To evaluate whether fingolimod (0.5 mg and 0.25 mg) has superior efficacy compared to glatiramer acetate (GA) 20 mg in reducing disease activity over 12 months in patients with relapsing-remitting multiple sclerosis.

In ASSESS, a Phase 3b, randomized, multicenter, rater- and dose-blinded study, eligible patients were randomized to receive once-daily oral fingolimod 0.5 mg (N=352), 0.25 mg (N=370), or subcutaneous GA 20 mg (N=342). Superiority of the fingolimod doses was tested hierarchically: 0.5 mg versus GA followed by 0.25 mg versus GA. The primary endpoint was reduction in annualized relapse rate (ARR), and secondary endpoints were MRI measures of disease activity at 12 months. Safety and tolerability were assessed.

Overall, 859 (80.7%) patients completed the study. Over 12 months, ARRs with fingolimod 0.5 mg and GA were 0.153 and 0.258, respectively (relative reduction [RR], 40.7%; p=0.0138); fingolimod 0.25 mg achieved a numerical RR of 14.6% but did not reach statistical significance. Compared to GA, fingolimod 0.5 mg and 0.25 mg significantly reduced the mean number of new/newly enlarged T2 (RR, 54.4% and 42.1%, respectively; p<0.0001) and gadolinium-enhancing T1 lesions (RR, 55.6% for both doses; p=0.0167 and p=0.0011, respectively). Adverse events (AEs) reported with both fingolimod doses were consistent with the known safety profile. More discontinuations from the study drug were reported with GA due to injection-related AEs, consent withdrawal and unsatisfactory therapeutic effects.