title: Fingolimod therapy in early multiple sclerosis: an efficacy analysis of the TRANSFORMS and FREEDOMS studies by time since first symptom.
abstract: OBJECTIVE
  The phase 3 TRANSFORMS and FREEDOMS studies established the efficacy of fingolimod in reducing multiple sclerosis (MS) relapses and magnetic resonance imaging lesions compared with intramuscular (IM) interferon (IFN) β-1a and placebo over 12 and 24 months, respectively.
  
  
  METHODS
  To investigate the efficacy of fingolimod at the approved 0.5 mg dose in patients early in the MS disease course, post hoc subgroup analyses of TRANSFORMS (n = 272) and FREEDOMS (n = 217) data were conducted in patients who experienced their first MS symptom <3 years before randomization.
  
  
  RESULTS
  Fingolimod 0.5 mg reduced annualized relapse rate by 73.4% (P = 0.0002) versus IFNβ-1a IM and by 67.4% (P < 0.0001) versus placebo in patients with <3 years since first symptom; respective reductions were 45.4% and 51.4% in subgroups of patients with ≥3 years since first symptom. For patients with <3 years since their first symptom, significantly fewer new/newly enlarged T2 lesions were observed with fingolimod versus IFNβ-1a IM (mean number, 1.94 vs. 2.95; P = 0.036) or placebo (4.1 vs. 10.7; P < 0.001); the mean number of gadolinium-enhancing T1 lesions was significantly reduced versus placebo (0.3 vs. 1.1; P < 0.001).
  
  
  CONCLUSIONS
  Fingolimod 0.5 mg is highly effective in reducing relapses and MRI activity in patients early in the MS disease course.
authors.affiliation: Department of Neurology, University of California Davis, Davis, CA, USA; Veteran's Affairs Northern California Health Care System, Mather, CA, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Agius
authors.forename: Xiangyi
authors.initials: X
authors.lastname: Meng
authors.forename: Peter
authors.initials: P
authors.lastname: Chin
authors.forename: Augusto
authors.initials: A
authors.lastname: Grinspan
authors.forename: Ronny
authors.initials: R
authors.lastname: Hashmonay
mesh_terms: D000328:Adult; D018450:Disease Progression; D005260:Female; D000068876:Fingolimod Hydrochloride; D005682:Gadolinium; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000627:therapeutic use; D053208:Kaplan-Meier Estimate; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000473:pathology; D011409:Propylene Glycols / Q000627:therapeutic use*; D055502:Secondary Prevention; D013110:Sphingosine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007155:Immunologic Factors; D007166:Immunosuppressive Agents; D011409:Propylene Glycols; D016899:Interferon-beta; D005682:Gadolinium; D000068876:Fingolimod Hydrochloride; D013110:Sphingosine; D000068556:Interferon beta-1a
keywords: Early medical intervention; Fingolimod; Interferon β; Pharmacotherapy; Relapse