Fingolimod for pediatric multiple sclerosis: The Ped-MS group systematic review and meta-analysis

Area of Science:

• Neurology
• Pediatric Neurology
• Immunology

Background:

• Pediatric multiple sclerosis (Ped-MS) requires careful treatment selection to prevent lifelong cognitive impairment.
• Disease-modifying therapies (DMTs) are crucial for managing Ped-MS and mitigating irreversible sequelae.

Purpose of the Study:

• To review the efficacy and safety of fingolimod, the sole FDA-approved DMT for Ped-MS.
• To provide a comprehensive analysis of fingolimod's impact on pediatric multiple sclerosis patients.

Main Methods:

• A PRISMA-based systematic review of 15 studies involving 585 pediatric multiple sclerosis patients.
• Meta-analysis focused on annualized relapse rate (ARR) and Expanded Disability Status Scale (EDSS) changes.
• Assessed patient persistence on fingolimod and reported adverse events.

Main Results:

• Fingolimod demonstrated a significant reduction in ARR by -1.17 relapses/patient-year.
• No significant decrease in EDSS was observed (p=0.24), with a change of -0.27.
• 79.8% of patients remained on fingolimod after 24 months, indicating good persistence.
• Adverse events occurred in 10.8%-88% of patients, most commonly leukopenia/lymphopenia, headache, cough, and infections.

Conclusions:

• Fingolimod, an oral DMT, significantly impacts ARR and stabilizes EDSS in pediatric multiple sclerosis.
• High patient persistence after 24 months suggests favorable efficacy and acceptable safety.
• Fingolimod represents a valuable treatment option for pediatric multiple sclerosis.