April 26, 2011
Fingolimod (Gilenya, Novartis) reduced the risk of disability progression in patients with relapsing-remitting multiple sclerosis (RRMS), regardless of treatment history, according to a phase 3, 2-year study reported at the 63rd annual meeting of the American Academy of Neurology.
The Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis (FREEDOMS) analysis showed that patients new to therapy (n=493) who were treated with 0.5 mg fingolimod had a 37% reduction in the risk of 3-month confirmed disability progression compared with placebo (HR=0.63; 95% CI, 0.41–0.95). In patients previously treated with alternate therapies (n=350), fingolimod 0.5 mg led to a 30% reduction in risk (HR=0.70; 95% CI, 0.43–1.14). Consistent favorable effects on disability progression were observed for fingolimod-treated patients compared to placebo for subgroups defined by age, gender, disease severity as defined by Expanded Disability Status Scale score, relapse activity prior to study, magnetic resonance imaging lesion burden, or lesion activity at the time of the start of the study.
The primary end point for the 2-year FREEDOMS study was relapse rate, in which fingolimod reduced relapses by 54% compared with placebo (P<.001). In a key secondary end point, fingolimod showed a 30% reduction (P<.05) in the risk of 3-month confirmed disability progression compared with placebo over 2 years.
“These data provide deeper insights into the effect of Gilenya in significantly reducing MS disability progression across the broad range of patient subpopulations that this analysis evaluated,” said Virginia Devonshire, MD, director of the University of British Columbia MS Clinic and a FREEDOMS trial investigator.