Roflumilast Cream 0.15% Leads to Consistent Eczema Improvements for Diverse Skin Types

Vimal H. Prajapati MD, FRCPC, DABD/ Credit: International Psoriasis Council

Roflumilast cream (Zoryve) 0.15% treatment leads to significant atopic dermatitis symptom improvements across a diverse set of ethnicities, races, and Fitzpatrick skin types, according to new findings presented at the European Academy of Dermatology & Venereology Congress in Amsterdam in September 2024.^1,2

These new data were shared by Arcutis Biotherapeutics, Inc. and drawn from a pooled subgroup analysis of the INTEGUMENT-1 and -2 phase 3 studies on roflumilast cream 0.15%. Roflumilast cream is a next-generation topical phosphodiesterase-4 (PDE4) inhibitor which is designed to target an enzyme involved in eczema-related inflammation.²

“Given that the clinical presentation of (atopic dermatitis) 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, said in a statement.¹

Atopic dermatitis, the most common form of eczema, is a chronic inflammatory skin condition known to impact around 9.6 million children and 16.5 million adult patients within the US. The 0.15% formulation of roflumilast cream has been approved by the US Food and Drug Administration (FDA) for patients aged 6 years and older with mild to moderate atopic dermatitis, and the 0.3% formulation was approved for psoriasis in the same age bracket.¹

The drug was evaluated for its efficacy and safety in the INTEGUMENT-1 and -2 trials, both of which were identical, double-blind, parallel group, vehicle-controlled studies. By the 4-week mark, those given roflumilast treatment were noted as having higher rates of successful achievement of Validated Investigator Global Assessment for AD (vIGA-AD) compared to subjects in the vehicle arm of the studies.^1,2

The research teams defined vIGA-AD success as achievement of a score of 0 or 1, alongside a 2-grade improvement from the point of baseline.

The notable finding highlighted by Arcutis was that these results were consistent across racial groups, with 32.3% success for White subjects and 25.8% for Black or African American subjects versus 13.3% and 11.5% in the vehicle arms, respectively. This was also observed among different ethnic groups, as 32.9% saw the same success among Hispanic or Latino subjects versus 16.5% given the vehicle cream.

These findings aligned as well with those of diverse Fitzpatrick skin types, as 33.0% saw such improvements for types I-III compared to only 13.4% of those on the vehicle cream.

“(Roflumilast) cream 0.15% consistently achieved meaningful and significant improvements in disease clearance and itch reduction, in all subgroups,” Prajapati said in his statement. “This analysis can give confidence to clinicians that (roflumilast) provides effective and well-tolerated relief of atopic dermatitis signs and symptoms across individuals with diverse skin types.”

Those treated with the cream also reported greater reductions in pruritus, as determined by the Worst Itch-Numeric Rating Scale (WI-NRS), with those aged 12 years and older with a baseline WI-NRS score of 4 or greater reporting 4 point or greater improvements in their scores by the 4-week mark. This was also consistent across all subgroups.

Specifically, the team noted that 33.5% of White subjects and 30.6% of Black or African American subjects were shown to have improvement in pruritus versus the lower rates observed among those in the vehicle groups. Comparable findings were also seen among subjects in the achievement of "Clear" or "Almost Clear" vIGA-AD scores or 75% improvement in subjects’ Eczema Area and Severity Index (EASI-75) scores.

Lastly, the investigators also found that treatment-emergent adverse events (TEAEs) incidence continued to be low for both the treatment and vehicle arms of the study. Those treated with the topical cream were noted as having consistent TEAE rates across the various subgroups, with common reactions being nausea, headaches, pain at application regions, diarrhea, and vomiting.

"We formulated (roflumilast) cream with all (atopic dermatitis) patients in mind, and we are pleased to present these data from our Phase 3 INTEGUMENT studies, which demonstrated (roflumilast’s) ability to significantly, consistently, and safely improve…symptoms regardless of race, ethnicity, or skin type,” Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis, said in a statement.

References

1. ^{New Data Shows ZORYVE® (Roflumilast) Cream 0.15% Provided Consistent Improvement of Atopic Dermatitis in Individuals With Diverse Skin Types. September 25, 2024. https://www.globenewswire.com/en/news-release/2024/09/25/2952682/0/en/New-Data-Shows-ZORYVE-Roflumilast-Cream-0-15-Provided-Consistent-Improvement-of-Atopic-Dermatitis-in-Individuals-With-Diverse-Skin-Types.html. Date accessed: September 25, 2024.}
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 & Venereology Congress held September 25-28, 2024, in Amsterdam.}