Briumvi®
ublituximab-xiiy
Quick Facts
Briumvi® is an immunosuppressant monoclonal antibody that targets CD20.
In-clinic intravenous infusion
Given every 24 weeks, following the initial dosing
Relapsing forms of multiple sclerosis (MS) in adults – including clinically isolated syndrome, relapsing-remitting MS, and active secondary-progressive MS
Potential Benefit:
Compared to the oral medication, Aubagio® (teriflunomide) in two identical studies, relapse rate was 0.08 in the Briumvi® group versus 0.19 in the Aubagio group in the first study and 0.09 and 0.18, respectively, in the second.
The mean number of T1 gadolinium-enhancing lesions was 0.02 and 0.01 in the Briumvi® groups versus 0.49 and 0.25, respectively, in the Aubagio groups. The mean number of new or enlarging T2 hypointense lesions was 0.21 and 0.28 in the Briumvi® groups versus 2.79 and 2.83 in the Aubagio groups.
In the two studies, “no evidence of disease activity” (NEDA) was seen in 44.6% and 43%, respectively, of those treated with Briumvi®, versus 15.0% and 11.4%, respectively, of those receiving Aubagio.
Common Potential Side Effects
Infusion-related reactions, infections, headache, nasopharyngitis (cold symptoms), pyrexia (fever), and nausea.
Prescription Assistance:
For assistance finding additional resources that might help cover the costs of your prescription, contact MSAA.
Hear from the Expert
Larry Steinman, MD
“We are making great progress, and these drugs that are approved really do work and have a very high potential of improving lives and shutting down the disease.”
DRUGMAKER
TG Therapeutics
HOW Briumvi® WORKS
Briumvi® (ublituximab-xiiy) is a monoclonal antibody that targets CD20, a protein found on the surface of B cells, and induces B-cell depletion within 24 hours. B cells are white blood cells shown to play a role in MS.
Briumvi® is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.
FDA-Approved
In 2022, Briumvi® was approved for the treatment of relapsing forms of multiple sclerosis (MS) in adults – including clinically isolated syndrome, relapsing-remitting MS, and active secondary-progressive MS.
Potential Side Effects
In studies, the most common adverse event was infusion-related reactions, often causing fever, headache, chills, and/or flu-like symptoms. Other side effects included headache, nasopharyngitis (cold symptoms), pyrexia (fever), and nausea.
Studies also showed that just over half of trial participants experienced infections. Most were related to the respiratory tract, but urinary tract infections and herpes virus infections were seen in smaller percentages of participants.
Serious and life-threatening infections were seen in 5% of study participants taking Briumvi®. Three infection-related deaths occurred with Briumvi®-treated patients. Administration of Briumvi® should be delayed in patients experiencing active infection.
OTHER KEY INFORMATION
Although cases of progressive multifocal leukoencephalopathy (PML) have been reported in patients taking other anti-CD20 antibodies, no cases of PML occurred during the 96-week period. Additionally, no opportunistic infections were reported.
Testing needed prior to and/or during treatment:
- All patients should be screened for HBV prior to starting Briumvi® and anyone with active HBV should not be given Briumvi®.
- Results of animal studies suggest that Briumvi® may harm the fetus if given to a pregnant woman. For this reason, women who could become pregnant should be given a pregnancy test prior to starting Briumvi® as well as prior to each infusion. Effective contraception is recommended during treatment with Briumvi® and for six months after discontinuing treatment.
- Decreased immunoglobulin levels can occur with any B-cell depleting therapy, so quantitative serum immunoglobulins levels should be monitored during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy until B-cell repletion.
Patient advocates talk about
their treatment experience
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Kristie Salerno Kent
“I have had situations where treatments aren’t approved at first. My doctors, nurses, they actually go to bat for me and made it happen.” -
Azure Antoinette
"I will be undergoing my first disease-modifying therapy to help treat multiple sclerosis in my body and while I’m very nervous, I am equally as excited and looking forward to the positive effects of how I will feel physically, and mentally, and emotionally." -
Damian Washington
“Nobody’s going to be looking out for your best interests better than you.” -
Cathy Chester
“I think it’s really important to talk about how to age with this illness.” -
Lauren Hutton-Work
“Just because you have this disease does not mean that your work life should be awkward or uncomfortable.” -
Chernise Joseph
“My first neurologist was a frontline neurologist, he wasn’t an MS specialist.” -
Julian Gamboa
“If you’re newly diagnosed with multiple sclerosis remember it’s always okay to get a second opinion.” -
Lauren and Sam Alcorn
“Our future is uncertain and we have to enjoy each other and love each other in the present.” -
Shawn Feliciano
“I want to know what medications might work best for someone who’s Hispanic.” -
Darlene Feigen
“The sooner you get on a therapy the better it is in the long run.” -
Birgit Bauer
“At the end of the appointment you should have an answer to the most important questions.” -
Ellen Tutton
“I looked up all the different disease-modifying therapies and compared them to my lifestyle.” -
Victoria Marie Reese
“I’m trying to show my daughter that taking care of yourself is cool.”
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