Relapsing Multiple Sclerosis
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New Data for BRIUMVI® Demonstrate 89.9% of Patients with Relapsing Multiple Sclerosis Were Free from Disability Progression After 6 Years of Continuous BRIUMVI Treatment
Globenewswire· 2025-09-24 13:10
Core Insights - TG Therapeutics announced updated six-year data for BRIUMVI (ublituximab-xiiy) showing a low annualized relapse rate of 0.012, indicating one relapse every 83 years of treatment [1][2] - The overall safety profile of BRIUMVI remained consistent over six years, with no new safety signals emerging [1][3] Efficacy and Safety Data - After six years of continuous treatment, 89.9% of patients remained free from disability progression, and 10.1% experienced confirmed disability progression lasting 24 weeks [3] - The annualized relapse rates decreased over the years: 0.053 in Year 3, 0.032 in Year 4, 0.020 in Year 5, and 0.012 in Year 6 [3] - 17% of patients achieved confirmed disability improvement lasting at least 24 weeks compared to 13.3% of those who switched from teriflunomide to BRIUMVI [3] Clinical Trial Background - The ULTIMATE I & II trials involved 1,094 patients with relapsing forms of multiple sclerosis (RMS) across 10 countries, comparing BRIUMVI to teriflunomide [5][29] - BRIUMVI is administered as an IV infusion, with a dosing regimen designed to optimize patient convenience and minimize infusion-related reactions [5][6] Real-World Observations - In the ENABLE observational study, 99.5% of participants reported no relapses on BRIUMVI, with infusion durations consistent with clinical trial expectations [9] - The safety profile in real-world settings was consistent with clinical trial data, showing lower rates of infusion-related reactions compared to pivotal studies [9] Company Overview - TG Therapeutics is focused on developing novel treatments for B-cell diseases, with BRIUMVI approved for RMS in the U.S. and Europe [29][30] - The company emphasizes the importance of early treatment with ublituximab for better disability outcomes in RMS patients [2][29]