NEJM -- Oral Fingolimod or Intramuscular Interferon for Relapsing Multiple Sclerosis
Posted Jan 21 2010 12:00am
Information for this posting was provided by Karen D., in South Florida:
Published at www.nejm.org January 20, 2010 (10.1056/NEJMoa0907839)
Background Fingolimod (FTY720), a sphingosine-1-phosphate–receptormodulator that prevents lymphocyte egress from lymph nodes,showed clinical efficacy and improvement on imaging in a phase2 study involving patients with multiple sclerosis.
Methods In this 12-month, double-blind, double-dummy study,we randomly assigned 1292 patients with relapsing–remittingmultiple sclerosis who had a recent history of at least onerelapse to receive either oral fingolimod at a daily dose ofeither 1.25 or 0.5 mg or intramuscular interferon beta-1a (anestablished therapy for multiple sclerosis) at a weekly doseof 30 µg. The primary end point was the annualized relapserate. Key secondary end points were the number of new or enlargedlesions on T2-weighted magnetic resonance imaging (MRI) scansat 12 months and progression of disability that was sustainedfor at least 3 months.
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