Briumvi (ublituximab) is a disease modifying drug (DMD) that is approved in England and Wales for active relapsing remitting multiple sclerosis (RRMS).
You take Briumvi every six months as an infusion (drip) into a vein. Briumvi reduces the number of B cell lymphocytes, a type of white blood cell. B cells are thought to influence the abnormal immune response that causes the attack on the myelin coating of nerves.
The most common side effect reported in a clinical trial was infusion-related reactions.
Briumvi is a disease modifying drug (DMD) for active relapsing remitting MS. You have fewer relapses than you might have had without treatment and any relapses you do have should be less severe. Disease progression is slowed.
In clinical studies, Briumvi reduced relapse rate by over 50% compared to Aubagio. It has not been compared directly with a non-active placebo, but this result is thought to put Briumvi into the highly effective category of DMDs. This means that it likely reduces the annual relapse rate (ARR) by around 70% compared to taking nothing at all. Briumvi also slowed down the build-up of disability associated with MS.
Briumvi can be prescribed for adults with active relapsing remitting MS. This means RRMS where there is evidence from MRI or clinical symptoms that the disease is causing inflammation and damage around the brain and spinal cord.
Briumvi has been approved for use on the NHS in England and Wales since 2024. It is not yet licenced in Scotland or Northern Ireland, but decisions on that are expected soon.
Briumvi has not yet been studied in children and young people under 18. It can only be prescribed by a neurologist.
Contraindications
You should not take Briumvi if you are allergic to ublituximab or any of the other ingredients of the medicine. You should not take Briumvi if you are suffering from a severe infection, if you have cancer or if you have severe problems with your immune system.
You may not be offered Briumvi if you have had hepatitis B, because medicines like Briumvi can cause the hepatitis B virus to become active again.
Before you start treatment with Briumvi, your neurologist will check whether you carry hepatitis B virus. They will also check whether need to have any vaccines in advance of starting Briumvi. This is because you should not take live or attenuated vaccines while taking Briumvi. You should take any live or attenuated vaccines at least 4 weeks before starting Briumvi, and inactivated vaccines at least 2 weeks before starting Briumvi.
Conception and pregnancy
If you are able to become pregnant, you should use contraception while taking Briumvi and for 4 months after your last infusion.
Tell your doctor before you take Briumvi if you are pregnant, think you may be pregnant or are planning to have a baby. Briumvi may cross the placenta and affect your baby as well as you. You and your doctor should consider the benefits and risks to you both when deciding whether to take Briumvi.
If you become pregnant while taking Briumvi, contact your neurologist or MS nurse. You should also tell your baby's doctor about receiving Briumvi so that they can recommend when your baby should have their childhood vaccinations.
It is not known whether Briumvi passes into breast milk.
Briumvi is taken as an intravenous infusion (drip) in a hospital or clinic. The first dose is given split into two separate infusions, two weeks apart. Further doses are given as one infusion every six months. Each infusion takes 1 hour except the first one which takes 4 hours.
When you take Briumvi, your infusion team will give you other medicines such as an antihistamine and a corticosteroid. This is to reduce the risk of infusion related reactions such as fever or a rash. They will monitor your health during and after the infusion.
If you show signs of an infusion related reaction, your infusion team will slow or stop the infusion.
The most common side effect reported in phase III clinical studies were infusion-related reactions. These are a type of allergic reaction which may develop while a medicine is given or up to 24 hours afterwards.
In trials for Briumvi, these were very common, affecting more than 1 person in 10. The reactions were mostly mild to moderate and were most frequent after the first infusion and less frequent following subsequent infusions. Your infusion team will give you other medicines each time to reduce the risk of having an infusion related reaction. You will also be monitored carefully.
Other side effects listed on the Patient Information Leaflet include:
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Increased risk of infections
More than 1 in 10 people taking Briumvi may have respiratory infections (nose, throat or airways)
Up to 1 in 10 people taking Briumvi may have chest or lung infections or herpes infections (cold sores or shingles).
- Neutropenia (low levels of a white blood cell type called neutrophils)
- Pain in your arms or legs
These may affect up to 1 in 10 people who take Briumvi.
Progressive multifocal leukoencephalopathy (PML) is a very rare and life-threatening brain infection. Although no-one taking Briumvi has developed PML, it is potentially possible. You should alert your neurologist if you notice new or worsening symptoms.
In a phase II study involving 48 participants, Briumvi reduced B cell counts by 99% at 4 weeks after treatment. This was maintained at weeks 24 and 48. MRI scans showed that active lesions were eliminated while overall lesion volume reduced by 10% after 48 weeks. 93% of participants were free of relapses during the 48 week study.
In two phase III studies, 1094 participants with relapsing remitting MS took either Briumvi or Aubagio (teriflunomide) for 96 weeks. Compared to Aubagio, Briumvi reduced relapse rate by over 59% in Ultimate 1 and 49% in Ultimate 2. Briumvi also significantly reduced the number of active lesions compared to Aubagio. Significantly more people taking Briumvi achieved NEDA (no evidence of disease activity). There was no significant difference between the two treatments in the number of participants with 12 or 24 week confirmed disability progression; however, significantly more participants taking Briumvi had 12 and 24 week confirmed disability improvement.
Further details of ULTIMATE I
Further details of ULTIMATE II
Briumvi (ublituximab) is a monoclonal antibody, a type of drug developed to attack specific targets in the immune system. The drug binds to a marker (CD20) on the surface of B cell lymphocytes, a type of white blood cell which is thought to influence the abnormal immune response that causes the attack on the myelin coating of nerves. Targeted B cells are destroyed. This reduces the chance of a relapse, relieves symptoms and slows down the progression of the disease.
Briumvi is also being developed as a treatment for some types of blood cancers.
Patient Information Leaflet: Clinical information given for Briumvi.
Briumvi announcement: Our news piece about the NICE approval.
Disease modifying drugs: Read about DMDs and how they are used in MS,
