title: Ten-year follow-up of the 'minimal MRI lesion' subgroup from the original CHAMPS Multiple Sclerosis Prevention Trial.
abstract: BACKGROUND
  Patients with clinically isolated syndrome (CIS) and characteristic magnetic resonance imaging (MRI) lesions are at high risk for multiple sclerosis (MS). However, patients with a minimal MRI lesion burden (a low T2-hyperintense [low T2] lesion count) may have borderline formal diagnostic criteria, presenting a clinical management challenge.
  
  
  OBJECTIVE
  Compare the 10-year disease progression of patients with low and higher T2 lesion counts treated over most intervals.
  
  
  METHODS
  CIS patients from the original CHAMPS MS trial were retrospectively assigned to low-T2 (first quartile; 2-8 lesions) or higher-T2 (second through fourth quartiles; ≥ 9 lesions) groups using baseline T2 lesion counts. The 5- and 10-year open-label extension of CHAMPS (CHAMPIONS) evaluated conversion to clinically definite MS (CDMS), MRI activity, relapses, and disability.
  
  
  RESULTS
  The vast majority of patients showed new disease activity by MRI and/or clinical criteria at 10 years (low-T2 86%; higher-T2 98%). Fewer low-T2 than higher-T2 patients developed CDMS (40% vs. 63%; p = 0.013); low-T2 patients also had fewer new brain lesions, less brain volume loss, and less disability progression.
  
  
  CONCLUSIONS
  CIS patients with low T2 lesion counts show continued disease activity. However, all assessments of disease progression over 10 years indicated a significantly less severe disease course for low-T2 patients.
authors.affiliation: Portland VA Medical Center, VA Medical Center and Oregon Health Science Center, USA jack.simon1@me.com.
authors.forename: J H
authors.initials: JH
authors.lastname: Simon
authors.affiliation: Department of Neurosciences, University of California San Diego, USA.
authors.forename: R P
authors.initials: RP
authors.lastname: Kinkel
authors.affiliation: Department of Biostatistics, Jaeb Center for Health Research, Tampa, FL, USA.
authors.forename: C
authors.initials: C
authors.lastname: Kollman
authors.affiliation: Multiple Sclerosis Clinic, St. Michael's Hospital, Toronto, ON, Canada.
authors.forename: P
authors.initials: P
authors.lastname: O'Connor
authors.affiliation: Department of Biomedical Engineering, Cleveland Clinic, Cleveland, OH, USA.
authors.forename: E
authors.initials: E
authors.lastname: Fisher
authors.affiliation: Departments of Biostatistics, Biogen Idec Inc, Cambridge, MA, USA.
authors.forename: X
authors.initials: X
authors.lastname: You
authors.affiliation: Global Medical Affairs, Biogen Idec Inc, Cambridge, MA, USA.
authors.forename: R
authors.initials: R
authors.lastname: Hyde
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000328:Adult; D001921:Brain / Q000473:pathology; D003711:Demyelinating Diseases / Q000188:drug therapy* / Q000473:pathology*; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000068556:Interferon beta-1a / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging; D008297:Male; D009103:Multiple Sclerosis / Q000453:epidemiology / Q000517:prevention & control*; D012008:Recurrence
chemical_list: D000276:Adjuvants, Immunologic; D000068556:Interferon beta-1a
keywords: CHAMPIONS; CHAMPS; MRI; clinically isolated syndrome; disease progression; intramuscular interferon beta-1a; multiple sclerosis