Briumvi outperforms Aubagio in highly active relapsing MS: Study
Infusion therapy better at reducing disease activity on brain MRI scans
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A doctor holds up an MRI brain scan of the head and skull.
- Briumvi significantly outperformed Aubagio in highly active relapsing multiple sclerosis.
- It reduces relapse rates and disease activity on brain MRI scans.
- Early use of Briumvi is supported to prevent nerve damage and disability.
The CD20 inhibitor Briumvi (ublituximab) significantly outperformed Aubagio (teriflunomide) at lowering relapse rates and reducing disease activity on brain MRI scans in people with highly active relapsing forms of multiple sclerosis (MS).
That’s according to a new analysis of pooled data from the ULTIMATE I (NCT03277261) and ULTIMATE II (NCT03277248) Phase 3 clinical studies, which formed the basis for Briumvi’s approval in 2022.
The findings support the use of Briumvi and other highly effective therapies early in the disease course to prevent the irreversible accumulation of nerve damage and disability in highly active MS patients who typically have a poor prognosis.
The study, “Efficacy of Ublituximab in People with Highly Active Relapsing Multiple Sclerosis,” was published in Neurology and Therapy. Briumvi’s developer, TG Therapeutics, funded it.
“These results demonstrate robust and rapid reductions in both clinical and radiologic disease activity and support the use of a high-efficacy therapy such as Briumvi early in the disease course,” Michael S. Weiss, executive chairman and CEO of TG Therapeutics, said in a company press release.
Briumvi targets B-cells that drive MS
Briumvi is an infusion therapy approved to treat adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. The therapy works by targeting B-cells, immune cells that normally produce antibodies to fight infections but play a key role in driving MS.
In the ULTIMATE clinical trials, nearly 1,100 patients with active, relapsing forms of MS were randomly assigned to receive Briumvi or the oral treatment Aubagio for nearly two years.
Results showed that the infusion therapy significantly reduced relapses by 49% to 59%, lowered the number of lesions with active inflammation by 96% to 97%, and increased by more than three times the likelihood of achieving no evidence of disease activity, or NEDA-3 — a disease outcome defined as no relapses, no new MRI activity, and no confirmed disability worsening.
In some patients, the disease follows a highly active course, with frequent relapses and more evidence of disease activity on brain MRI scans. These patients tend to have poorer outcomes due to a faster accumulation of nerve damage.
In this study, researchers aimed to determine whether Briumvi also improves outcomes in patients with highly active disease, defined as having at least two relapses in the previous year and at least one lesion with active inflammation. In the ULTIMATE trials, 168 patients met those criteria, of whom 88 received Briumvi and 80 received Aubagio.
“People with highly active MS have an increased risk of rapid accumulation of disability and faster disease progression,” they wrote. “Considering the faster progression of highly active disease, the window of opportunity for preventing accumulation of disability and disease progression in this subpopulation is relatively narrow.”
Therapy associated with improvements across multiple measures
Results showed that Briumvi was similarly effective in people with highly active disease. After nearly two years of treatment, people given the CD20 inhibitor experienced an average of 0.145 relapses per year, compared with 0.496 relapses per year with Aubagio — a 70.8% reduction in the annualized relapse rate.
The therapy also significantly reduced the number of lesions with active inflammation by 83.3% after about three months, and by 95.6% over the entire treatment period. New or enlarging lesions, which show the total number of lesions with and without inflammation, were similarly reduced with Briumvi — by 57.5% after three months and by 91.1% after two years.
Finally, the researchers found that a greater proportion of patients treated with Briumvi achieved NEDA-3, again mirroring the results seen in the overall trial population. After about three months, 29.5% of patients on Briumvi had achieved NEDA-3 compared with 10.1% on Aubagio.
These results suggest that ublituximab could be beneficial in managing disease and limiting future accumulation of disability to improve outcomes in this population of people with highly active MS.
Researchers also conducted an analysis that looked at disease activity starting six months after treatment began — a common approach that allows the therapy time to take full effect. Looking only at the period from month six through the end of the study, 77.9% of patients treated with Briumvi achieved NEDA-3, versus 16.4% of those on Aubagio.
“[Briumvi] was associated with significant improvements across multiple measures, including relapse rate, MRI lesion burden, and NEDA-3,” said Hans-Peter Hartung, MD, a professor at Heinrich Heine University Düsseldorf in Germany and the study’s first author.
“These results suggest that ublituximab could be beneficial in managing disease and limiting future accumulation of disability to improve outcomes in this population of people with highly active MS,” the team concluded.
