Significant benefits seen for brepocitinib 30 mg in dermatomyositis

For adults with dermatomyositis, brepocitinib, an oral tyrosine kinase 2/Janus kinase 1 inhibitor, demonstrates significant benefits at a 30-mg dose compared with placebo, according to a study published online March 28 in the New England Journal of Medicine to coincide with the annual meeting of the American Academy of Dermatology, held from March 27 to 31 in Denver.

Ruth Ann Vleugels, M.D., M.P.H., from Harvard Medical School in Boston, and colleagues conducted a phase 3, double-blind, randomized trial involving adults with dermatomyositis. Participants were randomly assigned to oral brepocitinib 30 mg, brepocitinib 15 mg, or placebo once daily for 52 weeks (81, 81, and 79 participants, respectively).

The researchers found that the mean Total Improvement Scores (TIS) at week 52 were 46.5, 37.5, and 31.2, respectively (brepocitinib 30 mg versus placebo difference: 15.3). On all nine key secondary end points, brepocitinib 30 mg was superior to placebo, including Cutaneous Dermatomyositis Disease Severity Index-Activity at week 4, moderate TIS response at week 52 with ≤2.5 mg/day of prednisone equivalent, and Health Assessment Questionnaire-Disability Index at week 52. The brepocitinib 30-mg arm had an increase in serious infections (9.9% versus 1.3% in placebo), but malignancies, thromboembolic events, and cardiovascular events were more frequent with placebo. There were no deaths reported.

“These findings underscore the need to move beyond the historical paradigm of suboptimal disease control and reliance on systemic corticosteroids toward a patient-centric model focused on rapid, sustained, steroid-sparing efficacy with a modern, targeted therapy,” Vleugels said in a statement.

Several authors disclosed ties to Priovant Therapeutics, which is developing brepocitinib and funded the study.

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