ULTIMATE I, ULTIMATE II studies show ublituximab decreases relapse rate in MS
Ublituximab, an anti-CD20 monoclonal antibody, resulted in a statistically significant decrease in annualized relapse rates among patients with relapsing forms of MS in the ULTIMATE I and ULTIMATE II studies, according to a press release.
“[Ublituximab] is a disease-modifying therapy,” Lawrence Steinman, MD, George A. Zimmermann Professor of Neurology and Neurological Sciences and professor of pediatrics at Stanford University and lead of the ULTIMATE I and II studies, told Healio Neurology. “The relapse rate below the 0.10 level is unprecedented and is better than that seen for the two anti-CD20 monoclonal antibodies that have already been approved.”
The ULTIMATE I and II studies examined the safety and efficacy of a 1-hour, 450-mg infusion of ublituximab every 6 months after the initial infusion of 150 mg over 4 hours on day 1 and a 450-mg infusion over 1 hour on day 15. The phase 3 randomized double-blinded and active-controlled trials were conducted in multiple centers in 10 countries, according to the press release. The researchers compared ublituximab vs. teriflunomide 14-mg oral tablets taken once per day. Annualized relapse rate (ARR) after 96 weeks of treatment served as the primary endpoint.
The studies included 1,094 patients with relapsing forms of MS.
Ublituximab resulted in a statistically significant decrease in ARR during the course of 96 weeks (P < .005 in both trials). The monoclonal antibody also led to an ARR of less than 0.10 in each trial, with a relative decrease in ARR of approximately 60% in ULTIMATE I and 50% in ULTIMATE II over teriflunomide, meeting the primary endpoint in both trials.
These results showed “a stellar impact on the annualized rate of clinical relapses,” Steinman said.
“The topline results represented the first phase 3 outcome of an anti-CD20 monoclonal antibody in relapsing forms of MS to achieve a [less than] 0.10 ARR,” he said. “This has been a barrier we have all wanted to see be broken and I am extremely pleased by the topline results.”
Researchers will next review the entire data set from both trials, including safety and secondary endpoints, according to Steinman. Presentation of those results is expected in the first half of 2021. In addition, data from these studies are expected to support a Biologics License Application submission for ublituximab in relapsing forms of MS in mid-year 2021.