Arcutis Announces Publication of Positive Data from INTEGUMENT-PED Trial Evaluating ZORYVE® (roflumilast) Cream 0.05% in Children 2 to 5 Years Old with Mild to Moderate Atopic Dermatitis in Pediatric Dermatology

Rhea-AI Summary

Arcutis Biotherapeutics (ARQT) announced positive results from the INTEGUMENT-PED phase 3 trial of ZORYVE® (roflumilast) cream 0.05% for treating mild to moderate atopic dermatitis in children aged 2-5 years. The trial, involving 652 children, demonstrated significant improvements across all primary and secondary efficacy endpoints.

Key results include: 25.4% of treated children achieved vIGA-AD Success versus 10.7% for vehicle (P<0.0001); 39.4% achieved EASI-75 compared to 20.6% for vehicle; and improvement in itch was observed within 24 hours. The treatment was well-tolerated with low incidence of adverse events, mainly including upper respiratory tract infection, diarrhea, and vomiting.

The company has submitted a supplemental New Drug Application (sNDA) to the FDA, targeting approximately 1.8 million children aged 2-5 with atopic dermatitis in the US who receive topical treatment.

Positive

• Significant efficacy demonstrated with 25.4% achieving vIGA-AD Success vs 10.7% for vehicle
• 39.4% of treated patients achieved EASI-75 vs 20.6% for vehicle
• Rapid improvement in itch observed within 24 hours of first application
• Well-tolerated safety profile with low adverse events incidence
• sNDA submitted to FDA targeting large market of 1.8M children aged 2-5

Negative

• None.

Insights

Medical Research Analyst

The INTEGUMENT-PED trial results represent a significant milestone for Arcutis's pediatric atopic dermatitis program. The 39.4% EASI-75 response rate and rapid onset of action within 24 hours are particularly impressive for a non-steroidal treatment. These efficacy metrics position ZORYVE cream 0.05% as a potentially transformative option in the $2+ billion pediatric AD market.

The steroid-free nature of ZORYVE addresses a critical unmet need in pediatric dermatology. Parents and physicians are often hesitant to use topical corticosteroids long-term due to concerns about skin thinning and other side effects. ZORYVE's safety profile, with TEAEs comparable to vehicle, could drive significant adoption as a maintenance therapy option.

The commercial implications are substantial. With 1.8 million children aged 2-5 requiring topical AD treatment in the US, even modest market penetration could drive meaningful revenue growth. The lower 0.05% concentration, specifically optimized for young children, demonstrates Arcutis's strategic approach to market segmentation and lifecycle management.

The timing of the sNDA submission is optimal, as the pediatric AD market lacks innovative non-steroidal options. Early efficacy signals, particularly the 24-hour itch improvement, could drive rapid adoption among pediatric dermatologists who prioritize quick symptom relief for young patients. The potential approval later this year could establish ZORYVE as a first-line therapy option for mild-to-moderate AD in this age group.

• ZORYVE® (roflumilast) cream 0.05% improved atopic dermatitis (AD) across all primary and secondary efficacy endpoints, with significant improvement as early as Week 1 on multiple efficacy endpoints.  
• 39.4% of children treated with roflumilast cream 0.05% achieved a 75% improvement in Eczema Area and Severity Index (EASI-75), a key secondary endpoint.
• Children treated with ZORYVE cream experienced improvement in itch as early as 24 hours. 
• Efficacy and safety results were consistent with previous trials of ZORYVE cream 0.15% in adults and children with AD down to age 6.  
• Approximately 1.8 million children with atopic dermatitis (AD) aged 2 to 5 are topically treated in the United States. 
• Supplemental New Drug Application (sNDA) for ZORYVE cream 0.05% submitted to the U.S. Food and Drug Administration (FDA).  

WESTLAKE VILLAGE, Calif., Feb. 24, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that Pediatric Dermatology published online positive results from INTEGUMENT-PED, the pivotal phase 3 randomized vehicle-controlled trial evaluating the efficacy and safety of ZORYVE (roflumilast) cream 0.05% as a once-daily, steroid-free treatment for mild to moderate atopic dermatitis (AD) in children 2 to 5 years old.  

The study found that treatment with investigational once-daily ZORYVE cream 0.05% resulted in significant improvements across multiple efficacy endpoints, including achieving a statistically significant improvement in the primary efficacy endpoint of IGA Success, as well as statistically significant improvements in additional endpoints, including 75% improvement in the Eczema Area and Severity Index (EASI-75) and Worst Itch Numeric Scale (WI-NRS) at Week 4. The data also show improvement in itch (pruritus) was observed as early as 24 hours after first application. 

“AD is a chronic, inflammatory skin disease affecting 1.8 million children ages 2 to 5 in the United States with burdensome symptoms that often result in impaired quality of life for both patients and their caregivers,” said Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego and lead author on the publication. “Results from the INTEGUMENT-PED trial demonstrate that ZORYVE cream 0.05% can quickly and reliably improve the symptoms of AD, especially itch. The publication of these results and the entire clinical development program highlight that ZORYVE cream 0.05%, if approved, could fill a significant gap in the current treatment landscape for a once-daily steroid-free topical therapy that is appropriate for both the short and long-term management of AD, key concerns for young patients and their caregivers.” 

INTEGUMENT-PED is a Phase 3, parallel group, double blind, vehicle-controlled trial in which roflumilast cream 0.05% or vehicle was applied once daily for four weeks to children 2 to 5 years of age with mild to moderate AD. A total of 652 children were enrolled in the study, with a mean Body Surface Area (BSA) of 22% overall, and a range from 3% to 82%.  

As previously reported, at Week 4, 25.4% of children treated with ZORYVE cream 0.05% achieved vIGA-AD Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘Clear’ or ‘Almost Clear’ plus a 2-grade improvement from baseline, compared to 10.7% of children treated with vehicle (P<0.0001), with significant improvements seen as early as Week 1. Other key findings included: 

• Rapid improvement in itch was observed in children treated with ZORYVE cream within 24 hours of the first application, as measured by the change from baseline in daily WI-NRS scores, compared with vehicle (nominal P≤.0014). 
• 35.3% of children treated with ZORYVE cream achieved a four-point reduction in WI-NRS at Week 4 vs. 18.0% for vehicle-treated subjects (nominal P=0.0002). 
• 39.4% of children treated with ZORYVE cream achieved a 75% improvement in EASI score (EASI-75) at Week 4 compared to 20.6% treated with vehicle (P<0.0001). Significant improvements based on EASI-75 were observed with ZORYVE cream compared to vehicle as early as Week 1. 
• 35.4% of children treated with ZORYVE cream 0.05% achieved a vIGA-AD score of ‘clear’ or ‘almost clear’ at Week 4, with significant improvements seen as early as Week 1. 
• ZORYVE cream was very well-tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low and similar in both active treatment and vehicle arms. The most frequent adverse events in the ZORYVE cream arm (≥2%) included upper respiratory tract infection, diarrhea, and vomiting. All individual AEs occurred in <4.1% of patients. 
• Safety and tolerability results were consistent with previous trials of ZORYVE cream 0.15% in patients aged ≥6 years with AD. 

“On the heels of our recent submission of a sNDA to the FDA for ZORYVE cream 0.05%, we’re proud to share the full INTEGUMENT-PED results published in Pediatric Dermatology with the dermatology community, supporting the well-established efficacy, safety, and tolerability profile of this lower concentration of ZORYVE cream,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “We’re committed to bringing forth meaningful innovation and addressing the significant unmet need for topical treatments of young children living with the challenges of AD. We look forward to the FDA’s potential approval of ZORYVE cream 0.05% anticipated later this year.” 

About ZORYVE (roflumilast) Cream 
Roflumilast cream is a next generation topical PDE4 inhibitor. PDE4 – an established target in dermatology – is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. Roflumilast cream 0.3% (ZORYVE®) is approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older. Roflumilast cream 0.15% (ZORYVE®) is approved by the FDA for the topical treatment of mild to moderate AD in patients 6 years of age and older. In 2024, ZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness award for “Eczema Product.” 

INDICATIONS 
ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. 

ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. 

IMPORTANT SAFETY INFORMATION 
ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C). 

The most common adverse reactions (≥1%) for ZORYVE cream 0.3% for plaque psoriasis 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 cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%). 

Please see full Prescribing Information. 

About Arcutis 
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio including three FDA approved products that harness our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, AD, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X. 

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 FDA approval of ZORYVE cream 0.05%, the potential of real-world use results of ZORYVE cream in AD in children aged 2 to 5, and the potential for ZORYVE cream to advance the standard of care in AD and other 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 the U.S. Securities and Exchange Commission (SEC) on February 27, 2024, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 

Contacts: 
Media 
Amanda Sheldon, Head of Corporate Communications 
media@arcutis.com 

Investors 
Latha Vairavan, Vice President, Finance and Corporate Controller 
ir@arcutis.com 

FAQ

What were the key efficacy results of ZORYVE cream 0.05% in the INTEGUMENT-PED trial (ARQT)?

The trial showed 25.4% of treated children achieved vIGA-AD Success vs 10.7% for vehicle, and 39.4% achieved EASI-75 vs 20.6% for vehicle. Improvement in itch was observed within 24 hours of first application.

What is the market size for ZORYVE cream 0.05% in pediatric atopic dermatitis (ARQT)?

Approximately 1.8 million children aged 2-5 years with atopic dermatitis are topically treated in the United States.

What were the main side effects reported in the INTEGUMENT-PED trial for ZORYVE (ARQT)?

The most frequent adverse events included upper respiratory tract infection, diarrhea, and vomiting, with all individual adverse events occurring in less than 4.1% of patients.

When does Arcutis (ARQT) expect FDA approval for ZORYVE cream 0.05%?

Following the submission of the supplemental New Drug Application (sNDA), Arcutis anticipates potential FDA approval later in 2025.