title: Interferon β-1b for the treatment of primary progressive multiple sclerosis: five-year clinical trial follow-up.
abstract: OBJECTIVE
  To investigate, during the 5-year period without treatment after termination of a 2-year clinical trial of interferon beta-1b for the treatment of primary progressive multiple sclerosis, differences in the evolution of clinical variables and magnetic resonance imaging results between trial arms and to investigate correlations between in-trial changes in Multiple Sclerosis Functional Composite (MSFC) score and magnetic resonance imaging variables and Expanded Disability Status Scale (EDSS) score evolution.
  
  
  METHODS
  Five-year clinical trial follow-up.
  
  
  METHODS
  Clinical Neuroimmunology Unit, Multiple Sclerosis Centre of Catalonia, Autonomous University of Barcelona, Spain. Patients  Seventy-three patients received interferon beta-1b or placebo during the trial.
  
  
  METHODS
  After 5 years without treatment, the EDSS and MSFC measures were scored for 63 and 59 patients, respectively. Neuropsychological and magnetic resonance imaging assessments were performed for 59 and 50 patients, respectively.
  
  
  RESULTS
  After 5 years without treatment, the interferon beta-1b group had better 9-Hole Peg Test (P = .02) and Word List Generation Test (P < .001) scores, and their magnetization transfer ratio measures in the normal-appearing white matter were significantly higher (P = .02, P = .009, and P = .03 for the mean, peak location, and peak height magnetic transfer ratios, respectively). During the entire study period (from trial baseline to assessment at 5 years without treatment), the placebo group showed a greater decrease in brain parenchymal fraction (P = .004). The in-trial increase of lesions correlated with the worsening of the EDSS score during the 5-year period without treatment (P = .004).
  
  
  CONCLUSIONS
  Modest but beneficial effects of interferon beta-1b on clinical variables and brain atrophy development were observed 5 years after trial termination. Moreover, in-trial lesion activity correlated with EDSS progression after trial termination. Therefore, we provide evidence to consider immunomodulation as a sensible approach to treat primary progressive multiple sclerosis.
authors.affiliation: Multiple Sclerosis Centre of Catalonia, Autonomous University of Barcelona, Centre d'Anàlisi i Recerca en Neuroimatge i Esclerosi Mùltiple-Vall d'Hebron University Hospital, Escola Universitària d'Infermeria 2ª Planta, Passeig de la Vall d'Hebron 119-129, 08035 Barcelona, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Tur
authors.forename: Xavier
authors.initials: X
authors.lastname: Montalban
authors.forename: Mar
authors.initials: M
authors.lastname: Tintoré
authors.forename: Carlos
authors.initials: C
authors.lastname: Nos
authors.forename: Jordi
authors.initials: J
authors.lastname: Río
authors.forename: Francesc Xavier
authors.initials: FX
authors.lastname: Aymerich
authors.forename: Luis
authors.initials: L
authors.lastname: Brieva
authors.forename: Nieves
authors.initials: N
authors.lastname: Téllez
authors.forename: Héctor
authors.initials: H
authors.lastname: Perkal
authors.forename: Manuel
authors.initials: M
authors.lastname: Comabella
authors.forename: Ingrid
authors.initials: I
authors.lastname: Galán
authors.forename: David
authors.initials: D
authors.lastname: Calle
authors.forename: Jaume
authors.initials: J
authors.lastname: Sastre-Garriga
authors.forename: Alex
authors.initials: A
authors.lastname: Rovira
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D020528:Multiple Sclerosis, Chronic Progressive / Q000188:drug therapy* / Q000473:pathology* / Q000523:psychology; D009483:Neuropsychological Tests; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000068576:Interferon beta-1b; D016899:Interferon-beta