Five-year results from a phase 2 study of oral fingolimod in relapsing multiple sclerosis. (June 2014)

• Record Type: Journal Article
• Authors: Izquierdo, G; O'Connor, P; Montalban, X; von Rosenstiel, P; Cremer, M; de Vera, A; Sfikas, N; Francis, G; Radue, EW; Kappos, L
• Is Part Of: Multiple sclerosis. Volume 20:Number 7(2014)
• Page Start: 877
• Page End: 881
• Publication Date: 2014-06
• Subjects: Fingolimod -- sphingosine 1-phosphate receptor modulator -- disease-modifying therapy -- relapsing–remitting multiple sclerosis -- phase 2 -- long term; Central nervous system -- Diseases -- Periodicals; Myelin sheath -- Diseases -- Periodicals; Inflammation -- Periodicals; Multiple sclerosis -- Periodicals; Central Nervous System Diseases -- Periodicals; Demyelinating Diseases -- Periodicals; Inflammation -- Periodicals; Multiple Sclerosis -- Periodicals; Système nerveux central -- Maladies -- Périodiques; Gaine de myéline -- Maladies -- Périodiques; Inflammation (Pathologie) -- Périodiques; Sclérose en plaques -- Périodiques; Electronic journals; 616.834005
• DOI: 10.1177/1352458513513059
• Languages: English
• ISSNs: 1352-4585

Abstract

We present here results at 60 months (M), from the extension component of a phase 2, randomized, placebo-controlled, double-blind, six-month study evaluating oral fingolimod (1.25 mg or 5 mg daily) in relapsing multiple sclerosis. Placebo patients from the core study were re-randomized to fingolimod 1.25 mg or 5 mg in the extension. All patients received 1.25 mg fingolimod after the M24 visit. A total of 140/281 (49.8%) patients completed M60. Fingolimod treatment was associated with a low annualized relapse rate (0.2 relapses/ year), low MRI activity, and a modest rate of disability progression in those treated for five years. No new safety issues were reported.