title: Switching from branded to generic glatiramer acetate: 15-month GATE trial extension results.
abstract: BACKGROUND
  Open-label 15-month follow-up of the double-blind, placebo-controlled Glatiramer Acetate clinical Trial to assess Equivalence with Copaxone®(GATE) trial.
  
  
  OBJECTIVE
  To evaluate efficacy, safety, and tolerability of prolonged generic glatiramer acetate (GTR) treatment and to evaluate efficacy, safety, and tolerability of switching from brand glatiramer acetate (GA) to GTR treatment.
  
  
  METHODS
  A total of 729 patients received GTR 20 mg/mL daily. Safety was assessed at months 12, 15, 18, 21, and 24 and Expanded Disability Status Scale and magnetic resonance imaging (MRI) scans at months 12, 18, and 24. The presence of glatiramer anti-drug antibodies (ADAs) was tested at baseline and months 1, 3, 6, 9, 12, 18, and 24.
  
  
  RESULTS
  The mean number of gadolinium-enhancing lesions in the GTR/GTR and GA/GTR groups was similar at months 12, 18, and 24. The change in other MRI parameters was also similar in the GTR/GTR and GA/GTR groups. The annualized relapse rate (ARR) did not differ between the GTR/GTR and GA/GTR groups, 0.21 and 0.24, respectively. The incidence, spectrum, and severity of reported adverse events did not differ between the GTR/GTR and GA/GTR groups. Glatiramer ADA titers were similar in the GTR/GTR and GA/GTR groups.
  
  
  CONCLUSIONS
  Efficacy and safety of GTR is maintained over 2 years. Additionally, switching from GA to GTR is safe and well tolerated.
authors.affiliation: Neurology Center Lodz, Lodz, Poland.
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Selmaj
authors.affiliation: Image Analysis Center, Department of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands/Institutes of Neurology & Healthcare Engineering, UCL, London, UK.
authors.forename: Frederik
authors.initials: F
authors.lastname: Barkhof
authors.affiliation: Research Institute of Traumatology and Orthopedics, Functional Diagnostics, Nizhny Novgorod, Russia.
authors.forename: Anna N
authors.initials: AN
authors.lastname: Belova
authors.affiliation: Lycalis sprl, Brussels, Belgium.
authors.forename: Christian
authors.initials: C
authors.lastname: Wolf
authors.affiliation: Synthon BV, Nijmegen, The Netherlands.
authors.forename: Evelyn Rw
authors.initials: ER
authors.lastname: van den Tweel
authors.affiliation: Synthon BV, Nijmegen, The Netherlands.
authors.forename: Janine Jl
authors.initials: JJ
authors.lastname: Oberyé
authors.affiliation: Synthon BV, Nijmegen, The Netherlands.
authors.forename: Roel
authors.initials: R
authors.lastname: Mulder
authors.affiliation: Synthon BV, Nijmegen, The Netherlands.
authors.forename: David F
authors.initials: DF
authors.lastname: Egging
authors.affiliation: Synthon BV, Nijmegen, The Netherlands.
authors.forename: Norbert P
authors.initials: NP
authors.lastname: Koper
authors.affiliation: Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Cohen
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D057915:Drug Substitution; D016568:Drugs, Generic; D005260:Female; D005500:Follow-Up Studies; D000068717:Glatiramer Acetate / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D006801:Humans; D007089:Image Enhancement; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000000981:diagnostic imaging* / Q000188:drug therapy*; D017063:Outcome Assessment, Health Care
chemical_list: D016568:Drugs, Generic; D007166:Immunosuppressive Agents; D000068717:Glatiramer Acetate
keywords: Multiple sclerosis; clinical trial; equivalence; generic; glatiramer acetate