Priovant Therapeutics Publishes Phase 3 VALOR Skin-Specific Outcomes for Brepocitinib in Dermatomyositis in JAMA Dermatology – Priovant Therapeutics
Priovant Therapeutics announced the publication in JAMA Dermatology of skin-specific outcomes from the Phase 3 VALOR trial evaluating brepocitinib, a first-in-class oral TYK2 and JAK1 inhibitor, in adults with dermatomyositis (DM). Primary efficacy and safety results from the trial were previously published in the New England Journal of Medicine, including benefit on measures of skin disease, muscle strength, physical function, and steroid-sparing.
“Skin disease is a major and often underappreciated driver of morbidity in dermatomyositis, with an impact on quality of life that exceeds most other inflammatory skin diseases. The rapid and sustained improvements in cutaneous disease activity and itch seen in the VALOR trial, together with the achievement of functional skin remission for many patients with moderate-to-severe skin disease at baseline, represent a monumental finding for patients with dermatomyositis. These results are particularly meaningful given how difficult cutaneous dermatomyositis manifestations and symptoms have historically been to control with conventional therapies.” – Victoria P. Werth, MD, Professor of Dermatology and Medicine at the Perelman School of Medicine at the University of Pennsylvania, Chief of the Division of Dermatology at the Philadelphia Veterans Administration Hospital, and one of the lead investigators of the Phase 3 VALOR Trial.
In the analyses published in JAMA Dermatology, brepocitinib 30 mg produced rapid, durable and clinically meaningful improvements across multiple dimensions of cutaneous dermatomyositis, including skin disease activity, itch and skin-related quality of life. Treatment effects were evident as early as Week 4 and sustained through Week 52, with significantly more brepocitinib-treated patients achieving clinically meaningful improvements in skin disease activity and itch, as well as remission-level skin outcomes, compared with placebo. The table below summarizes the results published in JAMA Dermatology:
Improvements in skin disease occurred alongside reductions in oral corticosteroid (OCS) use. Among patients receiving OCS at baseline, 61.7% of patients treated with brepocitinib 30 mg tapered to 2.5 mg/day (prednisone-equivalent) or less by Week 52 compared to 34.4% receiving placebo, while 41.7% discontinued OCS altogether compared with 23.4% receiving placebo. These findings support brepocitinib’s potential to deliver meaningful control of skin disease alongside substantial tapering of OCS, an important treatment goal in DM given the cumulative toxicity associated with systemic corticosteroid use.
As previously published in the New England Journal of Medicine, the VALOR trial enrolled a broad, representative DM population including patients with prior history of benign or malignant neoplasm and patients with multiple cardiovascular risk factors. 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. New or recurrent malignancy, cardiovascular events, and thromboembolic events in the study occurred more frequently in the placebo arm than the brepocitinib 30 mg arm. The brepocitinib safety database across all studies includes over 2,000 patients and subjects and supports a safety profile consistent with the known safety profile of JAK inhibitors.
