- Late breaking sessions to highlight new data from the INTEGUMENT-PED trial evaluating roflumilast cream 0.05% in children ages 2-5 with atopic dermatitis
- New patient-reported outcomes including pruritus data from two pooled Phase 3 trials (DERMIS-1 and DERMIS-2) of ZORYVE® (roflumilast) cream 0.3% in plaque psoriasis
- New efficacy and patient-reported outcome data of ZORYVE (roflumilast) topical foam, 0.3%, in seborrheic dermatitis and investigational roflumilast foam in scalp and body psoriasis
“Our significant presence at this year’s AAD is a testament to our commitment to bringing meaningful innovation in immuno-dermatology, and building on the body of evidence supporting our topical roflumilast development program. In particular, we are excited to be participating in the late breaking data presentations with new results from INTEGUMENT-PED, as part of our atopic dermatitis clinical program,” said
Presentation details follow:
- Late Breaking Data Presentation
Efficacy and Safety of Once-Daily Roflumilast Cream 0.05% in Pediatric Patients 2 to 5 Years ofAge With Mild to Moderate Atopic Dermatitis (INTEGUMENT-PED): A Phase 3 Randomized Controlled Trial
Presenting Author: Dr.Lawrence Eichenfield
Time:March 10, 2024 ,2:30 PM PT
Room: 20BCD
- Oral Poster Presentation
Roflumilast Cream 0.3% in Patients With Psoriasis: Improvement in Patient Reported Outcomes and Pruritus From Two Pooled Phase 3 Trials (DERMIS-1/DERMIS-2)
Presenting Author: Dr.Mark Lebwohl
Time:March 9, 2024 ,3:25 PM PT
Room: Upper Level,Sails Pavilion , Poster Center 2
The following posters will be electronically available for the entirety of the conference and online beginning
Pooled Efficacy, Patient-Reported Outcomes, and Safety of Roflumilast Cream 0.15% From the INTEGUMENT-1 and INTEGUMENT-2 Phase 3 Clinical Trials of Adults and Children With Atopic Dermatitis
Simpson, E et al.
ePoster 53863
Roflumilast Foam 0.3%
Bhatia, N et al.
ePoster 53894
Patient-Reported Outcomes With Roflumilast Foam 0.3% in Patients With Scalp and Body Psoriasis in the Phase 3 ARRECTOR Trial
Gooderham, M et al.
ePoster 53817
Roflumilast Cream 0.3% in Patients With Psoriasis: Improvement in Patient Reported Outcomes and Pruritus From Two Pooled Phase 3 Trials (DERMIS-1/DERMIS-2)
Lebwohl, M et al.
ePoster 53025
About Arcutis
INDICATIONS
ZORYVE cream is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older.
ZORYVE foam, 0.3%, is indicated for treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.
IMPORTANT SAFETY INFORMATION
ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).
Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application.
The most common adverse reactions (≥1%) for ZORYVE cream include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).
The most common adverse reactions (≥1%) for ZORYVE foam include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).
Please see full Prescribing Information for ZORYVE foam and full Prescribing Information for ZORYVE cream.
Forward-Looking Statements
Arcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential for topical roflumilast to advance the standard of care in inflammatory dermatological conditions. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with
Contacts:
Media
asheldon@arcutis.com
Investors
lvairavan@arcutis.com
Investor Relations Advisory Solutions
derek.cole@iradvisory.com
Source:
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