title: Effects of early treatment with glatiramer acetate in patients with clinically isolated syndrome.
abstract: BACKGROUND
  The placebo-controlled phase of the PreCISe study showed that glatiramer acetate delayed onset of clinically definite multiple sclerosis (CDMS) in patients with clinically isolated syndrome and brain lesions on MRI.
  
  
  OBJECTIVE
  To compare the effects of early versus delayed glatiramer acetate treatment in the open-label phase of PreCISe.
  
  
  METHODS
  Patients with a clinically isolated syndrome suggestive of MS with unifocal manifestation and ≥2 T2-weighted brain lesions were randomized to receive glatiramer acetate 20 mg/d (early-treatment, n=198) or placebo (delayed-treatment, n=211) for 36 months or until conversion to CDMS, followed by open-label glatiramer acetate treatment for two years.
  
  
  RESULTS
  Early glatiramer acetate treatment reduced CDMS conversion risk by 41% (hazard ratio 0.59, 95% confidence interval 0.44-0.80; p=0.0005) versus delayed-treatment, and was associated with a 972-day delay (185%) in conversion to CDMS, less brain atrophy (-28%, p=0.0209), fewer new T2 lesions/year (-42%, <0.0001) and lower T2 lesion volume (-22%, p=0.0005) versus delayed treatment. Adverse events were consistent with the established safety profile of glatiramer acetate.
  
  
  CONCLUSIONS
  Effects of early glatiramer acetate treatment on the rate of conversion to CDMS and on MRI measures of disease activity and lesion burden support initiating glatiramer acetate treatment soon after the first clinical symptoms suggestive of MS and continuing treatment to sustain benefits.
authors.affiliation: Institute of Experimental Neurology, Department of Neurology, University Vita-Salute, Scientific Institute San Raffaele, Milan, Italy.
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Comi
authors.forename: Vittorio
authors.initials: V
authors.lastname: Martinelli
authors.forename: Mariaemma
authors.initials: M
authors.lastname: Rodegher
authors.forename: Lucia
authors.initials: L
authors.lastname: Moiola
authors.forename: Letizia
authors.initials: L
authors.lastname: Leocani
authors.forename: Ovidiu
authors.initials: O
authors.lastname: Bajenaru
authors.forename: Adriana
authors.initials: A
authors.lastname: Carra
authors.forename: Irina
authors.initials: I
authors.lastname: Elovaara
authors.forename: Franz
authors.initials: F
authors.lastname: Fazekas
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Hartung
authors.forename: Jan
authors.initials: J
authors.lastname: Hillert
authors.forename: John
authors.initials: J
authors.lastname: King
authors.forename: Samuel
authors.initials: S
authors.lastname: Komoly
authors.forename: Catherine
authors.initials: C
authors.lastname: Lubetzki
authors.forename: Xavier
authors.initials: X
authors.lastname: Montalban
authors.forename: Kjell-Morten
authors.initials: KM
authors.lastname: Myhr
authors.forename: Paolo
authors.initials: P
authors.lastname: Preziosa
authors.forename: Mads
authors.initials: M
authors.lastname: Ravnborg
authors.forename: Peter
authors.initials: P
authors.lastname: Rieckmann
authors.forename: Maria A
authors.initials: MA
authors.lastname: Rocca
authors.forename: Daniel
authors.initials: D
authors.lastname: Wynn
authors.forename: Carolyn
authors.initials: C
authors.lastname: Young
authors.forename: Massimo
authors.initials: M
authors.lastname: Filippi
mesh_terms: D000328:Adult; D001921:Brain / Q000187:drug effects / Q000473:pathology; D003711:Demyelinating Diseases / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D000068717:Glatiramer Acetate; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008279:Magnetic Resonance Imaging; D008297:Male; D009103:Multiple Sclerosis / Q000517:prevention & control; D010455:Peptides / Q000008:administration & dosage*
chemical_list: D007166:Immunosuppressive Agents; D010455:Peptides; D000068717:Glatiramer Acetate