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 journalArticle

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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

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Multiple Sclerosis
Magnetic Resonance Imaging
Gadolinium
Placebos
Random Allocation
Research Personnel
Fingolimod Hydrochloride
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Kappos, L., Antel, J., Comi, G., Montalban, X., O'Connor, P., Polman, C. H., ... Radue, E. W. (2006). Oral fingolimod (FTY720) for relapsing multiple sclerosis. New England Journal of Medicine, 355(11), 1124-1140. https://doi.org/10.1056/NEJMoa052643

Oral fingolimod (FTY720) for relapsing multiple sclerosis. / Kappos, Ludwig; Antel, Jack; Comi, Giancarlo; Montalban, Xavier; O'Connor, Paul; Polman, Chris H.; Haas, Tomas; Korn, Alexander A.; Karlsson, Goeril; Radue, Ernst W.

In: New England Journal of Medicine, Vol. 355, No. 11, 14.09.2006, p. 1124-1140.

Research output: Contribution to journalArticle

Kappos, L, Antel, J, Comi, G, Montalban, X, O'Connor, P, Polman, CH, Haas, T, Korn, AA, Karlsson, G & Radue, EW 2006, 'Oral fingolimod (FTY720) for relapsing multiple sclerosis', New England Journal of Medicine, vol. 355, no. 11, pp. 1124-1140. https://doi.org/10.1056/NEJMoa052643
Kappos L, Antel J, Comi G, Montalban X, O'Connor P, Polman CH et al. Oral fingolimod (FTY720) for relapsing multiple sclerosis. New England Journal of Medicine. 2006 Sep 14;355(11):1124-1140. https://doi.org/10.1056/NEJMoa052643
Kappos, Ludwig ; Antel, Jack ; Comi, Giancarlo ; Montalban, Xavier ; O'Connor, Paul ; Polman, Chris H. ; Haas, Tomas ; Korn, Alexander A. ; Karlsson, Goeril ; Radue, Ernst W. / Oral fingolimod (FTY720) for relapsing multiple sclerosis. In: New England Journal of Medicine. 2006 ; Vol. 355, No. 11. pp. 1124-1140.
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