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Efficacy Data

THE FIRST AND ONLY ANTI‑CD20 TO ACHIEVE AN ARR OF <0.1 IN TWO PHASE 3 CLINICAL TRIALS1,2,a

Actor Portrayal. Image retouched using AI.

Efficacy Data

THE FIRST AND ONLY ANTI‑CD20 TO ACHIEVE AN ARR OF <0.1 IN TWO PHASE 3 CLINICAL TRIALS1,2,a

Actor Portrayal. Image retouched using AI.

Efficacy Data

THE FIRST AND ONLY ANTI‑CD20 TO ACHIEVE AN ARR OF <0.1 IN TWO PHASE 3 CLINICAL TRIALS1,2,a

Actor Portrayal. Image retouched using AI.

aARR for BRIUMVI observed in the ULTIMATE I and II Phase 3 clinical trials. Cross-trial comparisons are not appropriate given variation in patient populations enrolled across different trials.

I was interested to see the long‑term data, and the BRIUMVI open-label extension data was very informative.

 

Jacqueline Rosenthal, MD

Individual featured has been compensated by TG Therapeutics.

I was interested to see the long-term data, and the BRIUMVI open-label extension data was very informative.

 

Jacqueline Rosenthal, MD

Jacqueline Rosenthal MD

Individual featured has been compensated by TG Therapeutics.

ULTIMATE I and II Primary and Secondary Endpoints

Pooled post hoc subpopulation data

ULTIMATE I and II Primary and Secondary Endpoints
Pooled post hoc subpopulation data

BRIUMVI SIGNIFICANTLY REDUCED ARR VS TERIFLUNOMIDE AT WEEK 96 IN ULTIMATE I AND II1,2

ARR from ULTIMATE I and II.1,2 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 post baseline efficacy assessment.

ARR, annualized relapse rate; ITT, intention-to-treat; mITT, modified intention-to-treat.

ULTIMATE I:
<1 relapse for every 13 patient‑years with BRIUMVI3

ULTIMATE II:
<1 relapse for every 11 patient‑years with BRIUMVI3

MORE PATIENTS STAYED RELAPSE-FREE WITH BRIUMVI ACROSS THE 2 CLINICAL TRIALS4,b

BRIUMVI® (ublituximab-xiiy) Clinical Trials Ultimate I patient relapse percentage results vs. Teriflunomide
BRIUMVI® (ublituximab-xiiy) Clinical Trials Ultimate I patient relapse percentage results vs. Teriflunomide

ARR THROUGH YEAR 65

Annualized Relapse Ratea

 

PRIMARY ENDPOINT

ARR for BRIUMVI observed in the 4-year OLE.5 For patients who switched from teriflunomide to BRIUMVI, an additional post hoc analysis was conducted that showed a relative reduction in ARR of 58.5% from Year 2 to Year 3.

The OLE trial was designed to evaluate the long-term efficacy and safety of BRIUMVI and lacked a control group; results of the OLE trial should be interpreted with caution.

OLE, open-label extension.
aBased on pooled data from 2 studies.

Infographic summarizing long‑term study data for BRIUMVI® (ublituximab-xiiy), including annual relapse rate results, study methods, and outcomes from up to 6 years of follow‑up

Download the BRIUMVI
long-term data

I like that the BRIUMVI maintenance infusions are 1 hour twice per year following the starting dose, and my 6‑month MRI and checkup showed no new lesions in my brain or spine. With BRIUMVI, I only think about my next dose every 6 months, and those infusions have only been 1 hour.

 

Meaghan, living with RMS and taking BRIUMVI

People featured have been compensated by TG Therapeutics for their time. Individual results may vary.

RMS, relapsing forms of multiple sclerosis.

I like that the BRIUMVI maintenance infusions are 1 hour twice per year following the starting dose, and my 6‑month MRI and checkup showed no new lesions in my brain or spine. With BRIUMVI, I only think about my next dose every 6 months, and those infusions have only been 1 hour.

 

Meaghan, living with RMS and taking BRIUMVI

Person standing outdoors at a scenic overlook

People featured have been compensated by TG Therapeutics for their time. Individual results may vary.

RMS, relapsing forms of multiple sclerosis.

BRIUMVI SHOWED NEAR-COMPLETE SUPPRESSION OF GD+ T1 AND T2 LESIONS COMPARED WITH TERIFLUNOMIDE AT WEEK 96 IN ULTIMATE I AND II1,2

 

GD+ T1 LESIONS WERE SUPPRESSED BY 97% COMPARED WITH TERIFLUNOMIDE1,2

 

SECONDARY ENDPOINT

Mean number of T1 Gd+ lesions per MRI for teriflunomide-treated patients and BRIUMVI-treated patients in ULTIMATE I and II. Based on MRI-mITT population (ie, mITT patients who had baseline and postbaseline MRI).

T2 LESIONS WERE SUPPRESSED BY 92% IN ULTIMATE I AND 90% IN ULTIMATE II COMPARED WITH TERIFLUNOMIDE1,2

 

SECONDARY ENDPOINT

Mean number of T2 lesions per MRI for teriflunomide-treated patients and BRIUMVI-treated patients in ULTIMATE I and II. Based on MRI-mITT population (ie, mITT patients who had baseline and postbaseline MRI).

Gd+, gadolinium-enhancing; MRI, magnetic resonance imaging.

When new lesions showed up on my MRI, my doctor gave me several high‑efficacy options, and I chose BRIUMVI. As a husband and dad, the 1‑hour BRIUMVI maintenance infusion has worked well for me and my schedule. I just had my fifth infusion, and I am doing well.

 

David, living with RMS and taking BRIUMVI

People featured have been compensated by TG Therapeutics for their time. Individual results may vary.

When new lesions showed up on my MRI, my doctor gave me several high‑efficacy options, and I chose BRIUMVI. As a husband and dad, the 1‑hour BRIUMVI maintenance infusion has worked well for me and my schedule. I just had my fifth infusion, and I am doing well.

 

David, living with RMS and taking BRIUMVI

People featured have been compensated by TG Therapeutics for their time. Individual results may vary.

ULTIMATE I AND II TRIALS EVALUATED CDP AND CDI IN PARTICIPANTS AT 12 AND 24 WEEKS1,2

12-Week CDP

24-Week CDP

Ultimate I and II Trials CDP Evaluation in Participants at 24 Weeks Chart

Kaplan-Meier estimates of the percentages of participants in the mITT population with worsening of disability confirmed at Week 12 and Week 24. Disease progression was 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. CDP at Week 12 between the 2 treatment groups did not reach statistical significance, and CDP at Week 24 was not formally tested for significance. Prespecified pooled analysis.

12-Week CDI

Ultimate I and II Trials CDI Evaluation in Participants at 12 Weeks Chart

24-Week CDI

Ultimate I and II Trials CDI Evaluation in Participants at 24 Weeks Chart

Kaplan-Meier estimates of the percentages of participants in the mITT population with lessening disability confirmed at Week 12 and Week 24. 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 Weeks 12 and 24 was not formally tested for significance. Prespecified pooled analysis.

CDI, confirmed disability improvement;
CDP, confirmed disability progression;
EDSS, Expanded Disability Status Scale.

95% of all BRIUMVI patients in the ULTIMATE I and II trials experienced no 12-week CDP1,2

95%

of all BRIUMVI patients in the ULTIMATE I and II trials experienced no 12-week CDP1,2

ULTIMATE I AND II POOLED POST HOC ANALYSIS: NEDA WEEK 0-966,a

NEDA-3 is defined as patients with:

  • No confirmed relapses
  • No 12-week CDP
  • No lesion activity detected via MRI

Rebaselining NEDA7:

  • Often conducted posttreatment initiation
  • Better reflects the steady state of DMT impact
  • May minimize impact of pretreatment disease activity on the assessment
BRIUMVI® (ublituximab-xiiy) Rebaseline Chart

NEDA‑3 results from weeks 0 to 96, showing 12 percent for teriflunomide and 45 percent for BRIUMVI® (ublituximab-xiiy)

NEDA‑3 results from weeks 24 to 96, showing 23 percent for teriflunomide and 82 percent for BRIUMVI® (ublituximab-xiiy)

NEDA-3 (Weeks 0-96)

Rebaselined NEDA-3 (Weeks 24-96)

NEDA-3 (Weeks 0-96) and Rebaselined NEDA-3 (Weeks 24-96) Chart

Percentage of patients treated with BRIUMVI achieving individual component measures of NEDA-3 and rebaselined NEDA-3.

DMT, disease-modifying therapy; NEDA, no evidence of disease activity.

aLimitations of NEDA in ULTIMATE I and ULTIMATE II: The predefined secondary endpoint was not statistically significant, and it was considered nonconfirmatory because it fell below the break in the statistical hierarchy at the time of 12-week CDP during the 96-week treatment period. No conclusions can be drawn.

ULTIMATE I and II Primary and Secondary Endpoints

Pooled post hoc subpopulation data

ULTIMATE I and II Primary and Secondary Endpoints
Pooled post hoc subpopulation data

HIGHLY ACTIVE SUBPOPULATION ANALYSIS

Limitations: Post hoc pooled analyses of ULTIMATE I and II (Phase 3) evaluated outcomes at Weeks 12 and 96 in participants with highly active disease. Limitations include the post hoc design, small sample size, and potential differences from real-world populations. Conclusions about safety or efficacy cannot be drawn based on these data.

 

15% of patients from ULTIMATE I and II had highly active disease8

HIGHLY ACTIVE DISEASE IN THIS ANALYSIS WAS DEFINED AS8:

  • ≥2 relapses in the prior year, and
  • ≥1 Gd+ T1 lesion at baseline

Relative reduction in ARR at Week 96 in the highly active subpopulation vs teriflunomide8

 

aBased on mITT population.

Early radiological assessment of Gd+ T1 and new/enlarging T2 lesions in patients with highly active disease at Week 128,b


Gd+ T1 and new/enlarging T2 lesions in patients with highly active disease at Week 968

 

bBased on mITT-MRI population.

TREATMENT-NAÏVE SUBPOPULATION ANALYSIS

Limitations: The post hoc nature of the analyses; the definition of the treatment-naïve group as participants who had received no prior approved DMT within 5 years before enrollment; and the possibility that participants enrolled in the controlled trials may differ from the real-world population.

 

66% OF PATIENTS FROM ULTIMATE I AND II WERE TREATMENT-NAÏVE9

TREATMENT-NAÏVE POPULATION IN THIS ANALYSIS WAS DEFINED AS:
Participants who had not received an approved DMT in the 5 years prior to study enrollment.9

EARLY TREATMENT SUBPOPULATION IN THIS ANALYSIS WAS DEFINED AS:
A subset of treatment-naïve participants who had their first MS symptom ≤3 years prior to enrollment at Week 96.9

Relative reduction in ARR compared with teriflunomide in the treatment-naïve population and the early treatment subpopulation9,a

 

aBased on mITT population.

Relative reductions in Gd+ T1 and new/enlarging T2 lesions observed in treatment-naïve population and early treatment subpopulation9

 

Based on mITT-MRI population.

EXPLORE THE SAFETY PROFILE OF BRIUMVI

See Safety & Tolerability

FIND INFORMATION ON BRIUMVI DOSING AND ADMINISTRATION

See Dosing & Administration

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.

CONTRAINDICATIONS: 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): PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. JCV infection resulting in PML has been observed in patients treated with anti-CD20 antibodies, including BRIUMVI, 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. 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.

Liver Injury: Clinically significant liver injury, without findings of viral hepatitis, has been reported in the postmarketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of MS, including BRIUMVI. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred from weeks to months after administration.

Patients treated with BRIUMVI found to have an alanine aminotransaminase (ALT) or aspartate aminotransferase (AST) greater than 3x the upper limit of normal (ULN) with serum total bilirubin greater than 2x ULN are potentially at risk for severe drug-induced liver injury.

Obtain liver function tests prior to initiating treatment with BRIUMVI, and monitor for signs and symptoms of any hepatic injury during treatment. Measure serum aminotransferases, alkaline phosphatase, and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. If liver injury is present and an alternative etiology is not identified, discontinue BRIUMVI.

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.

References: 1. BRIUMVI. Prescribing information. TG Therapeutics Inc; 2026. 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. 3. Data on file. TG Therapeutics, Inc; 2026. 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 Annual Meeting; April 2-7, 24-26, 2022; Seattle, WA. 5. Cree BAC, Fox E, Hartung H-P, et al. Long-term efficacy and safety of ublituximab in relapsing multiple sclerosis: results from 6 years of ULTIMATE I and II open-label extension. Presented at: ECTRIMS; September 24-26, 2025; Barcelona, Spain. 6. Alvarez E, Steinman L, Fox EJ, et al. Improvements in no evidence of disease activity with ublituximab vs teriflunomide in the ULTIMATE phase 3 studies in relapsing multiple sclerosis. Front Neurol. 2024;15:1473284. 7. Giovannoni G, Turner B, Gnanapavan S, Offiah C, Schmierer K, Marta M. Is it time to target no evidence of disease activity (NEDA) in multiple sclerosis? Mult Scler Relat Disord. 2015;4(4):329-333. 8. Hartung H-P, Robertson D, Steinman L, et al. Efficacy of ublituximab in people with highly active relapsing multiple sclerosis. Neurol Ther. 2026;15:1081-1097. 9. Robertson D, Alvarez E, Steinem L, et al. Disease outcomes with ublituximab in treatment-naïve participants: subpopulation analyses of the phase 3 ULTIMATE I and II studies in participants with relapsing multiple sclerosis. Front Immunol. 2026;29:17:1771848.

Important Safety Information
CONTRAINDICATIONS: BRIUMVI is contraindicated in patients with:
  • Active HBV infection
  • A history of life-threatening infusion reaction to BRIUMVI
 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.

Click or scroll to see IMPORTANT SAFETY INFORMATION AND INDICATION