JAMA Dermatology Publishes Skin-Specific Outcomes from Phase 3 VALOR Trial Of Brepocitinib in Dermatomyositis
Rhea-AI Summary
Roivant Sciences (NASDAQ: ROIV), via Priovant Therapeutics, reported that JAMA Dermatology published skin-specific Phase 3 VALOR data for oral TYK2/JAK1 inhibitor brepocitinib 30 mg in adults with dermatomyositis.
At Week 52, 61.7% of patients achieved a clinically meaningful CDASI-A response versus 44.3% with placebo. Among those with at least moderate skin disease at baseline, 45.7% on brepocitinib reached “Clear”/“Almost Clear” on IGA and 43.5% achieved functional skin remission (CDASI-A ≤5), versus 21.8% and 20.8% on placebo. In patients with at least moderate itch at baseline, 54.0% on brepocitinib reached clinically meaningful itch reduction by Week 4 versus 9.5% with placebo, rising to 74.0% versus 33.3% by Week 52. Skin-related quality of life (Skindex-16) improved by 12.9 points by Week 4 with brepocitinib versus 0.9 with placebo. Among oral corticosteroid users at baseline, 61.7% on brepocitinib tapered to ≤2.5 mg/day and 41.7% discontinued steroids by Week 52, compared with 34.4% and 23.4% on placebo. Serious infections occurred more often with brepocitinib but resolved with medical management.
Positive
- Clinically meaningful CDASI-A response at Week 52: 61.7% brepocitinib vs 44.3% placebo
- Remission-level skin outcomes at Week 52: IGA Clear/Almost Clear 45.7% vs 21.8%; CDASI-A ≤5 43.5% vs 20.8%
- Rapid itch reduction by Week 4: 54.0% brepocitinib vs 9.5% placebo with ≥2-point PP-NRS improvement
- Itch response by Week 52: 74.0% brepocitinib vs 33.3% placebo with ≥2-point PP-NRS improvement
- Skindex-16 skin-related QoL improvement by Week 4: 12.9-point gain brepocitinib vs 0.9 with placebo
- OCS tapering among baseline users by Week 52: 61.7% to ≤2.5 mg/day and 41.7% discontinued vs 34.4% and 23.4% on placebo
Negative
- Serious infections occurred more frequently in the brepocitinib 30 mg arm than placebo, although events resolved with medical management
News Explained
The publication adds that, in VALOR, new or recurrent malignancies, cardiovascular events, and thromboembolic events occurred more frequently with placebo than brepocitinib 30 mg; the broader safety database includes over 2,000 patients and subjects.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Aug 06 | Phase 3 enrollment | Positive | +1.5% | BEACON+ enrolled first patients in Phase 3 cutaneous sarcoidosis study. |
| Apr 02 | Clinical program expansion | Positive | +1.8% | Brepocitinib LPP trial expanded while batoclimab TED results missed endpoints. |
| Mar 03 | NDA priority review | Positive | -0.9% | FDA accepted brepocitinib's dermatomyositis NDA for Priority Review. |
| Feb 06 | Phase 2 results | Positive | +22.1% | Brepocitinib produced statistically significant cutaneous sarcoidosis benefit. |
| Sep 17 | Phase 3 results | Positive | +7.8% | VALOR demonstrated brepocitinib superiority over placebo at Week 52. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
ROIV's tag-specific clinical-trial announcements were generally followed by positive 24-hour reactions, with one negative divergence.
Key Terms
tyk2 medical
jak1 medical
cdasi-a medical
skindex-16 medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- JAMA Dermatology publication includes results from VALOR skin-specific secondary endpoints, with rapid and durable improvements seen for brepocitinib 30 mg compared to placebo across multiple dimensions of cutaneous dermatomyositis (DM), including measurements of disease activity, itch, and skin-related quality of life
- In patients with at least moderate itch at baseline, clinically meaningful improvements were observed as early as Week 4 in
54% of brepocitinib 30 mg patients versus10% with placebo, increasing to74% versus33% , respectively, by Week 52 - Nearly half of brepocitinib 30 mg treated patients with moderate-to-severe skin disease at baseline achieved remission-level outcomes by Week 52, with
46% demonstrating “Clear” or “Almost Clear” skin on the Investigators Global Assessment (IGA) and44% achieving functional skin remission on the Cutaneous Dermatomyositis Activity and Severity Index – Activity Score (CDASI-A), more than two-fold higher than with placebo (22% and21% , respectively) - Results complement the primary efficacy and safety results from the VALOR trial previously published in the New England Journal of Medicine and reinforce brepocitinib’s potential as an important treatment for signs and symptoms of skin disease in dermatomyositis, regardless of muscle involvement
DURHAM, N.C., Aug. 26, 2026 (GLOBE NEWSWIRE) -- Priovant Therapeutics announced today 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,” said 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. “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.”
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:
| Brepocitinib 30 mg | Placebo | Delta ( | |
| Disease Activity1 | |||
| Achievement of Clinically Meaningful CDASI-A Response (≥ | |||
| Remission2 | |||
| Achievement of Gold Standard ≥ 2-category improvement on IGA to “Clear” / “Almost Clear” Skin at Week 52 | |||
| Achievement of Functional Skin Remission (CDASI-A ≤ 5) at Week 52 | |||
| Itch3 | |||
| Achievement of Clinically Meaningful Itch Reduction (≥ 2-point improvement in PP-NRS) by Week 4 | |||
| Achievement of Clinically Meaningful Itch Reduction (≥ 2-point Improvement in PP-NRS) by Week 52 | |||
| Skin-Related QoL1 | |||
| Improvement in Skindex-164 by Week 4 | 12.9 | 0.9 | 11.9 (6.0 to 17.9) |
1Among all participants
2Among participants with at least moderate skin disease at baseline
3Among participants with at least moderate itch at baseline
4Minimal clinically important difference defined as 10 units of improvement
Abbreviations: CDASI-A, Cutaneous Dermatomyositis Disease Area and Severity Index - Activity; CDA-IGA, Cutaneous Dermatomyositis Activity-Investigator’s Global Assessment; PP-NRS, Peak Pruritus-Numerical Rating Scale; Skindex-16, skin-related quality of life
Improvements in skin disease occurred alongside reductions in oral corticosteroid (OCS) use. Among patients receiving OCS at baseline,
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.
About the Phase 3 VALOR Study
The VALOR study was a global Phase 3 trial that enrolled 241 subjects with dermatomyositis across 90 sites. Subjects were randomized 1:1:1 to brepocitinib 30 mg, brepocitinib 15 mg, and placebo. Brepocitinib 30 mg demonstrated statistically significant and clinically meaningful improvement compared to placebo on the primary endpoint of Total Improvement Score (TIS) at Week 52. TIS is a composite endpoint of six core set measures of myositis disease activity. Benefit compared to placebo was seen as early as Week 4 and sustained at every visit thereafter through the end of the one-year double-blind treatment period. Brepocitinib 30 mg also demonstrated statistically significant and clinically meaningful improvement compared to placebo on all nine key secondary endpoints evaluated, including measures of muscle strength, skin disease activity, functional disability, and steroid tapering. More than two thirds of brepocitinib 30 mg patients achieved a Total Improvement Score of at least 40 (TIS40), twice the minimum clinically important difference. More than half achieved this TIS40 threshold while also reducing systemic corticosteroid use to ≤2.5 mg/day (prednisone-equivalent). Brepocitinib exhibited a safety profile consistent with the known safety profile of JAK inhibitors, with no new safety signals identified.
About Priovant
Priovant Therapeutics is a biotechnology company dedicated to developing novel therapies for autoimmune diseases with high morbidity and few available treatment options. The company's lead asset is brepocitinib, a first-in-class, selective inhibitor of TYK2 and JAK1. Through selective TYK2/JAK1 inhibition, brepocitinib distinctively suppresses key cytokines linked to autoimmunity—including type I IFN, type II IFN, IL-6, IL-12 and IL-23—with a single, targeted, once-daily oral therapy. Brepocitinib recently generated positive Phase 3 data in dermatomyositis. Brepocitinib is also being evaluated in a Phase 3 program in non-infectious uveitis, a Phase 3 program in cutaneous sarcoidosis, and a Phase 2b/3 program in lichen planopilaris. Priovant Therapeutics is a Roivant (Nasdaq: ROIV) company.
Contacts:
Stephanie Lee: stephanie.lee@priovant.com
