Multiple Sclerosis

Higher Ublituximab Dosing, Shorter Infusion Time Well-Tolerated in Relapsing MS

Jessica Nye, PhD
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Publish Date
Among patients with MS who are B-cell depleted, a 450-mg dose of ublituximab in 1 hour may be safely administered as the initial infusion.

The transition from an intravenous anti-CD20 monoclonal antibody to higher ublituximab dosing with a shorter infusion time is well-tolerated among patients with relapsing multiple sclerosis (MS), according to study results presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), held in Copenhagen, Denmark, from September 18 to 20, 2024.

Transitioning from disease-modifying therapy (DMT) to ublituximab is likely to occur in clinical practice, however, no data are available to inform the safety and efficacy of this changeover.

The ENHANCE study (ClinicalTrials.gov Identifier: NCT05877963) is an actively enrolling multicenter phase 3b trial amended to assess the efficacy and safety of switching from DMT to ublituximab with a modified dosing schedule in relapsing MS. In cohorts 1 and 2, patients receiving anti-CD20 therapy with B-cell levels less than 10 cells/mL transitioned to 450 mg ublituximab infused over 2 hours (cohort 1) or 1 hour (cohort 2). In cohort 3, patients on another DMT will transition to 150 mg ublituximab infused over 4 hours. Shorter ublituximab infusion durations are planned with a 450 mg dose after week 1 day 1.

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In the ENHANCE study, the transition from IV CD20 to ublituximab with reduced infusion time has been well tolerated.

To date, 34 patients have been recruited for cohorts 1 and 2. All patients were receiving ocrelizumab at baseline and most (59%) had experienced a wearing-off effect of ocrelizumab prior to study enrollment.

In cohort 1 (n=13), no infusion-related reactions (IRRs) were observed. Conversely, in cohort 2 (n=21), 19% had Grade 1 IRRs. There was only 1 Grade 2 IRR.

All patients completed all infusions.

No infusion related reactions were observed among the 7 patients who had completed 24 weeks of infusions.

The major limitation of this analysis was the immaturity of the data.

“In the ENHANCE study, the transition from [intravenous] CD20 to ublituximab with reduced infusion time has been well tolerated. Enrollment in ENHANCE is ongoing and additional data from cohorts including participants transitioning from other DMTs and a shorter infusion duration will be presented,” the researchers concluded.

Disclosure: This research was supported by TG Therapeutics, Inc. Please see the original reference for a full list of disclosures.

References:

Foley J, Miller T, Belkin M, et al. Efficacy and tolerability of ublituximab after transitioning from a different disease modifying therapy: Updates from the ENHANCE study. Abstract presented at: ECTRIMS 2024; September 18-20; Copenhagen, Denmark. Abstract 2259/P329.