Arcutis Presents Late-Breaking Data from the INTEGUMENT Phase 3 Trials in Atopic Dermatitis at American Academy of Dermatology Annual Meeting
WESTLAKE VILLAGE, Calif., March 18, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today presented in a late-breaking clinical trial session at the American Academy of Dermatology (AAD) annual meeting (New Orleans, LA, March 17-21) new data from its INTEGUMENT-1 and INTEGUMENT-2 pivotal Phase 3 studies of roflumilast cream 0.15% in adults and children 6 years and older with mild to moderate atopic dermatitis (AD). Roflumilast cream is a once-daily, steroid-free topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor.
Both studies met the primary endpoint of 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 (INTEGUMENT-1: 32.0% roflumilast cream vs. 15.2% vehicle, P<0.0001; INTEGUMENT-2: 28.9% roflumilast cream vs. 12.0% vehicle, P<0.0001). In addition, rapid and significant improvements in v-IGA success were demonstrated as early as Week 2 (INTEGUMENT-1: 21.2% for roflumilast cream vs. 6.4% for vehicle; P<0.0001; INTEGUMENT-2: 17.7% for roflumilast cream vs 5.3% for vehicle; P< 0.0001).
Over 30% of individuals treated with roflumilast cream in each study achieved Worst Itch Numeric Scale (WI-NRS) Success at Week 4. In addition, a daily improvement in itch was observed in those treated with roflumilast cream with a significant improvement at 24 hours following the first application (P<0.05) as measured by WI-NRS.
“Atopic dermatitis is a chronic skin disease common in both children and adults where pruritus, or itch, is the most reported and most burdensome symptom, and may cause substantially reduced quality of life and sleep disturbances,” said Lawrence F. Eichenfield, MD, Chief of Pediatric and Adolescent Dermatology at Rady Children's Hospital-San Diego, Professor of Dermatology and Pediatrics and Vice-Chair of the Department of Dermatology at UC San Diego School of Medicine, and study investigator. “Importantly, individuals treated with roflumilast cream experienced a significant and rapid improvement in the extent and severity of their atopic dermatitis, adding further to evidence of the potential of roflumilast cream as a treatment option for this disease. Additionally, these pivotal Phase 3 data show that roflumilast cream drove a significant and rapid reduction in itch as early as the first 24 hours, which could be a helpful early indication to children and adults that the treatment is working.”
Roflumilast cream also demonstrated rapid and statistically significant improvements compared to vehicle on key secondary endpoints, with more than 40% of children age 6 and older and adults treated with roflumilast cream achieving a 75% reduction in Eczema Area and Severity Index (EASI-75) at Week 4 compared to vehicle (INTEGUMENT-1: 43.2% vs. 22.0%, P<0.0001; INTEGUMENT-2: 42.0% vs. 19.7%, P<0.0001). Additionally, significant improvements in EASI-75 were observed with roflumilast cream as early as Week 1 in both studies compared to vehicle (INTEGUMENT-1: 14.0% vs. 5.5%, p=0.0006; INTEGUMENT-2: 13.3% vs. 7.8%, p=0.0329). In both studies, approximately 40% of children and adults treated with roflumilast cream achieved a vIGA-AD score of Clear (0) or Almost Clear (1) at Week 4 (INTEGUMENT-1: 41.5% vs. 25.2%, P<0.0001; INTEGUMENT-2: 39% vs. 16.9%, P<0.0001).
“Atopic dermatitis can have a huge impact on the quality of life for those affected, and also be challenging to treat,” said Julie Block, President and CEO, National Eczema Association. “Thankfully, our understanding of atopic dermatitis continues to grow, and the commitment from companies, such as Arcutis, to develop new treatment options aiming to provide people living with this disease a much-needed relief, is most welcome nd appreciated.”
“We are pleased to present these data from our pivotal Phase 3 INTEGUMENT program, which demonstrated significant improvements in atopic dermatitis in children and adults across multiple efficacy endpoints,” said Patrick Burnett MD, PhD, FAAD, Chief Medical Officer of Arcutis. “Roflumilast cream was also shown to be safe and well-tolerated, critical considerations for the treatment of atopic dermatitis. We look forward to the continued development of roflumilast cream 0.15% for atopic dermatitis as we prepare to file a supplemental new drug application (sNDA) with the U.S. Food & Drug Administration (FDA) in the second half of this year.”
Roflumilast cream 0.15% was well tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low in both active treatment and vehicle arms, with most TEAEs assessed as mild to moderate in severity, and no adverse event occurring in more than 3.5% of subjects in either arm. The most common TEAEs = 2% in roflumilast-treated patients were headache (INTEGUMENT-1 2.3% vs 1.4%; INTEGUMENT-2 3.5% vs 0.9%), nausea (1.8% vs 0.9%; 2.0% vs 0%), and application site pain (2.1% vs. 0.5%; 0.9% vs. 0.9%). Local tolerability was favorable with more than 90% of those treated with roflumilast cream reporting no or mild sensation across arms in both trials at any timepoint.
About the INTEGUMENT Phase 3 Trials
After completing INTEGUMENT-1 and INTEGUMENT-2, individuals were eligible to enroll in an open-label extension study (INTEGUMENT-OLE) evaluating treatment with once-daily roflumilast cream 0.15% for up to 12 months.
Arcutis is enrolling a third pivotal Phase 3 trial, the “INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients” (INTEGUMENT-PED) to evaluate roflumilast cream 0.05% in children 2 to 5 years of age with mild to moderate AD. The Company plans to report topline data from this study in the second half of 2023.
About Atopic Dermatitis
About Roflumilast Cream
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%).
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