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

29 May 20265 min read0 viewsJournal Feed

GIST (Key Takeaways)

Background. Evidence 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. Objectives.
To 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).Methods. Pooled post hoc analyses of ULTIMATE I/II were conducted at Week 96.Results. The 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.

Clinical Editorial

Summary

Frontiers in Immunology published a clinical update in Infectious Disease on 29 May 2026.

The item focuses on 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.

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