Briumvi is a medicine used to treat relapsing forms of multiple sclerosis (MS). Relapsing forms of MS include clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. Relapsing forms of MS have temporary worsening of symptoms followed by periods of improvement. Briumvi is an intravenous (IV) infusion given by your health care provider twice per year.
How Does Briumvi Work for MS?
Briumvi is a medicine that targets a part of your immune system known as B cells. These B cells are important in relapsing MS because they attack the protective covering in your central nervous system. This protective covering is known as myelin. Briumvi can help prevent MS relapses and progression of MS by stopping the B cells from attacking myelin.
How Do I Use Briumvi?
Briumvi is an IV given by your health care provider. You will receive a corticosteroid such as methylprednisolone and an antihistamine such as diphenhydramine before your dose of Briumvi. These medicines help prevent infusion reactions. An infusion reaction may cause a fever, chills, a headache, flu-like symptoms, a fast heartbeat, nausea, and throat irritation.
Your first Briumvi IV is given over about 4 hours. Two weeks after your first dose, the second dose is given over 1 hour. For the first two IVs, you will be monitored by your health care provider for 1 hour afterward.
After the first two doses, Briumvi is given every 24 weeks, which is about two times per year. These IVs are given over 1 hour, and monitoring by your health care provider is not required.
How Was Briumvi Studied?
Two studies known as ULTIMATE I and II compared Briumvi to teriflunomide, another treatment for MS. The studies included over 1,000 people 18 to 55 years of age. Everyone had a diagnosis of relapsing-remitting MS and had experienced at least one relapse in the past 1 or 2 years or had brain lesions on magnetic resonance imaging (MRI) scans within the last year. A score of 0 to 5.5 on the Expanded Disability Status Scale (EDSS) was also required. The EDSS is a tool for measuring and monitoring changes in disability in people with MS.
In the ULTIMATE I study, 63% of people were female, 97% were White, 2.2% were Black, and about 0.6% were listed as other. In the ULTIMATE II study, 65% of people were female, 98% were White, 0.9% were Black, and 0.4% were listed as other.
People in the studies received either Briumvi as an IV or teriflunomide as an oral medicine. The first Briumvi IV was a dose of 150 milligrams, followed by 450 milligrams 2 weeks later, then a dose of 450 milligrams was given every 24 weeks. The dose of teriflunomide was 14 milligrams daily. People randomized to Briumvi received an oral placebo (a fake treatment that contains no medicine), and people randomized to teriflunomide received placebo IVs on the same schedule as Briumvi.
What Benefits Were Seen in the Studies?
The efficacy of Briumvi was measured by the annualized relapse rate (ARR), which is the average number of relapses per year. A lower ARR means there were fewer relapses per year. Briumvi reduced the risk of relapse more than teriflunomide after nearly 2 years of follow-up. There were also fewer brain lesions seen on MRIs in people treated with Briumvi than those treated with teriflunomide. Worsening of disability was similar in people treated with teriflunomide and Briumvi after 12 weeks of treatment.
ULTIMATE I | ULTIMATE II | |||
| Briumvi | Teriflunomide | Briumvi | Teriflunomide | |
| ARR | 0.08 | 0.19 | 0.09 | 0.18 |
| Average number of MRI lesions | 0.02 | 0.49 | 0.01 | 0.25 |
Your results may differ from what was seen in clinical studies.
Are There Any Reasons I Should Not Take Briumvi?
Make sure your health care provider is aware of all your current or past health conditions.
You should not take Briumvi if you have or have had a hepatitis B infection or have had a serious allergic reaction to Briumvi.
You should not start Briumvi treatment within 4 weeks of a live vaccine or within 2 weeks of other vaccines. Tell your health care provider about all vaccines you have received or plan to receive before starting Briumvi. Your pharmacist or other health care provider can tell you if any of these are live vaccines.
What Are the Side Effects of Briumvi, and How Can I Tell if a Side Effect Is Happening?
The most common side effects seen with Briumvi are infusion reactions and upper respiratory tract infections.
Infusion reactions can occur during the Briumvi IV or up to 24 hours afterward. You will receive medicine before your IV to help lower the risk of infusion reactions. You should notify your health care provider right away if you have any of the following.
|
|
|
You may be more likely to get infections during treatment with Briumvi. Be sure you are up to date on vaccinations before starting the drug. Washing your hands and avoiding people who are sick can help prevent infections.
Contact your health care provider if you have signs of an infection such as a fever, chills, a cough that doesn’t go away, or painful urination.
Is There Any Cost Assistance Available?
There may be cost assistance to help you afford Briumvi. You may have options even if you do not have health insurance. With the Briumvi copay assistance program, you may have a $0 copay. There may also be assistance for the cost of giving you the IV. Your health care provider will help you get started. You can call 833-274-8684 for more information.
