title: Fingolimod in relapsing multiple sclerosis: An integrated analysis of safety findings.
abstract: BACKGROUND
  Fingolimod 0.5mg once daily is the first approved oral therapy for relapsing multiple sclerosis (MS).
  
  
  OBJECTIVE
  To report integrated long-term safety data from phase 2/3 fingolimod studies.
  
  
  METHODS
  Descriptive safety data are reported from the FTY720 Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis (FREEDOMS) study, a 24-month, randomized, double-blind study comparing fingolimod 0.5mg and 1.25mg with placebo, and an All Studies group (patients who received fingolimod 0.5mg (n=1640) or 1.25-0.5mg (n=1776) in phase 2/3 studies and associated extensions). Relevant post-marketing experience, up to December 2011, is included.
  
  
  RESULTS
  The incidence of adverse events (AEs) and serious AEs (SAEs) was similar with fingolimod and placebo in FREEDOMS. In the All Studies group, fingolimod 0.5mg was associated with transient, rarely symptomatic (0.5%), bradycardia and second-degree atrioventricular block on treatment initiation, minor blood pressure increases, frequent (9%) but generally asymptomatic liver enzyme elevations, and macular oedema (0.4%). The incidences of infections (including serious and herpes infections), malignancies, SAEs and treatment discontinuations due to AEs were similar with fingolimod 0.5mg and placebo.
  
  
  CONCLUSIONS
  The safety profile of fingolimod has been well characterized in this large combined trial population. Although infrequent SAEs can occur, there is no increased risk of infections, malignancies or serious cardiovascular events versus placebo.
authors: Neurology, Department of Medicine, Clinical Research and Biomedicine, University Hospital, Petersgraben 4, CH-4031 Basel, Switzerland. Electronic address: ludwig.kappos@usb.ch.
authors: Ludwig
authors: L
authors: Kappos
authors: Neurological Institute, The Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA.
authors: Jeffrey
authors: J
authors: Cohen
authors: Novartis Pharma AG, CH-4056 Basel, Switzerland.
authors: William
authors: W
authors: Collins
authors: Novartis Pharma AG, CH-4056 Basel, Switzerland.
authors: Ana
authors: A
authors: de Vera
authors: Novartis Pharma AG, CH-4056 Basel, Switzerland.
authors: Lixin
authors: L
authors: Zhang-Auberson
authors: Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07849-1080, USA.
authors: Shannon
authors: S
authors: Ritter
authors: Novartis Pharma AG, CH-4056 Basel, Switzerland.
authors: Philipp
authors: P
authors: von Rosenstiel
authors: Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07849-1080, USA.
authors: Gordon
authors: G
authors: Francis
keywords: Adverse events; Cardiovascular events; Fingolimod; Multiple sclerosis; Pooled analysis; Safety