title: Scoring treatment response in patients with relapsing multiple sclerosis.
abstract: BACKGROUND
  We employed clinical and magnetic resonance imaging (MRI) measures in combination, to assess patient responses to interferon in multiple sclerosis.
  
  
  OBJECTIVE
  To optimize and validate a scoring system able to discriminate responses to interferon treatment in patients with relapsing-remitting multiple sclerosis (RRMS).
  
  
  METHODS
  Our analysis included two large, independent datasets of RRMS patients who were treated with interferons that included 4-year follow-up data. The first dataset ("training set") comprised of 373 RRMS patients from a randomized clinical trial of subcutaneous interferon beta-1a. The second ("validation set") included an observational cohort of 222 RRMS patients treated with different interferons. The new scoring system, a modified version of that previously proposed by Rio et al., was first tested on the training set, then validated using the validation set. The association between disability progression and risk group, as defined by the score, was evaluated by Kaplan Meier survival curves and Cox regression, and quantified by hazard ratios (HRs).
  
  
  RESULTS
  The score (0-3) was based on the number of new T2 lesions (>5) and clinical relapses (0,1 or 2) during the first year of therapy. The risk of disability progression increased with higher scores. In the validation set, patients with score of 0 showed a 3-year progression probability of 24%, while those with a score of 1 increased to 33% (HR = 1.56; p = 0.13), and those with score greater than or equal to 2 increased to 65% (HR = 4.60; p < 0.001).
  
  
  CONCLUSIONS
  We report development of a simple, quantitative and complementary tool for predicting responses in interferon-treated patients that could help clinicians make treatment decisions.
authors.affiliation: Department of Health Sciences, University of Genoa, Italy. mariapia.sormani@unige.it
authors.forename: M P
authors.initials: MP
authors.lastname: Sormani
authors.forename: J
authors.initials: J
authors.lastname: Rio
authors.forename: M
authors.initials: M
authors.lastname: Tintorè
authors.forename: A
authors.initials: A
authors.lastname: Signori
authors.forename: D
authors.initials: D
authors.lastname: Li
authors.forename: P
authors.initials: P
authors.lastname: Cornelisse
authors.forename: B
authors.initials: B
authors.lastname: Stubinski
authors.forename: M l
authors.initials: Ml
authors.lastname: Stromillo
authors.forename: X
authors.initials: X
authors.lastname: Montalban
authors.forename: N
authors.initials: N
authors.lastname: De Stefano
mesh_terms: D000328:Adult; D001921:Brain / Q000473:pathology*; D018450:Disease Progression; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging; D008297:Male; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007155:Immunologic Factors; D016899:Interferon-beta; D000068556:Interferon beta-1a