Ublituximab for Multiple Sclerosis: 30-Minute Infusion Well-Tolerated at Week 24

A 30-minute, 450 mg ublituximab infusion at week 24 is well-tolerated among patients with relapsing multiple sclerosis (MS) and a full 450 mg infusion is well-tolerated on day 1 for the subset of patients who are B-cell depleted. These are the findings of a study presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2025, held in West Palm Beach, Florida from February 27 to March 1.

Ublituximab is approved for the treatment of relapsing MS with a dosing schedule of 150 mg on day 1, followed by a 1-hour 450 mg infusion on day 15 and week 24, followed by infusion every 24 weeks.

To evaluate the safety and efficacy of a modified 30-minute ublituximab infusion, the ENHANCE (ClinicalTrials.gov Identifier: NCT05877963) study is actively recruiting patients with relapsing MS. The patients with B-cell levels of 10 cells/mL or greater at baseline received a 150 mg ublituximab dose on day 1 and a 450 mg 1-hour infusion on day 15 whereas those with B-cell depletion received a 450 mg 1-hour infusion on days 1 and 15. At week 24, all participants received the 30-minute ublituximab infusion.

As of a data cutoff in October 2024, 44 patients had received the 30-minute ublituximab infusion at 16 study sites.

At study entry, 31 patients were B-cell depleted and 13 were non-depleted. Most patients transitioning from ocrelizumab (n=29) reported an ocrelizumab wearing off effect (51.7%).

Infusion-related reactions (IRRs) occurred among 15% of those who received a 150 mg dose and 26% of those who received a 450 mg dose of ublituximab on day 1.

At week 24, all 30-minute infusions were completed and 89% were completed without interruption or slowing. The IRR rate was 18% with the 30-minute infusion, in which all events were of Grades 1 or 2 in severity. All events were managed with supportive antihistamine and were resolved.

This study was limited by the small sample size; however, ENHANCE recruitment is ongoing.

“Administration of a full 450 mg dose in 1 hour on Day 1 was well tolerated in B-cell depleted patients transitioning from prior anti-CD20 therapy. Further, the frequency of IRRs observed during the 30-minute infusion at Week 24 was low and establishes feasibility of rapid infusions that may offer improved convenience. Enrollment in ENHANCE is ongoing and additional data will be presented,” the researchers concluded.

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