Researchers at the Swedish Neuroscience Institute in Washington and Novartis Pharma revealed that Gilenya (fingolimod) induced a consistent and significant reduction in disease activity in patients with relapsing-remitting multiple sclerosis (RRMS). The results were recently presented at the June 1-4 Consortium of Multiple Sclerosis Centers (CMSC) 2016 Annual Meeting held in National Harbor, Maryland, in a talk titled “The Effect of Fingolimod on Four Measures of Disease Activity in Patients with Relapsing-Remitting Multiple Sclerosis: A Meta-Analysis of the Phase 3 FREEDOMS Trials.”
Fingolimod is a sphingosine-1-phosphate receptor modulator that sequesters lymphocytes in the lymph nodes, decreasing the number of immune cells that enter the central nervous system, which may help reduce the severity of MS.
In individual trials, fingolimod 0.5 mg (the approved dose) demonstrated significant benefits when compared to placebo. The FREEDOMS Phase 3, randomized, double-blind, placebo-controlled study (NCT00289978), which evaluated the effects of daily, oral fingolimod administration in MS patients, revealed a lower annualized relapse rate, lesion activity, and brain volume loss in RRMS patients taking fingolimod in comparison to patients in the placebo group.
FREEDOMS II was a separate randomized, double-blind, placebo-controlled, Phase 3 clinical trial (NCT00355134) initiated shortly after FREEDOMS, designed to address FDA requirements and further assess fingolimod efficacy, safety, and tolerability. Similar to FREEDOMS, the trial also revealed significant health improvements with fingolimod.
To address the consistency of the treatment effect across the two-year FREEDOMS and FREEDOMS II clinical trials in patients with RRMS, the researchers performed a meta-analysis of both studies. The post-hoc analysis included 783 patients who had been included in the fingolimod 0.5 mg group, and 773 subjects who had received placebo.
Results demonstrated significant benefits of fingolimod in RRMS patients. In fact, compared to the placebo group, fingolimod induced a 52 percent reduction in the annualized relapse rate, and a 76 percent reduction in new or enlarging lesions in the brain. Treatment with fingolimod also reduced the rate of brain volume loss by 33 percent, and the risk of confirmed disability progression, measured by the Expanded Disability Status Scale (EDSS) score, was 39 percent lower.
All four endpoints (relapse rate, brain lesions, brain volume loss, and confirmed disability progression) were consistent between the two studies, suggesting that fingolimod is associated with a consistent reduction in inflammatory processes and disease worsening in patients with RRMS.