title: Peginterferon beta-1a in multiple sclerosis: 2-year results from ADVANCE.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of subcutaneous peginterferon beta-1a over 2 years in patients with relapsing-remitting multiple sclerosis in the ADVANCE study.
  
  
  METHODS
  Patients were randomized to placebo or 125 µg peginterferon beta-1a every 2 or 4 weeks. For Year 2 (Y2), patients originally randomized to placebo were re-randomized to peginterferon beta-1a every 2 weeks or every 4 weeks. Patients randomized to peginterferon beta-1a in Year 1 (Y1) remained on the same dosing regimen in Y2.
  
  
  RESULTS
  Compared with Y1, annualized relapse rate (ARR) was further reduced in Y2 with every 2 week dosing (Y1: 0.230 [95% CI 0.183-0.291], Y2: 0.178 [0.136-0.233]) and maintained with every 4 week dosing (Y1: 0.286 [0.231-0.355], Y2: 0.291 [0.231-0.368]). Patients starting peginterferon beta-1a from Y1 displayed improved efficacy versus patients initially assigned placebo, with reductions in ARR (every 2 weeks: 37%, p<0.0001; every 4 weeks: 17%, p=0.0906), risk of relapse (every 2 weeks: 39%, p<0.0001; every 4 weeks: 19%, p=0.0465), 12-week disability progression (every 2 weeks: 33%, p=0.0257; every 4 weeks: 25%, p=0.0960), and 24-week disability progression (every 2 weeks: 41%, p=0.0137; every 4 weeks: 9%, p=0.6243). Over 2 years, greater reductions were observed with every 2 week versus every 4 week dosing for all endpoints and peginterferon beta-1a was well tolerated.
  
  
  CONCLUSIONS
  Peginterferon beta-1a efficacy is maintained beyond 1 year, with greater effects observed with every 2 week versus every 4 week dosing, and a similar safety profile to Y1.Clinicaltrials.gov
  
  
  BACKGROUND
  NCT00906399.
authors.affiliation: Department of Neurology, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany Bernd.Kieseier@uni-duesseldorf.de.
authors.forename: Bernd C
authors.initials: BC
authors.lastname: Kieseier
authors.affiliation: Montreal Neurological Institute, McGill University, Montreal, Quebec, Canada/NeuroRx Research, Montreal, Quebec, Canada.
authors.forename: Douglas L
authors.initials: DL
authors.lastname: Arnold
authors.affiliation: Department of Neurology, New York University, School of Medicine, New York, USA.
authors.forename: Laura J
authors.initials: LJ
authors.lastname: Balcer
authors.affiliation: Moscow MS Center at 11 City Hospital and Department of Neurology & Neurosurgery of the RSMRU, Moscow, Russia.
authors.forename: Alexey A
authors.initials: AA
authors.lastname: Boyko
authors.affiliation: Departments of Neurology and Research, Aix-Marseille Université, CHU Timone, Marseille, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Pelletier
authors.affiliation: Biogen Idec Incorporated, Cambridge, USA.
authors.forename: Shifang
authors.initials: S
authors.lastname: Liu
authors.affiliation: Biogen Idec Incorporated, Cambridge, USA.
authors.forename: Ying
authors.initials: Y
authors.lastname: Zhu
authors.affiliation: Biogen Idec Incorporated, Cambridge, USA.
authors.forename: Ali
authors.initials: A
authors.lastname: Seddighzadeh
authors.affiliation: Biogen Idec Incorporated, Cambridge, USA.
authors.forename: Serena
authors.initials: S
authors.lastname: Hung
authors.affiliation: Biogen Idec Incorporated, Cambridge, USA.
authors.forename: Aaron
authors.initials: A
authors.lastname: Deykin
authors.affiliation: Biogen Idec Incorporated, Cambridge, USA.
authors.forename: Sarah I
authors.initials: SI
authors.lastname: Sheikh
authors.affiliation: Department of Neurology, Johns Hopkins University, Baltimore, USA.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Calabresi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004185:Disability Evaluation; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D016899:Interferon-beta / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012008:Recurrence; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D011092:Polyethylene Glycols; D016899:Interferon-beta; C428112:peginterferon beta-1a
keywords: Interferon; MRI; multiple sclerosis; peginterferon beta-1a; pegylated; phase 3; relapse; relapse-remitting multiple sclerosis