BACKGROUND: There is a need to identify effective switch therapies for patients with relapsing-remitting multiple sclerosis (RRMS) who experience high disease activity despite receiving disease-modifying therapy (DMT).
RESEARCH DESIGN AND METHODS: Clinical and magnetic resonance imaging outcomes over 24 months were analysed in patients from FREEDOMS and FREEDOMS II who had received treatment in the previous year and had: 1) ≥ 1 relapse in the previous year and either ≥ 1 gadolinium (Gd)-enhancing T1 lesion or ≥ 9 T2 lesions at baseline and/or 2) as many or more relapses in the year before baseline as in the previous year (as per fingolimod’s EU label).
MAIN OUTCOME MEASURES: The inclusion criteria were fulfilled by 249 and 257 patients in the fingolimod and placebo groups, respectively. Annualized relapse rates were reduced by 48% for fingolimod versus placebo (p < 0.001). Fingolimod reduced the risk of 3-month and 6-month confirmed disability progression by 34% (p = 0.031) and 45% (p = .016), respectively, versus placebo. Brain volume loss was reduced by 46% for fingolimod versus placebo (p < 0.001). The reduction in Gd-enhancing T1 lesion counts for fingolimod versus placebo was 65% (p < 0.001). Furthermore, fingolimod reduced the number of new or newly enlarged T2 lesions by 69% relative to placebo (p < 0.001).
LIMITATION: The analyses are post hoc, but the population is specified by the European Medicines Agency in the label for fingolimod.
CONCLUSIONS: Fingolimod demonstrated efficacy across all four key RRMS disease measures analysed in patients with high disease activity despite previous DMT.