NEW YORK, New York — October 12, 2026
TG Therapeutics, Inc. announced the publication of a five-year comparative analysis evaluating BRIUMVI® (ublituximab-xiiy) against ocrelizumab and ofatumumab in patients with relapsing multiple sclerosis (RMS). Published online in Multiple Sclerosis and Related Disorders, the study used a matching-adjusted indirect comparison (MAIC) to examine long-term relapse activity and confirmed disability progression across the three anti-CD20 therapies. The analysis found that BRIUMVI was associated with a 44% lower relative hazard of 24-week confirmed disability progression compared with ocrelizumab and a 49% lower relative hazard compared with ofatumumab. The treatment was also associated with lower annualized relapse rates over five years. The findings were generated by statistically reweighting individual patient-level data from the Phase 3 ULTIMATE I and II trials to align with published baseline characteristics from comparator studies. TG Therapeutics emphasized that the results are exploratory because the treatments were not compared in a direct randomized head-to-head trial.
BRIUMVI Analysis Shows Lower Disability Progression Risk
The five-year analysis evaluated 24-week confirmed disability progression (CDP24), an important measure of sustained worsening of disability in people with RMS. Researchers analyzed individual patient-level data from 545 participants treated with BRIUMVI in the Phase 3 ULTIMATE I and II trials and their open-label extension. These data were reweighted to align with published aggregate data from the Phase 3 OPERA I and II trials of ocrelizumab and the ASCLEPIOS I and II trials of ofatumumab. In the comparison with ocrelizumab, BRIUMVI was associated with a hazard ratio of 0.560 (95% confidence interval [CI]: 0.380–0.826), corresponding to a 44% lower relative hazard of CDP24. Against ofatumumab, the hazard ratio was 0.509 (95% CI: 0.350–0.741), representing a 49% lower relative hazard. Estimated cumulative CDP24 incidence at 240 weeks was 9.3% with BRIUMVI versus 16.1% with ocrelizumab, and 9.4% versus 17.9% with ofatumumab. These estimates suggest a potential long-term difference in disability outcomes, although the indirect comparison cannot establish that BRIUMVI directly causes better outcomes than the comparator therapies.
Five-Year Findings Show Lower Relapse Activity
The analysis also evaluated annualized relapse rates (ARRs), which measure the average number of relapses experienced per patient-year. BRIUMVI was associated with consistently low adjusted relapse rates throughout the five-year observation period. In the comparison with ocrelizumab, the adjusted ARR declined from 0.118 in Year 1 to 0.032 in Year 5. In the comparison with ofatumumab, the corresponding rate decreased from 0.116 to 0.030. The researchers also estimated that participants receiving BRIUMVI experienced more time free from confirmed disability progression over 240 weeks. The analysis estimated an average of 8.1 additional weeks without confirmed disability progression compared with ocrelizumab (95% CI: 2.3–14.1) and 13.1 additional weeks compared with ofatumumab (95% CI: 6.7–19.3). TG Therapeutics said the findings add to the evidence evaluating the long-term efficacy profile of BRIUMVI. The company’s chief executive officer, Michael S. Weiss, noted that comparative information can help inform treatment discussions because multiple anti-CD20 options are available for relapsing MS. Nevertheless, the reported differences should be interpreted in light of the study’s indirect design and should not be considered definitive evidence of comparative superiority.
Advertisement
Statistical Method and Clinical Context
The investigators conducted an unanchored matching-adjusted indirect comparison, a statistical approach used when randomized head-to-head trials are unavailable. Patient-level data from the BRIUMVI studies were weighted to match available baseline characteristics in the comparator trial populations, including age, sex, baseline Expanded Disability Status Scale scores, gadolinium-enhancing lesion prevalence, T2 lesion volume, previous relapse activity and time since diagnosis, where corresponding data were available. Although weighting can reduce differences in measured baseline characteristics, the method cannot adjust for all potential differences between studies, particularly unmeasured factors. Residual confounding cannot be excluded, and the authors state that the findings require confirmation through direct comparative trials or robust real-world evidence. The analysis was funded by Neuraxpharm, TG Therapeutics’ European commercialization partner for BRIUMVI. BRIUMVI is approved in the United States for adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The five-year analysis provides additional comparative evidence for consideration by clinicians, but treatment decisions must continue to account for individual patient characteristics, clinical history, safety considerations and approved prescribing information.
Source::TG Therapeutics, press release
