Earlier Initiation of Ublituximab Treatment Is Associated with Improved Disability Outcomes Among Treatment Naïve Participants in ULTIMATE I and II
Derrick Robertson1, Hans-Peter Hartung2, Peiqing Qian3, Sibyl Wray4, Lily Lee5, Koby Mok5, Christopher Garner5, Enrique Alvarez6
1University of South Florida, 2Heinrich Heine University Medical Faculty, 3Swedish Medical Center, 4Hope Neurology, 5TG Therapeutics, 6University of Colorado
Objective:
To evaluate disease progression in treatment naïve participants enrolled in ULTIMATE I and II stratified by time since first MS symptom.
Background:
Ublituximab is a novel monoclonal antibody targeting CD20 and is glycoengineered for enhanced antibody-dependent cellular cytolysis. In the ULTIMATE I and II Phase 3 studies ublituximab significantly reduced annualized relapse rate and radiologic disease activity vs teriflunomide. Delay in treatment has shown to increase MS patients’ likelihood of future disability progression, and early initiation of treatment can be beneficial in limiting this risk.
Design/Methods:
The Phase 3 ULTIMATE I (N=549) and II (N=545) studies evaluated ublituximab 450 mg IV infusion every 24 weeks or teriflunomide 14 mg oral once daily for 96 weeks. Pooled post hoc analyses evaluated disability measures in participants that were treatment naïve prior to enrollment stratified by time since first MS symptom.
Results:
In treatment naïve participants that had their first MS symptom ≤ 3 years prior to enrollment, significant improvement at week 96 in EDSS score was observed for ublituximab (N=139) vs teriflunomide (N=140) [-0.16 and 0.02 respectively (P=0.0086)]. Similarly, treatment naïve participants having their first MS symptoms > 3 years prior to entry, ublituximab (N=206) demonstrated a numerical improvement in EDSS score vs teriflunomide (N=237) from baseline to week 96 [-0.10 and 0.01 respectively (P=0.0511)]. Improvements in the change from baseline to week 96 in the MSFC z-score were observed for ublituximab vs. teriflunomide but were more pronounced in patients that initiated treatment early (≤ 3 years cohort: ublituximab 0.32, teriflunomide 0.09; 3.6 times improvement. > 3 years cohort: ublituximab 0.63, teriflunomide 0.36; 1.8 times improvement).
Conclusions:
In post hoc analyses of ULTIMATE studies, earlier ublituximab treatment was associated with improved disability outcomes measured by EDSS and MSFC versus teriflunomide in treatment naïve participants stratified by time since first MS symptom.