High-efficacy DMTs Boost Mid-term Prognosis for Relapsing MS: Study

People with relapsing multiple sclerosis (MS) treated with Tysabri (natalizumab) or Gilenya (fingolimod) are less likely to have disease activity than those on low-efficacy MS medications, according to a small study conducted in Japan.

Results also showed that patients receiving the high-efficacy therapies had less brain shrinkage, or atrophy, in certain regions.

The study, “High-efficacy therapy reduces subcortical grey matter volume loss in Japanese patients with relapse-onset multiple sclerosis: A 2-year cohort study,” was published in Multiple Sclerosis and Related Disorders.

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More than a dozen disease modifying therapies (DMTs) for MS are widely available, with varying profiles in terms of efficacy and safety.

While some studies showed that second-generation, or high-efficacy, DMTs are superior to low-efficacy DMTs at reducing brain atrophy in people with MS, others reported similar effects on brain volume loss.

Low-efficacy therapies are older medicines that are generally less potent, but have milder safety profiles.

Now, scientists in Japan set out to compare the effects of high-efficacy versus low-efficacy DMTs on whole and regional brain atrophy, in addition to disease activity, in Japanese people with relapsing MS.

The multicenter study enrolled 69 patients with relapsing MS, but due to the COVID-19 pandemic, only 44 had available follow-up data and were thereby included in the final analysis.

“Each doctor decided which treatment was administered to patients based on each situation, including a patient’s disease activity, future progression risks, own choice, and fertility,” the researchers wrote.

Which DMTs were included in the study?

A total of 19 patients were treated with one of two high-efficacy DMTs, Tysabri or Gilenya, while 25 patients were on low-efficacy DMTs that included interferon-beta, such as Rebif (interferon beta-1a) and Betaseron (interferon beta-1b); Tecfidera (dimethyl fumarate); and Copaxone (glatiramer acetate).

Both groups were majority female, with an average age of about 40 years. At the study’s start, the average disease duration was about a decade, and most patients had relatively mild MS severity with minimal disability.

Before treatment initiation, demographic, clinical, and brain imaging data were similar between the two groups.

Results showed that after an average of two years of follow-up, significantly more participants in the high-efficacy group had no evidence of disease activity relative to the those in the low-efficacy group (84% vs. 44%).

No evidence of disease activity was classified as the absence of relapses, worsening disability, or new or enlarging brain lesions on MRI.

While whole brain volume changes were similar between the groups, volume loss in certain brain regions appeared more evident in the low-efficacy group than in the high-efficacy group.

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When adjusting for potential influencing factors, including age, sex, and MS severity score at treatment start, patients given high-efficacy DMTs had significantly less atrophy in the areas of the brain called the cerebral cortex, the caudate, and the putamen. The cerebral cortex is the outermost part of the brain that is crucial for higher cognitive functions, while the caudate and the putamen are located under the cortex and support its functions.

“Our results indicate that HET [high-efficacy therapy] reduces disease activity and regional brain volume loss, even in patients with milder MS,” the researchers wrote.

As such, “HET may contribute to an improved mid-term prognosis in Japanese patients with relapse-onset MS,” they added.

The team noted that their study was limited by its small size, short follow-up time, and observational nature. Larger and longer-term studies are needed to confirm these findings.

The work was funded by the ministry of Health, Labour and Welfare of Japan and the Japan Society for the Promotion of Science. Several of the study’s researchers have links to pharmaceutical companies, including Biogen, which markets Tysabri, and Novartis, which sells Gilenya.