Roflumilast Reduces Disease Impact of Atopic Dermatitis

Mark Boguniewicz, MD

Credit: National Jewish Health

Roflumilast cream (ZORYVE; Arcutis) was efficacious in treating atopic dermatitis (AD) and decreased its impact on patients and families, according to new data from the INTEGUMENT-1 and –2 studies.¹

New patient-reported outcome (PRO) data from the studies were presented at the American College of Allergy Asthma and Immunology (ACAAI) 2024 Annual Scientific Meeting held October 24-28, 2024, in Boston, MA, by Mark Boguniewicz, MD, Professor, Pediatric Allergy /Immunology /Rheumatology, University of Colorado, and National Jewish Health, and Children's Hospital Colorado.

“AD is a chronic, complex disease that can negatively affect the individual and the broader family unit, impacting relationships, sleep, and basic functions in life, like school attendance, housework, food preparation, and more,” Boguniewicz said in a statement.¹ “These new data show that treatment with ZORYVE not only provides rapid disease clearance and significant reduction in itch for the patient, but extends beyond that, reducing the impact of quality of life challenges that families and caregivers experience as a result of having a loved one living with a chronic skin disease like AD.”

The new, PRO data demonstrated that 64.2% of participants in the roflumilast group had a clinically meaningful improvement in SCORAD Total Score compared to 36.3% treated with vehicle at Week 1 (P <.0001) and 46.2% had a clinically meaningful improvement compared to 26.6% at week 4 (P <.0001). Furthermore, 61.7% of the roflumilast group had a clinically meaningful improvement in POEM scores compared to 34.2% treated with the vehicle at Week 1 (P <.0001), with greater improvement seen in the roflumilast group at week 4 (7.5 vs. 3.9; P <.0001). Greater improvement was also seen in DFI scores in the roflumilast group compared to vehicle at Week 4 (3.12 vs. 1.74; P <.0001).¹

Roflumilast was approved for treating individuals aged 6 years and older with moderate-to-severe AD in July 2024, following an initial approval for plaque psoriasis in 2022.² Roflumilast cream is a next generation topical phosphodiesterase-4 (PDE4) inhibitor designed to decrease production of pro-inflammatory mediators and increase production of anti-inflammatory mediators.

The INTEGUMENT-1 and INTEGUMENT-2 (The INterventional Trial EvaluatinGroflUMilast cream for the treatmENt of aTopic dermatitis) Phase 3 trials were identical parallel group, double blind, vehicle-controlled trials evaluating the safety and efficacy of ZORYVE cream 0.15% or vehicle applied once-daily for 4 weeks in 1,337 adults and children 6 years of age and older with mild to moderate AD.¹

"When evaluating different treatment options for chronic skin conditions we often focus on the clinical efficacy outcomes, like disease clearance or reduction in symptoms like itch. However, this is just one piece of the puzzle and it’s just as important to understand the improvement in other aspects of patients’ lives that are impacted by this chronic disease,” Patrick Burnett, MD, PhD, FAAD, chief medical officer, Arcutis, added.¹ “We’re proud to share these data showcasing rapid improvement in patient reported outcomes, which translate to meaningful relief with ZORYVE cream for those with AD their families, and caregivers.”

REFERENCES

1. Arcutis Presents Positive Patient-Reported Outcome Data for ZORYVE® (Roflumilast) Cream 0.15% in Atopic Dermatitis at American College of Allergy, Asthma and Immunology 2024 Annual Scientific Meeting. News release. Arcutis. October 24, 2024. https://finance.yahoo.com/news/arcutis-presents-positive-patient-reported-120000669.html

2. FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age. Arcutis Biotherapeutics, Inc. June 9, 2024. https://www.globenewswire.com/en/news-release/2024/07/09/2910781/0/en/FDA-Approves-Arcutis-ZORYVE-roflumilast-Cream-0-15-for-the-Treatment-of-Atopic-Dermatitis-in-Adults-and-Children-Down-to-6-Years-of-Age.html. Date accessed: June 9, 2024.