Proven efficacy - Briumvi UK
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Proven efficacy

This promotional website is intended for UK healthcare professionals.

Briumvi® (ublituximab) is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features1

BRIUMVI®
:
Proven efficacy

BRIUMVI® is where efficacy meets efficiency for patients with relapsing MS

Significant relapse reduction (primary endpoint)1

Near-complete suppression of lesions1
Progression and improvement1
Increase in the proportion of patients with NEDA,2

The first anti-CD20 to achieve an ARR of <0.1 in two phase 3 clinical trials1,3,4,5

In the ULTIMATE I and II clinical studies, BRIUMVI® significantly reduced relapse rates vs teriflunomide at 96 weeks1

Primary endpoint: ARR

Less than 1 relapse for every 13 patient-years with BRIUMVI® in the ULTIMATE I study1,a,b

Less than 1 relapse for every 11 patient-years with BRIUMVI® in the ULTIMATE II study1,a,b

aARR for BRIUMVI® observed in the ULTIMATE I and II phase 3 trials.3
bPatient-years were calculated on the basis of the mean ARR of the mITT population 1/0.076 = 13.15 and 1/0.091 = 10.99.3 Data from the mITT population (all subjects in the ITT population who received at least one dose of the study medication and had at least one baseline and post-baseline assessment).

Data from the mITT population (all subjects in the ITT population who received at least one dose of the study medication and had at least one baseline and post-baseline assessment).

More patients stayed relapse-free with BRIUMVI® across the two clinical trials1

Proportion of patients relapse-free at 96 weeks.

BRIUMVI® showed near-complete suppression of T1 Gd+ lesions compared with teriflunomide1

Secondary endpoint: T1 Gd+ lesions at Week 96

New or enlarging T1 lesions were suppressed by 97% in ULTIMATE I and ULTIMATE II compared with teriflunomide1

Data from the MRI-mITT population (mITT patients who had baseline and post-baseline MRI).

Secondary endpoint: New or enlarging T2 lesions at Week 96

New or enlarging T2 lesions were suppressed by 92% in ULTIMATE I and 90% in ULTIMATE II compared with teriflunomide1

Data from the MRI-mITT population (mITT patients who had baseline and post-baseline MRI).

ULTIMATE I and II trials evaluated CDP in patients at 12 and 24 Weeks1,3

95% of patients in the ULTIMATE I and II trials experienced no 12-week CDP3

Pre-specified pooled analysis: CDP

Based on Kaplan–Meier estimates and mITT population.

  • • CDP at 12 weeks between the two treatment groups did not reach statistical 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 CDI in patients at 12 and 24 weeks2

12% of patients receiving BRIUMVI® achieved CDI at 12 weeks and 9.6% achieved CDI at 24 weeks3

These and all subsequent results were not considered to be significantly different between trial groups because of the failure of the hierarchical analysis

Pre–specified pooled tertiary analysis: CDI

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

45% of patients achieved NEDA with
BRIUMVI® in the ULTIMATE I and II studies2

Pooled post–hoc analysis of ULTIMATE I and II: proportion of patients with NEDA by Week 96
NEDA-3 (weeks 0-96)5
About NEDA-32 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® who achieved individual component measures of NEDA-32

The 2021 MAGNIMS-CMSC-NAIMS consensus recommendations on the use of MRI in patients with MS propose obtaining a new baseline brain MRI, usually at 3-6 months after treatment initiation to avoid misinterpretation of lesions that developed before therapeutic onset.7

>80% of patients achieved NEDA with BRIUMVI® when rebaselined at Week 24 (pooled post hoc analysis of ULTIMATE I and II)2,3

Pooled post hoc analysis of ULTIMATE I and II: rebaselined NEDA-3 data

Rebaselined NEDA-3 (weeks 24-96)2,3

Rebaselining at a later time point post-treatment initiation serves to better reflect the steady state of a DMT’s impact on disease and to minimise any impact of pretreatment disease activity.6

Percentage of patients treated with BRIUMVI® who achieved 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

BRIUMVI® (ublituximab) 150 mg concentrate for solution for infusion

BRIUMVI® (ublituximab) is indicated for the treatment of adult patients with relapsing forms of MS (RMS) with active disease defined by clinical or imaging features.1

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Reporting forms and information can be found at: https://yellowcard.mhra.gov.uk/. Adverse events should also be reported to Neuraxpharm by email: info-uk@neuraxpharm.com.

NXUK/0225/02 Date of preparation: October 2025

References
1BRIUMVI®. Summary of Product Characteristics.
2Giovannoni G, Turner B, Gnanapavan S, et al. Mult Scler Relat Disord. 2015;4(4):329–333. doi:10.1016/j.msard.2015.04.006.
3Steinman L, Fox E, Hartung H-P, et al. N Engl J Med. 2022;387(8):704–714 and Supplementary Appendix. doi:10.1056/NEJMoa2201904.
4Kesimpta Summary of product characteristics.
5Ocrevus Summary of product characteristics.
6Wattjes MP, Ciccarelli O, Reich DS, et al. Lancet Neurol. 2021;20(8):653–670. doi:10.1016/S1474-4422(21)00095-8.

Abbreviations
ARR, annualised relapse rate; CDI, confirmed disability improvement; CDP, confirmed disability progression; CI, confidence interval; DMT, disease-modifying therapy; EDSS, Expanded Disability Status Scale; Gd+, gadolinium-enhancing; ITT, intention-to-treat; mITT, modified intention-to-treat; MRI, magnetic resonance imaging; MS, multiple sclerosis; NEDA, no evidence of disease activity.