ACAAI Presentation Highlights Roflumilast’s Efficacy and Safety

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At the American College of Allergy, Asthma and Immunology (ACAAI) 2024 Annual Scientific Meeting, new data will be presented from Arcutis Biotherapeutics highlighting the potential of roflumilast (Zoryve) cream 0.15% in addressing both the clinical and quality of life aspects of atopic dermatitis (AD). The data, presented at the meeting in Boston, MA, from October 24-28, and will highlight the drug's efficacy, safety, and tolerability.¹

Study Overview

The data stems from 2 pivotal phase 3 trials, INTEGUMENT-1 and INTEGUMENT-2, which included 1,337 participants aged 6 and older with mild to moderate AD. The studies were designed as parallel-group, double-blind, vehicle-controlled trials, comparing the effects of roflumilast cream with a vehicle over a 4-week period.²

Results demonstrated that the cream significantly improved key patient-reported outcomes compared to the vehicle. Notably, the SCORing Atopic Dermatitis (SCORAD) total score, the Patient-Oriented Eczema Measure (POEM), and the Dermatitis Family Impact (DFI) scores reflected substantial improvements.

"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,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis, in a press release. “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.”

Results

• At week 1, 64.2% of participants treated with roflumilast achieved a clinically meaningful improvement in SCORAD scores, compared to 36.3% in the vehicle group (P<0.0001).
• By week 4, these figures rose to 46.2% for roflumilast versus 26.6% for the vehicle group (P<0.0001).
• For POEM scores, 61.7% of those using roflumilast experienced a meaningful improvement at week 1 versus 34.2% with the vehicle (P<0.0001), with even greater differences at week 4 (7.5 vs. 3.9, P<0.0001).
• Improvement in DFI scores at week 4 was also notable, with roflumilast-treated patients reporting a score of 3.12 compared to 1.74 for the vehicle (P<0.0001).

The company said in a release that these findings highlight the rapid onset of efficacy with roflumilast cream, with measurable benefits observed as early as one week into treatment.

Safety and Tolerability

“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,” said Mark Boguniewicz, MD, professor in the Division of Allergy-Immunology, Department of Pediatrics, at National Jewish Health and University of Colorado School of Medicine , and presenting author, in a press release. “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.”

Roflumilast cream 0.15%demonstrated a favorable safety profile, with a low incidence of treatment-emergent adverse events. Common adverse reactions included headache, nausea, application site pain, diarrhea, and vomiting. The release stated the overall tolerability in both roflumilast and vehicle-treated groups supports its use as a safe option for patients.

Conclusion

The company stated the recent findings from the INTEGUMENT studies provide compelling evidence for the efficacy and safety of roflumilast cream 0.15% in the treatment of AD. Not only does roflumilast facilitate rapid improvement in clinical outcomes, but it also significantly enhances quality of life for patients and their families. As clinicians seek to provide comprehensive care for AD, incorporating treatments like roflumilast that address both physical symptoms and psychosocial impact could be vital in managing this complex condition.

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 Biotherapeutics. Published October 24, 2024. Accessed October 24, 2024. https://investors.arcutis.com/news-releases/news-release-details/arcutis-presents-positive-patient-reported-outcome-data-zoryver
2. Simpson EL, Eichenfield LF, Alonso-Llamazares J, et al. Roflumilast cream, 0.15%, for atopic dermatitis in adults and children: INTEGUMENT-1 and INTEGUMENT-2 randomized clinical trials. JAMA Dermatol. September 18, 2024. doi:10.1001/jamadermatol.2024.3121