Safety of 30-minute ublituximab infusions confirmed

An update from the ENHANCE study confirmed that ublituximab 450 mg can be safely administered to patients with MS as a 30-minute (as opposed to 1-hour) infusion. All of the infusions were completed; 93% without interruption or delay. There was a low rate of infusion-related reactions (IRRs).

The administration schedule of ublituximab is 150 mg on day 1, followed by 450 mg doses on day 15, week 24, and every 24 weeks thereafter. The 450 mg infusions are administered over 1 hour. The 48-week ENHANCE study (TG1101-RMS401) was set up to evaluate the efficacy of a modified regimen including a faster, 30-minute infusion of ublituximab at week 24. ENHANCE is still enrolling patients with MS who are either treatment-naïve or transitioning from other disease-modifying therapies (DMTs). Those who switched from anti-CD20 therapy (mostly ocrelizumab) and were B-cell depleted (<10 cells/µL) received a 450 mg ublituximab infusion in 1 hour on day 1. All other patients received ublituximab 150 mg on day 1, followed by 450 mg administered in 1 hour on day 15. At week 24, all participants had a 30-minute infusion of ublituximab 450 mg.

Interim results were presented by Dr John Foley (Rocky Mountain Multiple Sclerosis Center, UT, USA) [1]. Of 81 participants, 47 were B-cell depleted at baseline. All 30-minute infusions were completed, 93% without interruption or delay. The median infusion time was 32 minutes. Almost all participants (91%) received non-drowsy anti-histamines as premedication. There was a low rate of IRRs (13.6%) after the 30-minute infusion; 7.4% was grade 1, 4.9% was grade 2, and 1.2% was grade 3. Throat irritation (11%) and itching (3.7%) were the most frequently reported IRRs.

Patient satisfaction was assessed at week 24 employing the Treatment Satisfaction Questionnaire for Medication 9 (TSQM-9). All participants were satisfied with the medication, 99% found it convenient, 100% found its use easy to plan, and 98% said it relieved their symptoms. Dr Foley and colleagues concluded that these results support the safety of ublituximab given as a 30-minute infusion, offering improved convenience.

1. Foley J, et al. Safety and tolerability of 30-minute ublituximab infusions: Updates from the ENHANCE study. P107, ACTRIMS 2025, 27 February–01 March 2025, West Palm Beach, FL, USA.

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Posted on 28 March 202528 March 2025