AAN 2024: Briumvi found to ease disability in certain MS patients
Nearly 15% of early, untreated patients improve over 2 years in trials
Two years of treatment with Briumvi (ublituximab) in clinical trials resulted in a confirmed reduction in disability for more than 1 in 10 people with early relapsing multiple sclerosis (MS) who had not received any prior treatment.
That’s according to new data from the ULTIMATE Phase 3 trials, which continue to show that early treatment with high-efficacy therapies is associated with improved disability outcomes.
The findings were presented at the American Academy of Neurology (AAN) 2024 Annual Meeting, held April 13-18, in Colorado and online.
“In treatment-naïve participants who had their first MS symptom [no more than] 3 years prior to enrollment, significant improvement at week 96 in [an MS assessment tool] score was observed” relative to other medication, the researchers wrote in a meeting poster.
Briumvi is designed to reduce MS inflammation by depleting B-cells, a type of inflammatory immune cell with a central role in MS. After two initial loading doses, the therapy is given via hour-long infusions every six months.
“The data presented … during the AAN annual meeting emphasizes our commitment to research and the multiple sclerosis community,” Michael Weiss, CEO and chairman of TG Therapeutics, Briumvi’s developer, said in a company press release.
Researchers analyze Briumvi impact after completion of ULTIMATE trials
To date, Briumvi has been approved in the U.S. and Europe for relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.
Those approvals were based on data from ULTIMATE I (NCT03277261) and ULTIMATE II (NCT03277248), a pair of Phase 3 trials that tested the therapy against an older MS treatment called Aubagio (teriflunomide). The trials, both launched in 2017, involved more than 1,000 people with relapsing forms of MS.
The results showed that patients on Briumvi had significantly lower relapse rates and less MRI disease activity than those on Aubagio after two years of treatment. Also, more patients on Briumvi experienced an easing of symptoms — so-called disability improvements — although no differences were observed in the rates of disability worsening.
At AAN, researchers presented post hoc analyses from the ULTIMATE studies. Such analyses are ones designed and carried out after a trial is over and all the data are unblinded.
In one analysis, researchers compared disability outcomes, as measured by scores on the Expanded Disability Status Scale (EDSS), for patients who had experienced their first MS symptoms no more than three years before entering the trials and had not received any prior MS treatment.
Early [Briumvi] treatment was associated with improved disability outcomes versus [Aubagio] in treatment-naïve participants who had their first MS symptom [within] 3 years prior to enrollment.
That poster was titled “Early Initiation of Ublituximab Treatment is Associated with Improved Disability Outcomes Among Treatment-Naïve Participants in ULTIMATE I and II.” Its scientists came from the U.S., Europe, and Australia.
Altogether, disability scores were generally stable with both treatments, according to the results, which showed that the average EDSS score worsened by 0.02 points for patients on Aubagio, and improved by 0.16 points for those on Briumvi.
However, the proportion of patients who experienced a confirmed disability improvement, or a meaningful reduction in EDSS scores lasting at least 12 weeks, or about three months, was more than four times higher with Briumvi than Aubagio — 14.4% versus 3.6%, a significant difference.
The researchers concluded that “early [Briumvi] treatment was associated with improved disability outcomes versus [Aubagio] in treatment-naïve participants who had their first MS symptom [within] 3 years prior to enrollment.”
Number of actively inflamed lesions reduced over 80% with Briumvi
In another poster at AAN, researchers analyzed MRI data from the ULTIMATE trials to determine how Briumvi impacted disease lesions in people who had highly active disease before entering the ULTIMATE trials. These were patients who had experienced at least two relapses in the year before the trials and had at least one actively inflamed lesion at the study’s start.
That poster was titled “Ublituximab Significantly Reduces Radiological Disease Activity at 12 Weeks: Post-hoc analysis of Participants with Highly Active Disease in the ULTIMATE I & II Phase 3 Studies.”
Its data showed that, after 12 weeks on the therapy, the total number of new or enlarging lesions was 58% lower for patients on Briumvi than for those on Aubagio. The number of actively inflamed lesions also was significantly reduced with Briumvi, by 83%.
In this subgroup, nearly one-third of patients (30%) on Briumvi had no evidence of disease activity after 12 weeks — meaning they had no new or inflamed lesions, no relapses, and no worsening disability. By comparison, 10% of patients on Aubagio achieved this outcome.
“We look forward to continuing to evaluate [data] from the ULTIMATE Phase 3 trials and presenting additional exploratory data throughout the year,” Weiss said.
TG wins VA contract to bring its approved therapy to US veterans
Briumvi specifically works by targeting a B-cell protein called CD20. A few other anti-CD20 therapies also are approved for use in MS.
In an announcement earlier this month, TG said it secured a contract with the U.S. Department of Veterans Affairs (VA) making Briumvi the preferred anti-CD20 therapy for veterans with MS.
“We believe this contract signifies a vote of confidence in the value that Briumvi brings to patients with [relapsing MS] and are pleased that veterans with MS will now have access to the only anti-CD20 therapy that offers a one-hour twice a year therapy, following the first dose,” Weiss said in a separate company release.
Under the contract, MS patients receiving care through the VA who are starting treatment with an anti-CD20 medication will use Briumvi unless that therapy is clinically contraindicated for them. Patients at the VA who are already taking other anti-CD20 medications may switch to Briumvi, but are not required to do so.
The contract will kick in June 17 and will last at least one year, though the U.S. government has the option to extend the agreement annually for at least five years. According to TG, which has touted Briumvi as the cheapest name-brand MS treatment, the total potential value of the contract is slightly more than $186 million.
“We are immensely proud to collaborate with the National VA Health System in bringing Briumvi to veterans across the country afflicted with [relapsing] MS at a significant discount,” Weiss said.
Note: The Multiple Sclerosis News Today team is providing coverage of the American Academy of Neurology (AAN) 2024 Annual Meeting April 13-18. Go here to see the latest stories from the conference.
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