STUDY DESIGN

BRIUMVI was evaluated in 2 identical phase 3 global randomized studies

BRIUMVI was studied in the ULTIMATE I and II clinical studies1,2

Inclusion criteria:

  • Relapsing multiple sclerosis
  • Expanded Disability Status Scale (EDSS) score 0-5.5
  • At least 1 relapse within prior year, or 2 or more in prior 2 years
  • One or more gadolinium-enhancing (Gd+) lesions on T1-weighted magnetic resonance imaging (MRI) scan in the prior year

Neurological evaluations were performed every 12 weeks, and patients underwent MRI scans at weeks 12, 24, 48, and 96.

Primary endpoint

  • Annualized relapse rate (ARR) at 96 weeks

Select secondary endpoints

  • The number of T1 Gd+ lesions by week 96
  • The number of new or enlarging T2 hyperintense lesions by week 96
  • Time to confirmed disability progression (CDP) for at least 12 weeks

Select tertiary endpoints

  • Time to CDP for at least 24 weeks (descriptive analysis)
  • Time to confirmed disability improvement (CDI) for at least 12 weeks (descriptive analysis)
  • Time to CDI for at least 24 weeks (descriptive analysis)
Patients studied in both trials had comparable baseline demographics1,2
ULTIMATE I
(n=545, mITT populationa)		ULTIMATE II
(n=544, mITT populationa)
BRIUMVITeriflunomideBRIUMVITeriflunomide
Age (mean)36 years old37 years old35 years old36 years old
Sex (%)
Female
Male
61%
39%
65%
35%
65%
35%
65%
35%
Time since RMS diagnosis (mean)4.9 years4.5 years5.0 years5.0 years
Relapses in prior year (mean)1.31.41.31.2
EDSS score (mean)3.02.92.83.0
Treatment with a DMT in previous 5 years (%)40%41%49%43%
One or more T1 Gd+ lesions (%)43%43%52%50%

aThe modified intent-to-treat (mITT) population consists of all subjects in the ITT population who received at least 1 dose of study medication and had at least 1 baseline and postbaseline efficacy assessment.
EDSS=Expanded Disability Status Scale, DMT=Disease Modifying Therapy

Get the results from ULTIMATE I and ULTIMATE II clinical trials
See Efficacy
Explore the established safety profile
of BRIUMVI
See Safety

References: 1. BRIUMVI. Prescribing information. TG Therapeutics Inc; 2022. 2. Steinman L, Fox E, Hartung H-P, et al. Ublituximab versus teriflunomide in relapsing multiple sclerosis. N Engl J Med. 2022;387(8):704-714. doi:10.1056/NEJMoa2201904.

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Indication and Important Safety Information

INDICATION

BRIUMVI is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

IMPORTANT SAFETY INFORMATION

Contraindication: BRIUMVI is contraindicated in patients with:

  • Active HBV infection
  • A history of life-threatening infusion reaction to BRIUMVI

WARNINGS AND PRECAUTIONS

Infusion Reactions:

BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization.

Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved.

Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.

Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for surface antigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.

Progressive Multifocal Leukoencephalopathy (PML): Although no cases of PML have occurred in BRIUMVI-treated MS patients, JCV infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies.

If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.

MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.

If PML is confirmed, treatment with BRIUMVI should be discontinued.

Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines at least 4 weeks and, whenever possible at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.

Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.

Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. A pregnancy test is recommended in females of reproductive potential prior to each infusion. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.

Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.

Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections.

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Indication and Important Safety Information

INDICATION: BRIUMVI is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

IMPORTANT SAFETY INFORMATION: Contraindication: BRIUMVI is contraindicated in patients with:

- Active HBV infection
- A history of life-threatening infusion reaction to BRIUMVI

  • fever
  • chills
  • headache
  • flu-like symptoms
  • fast heartbeat
  • hives
  • itchy skin
  • dizziness

  • feeling faint
  • welling of tongue or throat
  • trouble breathing
  • wheezing
  • nausea
  • abdominal pain
  • throat irritation
  • redness of the face or skin

 

These infusion reactions can happen over 24 hours after your infusion. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion. If you get an infusion reaction, your healthcare provider may need to stop or slow down the rate of your infusion.

  • Infection:
    • Infections are a common side effect, and upper respiratory tract infections are one of the most common side effects of BRIUMVI. BRIUMVI increases your risk of getting infections caused by bacteria or viruses that may be life-threatening or cause death. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, a cough that does not go away, or painful urination. Your healthcare provider should delay your treatment with BRIUMVI until your infection is gone.
    • Hepatitis B virus (HBV) reactivation: Before starting treatment with BRIUMVI, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with BRIUMVI. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving BRIUMVI.
    • Weakened immune system: BRIUMVI taken before or after other medicines that weaken the immune system could increase your risk of getting infections.
    • Progressive Multifocal Leukoencephalopathy (PML): PML may happen with BRIUMVI. PML is a rare, serious brain infection caused by a virus that may get worse over days or weeks. PML can result in death or severe disability. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These symptoms may include weakness on one side of your body, loss of coordination in arms and legs, vision problems, changes in thinking and memory which may lead to confusion, and personality changes.
  • Low immunoglobulins: BRIUMVI may cause a decrease in some types of antibodies. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.


Before receiving BRIUMVI, tell your healthcare provider about all of your medical conditions, including if you:

  • have or think you have an infection.
  • take or plan to take medicines that affect your immune system. These medicines may increase your risk of getting an infection.
  • have ever had hepatitis B or are a carrier of the hepatitis B virus.
  • have had a recent vaccination or are scheduled to receive any vaccinations.
    • You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with BRIUMVI. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with BRIUMVI and until your healthcare provider tells you that your immune system is no longer weakened.
    • When possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with BRIUMVI. If you would like to receive any non-live vaccines while you are being treated with BRIUMVI, talk to your healthcare provider.
    • If you have a baby and you received BRIUMVI during your pregnancy, it is important to tell your baby’s healthcare provider about receiving BRIUMVI so they can decide when your baby should be vaccinated.
  • are pregnant, think that you might be pregnant, or plan to become pregnant. BRIUMVI may harm your unborn baby. You should use birth control (contraception) during treatment with BRIUMVI and for at least 6 months after your last infusion of BRIUMVI. Talk with your healthcare provider about what birth control method is right for you during this time.
  • are breastfeeding or plan to breastfeed. It is not known if BRIUMVI passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take BRIUMVI.


Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of BRIUMVI?

The most common side effects of BRIUMVI include:

  • Infusion reactions, upper and lower respiratory tract infections, herpes infections, extremity pain, insomnia, and fatigue.


These are not all the possible side effects of BRIUMVI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to TG Therapeutics at 1-877-TGTXINC (1-877-848-9462).

For more important information, go to www.briumvi.com or call 1-833-BRIUMVI (1-833-274-8684).