Authors
Jeffrey A Cohen, Frederik Barkhof, Giancarlo Comi, Hans-Peter Hartung, Bhupendra O Khatri, Xavier Montalban, Jean Pelletier, Ruggero Capra, Paolo Gallo, Guillermo Izquierdo, Klaus Tiel-Wilck, Ana de Vera, James Jin, Tracy Stites, Stacy Wu, Shreeram Aradhye, Ludwig Kappos
Publication date
2010/2/4
Journal
New England Journal of Medicine
Volume
362
Issue
5
Pages
402-415
Publisher
Massachusetts Medical Society
Description
Background
Fingolimod (FTY720), a sphingosine-1-phosphate–receptor modulator that prevents lymphocyte egress from lymph nodes, showed clinical efficacy and improvement on imaging in a phase 2 study involving patients with multiple sclerosis.
Methods
In this 12-month, double-blind, double-dummy study, we randomly assigned 1292 patients with relapsing–remitting multiple sclerosis who had a recent history of at least one relapse to receive either oral fingolimod at a daily dose of either 1.25 or 0.5 mg or intramuscular interferon beta-1a (an established therapy for multiple sclerosis) at a weekly dose of 30 μg. The primary end point was the annualized relapse rate. Key secondary end points were the number of new or enlarged lesions on T2-weighted magnetic resonance imaging (MRI) scans at 12 months and progression of disability that was sustained for at least 3 months.
Results
A total of 1153 …
Total citations
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Scholar articles
JA Cohen, F Barkhof, G Comi, HP Hartung, BO Khatri… - New England Journal of Medicine, 2010