Fingolimod efficacy and safety in an African-American patient subgroup from freedoms ii

OBJECTIVE:To assess the efficacy and safety of fingolimod in a subgroup of African-Americans (AA) with relapsing-remitting multiple sclerosis (RRMS).BACKGROUND:AAs are thought to be at a lower risk of developing MS than Caucasians, but may experience a more aggressive disease course. Consequently, it is important to understand the effect of fingolimod in these patientsDESIGN/METHODS:This was a post hoc analysis of the AA subgroup from FREEDOMS II, a 2-year, double-blinded, randomized, controlled, phase 3 study comparing fingolimod 0.5mg and 1.25mg with placebo. Annualized relapse rate (ARR), gadolinium-enhancing (Gd+) T1 lesion counts and new/newly enlarged T2 lesion counts were assessed descriptively, without statistical analysis owing to the small analysis population. All adverse events (AEs) and severe AEs (SAEs) were recorded.RESULTS:Patients receiving fingolimod 0.5mg (n=24), fingolimod 1.25mg (n=25) and placebo (n=28) had ARRs of 0.26, 0.17 and 0.36, respectively (29% fingolimod 0.5mg and 54% fingolimod 1.25mg ARR reductions versus placebo). Mean/median (range) month 24 Gd+ lesion counts were: 1.1/0.0 (0-20; n=19), 0.0/0.0 (0-0; n=13) and 1.5/0.0 (0-14; n=19) for fingolimod 0.5mg, 1.25mg and placebo, respectively. In the fingolimod 0.5mg and 1.25mg groups, 89.5% and 100% of patients, respectively, were free from Gd+ lesions (63.2% for placebo). Mean/median (range) new/newly enlarged T2 lesion counts were 6.7/1.0 (0-97;n=19), 1.6/1.0 (0-7;n=13) and 11.5/3.0 (0-85;n=19); the proportion of patients free from new/newly enlarged T2 lesions was 36.8%, 46.2% and 15.8% in the fingolimod 0.5mg, 1.25mg and placebo groups, respectively. Over 24 months, 16.7%, 32.0% and 10.7% of patients discontinued due to an AE, and 8.3%, 16% and 17.9% reported SAEs, in the fingolimod 0.5mg, 1.25mg and placebo groups, respectively.CONCLUSIONS:Relapse rates and focal MRI activity were lower in AAs treated with fingolimod than with placebo; statistically significant differences were not expected owing to the small patient numbers. Fingolimod safety was consistent with the overall FREEDOMS II population.