Oral FTY720 (Fingolimod) in relapsing MS: Results of the dose-blinded extension of a Placebo-controlled phase II study

The oral sphingosine-1-phosphate receptor modulator fingolimod has shown clinical and MRI efficacy in a 6-month (M), placebo-controlled study in 281 relapsing MS patients. After M6, 250 patients entered an extension study where those in the 1.25 and 5 mg fingolimod groups continued blinded treatment as assigned, while patients in the placebo group were re-randomized to fingolimod 1.25 mg (placebo-1.25 mg) or 5 mg (placebo-5 mg). 205 (82%) completed M18. During M7-18, annualized relapse rates in placebo-1.25 mg (n=40) and placebo-5 mg (n=43) groups were reduced from 0.70 (on placebo) to 0.29 and 0.18, versus M0-6. In the continuous fingolimod groups, relapse rates remained low in both the 1.25 mg group (n=87, 0.21) and the 5 mg group (n=80, 0.17). In all fingolimod groups, no new safety issues emerged during M7-18 versus M0-6. The 24-month safety and clinical/MRI data will be presented.