Clinical trial results published in JAMA Neurology evaluated the efficacy of two different doses of fingolimod and glatiramer acetate showed that fingolimod (0.5mg) demonstrated superior clinical efficacy in adult patients with relapsing-remitting multiple sclerosis.
This phase 3b study included 1,064 participants who were randomised to receive fingolimod 0.5 mg (n=352), fingolimod 0.25 mg (n=370), or glatiramer acetate 20 mg (n=342). The primary endpoint was the reduction in annualised relapse rate (ARR). The researchers also assessed magnetic resonance imaging (MRI) parameters, safety, and tolerability.
The results show that treatment with fingolimod 0.5 mg was superior to treatment with glatiramer acetate 20 mg in reducing ARR. Treatment with fingolimod 0.5 mg reduced the ARR by 41 per cent, and treatment with fingolimod 0.25 mg reduced it by 15 per cent compared with glatiramer acetate. Adverse events were reported in similar proportions across treatment groups.
The authors conclude that this study demonstrates that fingolimod 0.5 mg is superior to glatiramer acetate 20 mg in reducing the rates of relapse and activity on MRI scans. These findings support the use of fingolimod 0.5 mg as the optimal efficacious dose for the treatment of adult patients with relapsing-remitting multiple sclerosis.