Priovant Therapeutics, a Roivant Sciences subsidiary, announced positive skin-specific results from its Phase 3 VALOR trial evaluating brepocitinib in patients with dermatomyositis, published in JAMA Dermatology on Wednesday.
The randomized, placebo-controlled study enrolled 241 participants across 90 clinical centers, with patients receiving either brepocitinib 30 mg, brepocitinib 15 mg, or placebo. Primary efficacy and safety findings were previously disclosed in the New England Journal of Medicine.
At Week 52, 74% of patients treated with brepocitinib 30 mg reported clinically significant itch improvement, compared with 33% in the placebo group. Among those with moderate-to-severe skin disease at baseline, 46% achieved "Clear or Almost Clear" skin on the investigator's global assessment, versus 22% with placebo. Functional cutaneous remission was observed in 44% of patients on brepocitinib 30 mg, compared to 21% in the placebo arm.
The drug also facilitated corticosteroid reduction, with 61.7% of patients on brepocitinib 30 mg who were using oral corticosteroids at baseline reducing their dose to 2.5 mg/day or less by Week 52, compared to 34.4% in the placebo group. Approximately 41.7% discontinued corticosteroid use entirely, versus 23.4% in the placebo cohort.
Safety data indicated a higher incidence of serious infections in the brepocitinib 30 mg group. However, new cases or recurrences of malignancy, cardiovascular events, and thromboembolic events were more frequent in the placebo group.
Priovant, headquartered in Durham, North Carolina, plans to present full trial results at an upcoming medical conference.
