title: Subcutaneous interferon β-1a may protect against cognitive impairment in patients with relapsing-remitting multiple sclerosis: 5-year follow-up of the COGIMUS study.
abstract: OBJECTIVE
  To assess the effects of subcutaneous (sc) interferon (IFN) -1a on cognition over 5 years in mildly disabled patients with relapsing-remitting multiple sclerosis (RRMS).
  
  
  METHODS
  Patients aged 18-50 years with RRMS (Expanded Disability Status Scale score ≤4.0) who had completed the 3-year COGIMUS study underwent standardized magnetic resonance imaging, neurological examination, and neuropsychological testing at years 4 and 5. Predictors of cognitive impairment at year 5 were identified using multivariate analysis.
  
  
  RESULTS
  Of 331 patients who completed the 3-year COGIMUS study, 265 participated in the 2-year extension study, 201 of whom (75.8%; sc IFN β-1a three times weekly: 44 µg, n = 108; 22 µg, n = 93) completed 5 years' follow-up. The proportion of patients with cognitive impairment in the study population overall remained stable between baseline (18.0%) and year 5 (22.6%). The proportion of patients with cognitive impairment also remained stable in both treatment groups between baseline and year 5, and between year 3 and year 5. However, a significantly higher proportion of men than women had cognitive impairment at year 5 (26.5% vs 14.4%, p = 0.046). Treatment with the 22 versus 44 µg dose was predictive of cognitive impairment at year 5 (hazard ratio 0.68; 95% confidence interval 0.48-0.97).
  
  
  CONCLUSIONS
  This study suggests that sc IFN β-1a dose-dependently stabilizes or delays cognitive impairment over a 5-year period in most patients with mild RRMS. Women seem to be more protected against developing cognitive impairment, which may indicate greater response to therapy or the inherently better prognosis associated with female sex in MS.
authors.affiliation: Department of Neurology, Multiple Sclerosis Centre Sicilia Region, First Neurology Clinic, University Hospital, Catania, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Patti
authors.forename: Vincenzo Brescia
authors.initials: VB
authors.lastname: Morra
authors.forename: Maria Pia
authors.initials: MP
authors.lastname: Amato
authors.forename: Maria
authors.initials: M
authors.lastname: Trojano
authors.forename: Stefano
authors.initials: S
authors.lastname: Bastianello
authors.forename: Maria Rosalia
authors.initials: MR
authors.lastname: Tola
authors.forename: Salvatore
authors.initials: S
authors.lastname: Cottone
authors.forename: Andrea
authors.initials: A
authors.lastname: Plant
authors.forename: Orietta
authors.initials: O
authors.lastname: Picconi
mesh_terms: D000293:Adolescent; D000328:Adult; D003072:Cognition Disorders / Q000150:complications* / Q000188:drug therapy / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007279:Injections, Subcutaneous; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D008297:Male; D009103:Multiple Sclerosis / Q000150:complications* / Q000188:drug therapy / Q000503:physiopathology*; D012008:Recurrence; D012449:Safety; D012727:Sex Characteristics; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D016899:Interferon-beta; D000068556:Interferon beta-1a