Oral fingolimod (FTY720) for relapsing multiple sclerosis

Ludwig Kappos, Jack Antel, Giancarlo Comi, Xavier Montalban, Paul O'Connor, Chris H. Polman, Tomas Haas, Alexander A. Korn, Goeril Karlsson, Ernst W. Radue

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Fingolimod (FTY720) is a new oral immunomodulating agent under evaluation for the treatment of relapsing multiple sclerosis. Methods: We randomly assigned 281 patients to receive oral fingolimod, at a dose of 1.25 mg or 5.0 mg, or a placebo once daily, and we followed these patients for 6 months with magnetic resonance imaging (MRI) and clinical evaluations (core study, months 0 to 6). The primary end point was the total number of gadolinium-enhanced lesions recorded on T 1-weighted MRI at monthly intervals for 6 months. In an extension study in which the investigators and patients remained unaware of the dose assignments (months 7 to 12), patients who received placebo underwent randomization again to one of the fingolimod doses. Results: A total of 255 patients completed the core study. The median total number of gadolinium-enhanced lesions on MRI was lower with 1.25 mg of fingolimod (1 lesion, P

Original languageEnglish
Pages (from-to)1124-1140
Number of pages17
JournalNew England Journal of Medicine
Volume355
Issue number11
DOIs
Publication statusPublished - Sep 14 2006

ASJC Scopus subject areas

  • Medicine(all)

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