Consistent control of disease activity with fingolimod versus IFN β-1a in paediatric-onset multiple sclerosis: further insights from PARADIG MS

J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):58-66. doi: 10.1136/jnnp-2019-321124. Epub 2019 Aug 29.


Background: In PARADIGMS, a double-blind phase III trial in 215 paediatric patients with multiple sclerosis (MS) (10 to <18 years), fingolimod administered for up to 2 years significantly reduced the annualised relapse rate (ARR) and rate of new/newly enlarged T2 (n/neT2) lesions compared with interferon (IFN) β-1a.

Objectives: To investigate (1) differences between treatment groups across subpopulations (treatment-naïve, younger/prepubertal patients); (2) disability progression.

Methods: ARRs at 10, 11 and 12 years were estimated based on predefined modelling extrapolations. Changes in Expanded Disability Status Scale (EDSS), and in 3 month (3M) and 6 month (6M) confirmed disability progression (CDP) were evaluated post hoc.

Results: In the treatment-naïve subpopulation, fingolimod reduced ARR and n/neT2 lesions by 85.8% and 53.4%, respectively versus INF β-1a (both p<0.001), compared with 81.9% and 52.6% in the overall population. Model-based ARR reductions in younger patients (≤12 years) were 91.9%-94.6%. Twice as many IFN β-1a-treated than fingolimod-treated patients had worse EDSS scores at study end (20.6% vs 10.5%, p=0.043). Risk reductions in 3M-CDP and 6M-CDP were 77.2% (p=0.007) and 80.2% (p=0.040), respectively.

Conclusions: Fingolimod in paediatric MS was associated with consistent control of disease activity versus IFN β-1a (including treatment-naïve and younger patients) and resulted in less disability progression for up to 2 years.

Trial registration number: NCT01892722.

Keywords: PARADIGMS; disability progression; fingolimod; gilenya; paediatric multiple sclerosis.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Age Factors
  • Age of Onset
  • Child
  • Disability Evaluation
  • Disease Progression
  • Double-Blind Method
  • Endpoint Determination
  • Female
  • Fingolimod Hydrochloride / therapeutic use*
  • Humans
  • Interferon beta-1a / therapeutic use*
  • Kaplan-Meier Estimate
  • Male
  • Multiple Sclerosis / drug therapy*
  • Risk Reduction Behavior
  • Sphingosine 1 Phosphate Receptor Modulators / therapeutic use*
  • Treatment Outcome


  • Sphingosine 1 Phosphate Receptor Modulators
  • Fingolimod Hydrochloride
  • Interferon beta-1a

Associated data