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Discussing Late-Breaking INTEGUMENT-PED Data With Arcutis' Chief Medical Officer, Patrick Burnett, MD, PhD, FAAD

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Burnett recently spoke with Dermatology Times to discuss the background, methods, and findings of the late-breaking INTEGUMENT-PED data, as well as its potential real-world and clinical implications.

At the 2024 American Academy of Dermatology Annual Meeting, Arcutis and researchers presented late-breaking clinical trial data from the phase 3 INTEGUMENT-PED study of roflumilast 0.05% cream in a pediatric population with atopic dermatitis (AD).

The study examined the use of 0.05% roflumilast cream in 2 to 5-year-olds with mild to moderate AD. Patients were racially diverse and had significant skin involvement and itchiness at baseline.

The treatment showed significant improvement compared to the vehicle cream, with about 25% achieving clear or almost clear skin at 2 steps by week 2. Similar positive responses were observed across various outcome measures, including EASI improvement and itch reduction.

Safety data were favorable, with low adverse events and high tolerability. The study supports the drug's efficacy and safety in AD, with potential to extend its use beyond other dermatological conditions like psoriasis and seborrheic dermatitis, according to a prior Dermatology Times interview with Lawrence Eichenfield, MD.

Patrick Burnett, MD, PhD, FAAD, is chief medical officer of Arcutis.

Burnett recently spoke with Dermatology Times to discuss the background, methods, and findings of the data, as well as its potential real-world and clinical implications. Burnett also provided an overview of additional Arcutis presentations at the meeting.

Q&A

Q: Can you please provide a brief summary of the background and methods of the INTEGUMENT-PED study, as well as the significance of this data?

A: The INTEGUMENT-PED is a phase 3 parallel-group, double-blind, vehicle-controlled trial studying the safety and efficacy of roflumilast cream 0.05% in children aged 2-5 years of age with mild to moderate atopic dermatitis. In this study, roflumilast cream 0.05% (n=437) was tested against the vehicle (n=215) once-daily for 4 weeks. INTEGUMENT-PED met the primary endpoint of validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Success as defined by a score of clear or almost clear with 2-grade improvement at Week 4, as well as all secondary endpoints. The study also found that treatment with this once-daily, steroid-free roflumilast cream 0.05% resulted in disease clearance as early as Week 1 and reduction in itch in the first 24 hours following application. Additionally, 39.4% of children treated with roflumilast cream 0.05% achieved a 75% improvement in EASI (EASI-75) at Week 4 compared to the vehicle.

The study results show that roflumilast cream 0.05% was also well tolerated, with the incidence of treatment emergent adverse events (TEAEs) was low, with the only adverse event occurring in >3% of subjects in either arm of the trial was upper respiratory tract infection. Local tolerability was also favorable, with application site pain only being reported in 1.6% of roflumilast-treated participants. These findings are consistent with the effective response of roflumilast cream across Arcuits’ atopic dermatitis development program.

Q: In your opinion, what are the possible real-world/clinical implications of this data on roflumilast cream 0.05% for pediatric AD?

A: Following these very promising results, I am quite hopeful of the real-world impact roflumilast cream 0.05% can have, if approved, for this young pediatric population (ages 2-5) afflicted with atopic dermatitis. The impact of this disease on the quality of life for both patients and the family is quite dramatic.

We know that there is a gap in care and a significant unmet need for a safe, tolerable, and efficacious topical treatment that can provide relief and be used anywhere. For caregivers of younger children, there is also a desire for steroid -free options - so a nonsteroidal treatment that can be used chronically is a profile that fits well with that gap. It is great to see our hard work at Arcutis come to life, and I am excited to continue advancing our therapeutics in atopic dermatitis and provide meaningful innovation through the continued development of roflumilast cream.

Q: Is there anything else related to Arcutis data being presented at AAD that you would like to share?

A: Along with the late-breaking session, we will be presenting 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. Additionally, we are sharing 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. Finally, Mt. Sinai will be sharing exciting new research sponsored by Arcutis that reveals the genomic profile of seborrheic dermatitis for the first time.

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