Positive Results Reported in Roflumilast 0.15% for AD Across Diverse Populations

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Arcutis Biotherapeutics, Inc. shared promising new data from its phase 3 clinical trials, INTEGUMENT-1 and INTEGUMENT-2, for roflumilast 0.15% (Zoryve; Arcutis) in treating atopic dermatitis (AD). The analysis found that roflumilast cream demonstrates consistent efficacy and safety across different racial, ethnic, and Fitzpatrick skin types. The findings were presented at the European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam.¹

Success Rates Among Subgroups

The phase 3 trials included a diverse cohort of participants, assessing the effectiveness of roflumilast cream compared to a vehicle control. A key measure of success was the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), which showed significant enhancements in vIGA-AD scores at week 4 for roflumilast-treated patients across all demographic subgroups. According to a press release, White patients saw a success rate of 32.3%, compared to 13.3% for those receiving the control. Among Black or African American participants, the success rate was 25.8% versus 11.5% for the control. Asian patients demonstrated a success rate of 33.7% compared to 21.8% in the control group, while other demographics had a success rate of 33.2% versus 13.7%.²

Moreover, the analysis revealed similar trends across ethnic backgrounds, with Hispanic or Latino patients showing a success rate of 32.9% versus 16.5% for the control group, while non-Hispanic or Latino patients had a success rate of 31.1% compared to 13.8% for the control. Researchers found results were also consistent when examining Fitzpatrick skin types; for skin types I-III, the success rate was 33.0% versus 13.4% for the control, and for skin types IV-VI, the rates were 29.2% versus 14.8%. This consistent efficacy is particularly significant, given that AD can manifest differently among individuals of varying races and skin types.

“Given that the clinical presentation of AD may differ among patients by race, ethnicity, and Fitzpatrick skin type, it is reassuring to see the consistency of efficacy, safety, and tolerability of a treatment across these various subgroups,” Vimal H. Prajapati, MD, FRCPC, DABD, clinical associate professor at the University of Calgary and co-founder/co-director of the Skin Health & Wellness Centre, Dermphi Centre, Dermphi Shop, and Dermatology Research Institute, said in a release. “ZORYVE cream 0.15% consistently achieved meaningful and significant improvements in disease clearance and itch reduction, in all subgroups. This analysis can give confidence to clinicians that ZORYVE provides effective and well-tolerated relief of AD signs and symptoms across individuals with diverse skin types.”

In addition to clearing AD symptoms, researchers found roflumilast cream provided significant relief from itching. The Worst Itch-Numeric Rating Scale (WI-NRS) indicated improvements of ≥4 points at week 4 across all subgroups.

Researchers stated these findings were similarly favorable for other endpoints, including the achievement of vIGA-AD scores of ‘Clear (0)’ or ‘Almost Clear (1)’ and significant improvements in the Eczema Area and Severity Index (EASI-75).

Percentage of patient success based on WI-NRS

“We formulated ZORYVE cream with all AD patients in mind, and we are pleased to present these data from our phase 3 INTEGUMENT studies, which demonstrated ZORYVE’s ability to significantly, consistently, and safely improve AD symptoms regardless of race, ethnicity, or skin type,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis, in the release. “It is critical that our clinical data represent the diversity in the world around us, and these results further reinforce our commitment to providing meaningful innovation for immune-mediated skin diseases.”

Safety Profile 

Safety assessments revealed a low incidence of treatment-emergent adverse events (TEAEs) for both roflumilast and vehicle-treated patients. TEAEs were similarly distributed among subgroups, with local tolerability remaining favorable. Researchers reported common adverse reactions such as headache, nausea, application site pain, diarrhea, and vomiting, but noted these were generally mild.

References

1. New data shows zoryve (roflumilast) cream 0.15% provided consistent improvement of atopic dermatitis in individuals with diverse skin types. News Release. Arcutis Biotherapeutics. September 24, 2024. Accessed September 25, 2024. https://www.arcutis.com/new-data-shows-zoryve-roflumilast-cream-0-15-provided-consistent-improvement-of-atopic-dermatitis-in-individuals-with-diverse-skin-types/
2. Prajapati V, Browning J, Chu D, et al. Once-daily roflumilast cream 0.15% for the treatment of atopic dermatitis in patients with diverse skin types: Pooled subgroup analysis from the phase 3 INTEGUMENT-1 and-2 trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress held September 25-28, 2024, in Amsterdam.