Brepocitinib Improves Skin Symptoms and Quality of Life in Dermatomyositis: JAMA
USA: Brepocitinib (Lisraya), a selective TYK2/JAK1 inhibitor, provided early, sustained, and clinically meaningful improvement in skin symptoms among previously treated patients with dermatomyositis. In a randomized trial, the once-daily oral therapy outperformed placebo in reducing severe itch and improving quality of life. Brepocitinib was generally well tolerated, with a safety profile consistent with other approved TYK2 and JAK inhibitors.
The findings come from a prespecified secondary analysis of the phase 3 VALOR randomized clinical trial, published in JAMA Dermatology by Aaron R. Mangold, Department of Dermatology, Mayo Clinic, Scottsdale, Arizona, and colleagues. The analysis examined whether brepocitinib could improve cutaneous disease activity, pruritus, skin-related quality of life (QOL), and remission-level outcomes over 52 weeks.
The double-blind, placebo-controlled trial was conducted between October 2022 and July 2025 across 90 sites in 20 countries and included adults with active dermatomyositis affecting both the skin and muscles. A total of 241 participants were randomized to once-daily brepocitinib 30 mg, brepocitinib 15 mg, or placebo.
Researchers assessed skin disease using the Cutaneous Dermatomyositis Disease Area and Severity Index–Activity (CDASI-A), while measuring itching with the Peak Pruritus Numeric Rating Scale. Researchers also evaluated skin-related QOL using the Skindex-16 and assessed whether patients achieved clear or almost-clear skin and functional skin remission.
The trial revealed the following findings:
- By week 4, CDASI-A scores decreased by 6.4 points with brepocitinib 30 mg versus 3.5 points with placebo, a between-group difference of −3.0 points.
- A clinically meaningful CDASI-A response was achieved by 33.3% of patients receiving brepocitinib versus 17.7% with placebo.
- Itch remission was achieved by 38.3% with brepocitinib versus 19.0% with placebo.
- Skin-related QOL improved, with Skindex-16 scores declining by 12.9 points with brepocitinib versus 0.9 points with placebo.
- Improvements in skin disease, itching, and QOL persisted from week 4 through week 52.
- Among patients with moderate-to-severe skin disease, 45.7% receiving brepocitinib achieved clear or almost-clear skin at week 52 versus 21.8% with placebo.
- Functional skin remission was achieved by 43.5% with brepocitinib versus 20.8% with placebo.
- Brepocitinib had a safety profile consistent with approved JAK and TYK2 inhibitors.
The researchers noted that the trial required background DMARD therapy to remain unchanged during the blinded treatment period, which may differ from routine practice where treatment may be reduced after disease control.
Overall, the findings support brepocitinib 30 mg as a targeted treatment capable of producing rapid, durable and remission-level improvement in cutaneous dermatomyositis, including among patients with substantial baseline skin disease.
Reference:
Mangold AR, Haemel A, Shahriari N, et al. Skin-Specific Outcomes of Brepocitinib in Patients With Dermatomyositis: Secondary Analysis of a Phase 3 Randomized Clinical Trial. JAMA Dermatol. Published online August 26, 2026. doi:10.1001/jamadermatol.2026.3199
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