Journal
ANNALS OF NEUROLOGY
Volume 69, Issue 1, Pages 75-82Publisher
WILEY
DOI: 10.1002/ana.22316
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Funding
- Teva Pharmaceutical industries, Ltd.
- Biogen Idec
- Genzyme
- Immune Tolerance Network
- Novartis
- Teva Pharmaceuticals
- U.S. Department of Defense
- NIAID
- Bayer-Schering
- Biogen-Dompe
- Genmab
- Merck-Serono
- Fondazione Italiana Sclerosi Multipla (FISM)
- Fondazione Mariani
- Bayer-Schering Pharma
- Sanofi-Aventis
- Canadian Institutes of Health Research
- Multiple Sclerosis Society of Canada
- Multiple Sclerosis Scientific Research Foundation
- Steering Committee Membership
- EMD Serono
- Avanir
- BioMS
- Pfizer
- Ono
- Eli Lilly
- Abbott
- Facet
- Opexa
- UCB
- Elan
- National Multiple Sclerosis Society
- National Institutes of Health
- Acorda Genzyme
- Chicago Center for Neurological Care and Research
- Teva Neuroscience
- Abbott Facet
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Objective: To evaluate the safety, tolerability, and efficacy of glatiramer acetate (GA) 40mg compared to a 20mg dose. Methods: Patients with multiple sclerosis (MS) with >= 1 documented relapse in 12 months prior to screening, or >= 2 documented relapses in 24 months prior to screening, and Expanded Disability Status Scale (EDSS) score 0 to 5.5 were enrolled. Patients were evaluated at screening, baseline, and at months 1, 2, 3, 6, 9, and 12. Primary endpoint was rate of confirmed relapses observed during 12-month study. Analysis was by intent-to-treat. Results: A total of 1,155 patients randomized to GA 20mg (n = 586) or 40mg (n = 569). The groups were well-matched at baseline on demographic, clinical, and magnetic resonance imaging (MRI) characteristics. The primary endpoint was similar in both groups (relative risk [RR] = 1.07; 95% confidence interval [CI], 0.88-1.31; p = 0.486) with mean annualized relapse rates (ARRs) of 0.33 for the 20mg group, 0.35 for the 40mg group, and 0.27 for patients from both groups who completed the entire 1-year treatment. A total of 77% of patients remained relapse-free in both groups. Both groups showed a reduction in mean number of gadolinium-enhancing and new T2 lesions over time with trend for faster reduction in the first trimester with the 40mg dose compared with 20mg dose. Both doses were well-tolerated with a safety profile similar to that observed in previous studies of 20mg GA. Interpretation: In relapsing-remitting MS patients, both the currently-approved GA 20mg and 40mg doses were safe and well-tolerated, with no gain in efficacy for the higher dose. ANN NEUROL 2011;69:75-82
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