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Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis

Steinman, Lawrence
Author Steinman, Lawrence From 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.)
Fox, Edward
Author Fox, Edward From 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.)
Hartung, Hans-Peter
Author Hartung, Hans-Peter From 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.)
Alvarez, Enrique
Author Alvarez, Enrique From 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.)
Qian, Peiqing
Author Qian, Peiqing From 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.)
Wray, Sibyl
Author Wray, Sibyl From 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.)
Robertson, Derrick
Author Robertson, Derrick From 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.)
Huang, DeRen
Author Huang, DeRen From 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.)
Selmaj, Krzysztof
Author Selmaj, Krzysztof From 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.)
Wynn, Daniel
Author Wynn, Daniel From 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.)
Cutter, Gary
Author Cutter, Gary From 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.)
Mok, Koby
Author Mok, Koby From 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.)
Hsu, Yanzhi
Author Hsu, Yanzhi From 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.)
Xu, Yihuan
Author Xu, Yihuan From 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.)
Weiss, Michael S
Author Weiss, Michael S From 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.)
Bosco, Jenna A
Author Bosco, Jenna A From 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.)
Power, Sean A
Author Power, Sean A From 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.)
Lee, Lily
Author Lee, Lily From 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.)
Miskin, Hari P
Author Miskin, Hari P From 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.)
Cree, Bruce A C
Author Cree, Bruce A C From 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.)
ULTIMATE I and ULTIMATE II Investigators
Author ULTIMATE I and ULTIMATE II Investigators

The New England journal of medicine. 2022 Aug 25 ; 387 (8) : 704-714.

N Engl J Med
ISSN 1533-4406 | 0028-4793
Source

Language English Country United States Media print

Document type Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial

Persistent link https://www.medvik.cz/link/pmid36001711

PubMed 36001711
DOI 10.1056/nejmoa2201904
Knihovny.cz E-resources

MeSH
Anti-Inflammatory Agents, Non-Steroidal therapeutic use MeSH
Double-Blind Method MeSH
Gadolinium therapeutic use MeSH
Hydroxybutyrates MeSH
Immunosuppressive Agents therapeutic use MeSH
Crotonates MeSH
Humans MeSH
Magnetic Resonance Imaging MeSH
Antibodies, Monoclonal * therapeutic use MeSH
Nitriles MeSH
Multiple Sclerosis, Relapsing-Remitting * complications diagnostic imaging drug therapy pathology MeSH
Multiple Sclerosis complications diagnostic imaging drug therapy pathology MeSH
Toluidines MeSH
Check Tag
Humans MeSH
Publication type
Journal Article MeSH
Clinical Trial, Phase III MeSH
Randomized Controlled Trial MeSH
Names of Substances
Anti-Inflammatory Agents, Non-Steroidal MeSH
Gadolinium MeSH
Hydroxybutyrates MeSH
Immunosuppressive Agents MeSH
Crotonates MeSH
Antibodies, Monoclonal * MeSH
Nitriles MeSH
teriflunomide MeSH Browser
Toluidines MeSH
ublituximab MeSH Browser

BACKGROUND: The monoclonal antibody ublituximab enhances antibody-dependent cellular cytolysis and produces B-cell depletion. Ublituximab is being evaluated for the treatment of relapsing multiple sclerosis. METHODS: In two identical, phase 3, double-blind, double-dummy trials (ULTIMATE I and II), participants with relapsing multiple sclerosis were randomly assigned 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 end point was the annualized relapse rate. Secondary end points included the number of gadolinium-enhancing lesions on magnetic resonance imaging (MRI) by 96 weeks and worsening of disability. RESULTS: 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<0.001); in the ULTIMATE II trial, the annualized relapse rate was 0.09 and 0.18, respectively (rate ratio, 0.51; 95% CI, 0.33 to 0.78; P = 0.002). The mean number of gadolinium-enhancing lesions was 0.02 in the ublituximab group and 0.49 in the teriflunomide group (rate ratio, 0.03; 95% CI, 0.02 to 0.06; P<0.001) in the ULTIMATE I trial and 0.01 and 0.25, respectively (rate ratio, 0.04; 95% CI, 0.02 to 0.06; P<0.001), in the ULTIMATE II trial. In the pooled analysis of the two trials, 5.2% of the participants in the ublituximab group and 5.9% in the teriflunomide group had worsening of disability at 12 weeks (hazard ratio, 0.84; 95% CI, 0.50 to 1.41; P = 0.51). Infusion-related reactions occurred in 47.7% of the participants in the ublituximab group. Serious infections occurred in 5.0% in the ublituximab group and in 2.9% in the teriflunomide group. CONCLUSIONS: Among participants with relapsing multiple sclerosis, ublituximab resulted in lower annualized relapse rates and fewer brain lesions on MRI than teriflunomide over a period of 96 weeks but did not result in a significantly lower risk of worsening of disability. Ublituximab was associated with infusion-related reactions. (Funded by TG Therapeutics; ULTIMATE I and II ClinicalTrials.gov numbers, NCT03277261 and NCT03277248.).

From the Beckman Center for Molecular Medicine Stanford University Stanford

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