Ublituximab is a new monoclonal antibody that targets a specific epitope on the antigen CD20. It’s been glycoengineered for improved antibody-dependent cellular cytotoxicity, and it’s given in 1-hour maintenance infusions after the initial. In individuals with relapsing multiple sclerosis (RMS), ublituximab met its primary end aim of a considerably lower annualized relapse rate compared to teriflunomide in the ULTIMATE I and II investigations. The number of gadolinium-enhancing T1 lesions, the number of new/enlarging T2 lesions, and the fraction of patients with no indication of disease activity all improved significantly after treatment with ubituximab. According to the predetermined statistical design for the individual studies, the secondary endpoint of 12-week confirmed disability progression was not fulfilled.
ULTIMATE I (N = 549) and II (N = 545) 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 of 12-week confirmed and unconfirmed disability progression, as well as the Expanded Disability Status Scale (EDSS) score area under the curve (AUC), was conducted. In patients who were confirmed with 12-week disability progression, the mean change from baseline in EDSS score was significant for ublituximab vs teriflunomide at week 84 (0.8 vs 1.2, respectively; P=.047) and week 96 (0.9 vs 1.4, respectively; P=.022). The proportion of patients with disability progression (12-week confirmed or unconfirmed) during the 96-week study period was 15.3% and 25.3% in the ublituximab (n=83) and teriflunomide (n=138) groups, respectively. The time to confirmed or unconfirmed disability progression was significant in favor of ublituximab (stratified hazard ratio, 0.586; 95% CI, 0.443-0.774; P=.0001). The mean AUC change in EDSS score during the study was –0.176 for ublituximab and –0.052 for teriflunomide, a difference of –0.124 (P=.0079). In the ULTIMATE I and II investigations, pooled post hoc analysis revealed a substantial improvement in various indicators of disability progression with ublituximab vs. teriflunomide.