Real-world ublituximab for MS demonstrates similar clinical benefits as in phase 3 studies
Key takeaways:
- A real-world cohort experienced fewer infusion-related reactions with ublituximab than clinical trial cohorts.
- 83.3% of individuals who switched to ublituximab due to MRI activity had stable MRIs.
WEST PALM BEACH, Fla. — Real-world effects of ublituximab after 1 year of administration were consistent with data from a pair of phase 3 clinical trials investigating the drug, according to a poster presented at ACTRIMS.
“We wanted to see the real-world comparison to ULTIMATE I and II, which was testing efficacy and tolerability of ublituximab,” Camille Boll, an undergraduate student at the University of Utah and study coordinator at Rocky Mountain Multiple Sclerosis Clinic, told Healio.
Boll and colleagues compared the real-world experiences of ublituximab (Briumvi, TG Therapeutics) in patients with relapsing forms of MS at their clinic in Salt Lake City with results from a pair of randomized, double-blind active-controlled phase 3 clinical trials.
They conducted a retrospective chart review including data from 163 individuals (median age, 41 years; 63% women) treated with ublituximab infusion at the clinic between March 2023 and June 2024 and followed up within a year of administration.
The researchers additionally conducted two substudies. The first examined MRI activity in 22 of 163 individuals who were given ublituximab for at least 1 year after switching from another medication, including 12 who switched from previous medications due to efficacy issues or increased MRI activity.
The second substudy involved 38 patients who switched from ocrelizumab (Ocrevus, Genentech), 22 of whom experienced wearing-off effects that prompted the switch after three to five rounds of ocrelizumab administration.
According to the results, after at least 1 year on ublituximab, 10 of 12 patients in the first substudy group demonstrated stable MRI activity post switch.
In the second substudy group, 19 of the 22 who switched experienced wearing-off effects, with 16 of the 19 experiencing resolution of wearing-off effects while on ublituximab. In addition, four of the 16 experienced B-cell repletion after the switch was made.
In the overall chart review, the median interval between the first and second doses of ublituximab was 2 weeks, with 67% of infusions occurring between weeks 24 and 26. Infusion-related reactions (IRRs) were mild to moderate, with 28.2% of patients in the real-world analysis experiencing IRRs during the initial dose compared with 43.3% of ULTIMATE trial participants.
“Our experience was consistent with ULTIMATE I and II,” Boll told Healio.