Evobrutinib shows promise in treatment of multiple sclerosis
Daily use of the selective oral Bruton’s tyrosine kinase (BTK) inhibitor evobrutinib in the treatment of patients with relapsing multiple sclerosis helps reduce the number of gadolinium-enhancing lesions, according to the results of a phase II trial.
A total of 267 patients were randomly assigned to one of the following treatment groups: placebo, evobrutinib (at a dose of 25 mg once daily, 75 mg once daily, or 75 mg twice daily), or open-label dimethyl fumarate (DMF) as a reference.
The primary endpoint of mean total (cumulative) number of gadolinium-enhancing lesions identified on T1-weighted magnetic resonance imaging at weeks 12 through 24 was 3.85 in the placebo group, 4.06 in the evobrutinib 25-mg group, 1.69 in the 75-mg once-daily group, 1.15 in the 75-mg twice-daily group and 4.78 in the DMF group.
Compared with placebo, evobrutinib 75-mg once-daily significantly reduced the reduced the number of lesions over time (adjusted rate ratio, 0.30; p=0.005). The difference noted between placebo and the 25-mg group (adjusted rate ratio, 1.45; p=0.32) or the 75-mg twice-daily group (adjusted rate ratio, 0.44; p=0.06) was not significant.
Annualized relapse rate at week 24 was 0.37 in the placebo group, 0.57 in the evobrutinib 25-mg group, 0.13 in the evobrutinib 75-mg once-daily group, 0.08 in the evobrutinib 75-mg twice-daily group, and 0.20 in the DMF group. Scores on the Expanded Disability Status Scale (EDSS) did not significantly change from baseline across all treatment groups.
There were elevations in liver aminotransferase values observed with evobrutinib.
The researchers acknowledged the need for longer and larger trials to establish the risk–benefit profile of the drug.