Long Term Data Published in JAMA Neurology Demonstrate Sustained Efficacy and Consistent Safety of BRIUMVI in Relapsing Multiple Sclerosis

Core Insights - TG Therapeutics announced five-year data from the ongoing open-label extension of the Phase 3 ULTIMATE I and II studies for BRIUMVI, demonstrating durable clinical efficacy and a consistent safety profile over extended treatment [1][2][3] Efficacy Results - The annualized relapse rate (ARR) for patients on BRIUMVI decreased significantly over five years, with rates of 0.053, 0.032, and 0.020 for Years 3, 4, and 5 respectively, indicating one relapse every 50 years of treatment [4] - 97.7% of continuous-treatment participants and 95.0% of switch participants remained relapse-free at Year 5 [4] - After five years, only 8% of patients on continuous BRIUMVI treatment experienced Confirmed Disability Progression (CDP) lasting 24 weeks, compared to 14.3% for those who switched from teriflunomide [4] - 17% of patients on continuous BRIUMVI achieved Confirmed Disability Improvement (CDI) lasting at least 24 weeks, compared to 12.2% for switch participants [4] Safety Profile - The overall safety profile of BRIUMVI remained consistent over five years, with no new safety signals emerging during prolonged treatment [1][4][5] - Immunoglobulin levels were stable, with no association found between decreased levels and serious infections [5] Study Details - The ULTIMATE I & II trials involved over 3,600 participant-years of ublituximab exposure, with more than 85% of eligible participants opting for the long-term open-label extension [3][6] - The trials enrolled a total of 1,094 patients with relapsing forms of multiple sclerosis across 10 countries [6] Company Overview - TG Therapeutics is focused on developing and commercializing novel treatments for B-cell diseases, with BRIUMVI approved for treating adult patients with relapsing forms of multiple sclerosis [7][10]