title: Five-year results from a phase 2 study of oral fingolimod in relapsing multiple sclerosis.
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.
authors.affiliation: Department of Neurology, Virgen Macarena Hospital, Spain.
authors.forename: G
authors.initials: G
authors.lastname: Izquierdo
authors.affiliation: St Michael's Hospital, Canada.
authors.forename: P
authors.initials: P
authors.lastname: O'Connor
authors.affiliation: Hospital Universitari Vall d'Hebron, Spain.
authors.forename: X
authors.initials: X
authors.lastname: Montalban
authors.affiliation: Novartis Pharma AG, Switzerland.
authors.forename: P
authors.initials: P
authors.lastname: von Rosenstiel
authors.affiliation: Novartis Pharma AG, Switzerland.
authors.forename: M
authors.initials: M
authors.lastname: Cremer
authors.affiliation: Novartis Pharma AG, Switzerland.
authors.forename: A
authors.initials: A
authors.lastname: de Vera
authors.affiliation: Novartis Pharma AG, Switzerland.
authors.forename: N
authors.initials: N
authors.lastname: Sfikas
authors.affiliation: Novartis Pharmaceuticals Corporation, USA.
authors.forename: G
authors.initials: G
authors.lastname: Francis
authors.affiliation: MS MRI Evaluation Center, Switzerland.
authors.forename: E W
authors.initials: EW
authors.lastname: Radue
authors.affiliation: Department of Neurology, University Hospital, University of Basel, Switzerland lkappos@uhbs.ch.
authors.forename: L
authors.initials: L
authors.lastname: Kappos
mesh_terms: D000284:Administration, Oral; D004185:Disability Evaluation; D018450:Disease Progression; D004311:Double-Blind Method; D000068876:Fingolimod Hydrochloride / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008279:Magnetic Resonance Imaging; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000068876:Fingolimod Hydrochloride
keywords: Fingolimod; disease-modifying therapy; long term; phase 2; relapsing–remitting multiple sclerosis; sphingosine 1-phosphate receptor modulator