title: Daclizumab high-yield process reduced the evolution of new gadolinium-enhancing lesions to T1 black holes in patients with relapsing-remitting multiple sclerosis.
abstract: OBJECTIVE
  In the SELECT study, treatment with daclizumab high-yield process (DAC HYP) versus placebo reduced the frequency of gadolinium-enhancing (Gd(+) ) lesions in patients with relapsing-remitting multiple sclerosis (RRMS). The objective of this post hoc analysis of SELECT was to evaluate the effect of DAC HYP on the evolution of new Gd(+) lesions to T1 hypointense lesions (T1 black holes).
  
  
  METHODS
  SELECT was a randomized double-blind study of subcutaneous DAC HYP 150 or 300 mg or placebo every 4 weeks. Magnetic resonance imaging (MRI) scans were performed at baseline and weeks 24, 36 and 52 in all patients and monthly between weeks 4 and 20 in a subset of patients. MRI scans were evaluated for new Gd(+) lesions that evolved to T1 black holes at week 52. Data for the DAC HYP groups were pooled for analysis.
  
  
  RESULTS
  Daclizumab high-yield process reduced the number of new Gd(+) lesions present at week 24 (P = 0.005) or between weeks 4 and 20 (P = 0.014) that evolved into T1 black holes at week 52 versus placebo. DAC HYP treatment also reduced the percentage of patients with Gd(+) lesions evolving to T1 black holes versus placebo.
  
  
  CONCLUSIONS
  Treatment with DAC HYP reduced the evolution of Gd(+) lesions to T1 black holes versus placebo, suggesting that inflammatory lesions that evolved during DAC HYP treatment are less destructive than those evolving during placebo treatment.
authors.affiliation: Department of Neurology and Medical Image Analysis Center, MIAC, University Hospital Basel, Basel, Switzerland.
authors.forename: E-W
authors.initials: EW
authors.lastname: Radue
authors.affiliation: Department of Neurology and Medical Image Analysis Center, MIAC, University Hospital Basel, Basel, Switzerland.|DKD Helios Klinik Wiesbaden, Wiesbaden, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Sprenger
authors.affiliation: Department of Neurology, University of Colorado School of Medicine, Aurora, CO, USA.
authors.forename: T
authors.initials: T
authors.lastname: Vollmer
authors.affiliation: Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
authors.forename: G
authors.initials: G
authors.lastname: Giovannoni
authors.affiliation: Department of Neurology, St. Josef-Hospital, Ruhr-University Bochum, Bochum, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Gold
authors.affiliation: Department of Neurology, First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic.
authors.forename: E
authors.initials: E
authors.lastname: Havrdova
authors.affiliation: Department of Neurology, Medical University of Lodz, Lodz, Poland.
authors.forename: K
authors.initials: K
authors.lastname: Selmaj
authors.affiliation: Department of Neurology, Rush University Medical Center, Chicago, IL, USA.
authors.forename: D
authors.initials: D
authors.lastname: Stefoski
authors.affiliation: Biogen, Cambridge, MA, USA.
authors.forename: X
authors.initials: X
authors.lastname: You
authors.affiliation: Biogen, Cambridge, MA, USA.
authors.forename: J
authors.initials: J
authors.lastname: Elkins
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000494:pharmacology*; D000077561:Daclizumab; D004311:Double-Blind Method; D005260:Female; D005682:Gadolinium / Q000008:administration & dosage / Q000494:pharmacology*; D006801:Humans; D007089:Image Enhancement; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000473:pathology*; D017063:Outcome Assessment, Health Care
chemical_list: D061067:Antibodies, Monoclonal, Humanized; C000598527:daclizumab HYP; D005682:Gadolinium; D000077561:Daclizumab
keywords: T1 black holes; daclizumab; gadolinium-enhancing lesions; magnetic resonance imaging; multiple sclerosis