Comment
Effects of fingolimod in relapsing-remitting multiple sclerosis Published Online March 28, 2014 http://dx.doi.org/10.1016/ S1474-4422(14)70067-5 See Articles page 545
526
Fingolimod, a sphingosine-1-phosphate receptor modulator, was the first oral drug to be approved for treatment of relapsing-remitting multiple sclerosis. Its approval was based on findings from the placebocontrolled FREEDOMS study of fingolimod 0·5 mg or 1·25 mg daily1 and those from a comparative trial of fingolimod versus interferon β-1a (30 μg weekly) given intramuscularly (TRANSFORMS),2 which both showed superiority of fingolimod. Because of safety issues, mainly cardiac symptoms associated with the first administration of fingolimod and two fatal cases of herpes virus infections, both occurring in patients treated with 1·25 mg, only 0·5 mg daily was approved, fingolimod was granted only second-line approval in the European Union, and the US Food and Drug Administration issued specific recommendations for monitoring patients and contraindications for use in some patients. The FREEDOMS II study began at the same time as FREEDOMS with similar inclusion criteria and identical treatment allocation.3 Findings from the FREEDOMS II study, reported in The Lancet Neurology, substantiate the beneficial effects in FREEDOMS. The annualised relapse rate, which was the primary endpoint in both studies, was 0·18 (95% CI 0·15–0·22 in FREEDOMS and 0·21 (0·17–0·25) in FREEDOMS II (in the 0·5 mg group) compared with 0·40 (0·34–0·47) in the placebo group in FREEDOMS and 0·40 (0·34–0·48) in the placebo group in FREEDOMS II, representing 54% relative reduction in FREEDOMS and a 48% relative reduction (0·40–0·66) in FREEDOMS II (p
Effects of fingolimod in relapsing-remitting multiple sclerosis Published Online March 28, 2014 http://dx.doi.org/10.1016/ S1474-4422(14)70067-5 See Articles page 545
526
Fingolimod, a sphingosine-1-phosphate receptor modulator, was the first oral drug to be approved for treatment of relapsing-remitting multiple sclerosis. Its approval was based on findings from the placebocontrolled FREEDOMS study of fingolimod 0·5 mg or 1·25 mg daily1 and those from a comparative trial of fingolimod versus interferon β-1a (30 μg weekly) given intramuscularly (TRANSFORMS),2 which both showed superiority of fingolimod. Because of safety issues, mainly cardiac symptoms associated with the first administration of fingolimod and two fatal cases of herpes virus infections, both occurring in patients treated with 1·25 mg, only 0·5 mg daily was approved, fingolimod was granted only second-line approval in the European Union, and the US Food and Drug Administration issued specific recommendations for monitoring patients and contraindications for use in some patients. The FREEDOMS II study began at the same time as FREEDOMS with similar inclusion criteria and identical treatment allocation.3 Findings from the FREEDOMS II study, reported in The Lancet Neurology, substantiate the beneficial effects in FREEDOMS. The annualised relapse rate, which was the primary endpoint in both studies, was 0·18 (95% CI 0·15–0·22 in FREEDOMS and 0·21 (0·17–0·25) in FREEDOMS II (in the 0·5 mg group) compared with 0·40 (0·34–0·47) in the placebo group in FREEDOMS and 0·40 (0·34–0·48) in the placebo group in FREEDOMS II, representing 54% relative reduction in FREEDOMS and a 48% relative reduction (0·40–0·66) in FREEDOMS II (p
