DMT19
Improved Cognitive Processing Speed with Ublituximab in Patients with Highly Active Relapsing Multiple Sclerosis

Thursday, June 2, 2022
Prince George's Exhibit Hall (Gaylord National Resort & Convention Center)
Derrick Robertson, MD , University of South Florida, Tampa, FL
Lawrence Steinman, MD , Beckman Center for Molecular Medicine, Stanford University Medical Center, Stanford, CA
Edward J Fox, MD, PhD , Central Texas Neurology Consultants, Round Rock, TX
Hans-Peter Hartung, MD , Heinrich Heine University, Dusseldorf, Germany, Department of Neurology, Medical University of Vienna, Vienna, Austria, Brain and Mind Centre, University of Sydney, Sydney, Australia, Department of Neurology, Palacky University, Olomouc, Czech Republic
Enrique Alvarez, MD, PhD , University of Colorado, Aurora, CO
Peiqing Qian, MD , Swedish Medical Center, Seattle, WA
Sibyl Wray, MD , Hope Neurology MS center, Knoxville, TN
DeRen Huang, MD, PhD , Center for Multiple Sclerosis, Mount Carmel Health System, Westerville, OH
Krysztof Selmaj, MD, PhD , Center of Neurology, Lodz, Poland, Department of Neurology, University of Warmia & Mazury, Olsztyn, Poland
Daniel Wynn, MD , Consultants in Neurology MS Center, Northbrook, IL
Koby Mok, PhD , TG Therapeutics, New York, NY
Christopher A Garner, PA-C , TG Therapeutics Inc, New York, NY
Bruce A Cree, MD, PhD, MAS , UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA
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Background: Ublituximab is a novel monoclonal antibody targeting a unique epitope on the CD20 antigen. It is glycoengineered for enhanced antibody-dependent cellular cytotoxicity and is administered in 1-hour maintenance infusions after the first infusion. In the ULTIMATE I and II Phase 3 studies in patients with relapsing multiple sclerosis (RMS), ublituximab met its primary endpoint of significantly reduced annualized relapse rate vs teriflunomide. Ublituximab provided significant improvements in the number of gadolinium-enhancing (Gd+) T1 lesions and new/enlarging T2 lesions and no evidence of disease activity vs teriflunomide. In a pooled post hoc analysis, ublituximab was associated with a 4.1 increase in Symbol Digits Modalities Test (SDMT) score from baseline to 96 weeks, considered a clinically meaningful improvement.

Objectives: To evaluate changes in cognitive processing speed using the SDMT in patients with highly active disease at baseline in the ULTIMATE I and II studies.

Methods: The Phase 3 ULTIMATE I (N=549) and II (N=545) studies evaluated ublituximab 450 mg intravenous 1-hour infusion every 24 weeks (following Day 1 infusion of 150 mg and Day 15 infusion of 450 mg) or teriflunomide 14 mg oral once daily for 96 weeks in patients with RMS. Pooled post hoc analyses evaluated the change from baseline in SDMT score in patients with highly active disease at baseline, defined as having received prior approved disease-modifying therapy (DMT) and having had ≥1 relapse in the prior year and either ≥1 Gd+ lesion or ≥9 T2 lesions at baseline. P values were analyzed by t test. An improvement of ≥4 points is considered clinically meaningful.

Results: In patients with highly active disease at baseline, the mean baseline SDMT score was 49.8 and 48.2 for the ublituximab (n=181) and teriflunomide (n=158) groups, respectively. The mean change from baseline was 2.8 vs 1.2, 3.8 vs 2.7, and 5.0 vs 2.5 for ublituximab vs teriflunomide at Weeks 24, 48, and 96, respectively. The difference at Week 96 was statistically significant: P=0.0205.

Conclusions: In patients with highly active RMS at baseline who had received prior DMT, ublituximab treatment provided clinically meaningful and statistically significant improvement in cognitive processing speed as measured by SDMT at 96 weeks vs teriflunomide in the ULTIMATE I and II studies.

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