Ublituximab Effective in Relapsing Multiple Sclerosis

Ublituximab is a chimeric monoclonal antibody engineered for potent antibody-dependent cellular CD20+ B-cell cytolysis, a target of some therapies for multiple sclerosis (MS). In these two phase 3, multicenter, double-blinded, randomized, parallel trials (ULTIMATE I and II) funded by the manufacturer, participants aged 18 to 55 years with relapsing forms of MS and evidence of disease activity in the prior year were randomized to ublituximab or teriflunomide. An initial 150-mg infusion over 4 hours on day 1 was followed by 450 mg over 1 hour on day 15 and then every 6 months.

ULTIMATE I recruited 549 participants and ULTIMATE II 545 participants. Annualized relapse rates during the 96-week follow-up for ULTIMATE I and II were 0.08 and 0.09, r…