title: No evidence of disease activity in patients receiving daclizumab versus intramuscular interferon beta-1a for relapsing-remitting multiple sclerosis in the DECIDE study.
abstract: BACKGROUND
  No evidence of disease activity (NEDA) is a composite endpoint being increasingly applied as an outcome measure in clinical trials as well as proposed for individual therapeutic decisions in multiple sclerosis (MS).
  
  
  OBJECTIVE
  Assess the proportion of patients with relapsing-remitting MS achieving NEDA in the DECIDE study of daclizumab 150 mg subcutaneous versus intramuscular interferon beta-1a 30 µg for 96-144 weeks.
  
  
  METHODS
  NEDA was defined as no relapses, no onset of 12-week confirmed disability progression (CDP), no new/newly enlarging T2 hyperintense lesions (NET2), and no gadolinium-enhancing (Gd+) lesions. Logistic regression models adjusted for baseline covariates compared treatment groups for baseline to week 96, weeks 0-24, and weeks 24-96.
  
  
  RESULTS
  From baseline to week 96, more daclizumab versus intramuscular interferon beta-1a patients achieved NEDA (24.6% vs 14.2%; odds ratio (OR; 95% confidence interval): 2.059 (1.592-2.661); p < 0.0001). ORs for clinical NEDA (no relapses, no CDP) and magnetic resonance imaging (MRI) NEDA (no NET2, no Gd+lesions) were 1.651 (1.357-2.007; p < 0.0001) and 2.051 (1.628-2.582; p < 0.0001), respectively. ORs in favor of daclizumab for weeks 24-96 were consistently higher than for weeks 0-24.
  
  
  CONCLUSIONS
  More daclizumab versus intramuscular interferon beta-1a patients achieved NEDA early in DECIDE, with effects increasing over time.
authors.affiliation: Neurology Clinic and Policlinic, Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital Basel, University of Basel, Basel, Switzerland.
authors.forename: Ludwig
authors.initials: L
authors.lastname: Kappos
authors.affiliation: Department of Neurology, First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic.
authors.forename: Eva
authors.initials: E
authors.lastname: Havrdova
authors.affiliation: Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
authors.forename: Gavin
authors.initials: G
authors.lastname: Giovannoni
authors.affiliation: Center for Neurological Disorders and The Regional Multiple Sclerosis Center, Wheaton Franciscan Health Care, Milwaukee, WI, USA.
authors.forename: Bhupendra O
authors.initials: BO
authors.lastname: Khatri
authors.affiliation: Judith Jaffe Multiple Sclerosis Center, Weill Cornell Medical College, New York, NY, USA.
authors.forename: Susan A
authors.initials: SA
authors.lastname: Gauthier
authors.affiliation: AbbVie, North Chicago, IL, USA.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Greenberg
authors.affiliation: Biogen, Cambridge, MA, USA.
authors.forename: Xiaojun
authors.initials: X
authors.lastname: You
authors.affiliation: Biogen, Cambridge, MA, USA.
authors.forename: Ping
authors.initials: P
authors.lastname: Wang
authors.affiliation: Biogen, Zug, Switzerland.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Giannattasio
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000494:pharmacology*; D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000494:pharmacology*; D000077561:Daclizumab; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000494:pharmacology*; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000494:pharmacology*; D007273:Injections, Intramuscular; D007279:Injections, Subcutaneous; D000068556:Interferon beta-1a / Q000008:administration & dosage / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology; D017063:Outcome Assessment, Health Care / Q000379:methods*
chemical_list: D000276:Adjuvants, Immunologic; D061067:Antibodies, Monoclonal, Humanized; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D000077561:Daclizumab; D000068556:Interferon beta-1a
keywords: Composite outcome; clinical endpoints; daclizumab; disease-activity-free; magnetic resonance imaging; no evidence of disease activity; radiological endpoints; relapsing-remitting multiple sclerosis; treatment