Ublituximab reduced brain volume loss by 22%, suppressed new lesion formation
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Key takeaways:
- Researchers analyzed data from 1,094 individuals with relapsing MS.
- At 2 years, treatment with ublituzimab reduced thalamic volume loss by 22% compared with teriflunomide.
Treatment with ublituximab suppressed new lesion formations after 1 year while reducing thalamic volume loss and increasing T1 hypointense lesion volume compared with teriflunomide, according to data presented at ECTRIMS 2023.
“Thalamic integrity is affected by both the direct effects of RMS and indirect effects of damage to tracts projecting into and out of the thalamus,” Douglas L. Arnold, MD, president and CEO of NeuroRx Research, and colleagues wrote. “As such, thalamic injury may reflect much of the RMS-related damage that occurs throughout the entire central nervous system rather than direct structural injury.”
Arnold and colleagues sought to evaluate the impact of ublituximab (Briumvi, TG Therapeutics) on thalamic volume and new lesion formation for those with relapsing MS in the ULTIMATE I and II clinical trials during and after year 1.
The companion placebo-controlled ULTIMATE I (n = 549) and II (n = 545) studies evaluated 450 mg intravenous infusions of ublituximab every 24 weeks (following an infusion of 150 mg on day 1 and 450 mg on day 15) compared with 14 mg of oral teriflunomide once daily for 96 weeks. In the pooled modified intention-to-treat population, the percentage of thalamic volume change was measured from baseline to week 96 and in yearly epochs using paired Jacobian integration. Researchers engaged in post hoc analyses of changes over both years as well as yearly intervals or T1 hypointense lesion volume, new T1 hypointense lesion counts, and new/enlarging T2 lesion counts.
The researchers reported that ublituximab treatment “significantly reduced” thalamic volume loss compared with teriflunomide, by 22% over 2 years.
The least squares (LS) mean percentage change from baseline to week 96 was -1.34 (95% CI: -1.56, -1.12) compared with - 1.71 (95% CI: -1.93, -1.5) for ublituximab and teriflunomide, respectively. For T1 hypointense lesion volume, LS mean percent change from baseline to week 96 for ublituximab was 6.32 (95% CI: -0.82, 13.46) compared with 24.87 (95% CI: 17.77, 31.96) for teriflunomide.
Data additionally showed reduction was more significant in T1 hypointense lesion volume in year 2 of treatment compared with year 1, with a similar pattern observed for new T1 hypointense lesion counts and new/enlarging T2 lesions.
“The reduction in T1 hypointense lesion volume in year 2 of treatment was more pronounced than in year 1, with the same pattern seen for new T1 hypointense lesion counts and new/enlarging T2 lesions,” Arnold and colleagues wrote.