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Getting the latest healthcare news for you
Brepocitinib, the first FDA-approved oral treatment for dermatomyositis, nearly doubled skin clearance rates and itch reduction compared to placebo in the phase 3 VALOR trial. Almost half of patients on the drug achieved clear or near-clear skin after a year, versus just 22% on placebo. It's a significant advance for a disease that has long had very few effective, on-label options.
Dermatomyositis, a rare autoimmune disease causing progressive damage to skin, muscles, and other organs, has long frustrated clinicians with a near-empty toolkit of approved therapies. That's changing. The TYK2/JAK1 inhibitor brepocitinib (Lisraya) — recently granted FDA approval as the first oral treatment for the condition — has now shown striking skin-specific results in a secondary analysis of the phase 3 VALOR trial, published in JAMA Dermatology.
The trial enrolled 241 patients who had already tried a median of four prior therapies. Those on brepocitinib 30 mg once daily saw rapid, durable improvements across multiple skin outcomes compared to placebo — with benefits emerging as early as week 4 and sustained through week 52. Notably, improvements in skin disease occurred alongside meaningful reductions in oral corticosteroid use, with over 40% of brepocitinib patients able to discontinue steroids entirely.
By the Numbers:
Why it matters: Until now, the only FDA-approved therapy for dermatomyositis was IV immunoglobulin — a cumbersome infusion-based treatment. Brepocitinib offers patients a once-daily pill that works quickly on the skin symptoms most visible and distressing to patients, filling a long-standing unmet need in this debilitating disease.
