Long-term results from the ULTIMATE I (NCT03277261) and II (NCT03277248) clinical trials, including 4 years of open-label extension (OLE), demonstrated durable efficacy and a consistent safety profile for individuals with relapsing multiple sclerosis (RMS) treated with Briumvi (ublituximab-xiiy; TG Therapeutics, New York, NY) as well as superior efficacy in individuals who switched from treatment with Aubagio (teriflunomide; Sanofi, Bridgewater, NJ) to Briumvi. These results were presented at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Adults with RMS who completed the 2-year double-blind period (DBP) of ULTIMATE I and II entered the OLE and received either continuous treatment with Briumvi (n=422) or switched from Aubagio to Briumvi (n=429). Efficacy end points included adjusted annualized relapse rates (ARR) and 24-week confirmed disability progression (CDP24) and improvement (CDI24). Safety assessments included immunoglobulin levels and adverse events.

Key results include the following:

  • In participants switching from Aubagio to Briumvi treatment, ARR fell 58.5% at 1 year (0.182 to 0.075; relative risk [RR] 0.415; 95% CI, 0.288 to 0.597; P<.0001) and decreased further to 0.047 at 4 years, 0.050 at 5 years, and 0.032 at 6 years.
  • In participants treated with continuous Briumvi, ARR declined to 0.053 at 3 years, 0.031 at 4 years, 0.021 at 5 years, and 0.012 at 6 years.
  • At 6 years, CDP24 was 10.1% in participant treated with continuous Briumvi vs 15.9% in participants who switched from Aubagio to Briumvi treatment (hazards ratio [HR] 0.658; 95% CI, 0.457 to 0.948; P=.0238).
  • By 6 years, CDI24 was 17.0% in participant treated with continuous Briumvi vs 13.3%  participants who switched from Aubagio to Briumvi treatment (HR 1.414; 95% CI, 1.015 to 1.970; P=.0396).
  • Mean serum immunoglobulin G (IgG) and immunoglobulin M (IgM) levels remained above the lower limit of normal through 6 years, and adverse events were consistent with the established Briumvi safety profile, with no new signals.

Source: Cree BAC, Fox E, Hartung HP, et al. Long-term efficacy and safety of ublituximab in relapsing multiple sclerosis: results from six years of ULTIMATE I and II open-label extension. Presented at 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2025. Abstract O026.