Tecfidera confirmed safe, effective in Black and Hispanic MS patients

Benefits seen in 5-year study in real world similar to other ethnic groups

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by Steve Bryson, PhD |

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Treatment with Tecfidera (dimethyl fumarate) provides a similar long-term benefit for Black and Hispanic people with multiple sclerosis (MS) as is found in other racial and ethnic populations, according to five years of data from the real-world ESTEEM study.

The study — which assessed the long-term safety and effectiveness of Tecfidera in newly prescribed MS patients over five years — found relapse rates for Black and Hispanic patients were similar to those of non-Black and non-Hispanic individuals taking the approved therapy.

Further, the occurrence of adverse side effects leading patients to stop treatment was comparable among all of the participants in the study.

“This study represents one of the largest Black and Hispanic MS [patient groups] to date and reports outcomes over the longest follow-up compared with previous studies. It confirms the real-world long-term benefit of [Tecfidera] in both Black and Hispanic populations, with safety and effectiveness findings that are consistent with the overall ESTEEM population,” the researchers wrote.

The findings of this new analysis were detailed in “Real-World Safety and Effectiveness After 5 Years of Dimethyl Fumarate Treatment in Black and Hispanic Patients with Multiple Sclerosis in ESTEEM,” a study published in the journal Neurology and Therapy.

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Investigating the real-world impact of Tecfidera in Black, Hispanic MS patients

Evidence indicates that Black and Hispanic people with MS experience greater disease severity than non-Black and non-Hispanic MS patients. While the reasons for this difference are unclear, one study suggested that Hispanic and Black patients have elevated levels of antibody-producing immune cells that mistakenly target the brain and spinal cord — the cause of MS.

Therapies like Tecfidera are being developed that target the underlying causes of MS.

Still, despite making up more than 13% of the U.S. population, Black or African Americans’ participation in clinical trials to test such treatments is only about 5%. Likewise, only 1% of Hispanic Americans, out of 18% in the U.S., have been clinical trial participants.

“Thus, data describing the effectiveness of disease-modifying therapies in these patients in real-world settings are limited,” the researchers wrote.

Tecfidera, developed by Biogen, is an oral treatment approved in the U.S. and many other countries for relapsing forms of MS. In both clinical and real-world studies, the disease-modifying therapy (DMT) has been shown to reduce relapse rates, delay disability progression, and slow the development of brain lesions.

To learn about the real-life impact of Tecfidera, Biogen a decade ago sponsored an international Phase 4 study called ESTEEM (NCT02047097). That study, completed last year, assessed the long-term safety and effectiveness of Tecfidera in newly prescribed MS patients over five years.

The company now examined data specifically from Black and Hispanic participants, most of whom are from the U.S.

Of the 5,251 individuals taking part in ESTEEM, 4% or 220 were Black patients, and 96%, or 5,031, were non-Black people. Similarly, 2% or 105 patients were Hispanic people, and 98%, or 5,146, were non-Hispanic individuals. The mean age at enrollment was similar between Black (42.5 years) and Hispanic (40.1 years) populations.

According to researchers, ESTEEM’s participants were among the largest groups of Black and Hispanic patients involved in studies to date.

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Relapse rates seen to drop for all MS patients on Tecfidera

Before treatment, the characteristics across all patient populations were similar regarding relapse rates and disease severity, as assessed with the Expanded Disability Status Scale (EDSS). Even so, Black patients were generally older than those in other groups.

Data showed that Black, Hispanic, non-Black, and non-Hispanic patients all experienced significant reductions in annualized relapse rates (ARRs) with Tecfidera. Those rates dropped by about 91% to 92% after five years, compared with their levels one year before study entry.

These data demonstrate a comparable real-world treatment benefit of [Tecfidera] in Black and Hispanic patients.

Among the Black population, the ARR dropped from 0.689 to 0.054 relapses per year with up to five years of treatment. Similarly, the ARR decreased from 0.875 to 0.069 in Hispanic patients, from 0.820 to 0.077 in non-Black patients, and from 0.813 to 0.076 in non-Hispanic patients.

The proportion of patients who were relapse-free at 54 months or 4.5 years — a time point selected because a few patients in some groups reached the five-year assessment mark — also was comparable across populations. Overall, 74.7% of Black patients, 77.3% of Hispanic individuals, and 70.6% of both non-Black and non-Hispanic participants were relapse-free.

Adverse events (AEs), or side effects, leading to treatment discontinuation were reported in 18% of Black individuals and 28% of Hispanic patients versus 22% of non-Black participants and 22% of non-Hispanic patients. Digestive tract problems were the most common reason for stopping Tecfidera. Serious AEs occurred in 5.5% of Black participants, 7.6% of Hispanic patients, 6.8% of non-Black individuals, and 6.8% of non-Hispanic participants.

Levels of immune cells dropped in the first year of treatment by 37% in Black patients, 40% in non-Black individuals, 10% in Hispanic participants, and 39% in non-Hispanic individuals. After that, the levels remained above the lower limit of normal in most patients, indicating a good ability to fight infections.

One limitation of this study, according to researchers, was the small proportion of Black and Hispanic individuals among the overall patient population.

“Although these are the largest [groups] of Black and Hispanic patients in a study of this kind to date, the numbers of patients in these groups are still small (220 in the Black population and 105 in the Hispanic population vs. 5251 in the overall population),” the researchers wrote, citing “a need for clinicians to encourage clinical trial participation in these populations.”

Nonetheless, according to the team, “these data demonstrate a comparable real-world treatment benefit of [Tecfidera] in Black and Hispanic patients.”