title: Disease-activity-free status in patients with relapsing-remitting multiple sclerosis treated with daclizumab high-yield process in the SELECT study.
abstract: BACKGROUND
  Daclizumab high-yield process (DAC HYP) is a humanized anti-CD25 monoclonal antibody that inhibits high-affinity interleukin-2 receptor signaling.
  
  
  OBJECTIVE
  The objective of this paper is to assess the proportion of DAC HYP- versus placebo-treated patients who were free from disease activity.
  
  
  METHODS
  SELECT was a randomized, double-blind, multicenter study of DAC HYP 150 mg or 300 mg, or placebo, administered subcutaneously every four weeks for 52 weeks. In this post-hoc analysis of the SELECT trial, 'disease-activity free' was defined as completion through week 52 without relapses or confirmed three-month disability progression (clinical), with no new/newly enlarging T2-hyperintense lesions and no new gadolinium-enhancing lesions at the week 52 scan (radiological). Primary analyses were based on logistic regression controlling for baseline characteristics.
  
  
  RESULTS
  More DAC HYP-treated (39%, n = 156) versus placebo-treated patients (11%, n = 22) were disease-activity free (odds ratio (95% confidence interval), 6.18 (3.71-10.32); p < 0.0001). Furthermore, 77% and 48% of DAC HYP-treated patients were free from clinical or radiological disease activity, respectively, compared with 60% and 18% of placebo-treated patients.
  
  
  CONCLUSIONS
  At one year, DAC HYP resulted in a meaningful increase in the proportion of relapsing-remitting MS patients who were disease-activity free versus placebo.
authors.affiliation: Department of Neurology, Charles University in Prague, Czech Republic.
authors.forename: Eva
authors.initials: E
authors.lastname: Havrdova
authors.forename: Gavin
authors.initials: G
authors.lastname: Giovannoni
authors.forename: Dusan
authors.initials: D
authors.lastname: Stefoski
authors.forename: Samantha
authors.initials: S
authors.lastname: Forster
authors.forename: Kimberly
authors.initials: K
authors.lastname: Umans
authors.forename: Lahar
authors.initials: L
authors.lastname: Mehta
authors.forename: Steven
authors.initials: S
authors.lastname: Greenberg
authors.forename: Jacob
authors.initials: J
authors.lastname: Elkins
mesh_terms: D000293:Adolescent; D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000077561:Daclizumab; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D000077561:Daclizumab
keywords: Relapsing–remitting multiple sclerosis; clinical endpoints; induction of remission; magnetic resonance imaging; radiological endpoints