TG Therapeutics’ BRIUMVI Reports 0.020 ARR and Consistent Safety at Year Five
TG Therapeutics’ BRIUMVI achieved an annualized relapse rate of 0.020 in year five of the ULTIMATE I & II open-label extension, with 97.7% of continuous-treatment patients relapse-free and 70% remaining on therapy. Its safety profile remained consistent over five years, with no new safety signals emerging.
1. Publication of Five-Year Open-Label Extension Data
TG Therapeutics released five-year efficacy and safety results from its ULTIMATE I & II open-label extension study, covering over 3,600 participant-years of ublituximab exposure and enrolling more than 85% of eligible patients after the initial double-blind period.
2. Durable Efficacy Across Five Years
Continuous BRIUMVI treatment yielded annualized relapse rates of 0.053, 0.032 and 0.020 in years three, four and five respectively, while 97.7% of continuous-treatment patients and 95.0% of those switched from teriflunomide remained relapse-free at year five.
3. Consistent Safety Profile
Over five years, adverse event rates remained stable with no new safety signals detected; immunoglobulin levels stayed above normal limits and there was no association between immunoglobulin changes and serious infections.
4. Strong Retention and Adoption Implications
With over 70% of participants remaining on BRIUMVI at year five, 8% experiencing confirmed disability progression versus 14.3% in the switch group, and 17% achieving sustained disability improvement, the data underscore long-term tolerability and support early high-efficacy treatment decisions.