Safety and Tolerability of a Modified Ublituximab Dosing Regimen: Updates From the ENHANCE Study
Barry Singer1, Craig Herrman2, Derrick Robertson3, Idanis Berrios Morales4, Sidarth Dasari5, Jonathan Calkwood6, Mary Hughes7, John Scagnelli8, Alise Carlson9, Theodore Brown10, Lawrence Goldstick11, Gabriel Pardo12, Sibyl Wray13, Michael Sy14, Martin Belkin15, Ahmed Obeidat16, Emily Riser17, Peiqing Qian18, Salvatore Napoli19, Christopher LaGanke20, Peter Sportelli21, Hari Miskin21, Edward Fox21, Chris Rowland21, John Foley22
1MS Center for Innovations in Care, 2JWM Neurology, 3University of South Florida, 4University of Massachusetts Medical School, 5Advanced Neurology of Colorado, 6Minnesota Center for MS, 7Premier Neurology, PC, 8Raleigh Neurology Associates, 9Cleveland Clinic Mellen Center, 10EvergreenHealth, 11University of Cincinnati UC Physcians Department of Neurology, 12Oklahoma Medical Research Foundation, 13Hope Neurology, 14University of California, Irvine, 15Michigan Institute for Neurological Disorders, 16Medical College of Wisconsin, 17Alabama Neurology Associates, 18Swedish Medical Center, 19Neurology Center of New England, 20North Central Neurology Associates, PC, 21TG Therapeutics, 22Rocky Mountain MS Clinic
Objective:
To provide comprehensive safety data on consolidating the initial 150 mg and 450 mg doses into a single 600 mg ublituximab infusion in participants with relapsing multiple sclerosis 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 ublituximab infusion of 600 mg was well-tolerated regardless of B-cell depletion status. Updated safety data encompasses all participants who received 600 mg ublituximab doses in single-arm cohorts.
Design/Methods:
ENHANCE is a 48-week trial evaluating the efficacy of a modified ublituximab regimen: 600 mg on Day 1 followed by a 450 mg infusion on Week 24. Participants received 600 mg at varying infusion times (1-4 hours). The Treatment Satisfaction Questionnaire for Medication (TSQM)-9 was administered at Weeks 24 and 48.
Results:
Overall, 221 participants have received initial ublituximab infusions of 600 mg with 90% completed without interruption or slowing. The incidence of infusion-related reactions (IRRs) was 15.4%, 27.9%, 30.6%, and 27.8% for durations of 1, 2, 3, and 4 hours, respectively. All IRRs completely resolved and were generally self-limiting with 12% requiring supportive medication. The most common symptoms were throat irritation and headache. Week 24 TSQM-9 scores demonstrated that 97.1% of participants reported 600 mg infusions were convenient and easy to use.
Conclusions:
Consolidating Day 1 (150 mg) and Day 15 (450 mg) infusions into a single 600 mg dose was well-tolerated across each duration evaluated. 600 mg infusions resulted in high levels of patient satisfaction on the dimensions of convenience and ease of use.
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