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Glatiramer Acetate 40 mg/mL in Relapsing–Remitting Multiple Sclerosis: A Review

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Abstract

Glatiramer acetate (Copaxone®) is a synthetic analogue of myelin basic protein, which is thought to be involved in the pathogenesis of multiple sclerosis (MS). The therapeutic effects of the drug in the treatment of MS are thought to be via immunomodulation and neuroprotection. Subcutaneous glatiramer acetate 20 mg/mL once daily is approved in several countries for the treatment of relapsing forms of MS. Recently, a high-concentration formulation of glatiramer acetate 40 mg/mL administered three times weekly was approved in the USA and several European countries in the same indication. This article reviews the efficacy and tolerability of the high-concentration regimen. In the randomized, phase III GALA study in patients with relapsing–remitting MS (RRMS), glatiramer acetate 40 mg/mL three times weekly reduced annualized relapse rates significantly more than placebo, and indirect comparisons indicate that the efficacy of the three-times-weekly regimen is similar to that of the 20 mg/mL once-daily regimen. Results of the randomized, phase IIIb GLACIER study in patients with RRMS demonstrated that the three-times-weekly regimen reduced the risk of injection-site reactions by 50 % and was associated with numerically greater patient convenience scores than the once-daily regimen. Thus, in the treatment of RRMS, glatiramer acetate 40 mg/mL three times weekly is effective and provides a better tolerated and possibly more convenient option than the once-daily regimen.

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit. Kate McKeage is a salaried employee of Adis/Springer.

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    Kate McKeage

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Correspondence to Kate McKeage.

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The manuscript was reviewed by: R. Arnon, The Department of Immunology, The Weizmann Institute of Science, Rehovot, Israel; J. L. Bainbridge, University of Colorado Anschutz Medical Campus, Skaggs School of Pharmacy and Pharmaceutical Sciences, Department of Clinical Pharmacy and Neurology, Aurora, CO, USA; M. D. Kaufman, Knoxville Neurologic Clinic and University of Tennessee Medical Center, Knoxville, TN, USA; C. Zecca, Multiple Sclerosis Center, Neurocenter of Southern Switzerland, Lugano, Switzerland; R. Zivadinov, Buffalo Neuroimaging Analysis Center, Department of Neurology, State University of New York, Buffalo, NY, USA.

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McKeage, K. Glatiramer Acetate 40 mg/mL in Relapsing–Remitting Multiple Sclerosis: A Review. CNS Drugs 29, 425–432 (2015). https://doi.org/10.1007/s40263-015-0245-z

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