BRIUMVI® and the ECTRIMS 2025 Symposium: Shaping the Future of MS Treatment

As the landscape for multiple sclerosis (MS) therapies continues to evolve, TG Therapeutics is making a compelling case for the long-term role of BRIUMVI® (ublituximab-xiiy) in managing relapsing forms of the disease. At this year’s European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Annual Meeting in Barcelona, the company will unveil a suite of data—including six-year results from its pivotal ULTIMATE I and II trials—that point to sustained efficacy and a favorable safety profile for BRIUMVI in patients with relapsing multiple sclerosis (RMS).

BRIUMVI, a glycoengineered anti-CD20 monoclonal antibody, was approved for the treatment of RMS in the U.S. in late 2022. Designed for twice-yearly administration following an initial titration dose, BRIUMVI offers a streamlined infusion schedule that has positioned it as a competitive alternative to other anti-CD20 therapies like ocrelizumab and ofatumumab. The latest data further affirm its staying power—not just in trials, but increasingly in real-world settings.

Leading the charge at ECTRIMS is Dr. Bruce Cree of the UCSF Weill Institute for Neurosciences, who will present long-term efficacy and safety findings from the open-label extension of the ULTIMATE trials. The studies originally enrolled over 1,000 RMS patients across 10 countries and compared BRIUMVI to teriflunomide over a 96-week period. Now, with six years of cumulative follow-up, the results suggest that the benefits of BRIUMVI extend well beyond the initial treatment window.

Although full data will be shared during the live presentation, the expectation is that sustained suppression of disease activity—particularly relapses and MRI lesion accumulation—will be a central theme. This kind of long-range data is crucial in MS, a chronic disease where treatment durability and long-term safety carry equal weight in clinical decision-making.

Complementing the extension data, TG Therapeutics will also present new findings from the ENHANCE study, which explores a modified dosing regimen of BRIUMVI. According to Dr. Barry Singer, Director of the MS Center for Innovations in Care in St. Louis, this research may offer insights into optimizing administration protocols for better tolerability and patient experience. While the core regimen of BRIUMVI is already more time-efficient than some legacy therapies—requiring only one-hour infusions every six months—the possibility of even more patient-centric flexibility could be a differentiator in clinical practice.

Further extending the drug’s footprint into routine care, Dr. Carrie Hersh of the Cleveland Clinic Lou Ruvo Center for Brain Health will present real-world results from the ENABLE study—the first Phase 4 observational study of BRIUMVI in RMS. This dataset is especially valuable as it provides early insight into how the drug performs outside the controlled environment of clinical trials. Real-world data often reveal nuances in tolerability, adherence, and patient-reported outcomes that can significantly influence therapeutic positioning.

Taken together, these presentations reflect a broader ambition by TG Therapeutics: to embed BRIUMVI not only as a viable alternative in the anti-CD20 space, but potentially as a frontline option for long-term RMS management. The drug’s competitive edge lies in its combination of efficacy, tolerability, and infusion convenience—a trifecta that addresses both physician and patient priorities in a treatment-saturated market.

The original ULTIMATE I & II trials, led by Dr. Lawrence Steinman of Stanford University, demonstrated that BRIUMVI significantly reduced annualized relapse rates and MRI activity compared to teriflunomide. Importantly, those benefits were achieved with an infusion protocol that reduces chair time and potentially lowers the burden on infusion centers—a logistical advantage that’s increasingly relevant in today’s healthcare environment.

As BRIUMVI continues to gain traction in the post-approval setting, these long-term and real-world data may serve as critical proof points for clinicians weighing treatment options. With anti-CD20 therapies now a cornerstone of MS care, distinguishing between agents on the basis of durability, safety, and patient preference is more important than ever.