Arcutis Announces Positive Results from INTEGUMENT-PED Pivotal Phase 3 Trial of Roflumilast Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5
WESTLAKE VILLAGE, Calif., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the INTEGUMENT-PED pivotal Phase 3 trial of roflumilast cream 0.05%, in children ages 2 to 5 years with mild to moderate atopic dermatitis (AD) met its primary endpoint and all secondary endpoints. In the study, 25.4% of children treated with roflumilast cream 0.05% achieved IGA 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 at Week 4, compared to 10.7% treated with vehicle (P<0.0001), with significant improvements seen as early as Week 1.
“Pediatric atopic dermatitis is a chronic, recurrent inflammatory skin condition that can negatively impact the quality of life of the child and family or caregivers. Children’s skin is uniquely sensitive and finding tolerable therapy is often more challenging. Ideally, sensitive areas such as the face and eyelids need a topical treatment that minimizes stinging and burning and is suitable for long-term use,” said Adelaide A. Hebert, MD, Chief of Pediatric Dermatology at McGovern Medical School at UTHealth Houston, and INTEGUMENT-PED investigator. “The positive findings from this study of roflumilast cream are highly consistent with the findings from the INTEGUMENT-1 and INTEGUMENT-2 studies. These results further reinforce the safety and efficacy profile of roflumilast cream as a potential treatment option, if approved, for pediatric atopic dermatitis down to 2 years of age.”
“Atopic dermatitis is a chronic disease that is unstable in its course. EASI-75 has emerged as an important endpoint in clinical trials and reflects clinically meaningful responses in the real world. EASI incorporates body surface area, and higher body surface area involvement is an important consideration for the severity and impact of the disease for patients suffering from pediatric atopic dermatitis,” said Jonathan Silverberg, MD, PhD, MPH, FAAD, Professor, Director of Clinical Research, and Director of Patch Testing at George Washington University School of Medicine and Health Sciences, Washington, DC.
Roflumilast cream was very well-tolerated. Overall, the incidence of adverse events in INTEGUMENT-PED was low, and the only adverse event occurring in =3% of subjects in either arm was upper respiratory tract infection. The most frequent adverse events in the roflumilast arm (=2%) included upper respiratory tract infection, pyrexia, diarrhea, and vomiting. Of children who were randomized to roflumilast cream in the study, 93.8% completed the full four weeks, and there were few discontinuations due to adverse events (1.1% and 1.9% in the roflumilast cream and vehicle groups, respectively). Of the children who completed INTEGUMENT-PED, 93.4% elected to continue open label, long-term treatment in the INTEGUMENT-OLE study.
“Roflumilast cream was formulated with the atopic dermatitis patient in mind, delivering drug without disrupting the skin barrier or the use of sensitizing excipients an irritants. The consistent safety and tolerability profile of roflumilast cream sets our next generation PDE4 inhibitor apart,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “In addition, roflumilast cream provided rapid improvement and control in atopic dermatitis as well as quick reduction of itch, which provides the positive feedback loop to the parent and caregiver that the treatment is working and an incentive to maintain therapy over time.”
The Company recently announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis in adults and children ages 6 years and older. Following the potential approval of roflumilast cream 0.15% and based on these positive results, Arcutis intends to submit an sNDA for roflumilast cream 0.05% for the treatment of mild to moderate atopic dermatitis in children ages 2 to 5 years.
The Company will host a conference call to discuss the results of both INTEGUMENT-PED and INTEGUMENT-OLE today at 8:30 a.m. ET. A live webcast of the call and the presentation material will be available on the “Events” section of the Company’s investor website. An archived replay of the webcast will be available on the Arcutis investor website following the conference.
About Atopic Dermatitis
About Roflumilast Cream
Roflumilast cream 0.3% (ZORYVE®) is approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Roflumilast cream for AD was evaluated at lower doses: 0.15% for adults and children 6 years of age and older and is being evaluated at 0.05% for children aged 2 to 5 years.
IMPORTANT SAFETY INFORMATION
The most common adverse reactions (=1%) include diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application site pain (1%), upper respiratory tract infection (1%), and urinary tract infection (1%).
Please see full Prescribing Information.
ZORYVE is for topical use only and not for ophthalmic, oral, or intervaginal use.
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