Drug updated on 4/17/2024
| 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.
Summary
- Fingolimod (Gilenya) is indicated for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in patients aged 10 years and older.
- A study on 16 systematic reviews/meta-analyses compared Gilenya with other medications used to treat multiple sclerosis in terms of safety and effectiveness.
- The medication has shown considerable efficacy in reducing relapses over a period of 12 to 24 months when compared to placebo. It offers a large reduction in relapse rates, placing it comparably with high-efficacy treatments such as natalizumab and cladribine.
- In comparison with interferons and modulators like dimethyl fumarate or ponesimod, fingolimod's efficacy seems similar or superior at controlling both the rate of MS-related relapses as well as disability progression.
- However, there are concerns regarding its safety profile due to an observed slight increase in treatment discontinuation because of adverse effects. This puts it on par with other medications like teriflunomide, natalizumab, daclizumab, but slightly less favorable than alemtuzumab, which may lead to fewer treatment discontinuations.
- Alternate dosing strategies have been explored due to side effects such as lymphopenia; however, these require further research given ambiguity around their effectiveness along with potential risk for disease reactivation under this regimen.
- Beyond standard measures for RRMS cases, conditions such as acute ischemic stroke (AIS) or cognitive impairment related to MS show some positive outcomes from using fingolimod, thus expanding its applicability beyond just treating typical forms associated with MS.
- While network meta-analysis shows that fingolimod compares favorably against several disease-modifying therapies concerning sustained disability improvement (SDI), newer options like cladribine tablets may offer competitive or superior outcomes in terms of disability progression.
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 |