Priovant Reports Skin Benefits of Brepocitinib in Phase 3

DURHAM, N.C., Aug 26, 2026

Brepocitinib Shows Rapid Skin Improvements

The newly published analysis highlights the impact of brepocitinib on several important manifestations of dermatomyositis. In patients with at least moderate itch at baseline, 54% of patients receiving brepocitinib 30 mg achieved a clinically meaningful reduction in itch by Week 4, compared with 9.5% receiving placebo. By Week 52, the response increased to 74% with brepocitinib versus 33.3% with placebo, demonstrating a sustained treatment effect. Among participants with moderate-to-severe skin disease at baseline, nearly half achieved remission-level outcomes after one year of treatment. At Week 52, 45.7% of patients treated with brepocitinib achieved “Clear” or “Almost Clear” skin according to the Investigators Global Assessment, compared with 21.8% for placebo. In addition, 43.5% achieved functional skin remission, defined by a CDASI-A score of 5 or less, versus 20.8% receiving placebo.The analysis also showed improvement in overall cutaneous disease activity. At Week 52, 61.7% of patients receiving brepocitinib 30 mg achieved a clinically meaningful CDASI-A response, compared with 44.3% in the placebo group. Improvements in skin-related quality of life were also observed, with Skindex-16 improvement reported as early as Week 4.

Phase 3 VALOR Supports Durable Disease Control

The skin-specific findings complement the broader results from the global Phase 3 VALOR study, which enrolled 241 patients with dermatomyositis across 90 sites. Participants were randomized to brepocitinib 30 mg, brepocitinib 15 mg or placebo. The 30 mg dose achieved a statistically significant and clinically meaningful improvement in the primary Total Improvement Score (TIS) endpoint at Week 52, with treatment benefits emerging as early as Week 4 and continuing throughout the one-year double-blind treatment period. Brepocitinib 30 mg also achieved statistically significant and clinically meaningful improvements across all nine key secondary endpoints, including measures of muscle strength, skin disease activity, functional disability and steroid tapering. More than two-thirds of patients receiving the 30 mg dose achieved a TIS40 response, representing twice the minimum clinically important difference. More than half achieved this response while simultaneously reducing systemic corticosteroid exposure to 2.5 mg/day or less.

Steroid Reduction Adds Clinical Significance

The newly reported skin outcomes were accompanied by reductions in oral corticosteroid use. Among patients receiving corticosteroids at baseline, 61.7% of brepocitinib 30 mg-treated patients tapered to 2.5 mg/day or less by Week 52, compared with 34.4% receiving placebo. Furthermore, 41.7% discontinued oral corticosteroids completely, compared with 23.4% in the placebo group. These findings are particularly relevant because reducing long-term systemic corticosteroid exposure remains an important treatment goal in dermatomyositis due to cumulative toxicity. The VALOR safety findings were consistent with the established safety profile of JAK inhibitors. Serious infections were increased in the brepocitinib 30 mg group compared with placebo, while new or recurrent malignancies, cardiovascular events and thromboembolic events occurred more frequently in the placebo arm in the study. The overall brepocitinib safety database includes more than 2,000 patients and subjects, according to Priovant.The JAMA Dermatology publication strengthens the evidence supporting brepocitinib as a potential treatment for cutaneous manifestations of dermatomyositis, particularly given the rapid improvements in skin activity and itch and the sustained remission-level outcomes observed through Week 52. Priovant is continuing development of brepocitinib across additional autoimmune indications, including non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris.

Source: Priovant Therapeutics press release