Brepocitinib Shows Sustained Skin Benefits in Phase 3 Dermatomyositis Trial

JAMA Dermatology published prespecified skin-specific secondary analyses from the phase 3 VALOR trial of oral brepocitinib in adults with dermatomyositis. The report was published online August 26, 2026.

At 30 mg once daily, brepocitinib produced rapid and sustained improvements in cutaneous disease activity, itch, and skin-related quality of life compared with placebo, with benefits evident by Week 4 and maintained through Week 52.

At Week 52, 61.7% of patients receiving brepocitinib 30 mg achieved a clinically meaningful CDASI-A response, compared with 44.3% receiving placebo.

Among patients with moderate-to-severe skin disease at baseline, 45.7% achieved clear or almost clear skin with brepocitinib versus 21.8% with placebo; functional skin remission was reached by 43.5% versus 20.8%, respectively.

Among patients with at least moderate itch, a clinically meaningful reduction was seen in 54.0% of brepocitinib-treated patients versus 9.5% with placebo at Week 4, rising to 74.0% versus 33.3% at Week 52.

Skin-related quality of life, measured using Skindex-16, improved by 12.9 points with brepocitinib versus 0.9 points with placebo.

The findings complement the trial’s primary results, in which the 30-mg dose improved overall dermatomyositis activity and met all nine key secondary endpoints. The 15-mg dose did not show the same statistically significant benefit for the primary endpoint.

Safety was broadly consistent with the known profile of JAK/TYK2 inhibitors, although serious infections were more frequent with brepocitinib 30 mg than placebo in the broader VALOR trial. The drug remains investigational for dermatomyositis.