The US Food and Drug Administration (FDA) has approved Lisraya (brepocitinib) 30 mg for the treatment of adults with dermatomyositis (DM).
DM is a rare autoimmune condition that targets small blood vessels in the skin and muscle. Symptoms can include a red skin rash around the eyelids, red bumps around the joints, and muscle weakness in the arms and legs. Muscle weakness gets worse over time and can lead to stiff joints and muscle wasting.
Brepocitinib is a dual selective inhibitor of TYK2 and JAK1 administered orally once daily. The medication targets and suppresses the signaling of pathogenic cytokines known to cause disease activity in dermatomyositis. It is the first and only targeted therapy approved for DM.
The FDA approval is based on results from the phase 3 multicenter, randomized, placebo-controlled, double-blind VALOR clinical trial (NCT05437263). Primary results from the trial were published in the New England Journal of Medicine in March 2026, with additional endpoints recently published in JAMA Dermatology.
Benefits were observed in the primary endpoint, the myositis Total Improvement Score, as early as week 4, increased over time, and were sustained to the end of the 52-week study. 55% of patients treated with brepocitinib were able to achieve both moderate or better improvement on the Total Improvement Score and minimal or no steroid use by the end of the study, compared to 30% on placebo. Among patients receiving brepocitinib who were taking 7.5 mg/day or greater of oral corticosteroids at baseline, 62% tapered to minimal or no steroid use by the end of the study, compared with 38% on placebo. Additionally, 45% came off corticosteroids entirely, compared with 29% on placebo.
Brepocitinib also demonstrated benefit on independent measures of skin disease, muscle strength, and on endpoints directly capturing patients’ lived experiences. Patients receiving brepocitinib reported more than four times as much improvement in overall disease activity as patients on placebo. On a measure of everyday function, including pain and core activities of daily living, patients treated with brepocitinib achieved clinically meaningful improvement, while those receiving placebo worsened.
The most common adverse reactions for patients on brepocitinib in the trial were upper respiratory tract infection, headache, fatigue, urinary tract infection, nausea, bronchitis, arthralgia, diarrhea, back pain, fall, influenza, and acne.
Full prescribing and safety information is available at lisraya.com.
To learn more about DM and other rare skin conditions, visit https://checkrare.com/diseases/skin-conditions/