Ublituximab meets primary endpoint for relapsing MS

Ublituximab was more efficacious than teriflunomide in patients with relapsing MS. Annualised relapse rates and MRI parameters demonstrated superiority of ublituximab over teriflunomide. These results, along with a favourable safety profile, showed that ublituximab has the potential to become the first 1-hour anti-CD20 infusion therapy in relapsing MS patients [1].

Prof. Lawrence Steinman (Stanford University, CA, USA) presented the 96-week results of the identical phase 3, randomised, multicentre, double-blind ULTIMATE I (NCT03277261) and ULTIMATE II (NCT03277248) trials. Subjects with relapsing MS (n=549, n=545) were randomised 1:1 to 450 mg intravenous ublituximab every 24 weeks or 14 mg oral teriflunomide once daily. The primary endpoint was the annualised relapse rate (ARR) at week 96.

Ublituximab significantly reduced the ARR in the ULTIMATE I (59.4% reduction) and II (49.1% reduction) trials compared with teriflunomide. The relative reductions of contrast-enhancing T1 lesions for patients in the ublituximab arms were 96.7% and 96.5%, respectively, compared with teriflunomide. The relative reductions of new or enlarging T2 lesions were similar. In both trials, the proportion of patients who showed No Evidence of Disease Activity (NEDA) were higher in the ublituximab group (44.6%; 43.0%) than in the teriflunomide group (15.0%; 11.4%). Multiple Sclerosis Functional Composite (MSFC) scores showed patients benefited from ublituximab (0.469; 0.521) over teriflunomide (0.266; 0.275). A favourable safety and tolerability profile was observed for ublituximab. Any adverse events (AEs) were reported in approximately 88% of the patients, regardless of treatment. Infusion-related reactions, headache, and nasopharyngitis were the most frequently reported AEs in the ublituximab groups. Serious AEs, mainly infections and infestations, were observed in 9.5% of patients treated with ublituximab.

1. Steinman L, et al. Phase 3 results of the ULTIMATE I & II global studies: ublituximab versus teriflunomide in relapsing multiple sclerosis. OP117, ECTRIMS 2021 Virtual Congress, 13–15 October.

 

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Posted on 9 December 202125 March 2024