John Foley1, Tamara Miller2, Sibyl Wray3, Gabriel Pardo4, Martin Belkin5, Jonathan Calkwood6, Derrick Robertson7, Salvatore Napoli8, Christopher LaGanke9, Emily Riser10, Theodore Brown11, Craig Herrman12, John Scagnelli13, April Erwin14, Peiqing Qian15, Peter Sportelli16, Hari Miskin16, Edward Fox16, Chris Garner16, Chris Rowland16, Barry Singer17
1Rocky Mountain MS Clinic, 2Advanced Neurology of Colorado LLC, 3Hope Neurology, 4Oklahoma Medical Research Foundation, 5Michigan Institute for Neurological Disorders, 6Minnesota Center for MS, 7University of South Florida, 8Neurology Center of New England, 9North Central Neurology Associates, PC, 10Alabama Neurology Associates, 11MS Center At Evergreen, 12JWM Neurology, 13Velocity Clinical Research, 14Rocky Mountain Multiple Sclerosis Clinic, 15Swedish Medical Center, 16TG Therapeutics, 17MS Center for Innovations in Care
Objective:
To describe a modified dosing regimen in the ENHANCE study evaluating ublituximab in participants with relapsing multiple sclerosis (RMS) who are treatment-naïve or transitioning from other disease modifying therapies.
Background:
Ublituximab is an anti-CD20 monoclonal antibody glycoengineered for enhanced antibody-mediated cellular cytotoxicity that is approved for RMS and administered as 150 mg on Day 1, 450 mg on Day 15, and every 24 weeks thereafter. Previous data from the ENHANCE trial showed that an initial infusion of 450 mg was well-tolerated among participants who had B-cells less than 10 cells/µL.
Design/Methods:
ENHANCE is a 48-week trial evaluating the efficacy of a modified ublituximab regimen that has been recently amended to 600 mg on Day 1 followed by a 30-minute, 450 mg infusion on Week 24. Participants were assigned sequentially to cohorts with decreasing infusion times (4, 3, 2, and 1 hr.) for the first 600 mg dose to identify the optimal infusion duration.
Results:
The primary endpoint is the proportion of participants with no change or reduction in number to T1 Gd-enhancing lesions from baseline to Week 48. Secondary endpoints include the incidence of IRRs, TSQM-9 scores, and the pharmacokinetics of ublituximab. As of the data cutoff, 9 patients received 600 mg as an initial infusion which has been well tolerated.
Conclusions:
Consolidating the Day 1 (150 mg) and Day 15 (450 mg) ublituximab doses into a single 600 mg infusion administered on Day 1 eliminates the need for repeated visits within the first two weeks of initiating treatment and consequently reduces patient burden. Enrollment in ENHANCE is ongoing and full data for this modified regimen will be presented.
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