Roflumilast cream 0.15% (Zoryve, Arcutis) reduced lesion clearance and eased itch in individuals with atopic dermatitis (AD) regardless of race, ethnicity, and Fitzpatrick skin type, new pooled subgroup analysis results from the Phase 3 INTEGUMENT-1 and -2 trials. The results will be presented at the European Academy of Dermatology & Venereology (EADV) Congress in Amsterdam.
At Week 4, patients taking roflumilast cream showed greater Validated Investigator Global Assessment for AD (vIGA-AD) success compared with vehicle-treated patients were observed regardless of race (White: 32.3% vs. 13.3%; Black or African American: 25.8% vs 11.5%; Asian: 33.7% vs. 21.8%; Others: 33.2% vs. 13.7%), ethnicity (Hispanic or Latino: 32.9% vs. 16.5%; Not Hispanic or Latino: 31.1% vs 13.8%), or Fitzpatrick score (I–III: 33.0% vs. 13.4%; IV–VI: 29.2% vs. 14.8%). In the study, vIGA-AD Success was defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline.
“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,” says 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, in a news 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 atopic dermatitis signs and symptoms across individuals with diverse skin types.”
Roflumilast-treated patients also achieved a greater improvement in itch as measured by reductions in Worst Itch-Numeric Rating Scale (WI-NRS) Success, defined as ≥4-point improvement in patients 12 years of age and older with baseline WI-NRS score ≥4, at Week 4 with consistent results regardless of subgroup (White: 33.5% vs. 16.5%; Black or African American: 30.6% vs. 21.0%; Asian: 25.4% vs. 7.9%; Others: 34.3% vs. 22.7%), ethnicity (Hispanic or Latino: 37.4% vs. 30.5%; Not Hispanic or Latino: 30.9% vs. 13.8%), or Fitzpatrick score (I–III: 35.5% vs. 15.0%; IV–VI: 27.3% vs. 18.2%). Similar findings were observed for additional endpoints including achievement of vIGA-AD score of ‘Clear (0)’ or ‘Almost Clear (1)’ and 75% improvement in the Eczema Area and Severity Index (EASI-75).
“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. “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.”
The Incidence of Treatment Emergent Adverse Events (TEAEs) was low in both roflumilast cream – and vehicle-treated patients. The incidence of TEAEs in roflumilast cream -treated patients was generally similar across subgroups. Local tolerability was also favorable. The most common adverse reactions were headache, nausea, application site pain, diarrhea, and vomiting.
INTEGUMENT-1 and INTEGUMENT-2 (The INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis) were two identical Phase 3, parallel group, double blind, vehicle-controlled trials evaluating the safety and efficacy of roflumilast cream 0.15% in AD.
