VALOR Data Show Sustained Skin Improvement With Brepocitinib

Once-daily oral brepocitinib 30 mg demonstrated rapid and sustained improvements in cutaneous disease activity, pruritus, and skin-related quality of life among adults with dermatomyositis, according to a prespecified secondary analysis of the phase 3 VALOR trial published in JAMA Dermatology.

The analysis included 241 adults with active skin and muscle disease enrolled in the 52-week, double-blind, placebo-controlled trial conducted at 90 sites across 20 countries. Participants received brepocitinib 30 mg, brepocitinib 15 mg, or placebo. The mean age was 50.6 years, and 77.6% were female.

Brepocitinib Demonstrates Early and Sustained Cutaneous Responses

By week 4, patients receiving brepocitinib 30 mg experienced significantly greater improvements in Cutaneous Dermatomyositis Disease Area and Severity Index–Activity (CDASI-A) scores compared with placebo (−6.4 vs −3.5; P < .001). Clinically meaningful CDASI-A responses occurred in 33.3% versus 17.7% of patients, respectively.

Itch remission, defined as a Peak Pruritus Numeric Rating Scale score of 1 or lower, occurred in 38.3% of brepocitinib-treated patients versus 19.0% receiving placebo. Skin-related quality-of-life improvements, measured using Skindex-16, were also greater with brepocitinib (−12.9 vs −0.9). The improvements persisted through week 52.

Among 155 participants with moderate to severe baseline skin disease, 45.7% receiving brepocitinib 30 mg achieved clear or almost clear skin at week 52, compared with 21.8% receiving placebo. Functional skin remission, defined as CDASI-A ≤5, occurred in 43.5% versus 20.8%, respectively.

The investigators reported a safety profile consistent with approved JAK and TYK2 inhibitors. Limitations include the secondary analysis design and restriction to patients with active skin and muscle disease.

"In this secondary analysis of a randomized clinical trial in dermatomyositis, once-daily brepocitinib, 30 mg, resulted in rapid, durable, and remission-level control of skin disease with an acceptable safety profile," the authors concluded.