What is the efficacy of fingolimod in the treatment of pediatric multiple sclerosis (MS)?

Updated: Jan 30, 2019
  • Author: Alice K Rutatangwa, DO, MSc; Chief Editor: Amy Kao, MD  more...
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Answer

Fingolimod, teriflunomide, and dimethyl fumarate are oral disease-modifying therapies to achieve FDA approval for treatment of relapsing and remitting MS in adults. Fingolimod was also approved for children aged 10 years or older with relapsing MS in May 2018. Approval of fingolimod in children was based on the Phase 3 PARADIGMS study (n=215) that compared fingolimod to interferon beta-1a in children and adolescents. Patients were randomized to receive once-daily oral fingolimod (n=107, 0.5 mg or 0.25 mg, dependent on patients' body weight) or intramuscular interferon (IFN) beta-1a (n=108) once weekly. Compared with IFN beta-1a, fingolimod reduced the annualized rate of n/neT2 lesions by 52.6% (p< 0.001) and number of Gd+T1 lesions per scan by 66.0% (p< 0.001). Treatment with fingolimod up to Month 24 compared with IFN beta-1a significantly reduced brain atrophy (ARBA: −0.48% vs. −0.80%, p=0.014), Fingolimod significantly reduced MRI activity and slowed brain volume loss for up to 2 years compared with IFN beta-1a. [80]


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