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NewsBrepocitinib (Lisraya) just became the first FDA-approved oral therapy for dermatomyositis, and rheumatologists say it's already changing the treatment conversation. The drug, a TYK2/JAK1 inhibitor, showed significant improvements across skin, muscle, and functional outcomes in the phase 3 VALOR trial. Experts are urging clinicians to prioritize it as a way to reduce reliance on steroids.
The FDA's approval of brepocitinib (Lisraya, Priovant Therapeutics) marks a turning point for dermatomyositis — a rare inflammatory muscle disease with limited treatment options. It's now the first oral targeted therapy approved for the condition, and rheumatologists are calling it a meaningful advance. Dr. Julie J. Paik of Johns Hopkins notes that patients are already proactively seeking it out online, underscoring the significant unmet need this drug addresses.
Brepocitinib works by dampening both type I and type II interferon responses via selective TYK2/JAK1 inhibition. In the pivotal phase 3 VALOR trial — one of the largest ever conducted in myositis — the 30 mg dose hit statistical significance on all 10 ranked endpoints at 52 weeks, outperforming placebo on skin disease, muscle strength, functional disability, and glucocorticoid tapering.
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Why it matters: Dermatomyositis patients have long relied on steroids and off-label immunosuppressants with limited evidence. Brepocitinib offers a fast-acting (effects seen at 4 weeks), orally administered, mechanism-targeted option — giving clinicians a meaningful tool to reduce steroid burden and improve patient outcomes.
