title: 250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study.
abstract: BACKGROUND
  The aim of the Betaferon Efficacy Yielding Outcomes of a New Dose (BEYOND) trial was to compare the efficacy, safety, and tolerability of 250 microg or 500 microg interferon beta-1b with glatiramer acetate for treating relapsing-remitting multiple sclerosis.
  
  
  METHODS
  Between November, 2003, and June, 2005, 2447 patients with relapsing-remitting multiple sclerosis were screened and 2244 patients were enrolled in this prospective, multicentre, randomised trial. Patients were randomly assigned 2:2:1 by block randomisation with regional stratification to receive one of two doses of interferon beta-1b (250 microg or 500 microg) subcutaneously every other day or 20 mg glatiramer acetate subcutaneously every day. The primary outcome was relapse risk, defined as new or recurrent neurological symptoms separated by at least 30 days from the preceding event and that lasted at least 24 h. Secondary outcomes were progression on the expanded disability status scale (EDSS) and change in T1-hypointense lesion volume. Clinical outcomes were assessed quarterly for 2.0-3.5 years; MRI was done at screening and annually thereafter. Analysis was by per protocol. This study is registered, number NCT00099502.
  
  
  RESULTS
  We found no differences in relapse risk, EDSS progression, T1-hypointense lesion volume, or normalised brain volume among treatment groups. Flu-like symptoms were more common in patients treated with interferon beta-1b (p<0.0001), whereas injection-site reactions were more common in patients treated with glatiramer acetate (p=0.0005). Patient attrition rates were 17% (153 of 888) on 250 microg interferon beta-1b, 26% (227 of 887) on 500 microg interferon beta-1b, and 21% (93 of 445) for glatiramer acetate.
  
  
  CONCLUSIONS
  500 microg interferon beta-1b was not more effective than the standard 250 microg dose, and both doses had similar clinical effects to glatiramer acetate. Although interferon beta-1b and glatiramer acetate had different adverse event profiles, the overall tolerability to both drugs was similar.
  
  
  BACKGROUND
  Bayer HealthCare Pharmaceuticals.
authors.affiliation: St Michael's Hospital, Toronto, Canada. oconnorp@smh.toronto.on.ca
authors.forename: Paul
authors.initials: P
authors.lastname: O'Connor
authors.forename: Massimo
authors.initials: M
authors.lastname: Filippi
authors.forename: Barry
authors.initials: B
authors.lastname: Arnason
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Comi
authors.forename: Stuart
authors.initials: S
authors.lastname: Cook
authors.forename: Douglas
authors.initials: D
authors.lastname: Goodin
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Hartung
authors.forename: Douglas
authors.initials: D
authors.lastname: Jeffery
authors.forename: Ludwig
authors.initials: L
authors.lastname: Kappos
authors.forename: Francis
authors.initials: F
authors.lastname: Boateng
authors.forename: Vitali
authors.initials: V
authors.lastname: Filippov
authors.forename: Maria
authors.initials: M
authors.lastname: Groth
authors.forename: Volker
authors.initials: V
authors.lastname: Knappertz
authors.forename: Christian
authors.initials: C
authors.lastname: Kraus
authors.forename: Rupert
authors.initials: R
authors.lastname: Sandbrink
authors.forename: Christoph
authors.initials: C
authors.lastname: Pohl
authors.forename: Timon
authors.initials: T
authors.lastname: Bogumil
authors.forename: P
authors.initials: P
authors.lastname: O'Connor
authors.forename: M
authors.initials: M
authors.lastname: Filippi
authors.forename: B
authors.initials: B
authors.lastname: Arnason
authors.forename: S
authors.initials: S
authors.lastname: Cook
authors.forename: D
authors.initials: D
authors.lastname: Goodin
authors.forename: H-P
authors.initials: HP
authors.lastname: Hartung
authors.forename: H-P
authors.initials: HP
authors.lastname: Harung
authors.forename: L
authors.initials: L
authors.lastname: Kappos
authors.forename: D
authors.initials: D
authors.lastname: Jeffery
authors.forename: G
authors.initials: G
authors.lastname: Comi
mesh_terms: D000293:Adolescent; D000328:Adult; D001921:Brain / Q000187:drug effects / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D000068717:Glatiramer Acetate; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000008:administration & dosage*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000473:pathology; D010455:Peptides / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D007155:Immunologic Factors; D010455:Peptides; D000068576:Interferon beta-1b; D000068717:Glatiramer Acetate; D016899:Interferon-beta