VALOR Skin Outcomes with Brepocitinib in Dermatomyositis Save

A secondary analysis of the brepocitinib vs. placebo (VALOR) trial in adult dermatomyositis (DM), demonstrates that the Tyk2/JAK1 inhibitor is superior to placebo in producing rapid and sustained improvements in cutaneous disease activity, pruritus, and skin-related quality of life as early as week 4 with continued improvement through week 52.

The VALOR trial was published earlier this year in the NEJM, demonstrating the efficacy of brepocitinib in DM - the primary outcome in that trial was the Total Improvement Score (TIS), a validated composite muscle outcome index.  This current report was a prespecified analysis of skin outcomes in the VALOR study.

The phase 3 study included 241 adult dermatomyositis patients, with active skin and muscle disease, who were treated with oral brepocitinib 30 mg qd vs. placebo and looked at cutaneous disease activity outcomes, including itch, skin-related quality of life (QOL), and achievement of remission-level end points.  Key secondary outcomes in VALOR included 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 validated measures of itch, skin-related QOL, and Cutaneous Dermatomyositis Activity–Investigator’s Global Assessment (CDA-IGA) score were used.

By week 4, brepocitinib, 30 mg, demonstrated superiority over placebo with improvement in:

• CDASI-A score (−6.4 vs −3.5; P < .001)
• CDASI-A response (33% vs 18%)
• Itch remission (38% vs 19%)
• Skin-related QOL (−12.9 vs −0.9)

In DM patients with moderate to severe skin disease (64%), brepocitinib had higher CDA-IGA score (46% vs 22%) and functional skin remission (43% vs 21%) at week 52.

Brepocitinib has shown significant efficacy in muscle and skin outcomes in dermatomyositis patients.