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

Hasan Kaveyee1, Masoud Etemadifar1, Amir Parsa Abhari2

  • 1School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.

Multiple Sclerosis and Related Disorders
|June 26, 2026
PubMed

Insights

Fingolimod significantly reduces relapses in pediatric multiple sclerosis (Ped-MS) and shows good long-term adherence. This oral therapy offers favorable efficacy and safety for young patients with MS.

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.
Abstract

Keywords:
Disease modifying treatmentFingolimodPed-MSPediatric multiple sclerosis

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