Five Years of Ublituximab in Multiple Sclerosis: ULTIMATE I and II Open-Label Extension Study

Area of Science:

• Neurology
• Immunology
• Clinical Trials

Background:

• Relapsing forms of multiple sclerosis (RMS) require effective long-term treatment strategies.
• Ublituximab demonstrated significant disease activity reduction versus teriflunomide in initial studies.

Purpose of the Study:

• To evaluate the long-term clinical efficacy and safety of ublituximab in participants with RMS.
• To assess sustained benefits of continuous ublituximab treatment versus switching from teriflunomide.

Main Methods:

• Phase 3 ULTIMATE I and II studies included a 2-year double-blind period followed by an open-label extension (OLE).
• Participants continued ublituximab (UBL-UBL) or switched from teriflunomide to ublituximab (TER-UBL) in the OLE.
• Efficacy outcomes included annualized relapse rate (ARR), 24-week confirmed disability progression (CDP24), and 24-week confirmed disability improvement (CDI24).

Main Results:

• Over 5 years, UBL-UBL participants showed further ARR reductions (0.020 at year 5), while TER-UBL participants experienced a 58.4% ARR reduction after switching.
• At year 5, CDP24 was 8.0% for UBL-UBL vs 14.3% for TER-UBL (P=.01), and CDI24 was 17.0% for UBL-UBL vs 12.2% for TER-UBL (P=.02).
• Safety profile remained consistent with pivotal trials; serious infection rates were comparable between groups, irrespective of immunoglobulin levels.

Conclusions:

• Five years of ublituximab treatment sustains significant clinical benefits in RMS, including reduced relapse rates and disability progression.
• Early initiation of high-efficacy ublituximab treatment is associated with long-term positive outcomes.
• Ublituximab offers a valuable long-term therapeutic option for individuals with relapsing multiple sclerosis.