TYK2-JAK1 Inhibitor Treatment Promising for Individuals with Refractory Dermatomyositis

Results from the Phase 3 VALOR trial presented at the American Academy of Dermatology (AAD) 2026 Annual Meeting revealed that individuals with refractory dermatomyositis treated with brepocitinib 30 mg/d achieved a statistical improvement in disease activity compared with those given placebo at 52 weeks. Complete details from the study were published online in The New England Journal of Medicine.

Brepocitinib is an oral, selective TYK2–JAK1 inhibitor designed to target cytokine pathways implicated in dermatomyositis pathogenesis. In the randomized, double-blind, placebo-controlled VALOR trial, 241 individuals were assigned to receive a once-daily oral dose of brepocitinib 30 mg, brepocitinib 15 mg, or placebo over 52 weeks in addition to standard-of-care therapies.

The primary outcome of the study was improvement in disease activity as measured by the Total Improvement Score (TIS), a validated composite measure of 6 dimensions, at week 52.

The TIS key end points reported include the following:

• Brepocitinib 30 mg/d: 46.5
• Brepocitinib 15 mg/d: 37.5
• Placebo: 31.2

Treatment difference (30 mg/d vs placebo): +15.3 (P<.001)

In terms of secondary outcomes, all 9 multiplicity-controlled secondary end points were met in the those taking brepocitinib 30 mg/d, with improvements observed in skin disease activity, physical function, glucocorticoid tapering, and onset of clinical benefit as early as week 4.

Specific findings reported at AAD 2026 revealed that treatment with brepocitinib 30 mg/d led to faster and significantly greater itch reduction, with ~19% more individuals reaching resolution of itch symptoms by week 4 versus those taking placebo.

Serious infections occurred in 10% of those receiving the 30 mg/d dose compared with 1% of those receiving a placebo.

Source:

Proviont Therapeutics. The New England Journal of Medicine publishes positive phase 3 VALOR trial results of brepocitinib in dermatomyositis. Accessed March 29, 2026.

https://www.globenewswire.com/news-release/2026/03/28/3264202/34323/en/New-England-Journal-of-Medicine-Publishes-Positive-Phase-3-VALOR-Trial-Results-of-Brepocitinib-in-Dermatomyositis.html