Incyte to Present New Dermatology Data at 2025 AAD Meeting
Incyte (Nasdaq: INCY) today announced that several abstracts showcasing new data from its dermatology portfolio will be presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting, set to take place from March 7-11, 2025, in
These presentations will feature significant findings on ruxolitinib cream (Opzelura®) in various dermatological conditions, including prurigo nodularis, and axatilimab (Niktimvo™) for patients with dermatologic manifestations of chronic graft-versus-host disease (GVHD).
Dr. Jim Lee, MD, PhD, Group Vice President of Inflammation and Autoimmunity at Incyte, expressed the company’s enthusiasm: “We are pleased to share new data for ruxolitinib cream in multiple indications, including prurigo nodularis, and axatilimab in patients with dermatologic manifestations of chronic graft-versus-host disease at this year’s AAD Annual Meeting. Incyte’s active participation in this key meeting reinforces our commitment to addressing critical needs in dermatology while fostering meaningful dialogue with researchers, patients, and stakeholders to inform the development of innovative treatments.”
The upcoming presentations include late-breaking research and several important poster sessions. Here’s an overview of the key data to be shared at the conference:
Oral Presentation: Prurigo Nodularis (PN)
Efficacy and Safety of Ruxolitinib Cream in Patients with Prurigo Nodularis: Results from a Phase 3, Randomized, Vehicle-Controlled Study (TRuE-PN1)
(Session: S028 – Late-Breaking Research: Session 1, Saturday, March 8, 2025, 9:24 a.m. ET)
This oral presentation will showcase results from a pivotal Phase 3 study (TRuE-PN1), which assessed the efficacy and safety of ruxolitinib cream for treating prurigo nodularis, a chronic skin condition characterized by severe itching and the formation of hard, raised bumps on the skin.
Poster Presentations
Atopic Dermatitis (AD)
Incyte will present several abstracts exploring the long-term safety and efficacy of ruxolitinib cream for treating atopic dermatitis (AD), a chronic inflammatory skin disorder. Key poster presentations include:
- Long-Term Safety of Ruxolitinib Cream in Adults and Adolescents with Mild-to-Moderate Atopic Dermatitis
This poster will highlight adverse events of interest from Phase 3 TRuE-AD1 and TRuE-AD2 studies, focusing on long-term safety data for ruxolitinib cream in patients aged 12 years and older with mild-to-moderate AD (Abstract: #64524). - Association of Ruxolitinib Cream Initiation with Reduction in Use of Other Topical Treatments, Oral Corticosteroids, and Biologics for Atopic Dermatitis
This poster will explore how the initiation of ruxolitinib cream impacts the use of other treatments for AD, including topical therapies, oral corticosteroids, and biologics. Notably, the analysis also investigates these effects independent of prior biologic use (Abstract: #64526). - Disease Control and Safety at 52 Weeks with As-Needed Application of Ruxolitinib Cream in Children Aged 2 to 11 Years with Moderate and/or More Extensive Atopic Dermatitis
A subgroup analysis of the TRuE-AD3 study will be presented, which evaluates disease control and safety outcomes for children with moderate or extensive AD after using ruxolitinib cream on an as-needed basis (Abstract: #64656). - Ruxolitinib Cream Demonstrated Long-Term Benefits in Disease Control and Quality of Life in Adults and Adolescents with Mild-to-Moderate Atopic Dermatitis
This poster will share findings on the long-term benefits of ruxolitinib cream, focusing on improvements in disease control and quality of life for adults and adolescents with mild-to-moderate AD (Abstract: #64727).
Graft-versus-Host Disease (GVHD)
In addition to its AD data, Incyte will also present findings on axatilimab (Niktimvo™) for treating chronic graft-versus-host disease, a condition where the transplanted immune cells attack the recipient’s body. One key poster presentation includes:
- Axatilimab for Patients with Dermatologic Manifestations of Chronic Graft-versus-Host Disease: A Post-Hoc Analysis
This presentation will provide additional insights into the safety and efficacy of axatilimab for treating dermatologic manifestations of chronic GVHD (Abstract: #64616).
The data presented at the AAD Annual Meeting will provide crucial insights into Incyte’s dermatology portfolio, particularly regarding the use of ruxolitinib cream (Opzelura) in managing atopic dermatitis and prurigo nodularis, and axatilimab in chronic graft-versus-host disease.
About Opzelura® (ruxolitinib) 1.5% Cream
Opzelura (ruxolitinib) is a selective JAK1/JAK2 inhibitor developed by Incyte. The cream formulation is FDA-approved for the topical treatment of non-segmental vitiligo in patients aged 12 years and older and is the first and only approved treatment in the United States for repigmentation. Opzelura is also approved for short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis in non-immunocompromised patients aged 12 years and older whose disease is not adequately controlled with other topical therapies or when such therapies are not recommended. However, the use of Opzelura in combination with biologic agents or other potent immunosuppressants is not recommended.
In Europe, Opzelura (ruxolitinib) 15 mg/g cream is approved for treating non-segmental vitiligo with facial involvement in adults and adolescents aged 12 years and older.
Incyte holds worldwide rights to develop and market ruxolitinib cream, marketed in the United States as Opzelura.
Opzelura and the Opzelura logo are registered trademarks of Incyte.
