Priovant Therapeutics, a Roivant company, published skin outcomes from its VALOR trial of brepocitinib in JAMA Dermatology on Wednesday, reinforcing earlier efficacy data released in the New England Journal of Medicine.
The randomized, placebo-controlled study enrolled 241 adults with dermatomyositis across 90 sites, testing oral brepocitinib at 30 mg and 15 mg doses. Patients receiving the 30 mg dose showed clinically meaningful improvements in itch by week 4, with 54% reporting relief compared to 10% in the placebo group. By week 52, the gap widened to 74% versus 33%.
Skin disease outcomes also favored brepocitinib 30 mg. At 52 weeks, 46% of treated patients achieved “Clear or Almost Clear” skin per the Investigator’s Global Assessment, versus 22% with placebo. Functional skin remission, measured by the Cutaneous Dermatomyositis Activity and Severity Index, was achieved by 44% in the treatment arm compared to 21% in the placebo arm. Overall, 61.7% of brepocitinib 30 mg patients saw clinically meaningful improvement in skin disease activity, compared to 44.3% with placebo.
Steroid-sparing effects were observed, with 61.7% of brepocitinib 30 mg patients tapering oral corticosteroids to 2.5 mg/day or less by week 52, versus 34.4% in the placebo group. Discontinuation of oral corticosteroids occurred in 41.7% of the treatment arm compared to 23.4% in the placebo arm.
Safety data showed higher rates of serious infections in the brepocitinib 30 mg group compared to placebo. Conversely, new or recurrent malignancies, cardiovascular events, and thromboembolic events were more frequent in the placebo arm than in the brepocitinib 30 mg arm.
