NEW DATA shows that ublituximab delivers sustained control of relapsing multiple sclerosis, with five-year outcomes showing reduced relapse rates and disability progression.
Ublituximab and Long-term Disease Control
Ublituximab is a monoclonal antibody targeting CD20 positive B cells, which play a central role in multiple sclerosis disease activity. Earlier trials showed significant short-term benefits, but long-term outcomes remained uncertain. Researchers extended the ULTIMATE I and II trials to evaluate sustained ublituximab efficacy and safety over five years. Understanding long term performance is essential because relapsing multiple sclerosis often requires lifelong treatment. Durable relapse prevention and disability control may improve patient quality of life and reduce cumulative neurological damage.
Five Year Ublituximab Outcomes
Of 985 adults with relapsing multiple sclerosis who completed the original trials, 851 enrolled in the extension. More than 85% of participants entered the extension, and more than 70% continued ublituximab at year 5. TER-UBL participants experienced a 58.4% ARR reduction at 1 year after the switch 0.182 vs 0.076; rate ratio, 0.42; 95% CI, 0.29-0.60; P < .001, with further decreases to 0.048 year 4 and 0.045 year 5. Continuous UBL-UBL participants achieved ARR reductions to 0.053, 0.032, and 0.020 for years 3, 4, and 5. At year 5, CDP24 was 8.0% vs 14.3% P = .01, and CDI24 was 17.0% vs 12.2% P = .02. Serious infection rates were 2.10 and 2.58 per 100 participant years.
Clinical Implications
These findings confirm sustained benefits of ublituximab over five years, with continued reductions in relapse activity and disability progression. Notably, the year 5 relapse rate of 0.020 equates to one relapse per 50 participant years, highlighting strong disease control. Safety findings remained consistent, with no new safety concerns identified. Early ublituximab initiation appeared more effective than delayed escalation, supporting a treatment strategy focused on early high efficacy therapy. Clinicians may consider ublituximab as a long-term option for maintaining neurological function and reducing progression risk. These long-term data further reinforce the value of sustained B-cell–targeted therapy in altering the trajectory of relapsing multiple sclerosis.
Reference
Cree BAC et al. Five years of ublituximab in multiple sclerosis: ULTIMATE I and II open-label extension study. JAMA Neurol. 2026;DOI:10.1001/jamaneurol.2026.0007.
