Krzysztof Selmaj1, Frederik Barkhof2, Anna N Belova3, Christian Wolf4, Evelyn Rw van den Tweel5, Janine Jl Oberyé5, Roel Mulder5, David F Egging5, Norbert P Koper5, Jeffrey A Cohen6. 1. Neurology Center Lodz, Lodz, Poland. 2. Image Analysis Center, Department of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands/Institutes of Neurology & Healthcare Engineering, UCL, London, UK. 3. Research Institute of Traumatology and Orthopedics, Functional Diagnostics, Nizhny Novgorod, Russia. 4. Lycalis sprl, Brussels, Belgium. 5. Synthon BV, Nijmegen, The Netherlands. 6. Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.
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 receivedGTR 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. CONCLUSION:Efficacy and safety of GTR is maintained over 2 years. Additionally, switching from GA to GTR is safe and well tolerated.
RCT Entities:
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. CONCLUSION: Efficacy and safety of GTR is maintained over 2 years. Additionally, switching from GA to GTR is safe and well tolerated.
Authors: Robert J Fox; David H Miller; J Theodore Phillips; Michael Hutchinson; Eva Havrdova; Mariko Kita; Minhua Yang; Kartik Raghupathi; Mark Novas; Marianne T Sweetser; Vissia Viglietta; Katherine T Dawson Journal: N Engl J Med Date: 2012-09-20 Impact factor: 91.245
Authors: Daniel D Mikol; Frederik Barkhof; Peter Chang; Patricia K Coyle; Douglas R Jeffery; Steven R Schwid; Bettina Stubinski; Bernard M J Uitdehaag Journal: Lancet Neurol Date: 2008-09-11 Impact factor: 44.182
Authors: D Cadavid; L J Wolansky; J Skurnick; J Lincoln; J Cheriyan; K Szczepanowski; S S Kamin; A R Pachner; J Halper; S D Cook Journal: Neurology Date: 2009-03-11 Impact factor: 9.910
Authors: Chris H Polman; Stephen C Reingold; Brenda Banwell; Michel Clanet; Jeffrey A Cohen; Massimo Filippi; Kazuo Fujihara; Eva Havrdova; Michael Hutchinson; Ludwig Kappos; Fred D Lublin; Xavier Montalban; Paul O'Connor; Magnhild Sandberg-Wollheim; Alan J Thompson; Emmanuelle Waubant; Brian Weinshenker; Jerry S Wolinsky Journal: Ann Neurol Date: 2011-02 Impact factor: 10.422
Authors: C Ford; A D Goodman; K Johnson; N Kachuck; J W Lindsey; R Lisak; C Luzzio; L Myers; H Panitch; J Preiningerova; A Pruitt; J Rose; H Rus; J Wolinsky Journal: Mult Scler Date: 2010-01-27 Impact factor: 6.312
Authors: Sigal Melamed-Gal; Pippa Loupe; Bracha Timan; Vera Weinstein; Sarah Kolitz; Jenny Zhang; Jason Funt; Arthur Komlosh; Nurit Ashkenazi; Oren Bar-Ilan; Attila Konya; Olga Beriozkin; Daphna Laifenfeld; Tal Hasson; Benjamin Zeskind; Michael Hayden; Steffen Nock; Iris Grossman Journal: eNeurologicalSci Date: 2018-11-28
Authors: S Melamed-Gal; P Loupe; B Timan; V Weinstein; S Kolitz; J Zhang; J Funt; A Komlosh; N Ashkenazi; O Bar-Ilan; A Konya; O Beriozkin; D Laifenfeld; T Hasson; R Krispin; T Molotsky; G Papir; L Sulimani; B Zeskind; P Liu; S Nock; M R Hayden; A Gilbert; I Grossman Journal: eNeurologicalSci Date: 2018-05-30
Authors: Sandra M Skovdal; Stig Hill Christiansen; Karen Singers Johansen; Ole Viborg; Niels Henrik Bruun; Søren Jensen-Fangel; Ida Elisabeth Holm; Thomas Vorup-Jensen; Eskild Petersen Journal: PLoS One Date: 2019-10-10 Impact factor: 3.240