TY - JOUR
T1 - A Placebo-Controlled Trial of Oral Fingolimod in Relapsing Multiple Sclerosis
AU - Kappos, Ludwig
AU - Radue, Ernst Wilhelm
AU - O'Connor, Paul
AU - Polman, Chris H.
AU - Hohlfeld, Reinhard
AU - Calabresi, Peter
AU - Selmaj, Krzysztof W.
AU - Agoropoulou, Catherine
AU - Leyk, Malgorzata
AU - Zhang-Auberson, Lixin
AU - Freedoms Study Group
AU - Hupperts, Raymond
AU - Burtin, Pascale
PY - 2010/2/4
Y1 - 2010/2/4
N2 - Oral fingolimod, a sphingosine-1-phosphate-receptor modulator that prevents the egress of lymphocytes from lymph nodes, significantly improved relapse rates and end points measured on magnetic resonance imaging (MRI), as compared with either placebo or intramuscular interferon beta-1a, in phase 2 and 3 studies of multiple sclerosis.In our 24-month, double-blind, randomized study, we enrolled patients who had relapsing-remitting multiple sclerosis, were 18 to 55 years of age, had a score of 0 to 5.5 on the Expanded Disability Status Scale (which ranges from 0 to 10, with higher scores indicating greater disability), and had had one or more relapses in the previous year or two or more in the previous 2 years. Patients received oral fingolimod at a dose of 0.5 mg or 1.25 mg daily or placebo. End points included the annualized relapse rate (the primary end point) and the time to disability progression (a secondary end point).A total of 1033 of the 1272 patients (81.2%) completed the study. The annualized relapse rate was 0.18 with 0.5 mg of fingolimod, 0.16 with 1.25 mg of fingolimod, and 0.40 with placebo (P
AB - Oral fingolimod, a sphingosine-1-phosphate-receptor modulator that prevents the egress of lymphocytes from lymph nodes, significantly improved relapse rates and end points measured on magnetic resonance imaging (MRI), as compared with either placebo or intramuscular interferon beta-1a, in phase 2 and 3 studies of multiple sclerosis.In our 24-month, double-blind, randomized study, we enrolled patients who had relapsing-remitting multiple sclerosis, were 18 to 55 years of age, had a score of 0 to 5.5 on the Expanded Disability Status Scale (which ranges from 0 to 10, with higher scores indicating greater disability), and had had one or more relapses in the previous year or two or more in the previous 2 years. Patients received oral fingolimod at a dose of 0.5 mg or 1.25 mg daily or placebo. End points included the annualized relapse rate (the primary end point) and the time to disability progression (a secondary end point).A total of 1033 of the 1272 patients (81.2%) completed the study. The annualized relapse rate was 0.18 with 0.5 mg of fingolimod, 0.16 with 1.25 mg of fingolimod, and 0.40 with placebo (P
U2 - 10.1056/NEJMoa0909494
DO - 10.1056/NEJMoa0909494
M3 - Article
C2 - 20089952
SN - 0028-4793
VL - 362
SP - 387
EP - 401
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 5
ER -