Ublituximab Reduces Multiple Sclerosis Disease Activity Across Subgroups

In the phase 3 ULTIMATE trials (NCT03277261 and NCT03277248), ublituximab (UTX: TG Therapeutics, New York, NY) reduced annualize relapse rate (ARR) and disease progression in relapsing multiple sclerosis (rMS).

For those treated with ublituximab, the ARR at week 96 ranged from 0.06 to 0.24 and was significantly lower than with teriflunomide treatment, which ranged from 0.14 to 0.38 (P<.001 for all but people age 38 and up or with more than 3 relapses).

At week 95, the reduction of gadolinium enhancing (Gd+) T1 lesions observed in those treated with ublituximab ranged from 0.00 to 0.08 compared 0.25 to 1.55 in those treated with teriflunomide. The reduction of new/enlarging T2 lesions in those treated with ublituximab vs teriflunomide were 0.19 to 0.69 vs 2.17 to 7.34.

The proportion of participants with no evidence of disease activity (NEDA) (24-96 weeks re-baselined; P<.0001 for all) ranged from 71.3% to 85.6% with ublituximab and vs 11.3% to 32.6% with terifluomide.

The ULTIMATE studies were multicenter double-blind double-dummy active-controlled phase 3 clinical trials. Participants were randomly assigned to teriflunomide treatment had daily oral doses plus placebo infusions for 96 weeks and were followed for an additional 20 weeks. Participants (n=1,094) had a diagnosis of relapsing MS using the McDonald 2010 criteria, expanded disability status scale (EDSS) scores of 0 to 5.5 and at least 2 documented relapses in the 2 years before enrollment or 1 relapse or 1 Gd+ lesion in the year before enrolling. 

The most common adverse events associated with ublituximab were infusion-related reactions (47.7% treated with ublituximab had at least 1 infusion-related reaction vs 12.2% of those treated placebo infusion).