BRIUMVI is where efficacy meets efficiency for patients with relapsing MS

The first anti-CD20 to achieve an ARR of <0.1 in 2 phase 3 clinical trials1,2,a

BRIUMVI significantly reduced relapse rates vs teriflunomide at 96 weeks1,2

Less than 1 relapse for every 13 patient-years with BRIUMVI in ULTIMATE I study3

Less than 1 relapse for every 11 patient-years with BRIUMVI in ULTIMATE II study3

Based on mITT population. The 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.
aARR for BRIUMVI observed in the ULTIMATE I and II phase 3 trials. Cross-trial comparisons are not appropriate given variation in patient populations enrolled across different trials.

More patients stayed relapse-free with BRIUMVI across the 2 clinical trials4

Based on Kaplan-Meier estimates and mITT population.

A portrait of Alex, a person with RMS taking BRIUMVI

“My doctor says I am doing really well on BRIUMVI, I haven’t had any relapses or any new or enlarging lesions.”

– Alex K. (clinical trial patient) has taken BRIUMVI since 2017

Individual results may vary

BRIUMVI showed near-complete suppression of lesions compared
with teriflunomide1,2

T1 Gd+ lesions were suppressed by 97% compared with teriflunomide1,2

Based on MRI-mITT population (mITT patients who have baseline and postbaseline MRI).

T2 lesions were suppressed by 92% in ULTIMATE I and 90% in ULTIMATE II compared with teriflunomide1,2

Based on MRI-mITT population (mITT patients who have baseline and postbaseline MRI).

ULTIMATE I and II Trials Evaluated the Progression of Disability in Patients at 12 and 24 Weeks1,2

95% of patients in the ULTIMATE I and II trials experienced no 12-week confirmed disability progression (CDP), and >95% of patients experienced no 24-week CDP1,2

Descriptive analysis

Based on Kaplan-Meier estimates and mITT population.

  • CDP at 12 weeks between the 2 treatment groups did not reach statistical significance
  • CDP at 24 weeks was not formally tested for significance
  • Disease progression was measured by EDSS and defined as an increase of ≥1.0 point from the baseline EDSS score if the baseline score was ≤5.5, or an increase of ≥0.5 points if the baseline score was >5.5

ULTIMATE I and II trials evaluated improvement of disability in patients2

12% of patients receiving BRIUMVI achieved confirmed disability improvement (CDI) at 12 weeks and 9.6% achieved CDI at 24 weeks as measured by EDSS2

Descriptive analysis

Based on Kaplan-Meier estimates and mITT population.

  • Disability improvement was measured by EDSS and defined as a reduction of ≥1.0 point from the baseline EDSS score, or a reduction of ≥0.5 points if the baseline EDSS score was >5.5
  • CDI at 12 and 24 weeks was not formally tested for significance

Nearly half (45%) of patients achieved NEDA (No Evidence of Disease Activity) with BRIUMVI5

About NEDA-35

NEDA-3 is a composite assessment defined as patients with

  • No confirmed relapses
  • No 12-week CDP
  • No lesion activity detected via MRI
Percentage of patients treated with BRIUMVI achieving individual component measures of NEDA-35


86.5% No confirmed relapses

94.0% No Gd+ T1 lesions

55.2% No new/enlarging T2 lesions

94.6% No 12-week CDP

>80% of patients achieved NEDA with BRIUMVI
when rebaselined at week 245

Percentage of patients treated with BRIUMVI achieving individual component measures of NEDA-3 (rebaselined)5


88.6% No confirmed relapses

99.4% No Gd+ T1 lesions

96.9% No new/enlarging T2 lesions

95.1% No 12-week CDP

NEDA analyses are often rebaselined to a later time point post-treatment initiation to better reflect the steady state of a DMT’s impact on disease and to minimize any impact of pretreatment disease activity.6

Explore the established safety profile
see safety
Find information on BRIUMVI dosing and administration

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. 3. Data on file. TG Therapeutics Inc. 4. Steinman L, Fox EJ, Hartung H-P, et al. Relapse rate and time to first relapse were improved with ublituximab vs teriflunomide in the phase 3 ULTIMATE I and ULTIMATE II studies in patients with relapsing multiple sclerosis (RMS). Presented at: 2022 American Academy of Neurology (AAN) Annual Meeting; April 2-7, 24-26, 2022; Seattle, WA. 5. Alvarez E, Steinman L, Fox EJ, et al. Ublituximab treatment is associated with a significant proportion of patients achieving no evidence of disease activity (NEDA): results from the ULTIMATE I and ULTIMATE II phase 3 studies of ublituximab vs teriflunomide in relapsing multiple sclerosis (RMS). Presented at: 2022 American Academy of Neurology (AAN) Annual Meeting; April 2-7, 24-26, 2022; Seattle, WA. 6. Giovannoni G, Turner B, Gnanapavan S, Offiah C, Schmierer K, Marta M. Is it time to target no evident disease activity (NEDA) in multiple sclerosis? Mult Scler Relat Disord. 2015;4(4):329-333. doi:10.1016/j.msard.2015.04.006.

Have questions?
Call 1-833-BRIUMVI (1-833-274-8684) to speak with a BRIUMVI Patient Support
Case Manager (Mon-Fri, 8 AM to 8 PM ET)
Sign up for more information and request
a TG Therapeutics representative

Indication and Important Safety Information


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.


Contraindication: BRIUMVI is contraindicated in patients with:

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


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.