In PARADIGMS, a double-blind phase III trial of 215 pediatric MS patients (age 10–<18 years), fingolimod administered up to 2 years significantly reduced both the annualized relapse rate (ARR) (primary endpoint) and the rate of new/newly enlarged T2 (n/neT2) lesions (key secondary endpoint) compared to IFN β-1a.

Predefined analyses of the endpoints were performed after excluding patients in the IFN β-1a arm who were IFN neutralizing antibody (Nabs)-positive at study end (sensitivity analysis) and in disease-modifying therapy (DMT)-naïve patients (supportive analysis). A post-hoc evaluation of 3-month confirmed disability progression (3M-CDP) was also conducted.

Excluding Nabs-positive IFN β-1a patients (n=9) resulted in an 81.5% ARR reduction and 47.6% reduction in n/neT2 lesions, both p<0.001, versus 81.9% and 52.6% in the overall population, respectively. At baseline, 63.3% of patients were treatment naïve. The effect of fingolimod treatment in the DMT-naïve subpopulation (85.8% ARR reduction and 53.4% n/neT2 lesion reduction versus IFN β-1a, both p<0.001) was also consistent with the overall patient population.

The percentage of patients without 3M-CDP up to 2 years was higher in the fingolimod group (95.2%) compared with the IFN β-1a group (84.7%) (p=0.015), with a risk reduction in 3M-CDP of 77.2% (hazard ratio=0.23, p=0.007). 3M-CDP sustained until the last observation yielded similar results. Expanded disability status scale (EDSS) measurements will be presented.

Fingolimod in pediatric MS was associated with consistent control of disease activity across sensitivity/supportive analyses, and benefits on disability progression over the treatment duration of up to 2 years.