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Published on: December 9, 2015
Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis
Lawrence Steinman1, Edward Fox1, Hans-Peter Hartung1
1From the Beckman Center for Molecular Medicine, Stanford University, Stanford (L.S.), and the Weill Institute for Neurosciences, University of California, San Francisco, San Francisco (B.A.C.C.) - both in California; Central Texas Neurology Consultants, Round Rock (E.F.); Heinrich Heine University Medical School, Düsseldorf, Germany (H.-P.H.); the Brain and Mind Centre, University of Sydney, Sydney (H.-P.H.); Medical University of Vienna, Vienna (H.-P.H.); Palacký University Olomouc, Olomouc, Czech Republic (H.-P.H.); University of Colorado, Aurora (E.A.); Swedish Medical Center, Seattle (P.Q.); Hope Neurology, Knoxville, TN (S.W.); University of South Florida, Tampa (D.R.); Columbus Neuroscience, Westerville, OH (D.H.); the Department of Neurology, University of Warmia and Mazury, Olsztyn, and Center of Neurology, Lodz - both in Poland (K.S.); Consultants in Neurology, Northbrook, IL (D.W.); and TG Therapeutics, New York (G.C., K.M., Y.H., Y.X., M.S.W., J.A.B., S.A.P., L.L., H.P.M.).
Ublituximab significantly reduced relapse rates and MRI lesions in relapsing multiple sclerosis patients compared to teriflunomide. However, it did not show a significant difference in disability worsening and was associated with infusion reactions.
Area of Science:
- Immunology and Neurology
- Clinical Trials and Therapeutics
Background:
- Ublituximab is a monoclonal antibody that enhances antibody-dependent cellular cytolysis and causes B-cell depletion.
- It is under investigation for treating relapsing multiple sclerosis (RMS).
Purpose of the Study:
- To evaluate the efficacy and safety of ublituximab compared to teriflunomide in patients with RMS.
- Primary endpoint: annualized relapse rate (ARR).
- Secondary endpoints: MRI gadolinium-enhancing lesions and disability worsening.
Main Methods:
- Two identical Phase 3, double-blind, double-dummy trials (ULTIMATE I and II) were conducted.
- Participants were randomized 1:1 to receive intravenous ublituximab or oral teriflunomide.
- Treatment duration was 96 weeks, with follow-up for approximately 95 weeks.
Main Results:
- Ublituximab significantly lowered ARR in both trials (ULTIMATE I: 0.08 vs 0.19; ULTIMATE II: 0.09 vs 0.18).
- Ublituximab markedly reduced gadolinium-enhancing lesions on MRI compared to teriflunomide (e.g., ULTIMATE I: 0.02 vs 0.49).
- No significant difference in disability worsening was observed between groups (pooled analysis: 5.2% vs 5.9%).
- Infusion-related reactions occurred in 47.7% of ublituximab recipients; serious infections in 5.0%.
Conclusions:
- Ublituximab demonstrated superior efficacy in reducing annualized relapse rates and MRI lesions in RMS patients over teriflunomide.
- The drug did not significantly reduce the risk of disability worsening.
- Infusion-related reactions are a notable side effect of ublituximab treatment.
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