Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis

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

Research output: Contribution to journalArticlepeer-review

Abstract

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 patients (89%) completed the study. The annualized relapse rate was significantly lower in both groups receiving fingolimod - 0.20 (95% confidence interval [CI], 0.16 to 0.26) in the 1.25-mg group and 0.16 (95% CI, 0.12 to 0.21) in the 0.5-mg group - than in the interferon group (0.33; 95% CI, 0.26 to 0.42; P

Original languageEnglish
Pages (from-to)402-415
Number of pages14
JournalNew England Journal of Medicine
Volume362
Issue number5
DOIs
Publication statusPublished - Feb 4 2010

ASJC Scopus subject areas

  • Medicine(all)

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