The use of ublituximab therapy for patients with highly active relapsing multiple sclerosis (RMS) led to clinically meaningful, statistically significant improvements in cognitive processing speed, according to study results presented at the 2022 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) held from June 1-4, in National Harbor, Maryland.
The researchers sought to evaluate changes in cognitive processing speed with the use of the Symbol Digit Modalities Test (SDMT) among patients with highly active RMS. Ublituximab is a novel monoclonal antibody that targets a unique epitope on the CD20 antigen. ULTIMATE I enrolled a total of 549 participants and ULTIMATE II enrolled a total of 545 patients.
The phase 3 ULTIMATE I and ULTIMATE II studies were conducted to assess treatment with ublituximab 450 mg, administered by 1-hour IV infusion every 24 weeks (following day 1 IV infusion of ublituximab 150 mg and day 15 IV infusion of ublituximab 450 mg) or teriflunomide 14 mg administered orally once daily for 96 weeks in patients with RMS.
Pooled post hoc analysis was used to assess the change from baseline in SDMT scores in patients with highly active RMS at baseline, which was defined as having received prior disease-modifying therapy (DMT) and having experienced 1 or more relapses in the past year and either 1 or more gadolinium-enhancing lesions or 9 or more T2 lesions at baseline.
Study findings revealed that in patients with highly active RMS at baseline, the mean baseline SDMT scores were 49.8 and 48.2 in the 181 participants treated with ublituximab and the 158 participants treated with teriflunomide, respectively. At week 24, week 48, and week 96, the mean changes from baseline were 2.8 vs 1.2, 3.8 vs 2.7, and 5.0 vs 2.5, respectively, with ublituximab therapy compared with teriflunomide therapy. At week 96, this difference was statistically significant (P =.0205).
The researchers concluded, “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,” in patients with highly active RMS at baseline who previously received DMT.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Robertson D, Steinman L, Fox EJ, et al. Improved cognitive processing speed with ublituximab in patients with highly active relapsing multiple sclerosis. Presented at: CMSC 2022 Annual Meeting; June 1-4, 2022; National Harbor, Maryland. Abstract DMT19.