2-year Copaxone Treatment in RRMS Found to Slow Loss of Gray Matter

Two years of treatment with the approved therapy >Copaxone (glatiramer acetate) was found to slow the loss of cerebral gray matter and whole brain volume — two markers of neurodegeneration — in people with relapsing-remitting multiple sclerosis (RRMS).

Notably, individuals on Copaxone had a similar rate of changes in brain volume as patients with benign RRMS — those with minimal disability after more than a decade with the disease.

These findings indicate a beneficial effect of Copaxone in this patient population, according to scientists.

“In this pilot study, [Copaxone] was associated with preservation of cerebral gray matter and whole brain volumes,” the researchers wrote.

“Patients with RRMS started on [Copaxone] did not show significant [gray matter] or whole brain atrophy over 2 years, resembling MS patients with a clinically benign disease course,” they concluded.

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The study, “Exploring the effect of glatiramer acetate on cerebral gray matter atrophy in multiple sclerosis,” was published in the Journal of the Neurological Sciences. It was funded by Teva Neuroscience, which markets Copaxone.

Brain volume loss is considered a relevant measure of MS progression. Generally, patients experience an annual change in brain volume of approximately 0.7%, which exceeds the rate associated with normal aging.

The loss of brain volume, also called brain atrophy, can occur in MS via multiple mechanisms, including loss of nerve tissue in brain lesions, which are located in the brain’s white matter — regions composed mainly of nerve fibers. It also can occur due to damage to the brain’s gray matter, which contains mainly cell bodies, or to regions in white matter that appear normal (without lesions).

While damage to white matter regions is a hallmark in MS, gray matter atrophy has a stronger correlation with other measures of disease severity and has been proposed as a relevant method to evaluate the protective effect of MS disease-modifying therapies (DMTs).

“Gray matter volume is a sensitive and clinically relevant measurement of assessing the neuroprotective effect of DMTs in MS,” the researchers wrote.

Copaxone is an approved DMT, used since 1996 for treating adults with relapsing forms of MS. It induces an anti-inflammatory effect by modulating the activity of a number of different types of immune cells. 

In addition to reducing relapse rates and the number of lesions, the treatment also seems to slow whole brain atrophy in RRMS patients. However, the impact of Copaxone treatment on gray matter atrophy has not been well-established.

To address that, researchers in the U.S. conducted a pilot study to investigate gray matter atrophy in 14 RRMS patients starting on Copaxone. The findings were compared with data from a group of six people with benign MS, defined as having no disability after 10–14 years of living with MS, or minimal disability after 15 years. The rate of brain atrophy in these patients typically resembles that of healthy people.

During the study, none of the RRMS patients treated with Copaxone experienced a relapse, while one patient in the control group did. Disability scores also remained stable, with only two treated patients and one in the benign group showing disease worsening.

At the end of the first year, RRMS patients on Copaxone did not experience significant changes in lesion volume, white and gray matter volume, or whole brain volume. However, by the end of year two, these patients presented a significant increase in lesion volume and a reduction in white matter volume compared with treatment start.

For the benign RRMS patients, lesion volume and gray matter volume did not change over time, but white matter and whole brain volume were significantly reduced after one year.

Notably, there were no significant differences in MRI volumetric parameters between the two groups.

“Taken together, these preliminary results suggest there may be a partial, but significant, effect of [Copaxone] on attenuation of cerebral [gray matter] atrophy,” the researchers wrote.

“Although the sample size is small to draw firm conclusions, these results show that the extent of [white matter] damage in [Copaxone] treated patients was similar to a benign course of MS,” the team wrote.

Overall, the study had other limitations, including that treated patients were not compared with healthy nor untreated matching groups to further confirm the effect of Copaxone.

“We thus emphasize that any conclusions are not firm and would need to be confirmed and extended in larger prospective studies,” the researchers wrote.