Five Years of BRIUMVI Data Cements Long-Term Efficacy in MS Treatment

NEW YORK, NY – February 17, 2026 – By Carol Thomas

New long-term data published today in the prestigious journal JAMA Neurology provides a compelling look at the sustained efficacy and consistent safety of BRIUMVI (ublituximab-xiiy) for patients with relapsing forms of multiple sclerosis (RMS). The five-year results from the ULTIMATE I and II open-label extension studies demonstrate remarkably low relapse rates and stable disability, offering a new pillar of evidence for the long-term management of the chronic neurological disease.

For patients treated continuously with BRIUMVI, an anti-CD20 monoclonal antibody developed by TG Therapeutics, the annualized relapse rate (ARR) fell to just 0.020 by the fifth year. This figure translates to an equivalent of one relapse occurring for every 50 years of patient treatment, a statistic that underscores a profound level of disease control. The data further revealed that 92% of patients on continuous treatment for five years remained free from confirmed disability progression, a key goal in MS therapy aimed at preserving neurological function and quality of life.

Michael S. Weiss, Executive Chairman and CEO of TG Therapeutics, highlighted the significance of the publication. “Acceptance of these five-year ULTIMATE I & II results in JAMA Neurology represents a major milestone for TG Therapeutics and the MS field,” he stated. “These data underscore not only the durable clinical efficacy and consistent safety of BRIUMVI through extended treatment, but also our commitment to advancing long-term evidence that helps clinicians and patients make informed treatment decisions.”

Redefining Stability in a Chronic Condition

Multiple sclerosis is characterized by its unpredictability, with relapses often causing new or worsening symptoms that can lead to accumulating disability. The latest findings for BRIUMVI suggest a future where that unpredictability is significantly muted for many patients.

Beyond the headline relapse rate, the study showed that by year five, 97.7% of participants who received continuous treatment remained entirely relapse-free. Perhaps even more encouraging for the MS community, the data also pointed to functional recovery. Seventeen percent of patients on continuous BRIUMVI for five years achieved a Confirmed Disability Improvement (CDI) that lasted for at least 24 weeks. This means that nearly one in six patients not only avoided getting worse but actually saw a sustained improvement in their neurological function.

Dr. Bruce A. C. Cree of the University of California, San Francisco, and lead author of the JAMA Neurology manuscript, emphasized the clinical implications. “The long-term results from the ULTIMATE I & II open-label extension demonstrate that continued treatment over five years provided sustained clinical benefits, with relapse rates declining further over time and disability progression remaining low,” he noted. “Importantly, the overall safety experience remained consistent over extended follow-up. Together, these findings confirm the long-term benefits of ublituximab and support the early initiation of high-efficacy therapy in relapsing multiple sclerosis to help optimize long-term outcomes for patients.”

Raising the Bar in a Competitive Field

The publication in JAMA Neurology, a journal with a high impact factor and a discerning readership of neurologists and researchers, lends significant scientific credibility to the findings. This level of peer-reviewed validation is critical in a competitive treatment landscape that has seen a paradigm shift toward high-efficacy B-cell depleting therapies.

BRIUMVI belongs to the same class as other established anti-CD20 treatments like Ocrevus (ocrelizumab) and the subcutaneously-injected Kesimpta (ofatumumab). While all target B-cells to suppress MS activity, BRIUMVI distinguishes itself with a unique administration schedule: a one-hour intravenous infusion given twice a year after the initial doses. This combination of high efficacy and a rapid infusion schedule has already made it an attractive option since its approval.

This robust five-year data set further strengthens its position. While the original 96-week trials demonstrated BRIUMVI's superiority over the oral therapy teriflunomide, this long-term extension provides the endurance data that clinicians and patients increasingly demand. As one independent neurologist commented, “Short-term trial data is one thing, but MS is a lifelong disease. Seeing this level of sustained control and safety over five years gives us much greater confidence in counseling patients about their long-term treatment journey.”

The Value of Enduring Evidence

Generating such long-term data is a monumental undertaking for pharmaceutical companies, requiring significant investment and patient commitment. The ULTIMATE open-label extension (OLE) study design, where over 85% of eligible participants from the initial trials chose to enroll, speaks volumes. Furthermore, the fact that more than 70% of participants remained on treatment at the five-year mark underscores the drug’s long-term tolerability and the value patients perceive in the therapy.

A critical aspect of the long-term findings is the consistent safety profile. No new safety signals emerged over the five years of continuous treatment. Specifically, the study monitored immunoglobulin levels, which can sometimes decrease with B-cell depleting therapies and potentially increase infection risk. However, with BRIUMVI, mean immunoglobulin levels remained stable and above the lower limit of normal, and the data showed no association between decreased levels and the risk of serious infections. This provides crucial reassurance for both physicians and patients considering a therapy that will likely be used for decades.

The research, involving over 3,600 participant-years of exposure, provides a solid foundation for BRIUMVI's role in the MS treatment arsenal. It validates the approach of targeting a unique epitope on CD20-expressing B-cells, which allows for efficient B-cell depletion at a low dose, a key feature of the drug's design.

From Clinical Trial to Clinical Practice

The positive data is expected to have a ripple effect, bolstering market confidence in TG Therapeutics and potentially influencing prescribing patterns. As the MS treatment philosophy continues to evolve toward using high-efficacy therapies earlier in the disease course to prevent irreversible damage, data like this becomes indispensable.

For patients, the practical implications are significant. The evidence supports deeper conversations with healthcare providers about the long-term outlook with a given therapy. It also provides a stronger basis for insurance providers to continue coverage, as the data clearly demonstrates a reduction in the relapses and disability progression that drive up long-term healthcare costs. TG Therapeutics has established a patient support program designed to help individuals navigate insurance and affordability, a crucial component for access to advanced specialty medicines.

Ultimately, the publication of this five-year data marks a step forward in the collective effort to transform multiple sclerosis from an unpredictable, debilitating condition into a manageable one. For a community long defined by uncertainty, this level of sustained data offers a powerful new basis for planning a future with greater confidence.