Clinical research data, published in the journal Multiple Sclerosis, provided evidence that Copaxone ( Glatiramer ) may offer protection from axonal injury and induced neuronal metabolic recovery in patients with relapsing remitting multiple sclerosis ( RRMS ).

In a pilot study of 18 RRMS patients using brain imaging techniques, Copaxone was found to produce significant increases in n-acetylaspartate/creatine ( NAA/Cr ) 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.
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 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 agent," said Omar Khan, director of Multiple Sclerosis Center, Wayne State University.

" This data is of critical significance because axonal transection is a well-known feature of active multiple sclerosis lesions and represents an irreversible stage of the disease process," said Khan.

Twenty-two treatment-naïve 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 ) and followed for two years with neurological assessments every six months and MRSI scans annually.
Due to needle phobia, 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 ) 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 Khan. " However, our 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 Khan.

Copaxone is a selective MHC class II modulator.
Copaxone is indicated for the reduction of the frequency of relapses in relapsing remitting multiple sclerosis.
The most common side effects of Copaxone are redness, pain, swelling, itching, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

Source: Teva Pharmaceutical, 2005


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