Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial

This 2-year RCT (n=1083) reported lower mean annualised relapse rate with fingolimod 0•5 mg vs. placebo (0.21 vs. 0•40; rate ratio 0.52; 95% CI, 0.40-0.66; p<0.0001). Safety and tolerability were generally consistent with previously described safety profile of fingolimod.

FREEDOMS II, which started shortly after the pivotal phase 3 FREEDOMS and TRANSFORMS studies, was conducted predominantly in the US and incorporated FDA requirements to further assess the efficacy, safety, and tolerability of fingolimod in patients with relapsing remitting multiple sclerosis (RRMS) treated for up to 24 months.

 

According to an accompanying commentary, the results of this study will probably not change the status of fingolimod from a second-line to a first-line treatment for RRMS. Only post-marketing experience in large cohorts of patients will make it possible to weigh the benefits against risks and provide the evidence needed to justify changes in its licensed indication.

 

NICE guidance (TA 254) issued in 2012 supports the use of fingolimod as an option for the treatment of highly active RRMS in adults, only if they have an unchanged or increased relapse rate or ongoing severe relapses compared with the previous year despite treatment with beta interferon, and the manufacturer provides the drug with the discount agreed as part of the patient access scheme.