Brepocitinib Skin Outcomes in Patients With Dermatomyositis Save

This was a prespecified secondary analysis of the 52-week, phase 3, double-blind, placebo-controlled, randomized, multinational VALOR trial, that enrolled and treated 241adults with active skin and muscle disease due to dermatomyositis. Patients were randomized to receive either brepocitinib, 30 mg; brepocitinib, 15 mg; or placebo. Skin outcomes were assessed using change in the Cutaneous Dermatomyositis Disease Area and Severity Index–Activity (CDASI-A) score and achievement of clinically meaningful CDASI-A response (≥40% relative and ≥4-point absolute improvement). Other exploratory outcomes included itch (Peak Pruritus Numeric Rating Scale [PP-NRS]); skin-related QOL (Skindex-16); achievement of Cutaneous Dermatomyositis Activity–Investigator’s Global Assessment (CDA-IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement; and functional skin remission (CDASI-A ≤5). 

Clinical responses were noted as early as week 4, where brepocitinib, 30 mg was significantly superior to placebo in mean change from baseline in: 

• CDASI-A score (−6.4 vs −3.5; P < .001
• CDASI-A responders (33.3% vs 17.7%)
• Itch remission (PP-NRS ≤1: 38.3%  vs 19%)
• Improved skin-related QOL (Skindex-16 score: −12.9 vs −0.9)

In two-thirds (64%) of patients with moderate to severe skin disease at baseline, brepocitinib, 30 mg, was also associated with higher rates of achievement of a Cutaneous Dermatomyositis Activity–Investigator’s Global Assessment  CDA-IGA score (45.7% vs 21.8%)

Brepocitinib exhibited a safety profile consistent with approved JAK and TYK2 inhibitors.