod was associated with a higher withdrawal rate due to adverse events compared to placebo (RR 1.69).
- Fingolimod had a higher rate of adverse events and a higher risk of infections compared to interferons and some other disease-modifying treatments (DMTs).
- Serious adverse events (SAEs) related to fingolimod were not well reported in short-term trials, with data being limited and heterogeneous.
- Most studies focused on adults with relapsing-remitting multiple sclerosis (RRMS), with specific subgroup considerations including patients with acute ischemic stroke, those with high relapse rates, cognitive disability, and those experiencing intolerable adverse effects from daily dosing. Cladribine tablets showed comparable efficacy across all subpopulations, and real-world data highlighted issues with adherence and persistence to daily oral DMDs.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Gilenya (fingolimod) Prescribing Information. | 2022 | Novartis Pharmaceuticals Corporation, East Hanover, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| How to switch disease-modifying treatments in multiple sclerosis: Guidelines from the French Multiple Sclerosis Society (SFSEP). | 2021 | Multiple Sclerosis and Related Disorders |
| Second-line therapy for patients with relapsing remitting multiple sclerosis: A review of guidelines. | 2019 | CADTH |