Tecfidera Safe and Effective in Hispanic/Latino MS Patients, Real-world Data Show

Tecfidera (dimethyl fumarate) is as safe and effective in Hispanic/Latino multiple sclerosis (MS) patients as it is in their non-Hispanic and non-Latino peers, three-year data from a real-world study show.

These interim findings, based on the largest group of Tecfidera-treated Hispanic and Latino MS patients studied to date, support the therapy’s benefits in a patient population often underrepresented in MS research.

This observational trial, called ESTEEM (NCT02047097), will run for two more years to further assess Tecfidera’s benefit-risk profile across different ethnicities.

The study, “Real-World Safety and Effectiveness of Dimethyl Fumarate in Hispanic or Latino Patients with Multiple Sclerosis: 3-Year Results from ESTEEM,” was published in the journal Neurology and Therapy.

Increasing evidence suggests that Hispanics and Latino-Americans, as well as African-Americans, have a more severe MS progression than Caucasians.

Reasons behind these ethnic differences remain largely unknown, but a previous U.S. study showed that MS patients of Hispanic or African ancestry have higher levels of antibody-secreting cells, which may contribute to a more severe disease course.

Still, ethnic minority populations continue to be underrepresented in MS clinical trials and real-world studies.

“The underrepresentation of these populations leads to limited data on the effectiveness of treatments in these groups of patients and underscores the lack of an evidence-based approach used in treatment,” the researchers wrote.

Tecfidera (marketed by Biogen) is an approved oral disease-modifying therapy for  relapsing multiple sclerosis.

In relapsing-remitting multiple sclerosis (RRMS) patients, it has shown strong, sustained effectiveness and a favorable benefit–risk profile in the pivotal Phase 3 trials DEFINE (NCT00420212) and CONFIRM (NCT00451451), their open-label ENDORSE extension study (NCT00835770), and in real-world studies.

While data from a total of 54 Hispanic patients participating in DEFINE and CONFIRM showed that Tecfidera treatment resulted in a significant drop in their relapse rate, this sample size was too small to draw definitive conclusions for this subgroup.

Biogen researchers and colleagues set out to evaluate Tecfidera’s safety and effectiveness in Hispanic/Latino MS patients using data from the ESTEEM study.

ESTEEM is an ongoing, Biogen-sponsored, five-year Phase 4 study of the long-term safety and effectiveness of Tecfidera when newly prescribed to MS patients at 394 clinical practice sites globally.

For this study, Tecfidera’s effects were evaluated in patients reporting Hispanic or Latino ethnicity — including a subgroup switching from interferon therapy (brand names Avonex, Betaseron, and others) or glatiramer acetate (sold as Copaxone, Glatopa, and other generics) to Tecfidera — and those identifying as non-Hispanic/non-Latino.

The therapy’s effectiveness was measured through changes in the annualized relapse rate (between the year before Tecfidera treatment and three years post-treatment), and the proportion of patients with a relapse.

At a median follow-up of 18 months (range, 2–37 months), 4,986 non-Hispanic/non-Latino and 98 Hispanic/Latino patients, including 64 who switched therapy, had received at least one dose of Tecfidera.

Most of the Hispanic/Latino patients (98%) were from the U.S. (including Puerto Rico), while 56% of non-Hispanic/non-Latino patients were of European background. Those with Hispanic/Latino ancestry had a mean age of 40, and 79% were women.

Several demographic (mean or average age, sex ratio) and clinical features (median age at diagnosis, number of relapses in the previous year) were similar between the two groups of patients.

Results showed that Tecfidera led to a significant and comparable drop in annualized relapse rates for patients in the Hispanic/Latino (89%) group and those in the non-Hispanic/non-Latino (88%) group. An 87% reduction in the relapse rate was also observed among Hispanic/Latino patients previously treated with interferon therapy or glatiramer acetate.

Most Hispanic/Latino patients (84%), including those switching therapy (88%), were also free from relapses after three years of treatment. This was consistent with the proportion of non-Hispanic/non-Latino patients experiencing no disease relapses (80%).

In the first year of Tecfidera’s use, both groups showed a drop in white blood cells counts (by 24% vs. 36% in non-Hispanic/non-Latino patients), after which they remained stable and above the lower limit of normal.

Tecfidera’s safety profile in the Hispanic/Latino population was similar to that seen in the remaining study population, with no unexpected safety findings. A greater proportion of Hispanic/Latino patients stopped treatment due to adverse events (29% vs. 19%), with gastrointestinal problems being the most common reason for discontinuation in both groups (10% vs. 8%).

Due to the small number of patients, it was impossible to draw conclusions about these differences in treatment discontinuations, the researchers wrote. Further evaluations or additional studies may help clarify this.

“In conclusion, these safety and effectiveness analyses demonstrate the real-world treatment benefit of [Tecfidera] in Hispanic/Latino patients, consistent with findings in the overall ESTEEM population,” they wrote.

The team noted, however, that since most Hispanic/Latino patients were from the U.S., these findings may not be representative of the global Hispanic/Latino MS patient population.

They also noted that similar findings were observed in an ESTEEM subgroup analysis of 181 African-American patients, and that the study’s final five-year data may provide further insights into Tecfidera’s effects in different ethnic groups.