Priovant's Brepocitinib Shows Positive Phase 3 Results in Dermatomyositis Trial

Priovant Therapeutics announced the publication of results from the Phase 3 VALOR trial evaluating brepocitinib in adults with dermatomyositis in the New England Journal of Medicine. The trial enrolled 241 patients across 90 sites globally and met its primary endpoint, with brepocitinib 30 mg achieving a 15.3-point greater improvement in mean Total Improvement Score at Week 52 compared to placebo. This clinical improvement was observed alongside meaningful corticosteroid tapering in the brepocitinib treatment arms, with nearly twice as many patients reducing background corticosteroids in the brepocitinib 30 mg group compared to placebo.

Brepocitinib 30 mg also demonstrated statistically significant and clinically meaningful improvements on all nine key secondary endpoints, with treatment effects evident as early as Week 4 and sustained through Week 52. VALOR enrolled a broad, representative dermatomyositis population that included patients with prior history of benign or malignant neoplasm and patients with multiple cardiovascular risk factors at baseline.

Serious infections in the study were increased in brepocitinib 30 mg compared to placebo; these events resolved with medical management, and brepocitinib treatment was completed in most cases. Adverse events leading to treatment discontinuation occurred more frequently with placebo, as did malignancies, cardiovascular events, and thromboembolic events. The authors hypothesize that the elevated rates of these events in the placebo group reflect the baseline risks associated with dermatomyositis itself and the immunosuppressive agents — particularly systemic steroids — commonly used in its treatment.

Additional analyses presented during the late-breaking abstract session at the 2026 Annual American Academy of Dermatology Meeting provide deeper insight into the skin-specific and patient-reported benefits of brepocitinib. These data demonstrate rapid and statistically significant reductions in itch, with an 18.9% greater proportion of patients achieving itch remission at Week 4 with brepocitinib 30 mg compared to placebo. Parallel improvements were observed in patient-reported, skin-related quality of life, with benefits sustained throughout the 52-week trial.

Notably, among the 64% of patients with moderate-to-severe skin disease at baseline, brepocitinib 30 mg was also associated with a 26.6% higher rate of functional skin remission compared to placebo. The VALOR study was a global Phase 3 trial that enrolled 241 subjects with dermatomyositis across 90 sites, with subjects randomized 1:1:1 to brepocitinib 30 mg, brepocitinib 15 mg, and placebo.