Ublituximab Shows Benefit Among Patients With Relapsing Multiple Sclerosis

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Using data from the Ultimate I and II phase 3 trials, researchers conducted a post-hoc analysis to study the effects of ublituximab on disease activity in relapsing multiple sclerosis.

The following article is part of conference coverage from the 2022 American Academy of Neurology (AAN) Annual Meeting. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from the 2022 AAN Annual Meeting.

 

Ublituximab was found to demonstrate consistent no evidence of disease activity (NEDA) among patients with relapsing multiple sclerosis (RMS), according to study findings presented at the 2022 American Academy of Neurology (AAN) Annual Meeting, held from April 2 to April 7 in Seattle, Washington, and virtually from April 24-26, 2022.

Previous phase 3 ULTIMATE I and II trials showed significant improvements with ublituximab vs teriflunomide in relapse rate, number of gadolinium-enhancing (Gd+) T1 lesions, new/enlarging T2 lesions, and NEDA at 96 weeks. Using these data, researchers sought to characterize the effects of ublituximab on NEDA in a post hoc analysis.

Patients with RMS (n=549 and n=545 from the Ultimate I and II, respectively) receiving 450 mg of intravenous ublituximab every 24 weeks or once-daily 14 mg teriflunomide for 96 weeks were included in the post-hoc analysis.

NEDA was defined as lack of confirmed relapses, T1 Gd+ lesions, new/enlarging T2 lesions, and 12-week disability progression. Researchers evaluated NEDA by treatment epoch and patient subtypes, including treatment-naive, disease-modifying-therapy-experienced, and early (3 years or less) and late diagnosis (more than 3 years).

Based on treatment epoch, the NEDA rates for ublituximab vs teriflunomide were 44.6% vs 12.4% at 0 to 96 weeks, 82.1% vs 22.5% at 24 to 96 weeks, 53.3% to 29.2% at 0 to 24 weeks, 49.3% vs 20.1% at 0 to 48 weeks, and 88.2% vs 30.4% at 48 to 96 weeks (P <.001 for all).

Based on patient subtype, a total of 82.7% vs 23.1%, 81.1% vs 21.1%, 82.4% vs 18.6%, and 81.9% vs 26.5% of the ublituximab vs teriflunomide cohorts, respectively, achieved NEDA at 24 to 96 weeks (P <.001 for all).

Disease activity as measured by relapse, progression, Gd+ lesions, and new/enlarging T2 lesions between week 24 and 96 for participants receiving ublituximab vs teriflunomide was 11.4% vs 22.9%, 4.9% vs 6.3%, 0.6% vs 40.9%, and 3.1 vs 71.6%, respectively.

Overall, the researchers concluded, “ULTIMATE I and II post hoc pooled analyses demonstrated a consistent NEDA benefit for ublituximab-treated patients across treatment epochs and key patient subpopulations.”

Reference

Alvarez E, Steinman L, Fox E, 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: the 2022 AAN Annual Meeting; April 2-7, 2022; Seattle, Washington; April 24-26, 2022; Virtual Meeting. Abstract P6.005.