Kesimpta outperforms Aubagio among ethnically diverse groups
Call for clinical trials to enroll more patients from different racial, ethnic groups
Kesimpta (ofatumumab) is more effective than Aubagio (teriflunomide) among people with multiple sclerosis (MS) from ethnically diverse groups, including Black and African American, Hispanic and Latino, and Asian individuals, according to an analysis of pooled clinical trial data.
“Determining whether there are differences in how people respond to MS therapies is of great importance so that ultimately, each person is given the most effective treatment for them,” Mitzi Joi Williams, MD, the study lead author and founder of the Joi Life Wellness MS Center in Atlanta, Georgia, said in a press release. “Underrepresentation of diverse populations continues to be an issue in research. Future studies should strive to enroll racially and ethnically diverse groups to better inform treatment decisions.”
The study, “Efficacy of Ofatumumab and Teriflunomide in Patients With Relapsing MS From Racial/Ethnic Minority Groups,” was published in the journal Neurology.
Multiple risk factors may trigger MS in genetically predisposed individuals, including infection with the Epstein-Barr virus, vitamin D deficiency, and adolescent obesity. Social factors such as living conditions and the work environment may also influence MS risk.
Relatively few people from ethnically diverse groups participate in clinical trials
While the impact of race and ethnicity on MS risk remains unclear, clinical outcomes and responses to treatment can differ across distinct racial and ethnic subgroups. Still, relatively few people from ethnically diverse groups have participated in clinical trials.
“Ethnically diverse groups, including Black and African American, Hispanic and Latino, and Asian individuals, are consistently underrepresented in clinical trials, limiting the data available to help make the best treatment decisions for people in these groups,” Williams said.
CD20 inhibitors are currently among the most effective disease-modifying therapies in MS. These therapies work by targeting the CD20 protein at the surface of immune B-cells, which are known to contribute to disease onset and progression, and depleting them.
However, previous studies have shown that people from underrepresented groups have greater B-cell activity than white patients and may experience faster increases in B-cells after treatment with CD20 inhibitors, which may reduce their efficacy.
Yet, not many studies have been conducted to understand if the different B-cell dynamics affect the benefits of anti-CD20 antibodies in these minority groups, or whether these patients should be offered distinct treatment approaches to improve outcomes.
In the study, researchers examined data from two identical Phase 3 clinical trials — ASCLEPIOS I (NCT02792218) and ASCLEPIOS II (NCT02792231) — that supported the approval of the CD inhibitor Kesimpta.
The trials collectively enrolled 1,822 patients with relapsing forms of MS, ages 18-55, who were randomly assigned to monthly Kesimpta injections or once-daily Aubagio for up to 2.5 years.
We found overall the drug was effective and safe across racial and ethnic groups.
Data show Kesimpta significantly reduced relapse rates compared with Aubagio
Results showed Kesimpta significantly reduced annual relapse rates compared with Aubagio. It also significantly outperformed Aubagio at reducing the risk of sustained disability worsening and lowering the number of new or enlarging brain lesions.
Now, Williams’ team compared the efficacy and safety of these therapies among participants from different ethnic groups. Novartis, the maker of Kesimpta, sponsored this analysis.
Of the participants enrolled in both trials, 81.7% self-identified as non-Hispanic white, 7.7% as Hispanic/Latino, 3.8% as non-Hispanic Asian, and 3.4% as non-Hispanic Black. The remaining 2.4% were included as other/unknown.
The researchers determined the proportion of patients in each group who achieved no evidence of disease activity (NEDA-3), defined as no new relapses, no sustained increases in disability lasting at least six months, and no inflammatory or new or enlarging lesions on MRI scans.
Results showed Kesimpta was consistently better than Aubagio at increasing the likelihood of achieving NEDA-3 across most ethnic and racial groups over two years of treatment.
For example, among non-Hispanic Black patients, 33.3% of those on Kesimpta achieved NEDA-3, compared with 3.4% of those on Aubagio. Similar results were seen with Hispanic/Latino (36.6% vs. 18.6%) and non-Hispanic white patients (37.4% vs. 16.6%), but no significant differences were observed in the non-Hispanic Asian group.
“Our study examined the efficacy and safety of [Kesimpta] in diverse populations,” Williams said. “We found overall the drug was effective and safe across racial and ethnic groups.”
Rates of side effects similar between Kesimpta, Aubagio
The most common side effects reported included injection-site reactions, common cold, headache, infections, hair loss, and diarrhea. Rates of side effects, including those that led to treatment discontinuation, were similar between the two therapies and across race and ethnic subgroups.
Still, more side effects, including serious side effects, occurred in the non-Hispanic Black subgroup. Moreover, one in three (33.3%) non-Hispanic Asian participants receiving Kesimpta reported fever.
“This analysis provides further evidence supporting use of [Kesimpta] in these participant subgroups,” the researchers concluded. “Future studies should strive to enroll racially and ethnically diverse groups, including Black and African American, Asian, and Hispanic/Latino individuals, to better inform treatment decisions and outcomes for these populations.”
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