We are pleased to share that long‑term data of BRIUMVI® in relapsing multiple sclerosis was published in JAMA Neurology, demonstrating sustained efficacy and a consistent safety profile with up to five years of continuous treatment. The publication highlights the following key long‑term outcomes:
- Sustained reduction in relapses with an ARR of < 0.020 for continuous treatment, equivalent to 1 relapse every 50 patient-years.
- 92% of patients with continuous BRIUMVI® treatment remained free of disability progression (CDP24) after five years.
- 1 in 6 improved motor-function (17% CDI24).
- Favorable long-term safety and tolerability profile, with minimal impact on immunoglobulins.
See below the announcement released on 17/02/2026 by our partner, TG Therapeutics. The full press release is attached.
Long-Term Data Published in JAMA Neurology Demonstrate Sustained Efficacy and Consistent Safety of BRIUMVI in Relapsing Multiple Sclerosis
February 17, 2026
During year 5 of treatment with BRIUMVI the annualized relapse rate was 0.020, equivalent to one relapse occurring every 50 years of patient treatment
Overall safety profile of BRIUMVI remained consistent over 5 years of continuous treatment, with no new safety signals emerging with prolonged treatment
NEW YORK, Feb. 17, 2026 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the publication of long term/five-year data from the ongoing open-label extension (OLE) of the Phase 3 ULTIMATE I and II studies evaluating BRIUMVI (ublituximab-xiiy) in adults with relapsing forms of multiple sclerosis (RMS). The manuscript, authored by Bruce A. C. Cree, MD, PhD, MAS, of the University of California, San Francisco, and colleagues, was published in JAMA Neurology. The publication presents a comprehensive long-term evaluation of BRIUMVI and demonstrates durable clinical efficacy, low relapse rates, and a consistent safety profile with up to five years of continuous treatment. Additional details from the publication are included below.
Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, “Acceptance of these five-year ULTIMATE I & II results in JAMA Neurology represents a major milestone for TG Therapeutics and the MS field. 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. We believe these findings support BRIUMVI’s continued role as a valuable option for people living with relapsing MS.”
Bruce Cree, MD, PhD, MAS, Zimmermann Endowed Professor in Multiple Sclerosis, and Professor of Neurology at UCSF Weill Institute for Neurosciences, University of California, San Francisco and lead author of this publications noted, “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. 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.”
The manuscript can be accessed at the JAMA Neurology website or at our TG Therapeutics publication page.
Five Years of Ublituximab in Multiple Sclerosis: ULTIMATE I and II Open-Label Extension Study
The research article reports clinical outcomes from more than 3,600 participant-years of ublituximab exposure. Following completion of the original 96-week double-blind period, more than 85% of eligible participants elected to enroll in the long-term OLE, where they either continued ublituximab or switched from teriflunomide to ublituximab. More than 70% remained on treatment at Year 5, underscoring strong long-term tolerability and treatment adherence.
Key Efficacy Results
- Patients who continued BRIUMVI treatment exhibited low and decreasing annualized relapse rate (ARR) throughout the observation period, ARR: 0.053, 0.032, and 0.020 for Years 3, 4, and 5, respectively.
- During Year 1 of the open label extension (OLE), patients who switched from teriflunomide to BRIUMVI experienced a significant reduction (-58.4%) in ARR (0.182 vs 0.076).
- At Year 5, 97.7% of continuous-treatment participants and 95.0% of switch participants remained relapse-free.
- After 5 years of continuous BRIUMVI treatment, 8% of patients had Confirmed Disability Progression (CDP) lasting 24 weeks compared to 14.3% of patients who switched from teriflunomide to BRIUMVI [HR (95% CI): 0.612 (0.414, 0.904); p=0.0126], and 92% remained progression free with continuous BRIUMVI treatment.
- 17% of patients treated with BRIUMVI continuously for 5 years achieved Confirmed Disability Improvement (CDI) lasting at least 24 weeks compared to 12.2% of patients who switched from teriflunomide to BRIUMVI [HR (95% CI): 1.472 (1.048, 2.067); p=0.0249], resulting in one in six patients experiencing improvement in disability after 5 years of continuous BRIUMVI treatment.
- The overall safety profile of BRIUMVI remained consistent over 5 years of continuous treatment in an exposure-adjusted analysis of adverse events (AEs), with no new safety signals emerging with prolonged treatment.
- Immunoglobulin levels remained stable with prolonged BRIUMVI treatment, and the mean IgM and IgG levels remained above the lower limit of normal. There was no association between decreased immunoglobulin levels and risk of serious infections.
ABOUT THE ULTIMATE I & II PHASE 3 TRIALS
ULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or teriflunomide, the active comparator, given orally as a 14 mg daily dose with IV placebo administered on the same schedule as BRIUMVI. Both studies enrolled patients who had experienced at least one relapse in the previous year, two relapses in the previous two years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline. The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were
led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University. Additional information on these clinical trials can be found at https://clinicaltrials.gov/(NCT03277261; NCT03277248).