title: Changes in magnetic resonance imaging disease measures over 3 years in mildly disabled patients with relapsing-remitting multiple sclerosis receiving interferon β-1a in the COGnitive Impairment in MUltiple Sclerosis (COGIMUS) study.
abstract: BACKGROUND
  Conventional magnetic resonance imaging (MRI) has improved the diagnosis and monitoring of multiple sclerosis (MS). In clinical trials, MRI has been found to detect treatment effects with greater sensitivity than clinical measures; however, clinical and MRI outcomes tend to correlate poorly.
  
  
  METHODS
  In this observational study, patients (n = 550; 18-50 years; relapsing-remitting MS [Expanded Disability Status Scale score ≤4.0]) receiving interferon (IFN) β-1a therapy (44 or 22 µg subcutaneously [sc] three times weekly [tiw]) underwent standardized MRI, neuropsychological and quality-of-life (QoL) assessments over 3 years. In this post hoc analysis, MRI outcomes and correlations between MRI parameters and clinical and functional outcomes were analysed.
  
  
  RESULTS
  MRI data over 3 years were available for 164 patients. T2 lesion and T1 gadolinium-enhancing (Gd+) lesion volumes, but not black hole (BH) volumes, decreased significantly from baseline to Year 3 (P < 0.0001). Percentage decreases (baseline to Year 3) were greater with the 44 μg dose than with the 22 μg dose for T2 lesion volume (-10.2% vs -4.5%, P = 0.025) and T1 BH volumes (-7.8% vs +10.3%, P = 0.002). A decrease in T2 lesion volume over 3 years predicted stable QoL over the same time period. Treatment with IFN β-1a, 44 μg sc tiw, predicted an absence of cognitive impairment at Year 3.
  
  
  CONCLUSIONS
  Subcutaneous IFN β-1a significantly decreased MRI measures of disease, with a significant benefit shown for the 44 µg over the 22 µg dose; higher-dose treatment also predicted better cognitive outcomes over 3 years.
authors: National Neurological Institute, C Mondino Foundation, Pavia, Italy. stefano.bastianello@yahoo.it
authors: Stefano
authors: S
authors: Bastianello
authors: Elisabetta
authors: E
authors: Giugni
authors: Maria Pia
authors: MP
authors: Amato
authors: Maria-Rosalia
authors: MR
authors: Tola
authors: Maria
authors: M
authors: Trojano
authors: Stefano
authors: S
authors: Galletti
authors: Giacomo
authors: G
authors: Luccichenti
authors: Mario
authors: M
authors: Quarantelli
authors: Orietta
authors: O
authors: Picconi
authors: Francesco
authors: F
authors: Patti
mesh_terms: D000328:Adult; D001921:Brain / Q000187:drug effects / Q000473:pathology; D003072:Cognition Disorders / Q000150:complications / Q000188:drug therapy* / Q000473:pathology*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging / Q000379:methods / Q000523:psychology*; D008297:Male; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000150:complications / Q000188:drug therapy* / Q000473:pathology* / Q000523:psychology; D059906:Neuroimaging / Q000379:methods / Q000523:psychology; D009483:Neuropsychological Tests / Q000706:statistics & numerical data; D011788:Quality of Life
chemical_list: D007155:Immunologic Factors; D016899:Interferon-beta; D000068556:Interferon beta-1a