Five-year Study Findings Published in the Journal of the Neurological Sciences
JERUSALEM, Israel, Oct 11, 2011 (BUSINESS WIRE) -- Results from a five-year study of treatment-naive patients with relapsing-remitting multiple sclerosis (RRMS) demonstrated that patients treated with COPAXONE(R) (glatiramer acetate injection) showed significant reduced loss of brain volume compared to patients treated with other disease modifying therapies (DMTs).
Though all DMT treatment arms resulted in a reduction in brain volume loss compared to the control group of non-treated patients, COPAXONE(R) had a significantly better effect than both low and high dose interferons, in reducing loss of brain volume. A paper published by Dr. Omar Khan, detailing the study findings, "Effect of disease-modifying therapies on brain volume in relapsing--remitting multiple sclerosis: Results of a five-year brain MRI study," was recently published in the Journal of the Neurological Sciences.
"These data represent the importance of ongoing research in a practical clinical setting to better understand multiple sclerosis and the impact of therapy on the course of the disease ," said Jon Congleton, Senior Vice President and General Manager, Teva Neuroscience. "Not only does this study highlight the benefit of COPAXONE(R) in reducing brain volume loss, it underscores the value of early treatment in influencing long-term outcomes."
Brain volume loss in multiple sclerosis patients exceeds the rate of healthy control groups. Brain volume loss, sometimes referred to as atrophy, may be correlated with cognitive and physical deficits. Modern magnetic resonance (MR) techniques can reliably measure loss of brain volume over time.
ABOUT THE STUDY
In the study, the COPAXONE(R) treatment arm resulted in a -2.27 percent change in brain volume (PCVB) as compared to baseline versus -2.62 percent for Avonex(R) (low-dose interferon), -3.21 percent for Betaseron(R)/Rebif(R) (high-dose interferon).
This was a retrospective study in which the brain magnetic resonance imaging (MRI) scans of 275 RRMS patients treated with DMTs were examined with Structural Image Evaluation, using Normalization of Atrophy (SIENA). Data analysis was conducted in 2007-08 and the study period included patients who started DMTs in 2001-02 and subsequently received the same DMT for five years. Inclusion criteria for the study were diagnosis of clinically definite RRMS, disease duration of five years or less at the time of initiating DMT and treatment-naive prior to initiation of DMT at onset of study observation period. Untreated RRMS patients with follow-up ranging from eight to 24 months were enrolled as controls. All untreated patients also had prior brain MRI scans on no therapy that could be analyzed with SIENA, so that their rate of brain volume loss was annualized and then projected over five years assuming a constant rate of brain volume loss over five years.
121 patients in the study were treated with COPAXONE(R), 101 were treated with Betaseron(R) or Rebif(R) and 53 were treated with Avonex(R). All patients had brain MRI scans (at onset of DMT and five years later) on the same 1.5T scanner. Image analysis was performed blinded to treatment allocation.
The study was supported by Wayne State University Neuroscience Program. Preliminary results from this study were presented at the American Academy of Neurology annual meeting in 2008.
COPAXONE(R) is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis, including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. The most common side effects of COPAXONE(R) are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. COPAXONE(R) (glatiramer acetate injection) is now approved in more than 50 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries. In North America,
COPAXONE(R) is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva Pharmaceutical Industries Ltd. In Europe, COPAXONE(R) is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. COPAXONE(R) is a registered trademark of Teva Pharmaceutical Industries Ltd.
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