COPAXONE may prevent nerve damage in MS patients
KANSAS CITY, Mo. (November 15, 2005) -- Clinical research data published in the December issue of Multiple Sclerosis(多发性硬化症) provided evidence that COPAXONE(glatiramer acetate injection,醋酸格拉太咪尔注射液,为多发性硬化症治疗药) may offer protection from axonal(轴突的) injury and induced neuronal metabolic recovery in patients with relapsing remitting multiple sclerosis (RRMS,复发-缓解型多发性硬化).
In a pilot study(初步研究) of 18 RRMS patients using brain imaging techniques, COPAXONE was found to produce significant increases in n-acetylaspartate/creatine (NAA/Cr,乙酰天门冬氨酸/肌氨酸) ratio, an indicator of neuron and axon integrity, compared to four untreated control patients after one year of treatment. This increase was maintained at two years of follow-up(追踪调查). Additionally, patients treated with COPAXONE showed a significant 50 percent reduction in relapses compared to baseline (p<0.001) while relapse rate in the untreated group remained unchanged.
"The increases in NAA/Cr ratios with COPAXONE suggested sustained beneficial effects on cerebral(脑的,大脑的) axonal recovery. We believe this indicates a potential for improved electrical conduction pathways in the brain, supporting the emerging concept that, centrally, COPAXONE may be acting as a neuroprotective(神经保护性的) agent," said Omar Khan, M.D., associate professor of neurology and director of experimental therapeutics/clinical research, Multiple Sclerosis Center, Wayne State University. "This data is of critical significance because axonal transection(横断,横切) is a well-known feature of active MS lesions(损害,损伤) and represents an irreversible stage of the disease process," said Dr. Khan.
Twenty-two treatment RRMS patients were included in the study. Baseline neurological assessments and magnetic resonance spectroscopy imaging (MRSI) scans were performed. Eighteen patients were treated with COPAXONE (glatiramer acetate injection) and followed for two years with neurological assessments every six months and MRSI scans annually. Due to needle phobia(惧怕,憎恶), four patients elected to remain untreated and were followed using the same assessment and MRSI schedule. NAA/Cr ratio measurements were obtained in a selected volume of interest (VOI) within the brain and included normal-appearing white matter (NAWM,正常出现的白质,尤指大脑及脊髓中的白色神经组织,主要由有髓鞘的神经纤维组成) within the VOI.
In the COPAXONE group, the NAA/Cr levels within the VOI were significantly increased by 9.1 percent at year one and by 10.7 percent at year two, compared to baseline (p=0.03 for both assessments). Conversely, in the untreated group, a 5.5 percent decrease in NAA/Cr levels was observed in the VOI at year one (p=0.04) and an 8.9 percent decrease at year two (p=0.03). COPAXONE patients also demonstrated a 5.4 percent and 7.1 percent increase in NAA/Cr ratios within the NAWM at years one and two, respectively (p=0.04 for both). Untreated patients had a two percent (p=n.s.) and 8.2 percent (p=0.03) decrease in NAA/Cr ratios within the NAWM at year one and two, respectively.
"We recognize our study contains limitations, such as the number of patients, open-label design, and the MRS technique of evaluating NAA levels," stated Dr. Khan. "However, our recently presented three-year data showed sustained improvements in NAA/Cr ratios which clearly demonstrated a long-term clinical benefit and showed that COPAXONE treatment may lead to neuronal recovery," said Dr. Khan.