Disease outcomes with ublituximab in treatment-naïve participants: subpopulation analyses of the phase 3 ULTIMATE I and II studies in participants with relapsing multiple sclerosis

BackgroundEvidence suggests that treating relapsing multiple sclerosis (RMS) initially with a high-efficacy disease-modifying therapy (DMT) is superior to an escalating approach at reducing disability progression and relapse rate.ObjectivesTo evaluate the efficacy of ublituximab versus teriflunomide in participants without prior DMT (treatment-naïve population) and in a subset of treatment-naïve participants with symptom onset ≤ three years (early treatment subpopulation).MethodsPooled post hoc analyses of ULTIMATE I/II were conducted at Week 96.ResultsThe annualized relapse rate was 0.081 for ublituximab (n = 345) versus 0.188 for teriflunomide (n = 377) (p < 0.001) in the treatment-naïve population and 0.130 for ublituximab (n = 139) versus 0.334 for teriflunomide (n = 140) in the early treatment subpopulation (p = 0.004). Twelve-week confirmed disability improvement rates were 10.7% versus 5.3% (p = 0.010) in the treatment-naïve population and 14.4% versus 3.6% (p = 0.002) in the early treatment population (ublituximab vs.

teriflunomide). Significant reductions in gadolinium-enhancing T1 lesions and new/enlarging T2 lesions, respectively, occurred for ublituximab versus teriflunomide (treatment naïve: 0.031 vs.

0.791 and 0.390 vs. 4.144; p < 0.001 for both; early treatment: 0.051 vs.