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Placebo-controlled trial of an oral BTK inhibitor in multiple sclerosis

New England Journal of Medicine Jun 24, 2019

Montalban X, et al. - Via a double-blind, randomized, phase 2 trial on 267 patients with relapsing multiple sclerosis, researchers intended to assess the effectiveness and risks of evobrutinib, a selective oral Bruton's tyrosine kinase inhibitor. Patients were allocated to one of five 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) for reference. Patients who took 75 mg of evobrutinib once daily had significantly less enhancing lesions from week 12 through 24 vs placebo. Further, no significant difference with placebo for either the 25-mg once daily or 75-mg twice-daily dose of evobrutinib, nor in the annualized relapse rate or disability progression at any dose was observed. For patients with multiple sclerosis, long and extensive trials to ascertain the effectiveness and risks of evobrutinib is needed. Evobrutinib resulted in increases in liver aminotransferase values.

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