Oral fingolimod for relapsing-remitting multiple sclerosis Evaluation of: Kappos L, Radue E-M, O'Connor P, et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med 2010;362:387-401; and Cohen JA, Barkhof F, Comi G, et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med 2010;362:402-15.

Most people with multiple sclerosis (MS) have the relapsing-remitting type. The objective was to evaluate two clinical trials of fingolimod in relapsing MS. FREEDOMS (FTY720 Research Evaluation Effects of Daily Oral therapy in Multiple Sclerosis), a Phase III placebo-controlled trial, showed that fingolimod (0.5 or 1.25 mg) reduced the relapse rate and disability in MS, compared with placebo. Fingolimod (0.5 or 1.25 mg) has been compared to interferon-beta-1a in a Phase III clinical trial (TRANSFORMS; Trial Assessing Injectable Interferon versus FTY720 Oral in Relapsing-Remitting Multiple Sclerosis) and shown to be more efficacious than interferon-beta-1a in reducing relapse rates. However, fingolimod did increase the risk of infections and skin cancers. Only the lower dose of fingolimod (0.5 mg), which possibly has less toxicity, should be considered for prevention of relapses in relapsing-remitting MS.

RCT Entities:   Population Interventions Outcomes