What Briumvi is, how it works, success rates, potential side effects, how it compares to other MS drugs, cost, & more.
The FDA's recent approval of Briumvi (ublituximab or ublituximab-xiiy) has provided a new option for patients with multiple sclerosis (MS).
In this guide, we’ll explore what Briumvi is, how it works, success rates, potential side effects, how it compares to other MS drugs, cost, and more.
What is Briumvi?
Briumvi (ublituximab or ublituximab-xiiy) is an approved disease-modifying therapy used to treat MS patients with relapsing forms of multiple sclerosis, clinically-isolated syndrome (CIS), relapsing-remitting disease, and active secondary progressive disease. It belongs to a class of drugs called Neurologics, Anti-CD20 Monoclonal Antibodies.
Briumvi is a CD20-directed monoclonal antibody that slows disease progression in relapsing multiple sclerosis by depleting immune B-cells.
When was Briumvi approved by the U.S. Food and Drug Administration (FDA)?
On December 28, 2022, FDA approval of Briumvi was announced. As it is a recently authorized medication, it may not be widely available yet since many facilities, particularly those that aren’t specialized in infusion therapy, often take longer to add a new drug into their formulary.
Is Briumvi offered at Local Infusion?
Yes, Local Infusion offers Briumvi in all of their locations, and was proud to be the first center in New England to administer Briumvi in March 2023.
How does Briumvi work?
Briumvi is classified as a monoclonal antibody that is used in the treatment of MS. Although the exact mechanism of action is not fully understood, it is believed to work by inhibiting certain immune cells in the body from attacking the protective sheath surrounding nerve cells, thereby alleviating MS symptoms.
In MS, the immune system unintentionally triggers an inflammatory attack that affects the healthy parts of the central nervous system tissue. These autoimmune assaults are primarily driven by a class of immune cells known as B-cells.
Briumvi specifically targets the B-cell antigen CD20. To lower inflammation that causes MS and lower the body's B-cell count, it binds to CD20.
Briumvi functions like other anti-CD20 antibodies like Genentech’s Ocrevus (ocrelizumab) and Novartis’ Kesimpta (ofatumumab), but with a glycoengineering modification. This adjustment involves modifying certain sugar molecules attached to the antibody to enhance its potency. When Briumvi attaches to specific proteins in cells, it can elicit two primary mechanisms to kill the cell: antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
- ADCC signals other immune cells to eliminate the target cell after the antibody binds to it.
- In CDC, the antibody triggers the activation of immunological proteins, known as the complement cascade, which destroys the target cell.
In comparison to other anti-CD20 antibodies used for MS, TG Therapeutics (the developer and producer of Briumvi) claims that Briumvi's design makes it significantly more powerful at activating ADCC and a less potent trigger of CDC.
What is the success rate of Briumvi?
The treatment was found to fully eradicate the patients' symptoms of inflammatory brain lesions and lower recurrence rates, from 1.45 to 0.07 relapses per year. Moreover, a composite index known as NEDA-3 revealed no disease activity in 74% of study subjects. At week 48, there were no relapses, no worsening of the impairment that had been verified, and no new or enlarging lesions.
Two Phase 3 trials in patients with relapsing MS were led by Lawrence Steinman, Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University. The findings of two Phase 3 trials, ULTIMATE I (NCT03277261) and ULTIMATE II (NCT03277248) showed that Briumvi could significantly reduce the annualized relapse rate (ARR) and disability progression when compared to Aubagio. In both studies, relapse rates were reduced from more than 0.175 relapses per year in the control group to fewer than 0.92 relapses per year with Briumvi.
Additionally, Briumvi was the first MS treatment in clinical trials to lower the annualized relapse rate (ARR) below the 0.1 threshold, indicating fewer than one relapse per year. The number of lesions with active inflammation was also reduced by 97% in both trials and the number of new or enlarging lesions, with or without active inflammation, was reduced by approximately 90%.
How long does treatment with Briumvi take?
The starting dose is 150 mg via intravenous infusion and is given over four hours. This is to ensure the medication is well-tolerated without side effects. The second dose of 450 mg is administered two weeks after the first infusion as a one-hour infusion as tolerated.
Briumvi can only be administered under the close supervision of an experienced healthcare professional who has the appropriate medical support to manage severe reactions. A pregnancy test is recommended in females prior to each infusion. Also patients are to receive any required vaccines at least four weeks before they start treatment.
What are the potential side effects of Briumvi?
According to TG Therapeutics, the most common side effects associated with Briumvi are:
- Infusion reactions
- Low antibody levels and infections
- Upper respiratory tract infections
One of the most frequent adverse effects of Briumvi is infusion reactions. Briumvi may result in infusion-related side effects like headache, flu-like sickness, nausea, throat irritation, or skin reddening. These usually happen a day after dosage, and after the first infusion is when they occur the most. Other infusion reactions include swelling of the tongue or throat, dizziness, abdominal pain, feeling faint, wheezing, hives, trouble breathing, and itchy skin.
Low antibody levels and infections
The use of Briumvi may cause B-cell depletion, which is responsible for generating antibodies that defend the body against infections. As a result, individuals using Briumvi may experience reduced levels of circulating antibodies, making them more vulnerable to serious infections.
Before starting Briumvi, healthcare providers should measure the patient's antibody levels, and individuals should be monitored for any signs of an active infection before each infusion.
Upper respiratory tract infections
This is a common adverse reaction of using Briumvi according to RMS clinical trials. Examples of these infections are chronic tonsillitis, nasopharyngitis, viral pharyngitis, viral rhinitis, pharyngitis streptococcal, etc.
Other side effects
Also, Briumvi can result in decreased immunoglobulin levels as expected from any B-cell depleting therapy. In RMS clinical trials a decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide.
How does Briumvi compare to other MS drugs?
Difference between Briumvi and Rebif
- Drug class: Briumvi is in the CD20 monoclonal antibodies drug class while Rebif is in the Interferons drug class.
- Dosage form(s) available: Briumvi is available in intravenous solutions while Rebif is available in subcutaneous kit and subcutaneous solution.
- Half-life: Briumvi's half-life is 528 hours and Rebif's half-life is three hours
Difference between Briumvi and Ocrevus
- Half-life: Briumvi's half-life is 528 hours and Ocrevus’ half-life is 624 hours.
- Dosage: One-hour IV infusion every six months following the first dose. Ocrevus is given as a 2.5-hour IV infusion every six months
READ MORE: Tysabri vs Ocrevus for MS: What's The Difference?
How much does Briumvi cost?
According to TG Therapeutics, Briumvi, at $59,000/year, is the lowest-price branded disease modifying therapy (DMT) approved for MS. The amount that a patient pays will depend on insurance policies and eligibility for co-pay assistance programs.
READ MORE: How Much Does Infusion Therapy Cost?