New Data: 92% of BRIUMVI® Patients with Relapsing MS Free from Disability Progression After 5 Years

TG Therapeutics, Inc. recently unveiled new five-year data from the ULTIMATE I & II Phase 3 trials at the 2024 ECTRIMS annual meeting. These trials evaluated BRIUMVI® (ublituximab-xiiy) for patients with relapsing forms of multiple sclerosis (RMS). Dr. Bruce Cree, a respected neurology professor, emphasized BRIUMVI’s potential to significantly benefit RMS patients, highlighting its sustained efficacy and manageable safety profile over five years. Michael S. Weiss, the company’s CEO, noted that patients receiving BRIUMVI showed sustained clinical benefits, including reduced relapse risks and lower rates of confirmed disability progression over time.

Key data points from the poster presentation revealed that BRIUMVI treatment resulted in low and decreasing annualized relapse rates (ARR) over the observation period. Specifically, the ARR was 0.053, 0.032, and 0.020 for Years 3, 4, and 5, respectively. Patients who switched from teriflunomide to BRIUMVI during the first year of the open-label extension (OLE) experienced a notable 58.4% reduction in ARR. After five years, only 8% of continuous BRIUMVI users showed confirmed disability progression (CDP) compared to 14.3% of patients who switched from teriflunomide, indicating a significant improvement in long-term outcomes.

Furthermore, 92% of patients on continuous BRIUMVI treatment remained progression-free after five years. About 17% of these patients experienced confirmed disability improvement (CDI) for at least 24 weeks, compared to 12.2% of those who switched from teriflunomide. These results suggest that prolonged BRIUMVI use can lead to substantial improvements in disability.

The overall safety of BRIUMVI remained stable with no new safety signals emerging over the five-year treatment period. Immunoglobulin levels were stable, with mean IgM and IgG levels staying above the lower limit of normal. Interestingly, there was no link between decreased immunoglobulin levels and an increased risk of serious infections.

Additional data included a post-hoc analysis comparing Multiple Sclerosis Disease Activity (MSDA) test results between patients treated with BRIUMVI and those treated with teriflunomide during the 96-week ULTIMATE I and II studies. BRIUMVI treatment resulted in significant reductions in disease activity scores and improved biomarkers.

The ULTIMATE I & II trials were large-scale, double-blind studies involving 1,094 patients with RMS across 10 countries. Patients were randomized to receive either BRIUMVI or teriflunomide. The trials were meticulously designed and led by Dr. Lawrence Steinman of Stanford University. These studies required participants to have experienced at least one relapse in the previous year, two relapses in the prior two years, or have had a T1 gadolinium-enhancing lesion in the past year.

BRIUMVI, an anti-CD20 monoclonal antibody, targets B-cells and is glycoengineered for efficient depletion at low doses. It is approved for treating adults with various relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

BRIUMVI's safety profile includes warnings on infusion reactions, serious infections, hepatitis B reactivation, and potential risks of progressive multifocal leukoencephalopathy (PML). Vaccinations, particularly live vaccines, require careful timing in relation to BRIUMVI treatment. There are also specific recommendations for monitoring immunoglobulin levels and managing potential fetal risks during pregnancy.

TG Therapeutics, Inc., is committed to enhancing patient support through specialized programs and continues to advance its pipeline of treatments for B-cell diseases. Their focus remains on developing and commercializing innovative therapies, with BRIUMVI being a significant addition to their portfolio, addressing the needs of patients with relapsing forms of multiple sclerosis.