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Tolebrutinib reduces brain lesions in very active MS

AAN 2021
Phase 2

A subgroup analysis of a phase 2b trial demonstrated that tolebrutinib 60 mg effectively reduced new Gd-enhancing and new/enlarging T2 lesions in relapsing multiple sclerosis (MS) patients with highly active disease.

The randomised, double-blind, placebo-controlled, cross-over phase 2 study (NCT03889639) assessed the dose-response relationship after 12 weeks of treatment with tolebrutinib (5, 15, 30, and 60 mg), by measuring the number of new brain lesions on MRI. This study had a novel design which limited placebo exposure to only 4 weeks. At a dose of 60 mg, tolebrutinib was associated with an 85% relative reduction of new Gd-enhancing T1 hyperintense lesions [1]. Of 130 enrolled MS patients, 61 (47%) met the criteria for highly active disease at baseline; 29 of those started in the placebo cohort and later crossed over to tolebrutinib, evenly distributed across each dose arm.

After 4 weeks of placebo treatment, patients with highly active disease had a mean of 0.89 Gd-enhancing lesions and 1.44 new/enlarging T2 lesions. After 12 weeks of tolebrutinib treatment, mean numbers of new Gd-enhancing lesions in the subgroup with highly active disease were lowest in the 60 mg group: 0.82 (5 mg), 0.5 (15 mg), 0.38 (30 mg), and 0.08 (60 mg). The numbers of new/enlarging T2 lesions showed a very similar pattern: 1.09 (5 mg), 0.89 (15 mg), 0.75 (30 mg), and 0.15 (60 mg). Tolebrutinib was well tolerated over 12 weeks. Safety in the highly active disease group was consistent with the overall population.

  1. Traboulsee A, et al. Efficacy and Safety of Tolebrutinib in Patients With Highly Active Relapsing MS: Subgroup Analysis of the Phase 2b Study. S25.004, AAN 2021 Virtual Congress, 17-22 April.

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