Researchers utilizing an advanced magnetic resonance imaging (MRI) technology to characterize and chart the evolution of MS lesions found that relapsing-remitting multiple sclerosis (RRMS) patients treated with COPAXONE® (glatiramer acetate injection) experienced significantly increased magnetization transfer ratio (MTR). Magnetization transfer ratio is a nonconventional MRI technique used to investigate abnormalities in brain structures, and increased values indicate potential remyelination and axonal tissue repair.

The 12-month MRI study, conducted at the Buffalo Neuroimaging Analysis Center (BNAC) located in the Jacobs Neurological Institute at the University at Buffalo, State University of New York, examined 40 RRMS COPAXONE® naive patients. Patients received monotherapy with COPAXONE® (20 mg/day) everyday beginning at the baseline visit for 12 months. Study patients were assessed at baseline and after 12 months based on clinical examinations and using detailed conventional and nonconventional MRI protocols, including magnetization transfer imaging (MTI), an emerging MRI technique used to assess remyelination in the brains of MS patients.

These data indicate that treatment with COPAXONE® resulted in a measureable amount of tissue repair in study patients, said Robert Zivadinov, MD, PhD, Director of the BNAC, Professor of Neurology at the University at Buffalo, and lead study author. The observed increases in MTR point to a potential for remyelination. Overall, these findings contribute to the vast body of research that supports the long-term efficacy and safety of the therapy.

This is the first longitudinal study to evaluate lesions of RRMS patients as potential evidence for remyelination (as demonstrated by MTR data) in association with COPAXONE®. The results of the study, Magnetization transfer imaging of acute black holes in patients on glatiramer acetate, which were published in the January issue of Frontiers in Bioscience, highlight that the MTR technique may be a useful tool to monitor lesion evolution and MS disease progression in future studies.

ABOUT THE STUDY:
In the study, among 40 RRMS COPAXONE® naive patients who presented with one or more contrast enhancing lesions (CELs) at baseline, 115 CELs were detected. Patients underwent 1.5T MRI at baseline and after 12 months to assess presence CELs. After 12 months of COPAXONE® treatment the number of CELs decreased to 21. The highest MTR increases were observed among hypointense CELs that became isointense (29 percent) and hypointense CELs that remained hypointense (10 percent).

The study was a Phase IV, open-label, single-blinded, post-marketing MRI observational study conducted over a period of 12 months at the BNAC, University at Buffalo, State University of New York. Patients were COPAXONE® naive, between the ages of 18-65 years and disease duration ranged from 6 months to 30 years. All patients had to have one or more contrast-enhancing lesions (CELs) and a Kurtzke Expanded Disability Status Scale (EDSS) score less than or equal to 5.5.

Marketing Weekly News - Jan. 3, 2012