Ublituximab, a monoclonal antibody, enhances antibody-dependent cell cytolysis and produces B cell depletion. Ublituximab is being evaluated for the treatment of relapsing multiple sclerosis.


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In two identical Phase 3, double-blind, double-sham trials (ULTIMATE I and II), participants with relapsing multiple sclerosis were randomized in a 1:1 ratio to receive intravenous ublituximab ( 150 mg on day 1, followed by 450 mg on day 15 and at weeks 24, 48, and 72) and oral placebo or oral teriflunomide (14 mg once daily) and intravenous placebo. The primary endpoint was the annualized relapse rate. Secondary endpoints included the number of gadolinium-enhancing lesions on magnetic resonance imaging (MRI) at 96 weeks and worsening of disability.


A total of 549 participants were enrolled in the ULTIMATE I trial and 545 were enrolled in the ULTIMATE II trial; the median follow-up was 95 weeks. In the ULTIMATE I trial, the annualized relapse rate was 0.08 with ublituximab and 0.19 with teriflunomide (rate ratio: 0.41; 95% confidence interval [CI], 0.27 to 0.62; P


In participants with relapsing multiple sclerosis, ublituximab resulted in lower annualized relapse rates and less brain damage on MRI than teriflunomide over 96 weeks, but did not result in a significantly lower risk lower rate of disability aggravation. Ublituximab has been associated with infusion-related reactions. (Funded by TG Therapeutics; ULTIMATE I and II numbers, NCT03277261 and NCT03277248.)

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Ublituximab in relapsing multiple sclerosis