Copaxone Significantly Reduced Brain Atrophy and Tissue Loss over Five Years in Treatment-Naive Relapsing-Remitting Multiple Sclerosis PatientsKANSAS CITY, Mo.--(BUSINESS WIRE)--April 17, 2008 - Final results from a five-year comparative imaging study examining the long-term effect of disease-modifying therapies (DMTs) in treatment-naive, early relapsing-remitting multiple sclerosis (RRMS) patients, demonstrated that Copaxone(R)-(glatiramer acetate injection) treated patients experienced significantly less brain tissue loss, as measured by percent change in brain volume, compared with patients on other DMTs. In the study, patients receiving COPAXONE(R) experienced a reduced mean annualized rate of brain atrophy (ARBA) of -0.46 percent over five years, while patients receiving Avonex(R) or Betaseron(R)/Rebif(R) experienced mean ARBA of -0.52 percent and -0.64 percent, respectively. Patients in the untreated control group with an average follow-up of 15.2 months experienced the highest rate of brain atrophy (-0.95 percent). These data were presented at the 60th Annual Meeting of the American Academy of Neurology (AAN).
"Brain atrophy is a clinically relevant tool to measure disease progression and subsequent neurological disability in RRMS patients," said Omar Khan, M.D., Professor of Neurology, Director, Multiple Sclerosis Center, Wayne State University and lead investigator of the study. "Long-term brain volume measurements may be more appropriate than short-term examination to assess the ability of DMTs to affect brain tissue loss in RRMS. Although patients showed a significantly lower ARBA in all three treatment groups compared with the untreated group, COPAXONE(R)-treated patients demonstrated significantly reduced brain atrophy versus patients treated with either low-dose or high-dose interferon-beta."
About the Study
The study analyzed 309 treatment-naive RRMS patients who began and remained on the same DMT for five years. Patients included were those with disease duration of five years or less and an Expanded Disability Status Scale (EDSS) score of 3.0 or less at baseline. All patients had brain magnetic resonance imaging (MRI) scans (at onset of DMT and five years later) on the same 1.5T scanner. Untreated RRMS patients with follow-up ranging from 8 to 24 months were enrolled as controls. A fully automated technique known as SIENA was used to measure brain volume change. Image analysis was performed blinded to treatment allocation.
There were 121 patients on COPAXONE(R), 101 on high-dose interferon beta (Betaseron(R) or Rebif(R)) and 53 on Avonex(R). All treatment groups were well-matched at baseline. The mean ARBA over five years was -0.46 percent, -0.52 percent, and -0.64 percent in the COPAXONE(R), Avonex(R) and Betaseron(R)/Rebif(R) groups, respectively. The untreated control group with an average follow-up of 15.2 months had a mean ARBA of -0.95 percent. The ARBA was lower in all three treatment groups compared to the untreated group (p less than 0.0001). COPAXONE(R)-treated patients demonstrated significantly reduced ARBA than patients treated with either Avonex(R) or Betaseron(R)/Rebif(R) (p=0.0336 and p less than 0.0001).
"This study also demonstrated that brain atrophy is a dynamic process that can be detected in mildly affected early MS patients. Therefore, in accordance with National MS Society recommendations, it is important to initiate therapy soon after the diagnosis of MS is confirmed," said Omar Khan, M.D.
The study was supported by Wayne State University Neuroscience Program.
COPAXONE(R) (glatiramer acetate injection) is indicated for the reduction of the frequency of relapses in RRMS.
The most common side effects of COPAXONE(R) are redness, pain, swelling, itching, a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.
COPAXONE(R) is now approved in 51 countries worldwide, including the United States, all European countries, Canada, Mexico, Australia, and Israel. In Europe, COPAXONE(R) is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE(R) is marketed by Teva Neuroscience, Inc.
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About Teva Neuroscience
Teva Neuroscience is dedicated to investigating, developing and marketing ground-breaking products and technologies, with emphasis on cutting-edge treatments for patients who are living with neurological conditions, including multiple sclerosis (MS) and Parkinson's disease (PD). Therapies developed by Teva Neuroscience include COPAXONE(R) (glatiramer acetate injection) for relapsing-remitting multiple sclerosis (RRMS) and AZILECT(R) (rasagiline tablets) for the treatment of PD.
Teva Neuroscience's suite of innovative products continues to demonstrate the company's commitment to fulfilling unmet medical needs and has helped the company evolve into a global leader in RRMS. Teva Neuroscience is a North American division of Teva Pharmaceutical Industries Ltd., the world's largest generic drug company. Teva Neuroscience is proud of the role it plays in providing effective treatment options to patients worldwide. For more information, please visit www.tevaneuro.com or www.tevaclinicaltrials.com.
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Posted: April 2008