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Randomized Controlled Trial
. 2017 Dec;23(14):1909-1917.
doi: 10.1177/1352458516688956. Epub 2017 Jan 16.

Switching from branded to generic glatiramer acetate: 15-month GATE trial extension results

Krzysztof Selmaj  1 , Frederik Barkhof  2 , Anna N Belova  3 , Christian Wolf  4 , Evelyn Rw van den Tweel  5 , Janine Jl Oberyé  5 , Roel Mulder  5 , David F Egging  5 , Norbert P Koper  5 , Jeffrey A Cohen  6 ; GATE study group
Affiliations
Randomized Controlled Trial

Switching from branded to generic glatiramer acetate: 15-month GATE trial extension results

Krzysztof Selmaj et al. Mult Scler. 2017 Dec.

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.

Conclusion: Efficacy and safety of GTR is maintained over 2 years. Additionally, switching from GA to GTR is safe and well tolerated.

Keywords: Multiple sclerosis; clinical trial; equivalence; generic; glatiramer acetate.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: K.S. reports grants and personal fees from Synthon during the conduct of the study; grants from Neuron; and grants and personal fees from Roche, Biogen Idec, Novartis, TEVA, Merck, Genzyme, and Receptos outside the submitted work. F.B. reports personal fees from Bayer Schering Pharma, Sanofi Aventis, Biogen Idec, Teva, Merck Serono, Novartis, Roche, Synthon BV, Jansen Research, and Genzyme outside the submitted work. A.N.B. reports no disclosure. C.W. reports personal fees from Synthon BV during the conduct of the study; personal fees from Novartis AG, Teva Ltd, BBB BV, and Desitin GmbH outside the submitted work. E.R.W.v.d.T., J.J.L.O., D.F.E., R.M., and N.P.K. report personal fees from Synthon BV during the conduct of the study and personal fees from Synthon BV outside the submitted work. J.A.C. is a co-editor of Multiple Sclerosis Journal Experimental, Translational and Clinical and reports personal fees from EMD Serono, Genentech, Genzyme, Innate Immunotherapeutics, and Vaccinex outside the submitted work.

Figures

Figure 1.
Figure 1.
Enrollment and follow-up of study participants.
Figure 2.
Figure 2.
Gadolinium-enhancing lesion number. Mean (SEM) number of new and persisting gadolinium-enhancing lesions during open-label extension part of the trial.
Figure 3.
Figure 3.
Glatiramer anti-drug antibody titer. Mean (SD) glatiramer ADA titer values in patients treated with GTR over 24 months and patients treated with GA for 9 months then switched to GTR for 15 months.
See this image and copyright information in PMC

References

    1. Racke MK, Lovett Racke AE, Karandikar NJ. The mechanism of action of glatiramer acetate treatment in multiple sclerosis. Neurology 2010; 74: S25–S30. - PubMed
    1. Bornstein MB, Miller A, Slagle S, et al. A pilot trial of Cop 1 in exacerbating-remitting multiple sclerosis. N Engl J Med 1987; 317: 408–414. - PubMed
    1. Comi G, Filippi M, Wolinsky JS. European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging—Measured disease activity and burden in patients with relapsing multiple sclerosis. European/Canadian Glatiramer Acetate Study Group. Ann Neurol 2001; 49: 290–297. - PubMed
    1. Johnson KP, Brooks BR, Cohen JA, et al. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: Results of a phase III multicenter, double-blind placebo-controlled trial. The Copolymer 1 Multiple Sclerosis Study Group. Neurology 1995; 45: 1268–1276. - PubMed
    1. Comi G, Martinelli V, Rodegher M, et al. Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): A randomised, double-blind, placebo-controlled trial. Lancet 2009; 374: 1503–1511. - PubMed

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