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This long-term extension study evaluated the durability of ublituximab treatment in adults with relapsing multiple sclerosis who had completed the phase 3 ULTIMATE I and II trials. Of 985 participants completing the original studies, 851 entered the extension. Participants who switched from teriflunomide to ublituximab experienced a 58.4% reduction in annualized relapse rate during the first year after switching, from 0.182 to 0.076 (rate ratio, 0.42; 95% CI, 0.29–0.60; \(p<0.001\)). Among participants who received ublituximab continuously, the annualized relapse rate decreased to 0.020 by year five. At year five, 8.0% of continuously treated participants had 24-week-confirmed disability progression compared with 14.3% of those who initially received teriflunomide before switching (\(p=0.01\)). The safety profile remained consistent with previous trials. Although the findings support sustained disease control, the open-label extension and attrition limit direct causal comparisons between treatment groups.

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This long-term extension study evaluated the durability of ublituximab treatment in adults with relapsing multiple sclerosis who had completed the phase 3 ULTIMATE I and II trials. Of 985 participants completing the original studies, 851 entered the extension. Participants who switched from teriflunomide to ublituximab experienced a 58.4% reduction in annualized relapse rate during the first year after switching, from 0.182 to 0.076 (rate ratio, 0.42; 95% CI, 0.29–0.60; \(p<0.001\)). Among participants who received ublituximab continuously, the annualized relapse rate decreased to 0.020 by year five. At year five, 8.0% of continuously treated participants had 24-week-confirmed disability progression compared with 14.3% of those who initially received teriflunomide before switching (\(p=0.01\)). The safety profile remained consistent with previous trials. Although the findings support sustained disease control, the open-label extension and attrition limit direct causal comparisons between treatment groups.
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