Briumvi (ublituximab) is an antibody treatment given in the vein that removes B cells in the body. The first dose is 150 mg given over 4 hours, followed by 450 mg dose over 1 hour 2 weeks later. Follow-up doses are 450 mg over 1 hour every 6 months.
In the ULTIMATE I and II trials, a total of 1094 relapsing multiple sclerosis patients were randomly assigned to I.V. Briumvi and oral placebo or oral teriflunomide and I.V. placebo. Relapses were 59% lower on Briumvi than teriflunomide in ULTIMATE I trial and 49% lower in ULTIMATE II. Active, contrast-enhancing MRI brain lesions were reduced 96-97% on Briumvi compared to teriflunomide. New or enlarging T2 lesions were reduced by 90-92% on Briumvi compared to teriflunomide. Disability progression was not significantly different between Briumvi and teriflunomide despite planned combining data from both trials (5.2% progressed on Briumvi and 5.9% on teriflunomide).
In the clinical trials, Briumvi treatment was associated with infusion-related reactions (47.7%), headache, upper respiratory infection, fever and nausea. Herpes virus–associated infections such as cold sores and shingles occurred in 5.7% of ublituximab recipients and in 4.6% of teriflunomide recipients.