Arcutis announces new pooled subgroup analysis results from INTEGUMENT-1 trial

Arcutis Biotherapeutics announced new pooled subgroup analysis results from the Phase 3 INTEGUMENT-1 and -2 trials showing that Zoryve cream 0.15% provided consistent and meaningful improvements in signs and symptoms of AD in individuals regardless of race, ethnicity, and Fitzpatrick skin types. The results will be presented in a poster at the European Academy of Dermatology & Venereology Congress held September 25-28 in Amsterdam. At Week 4, higher percentages of Validated Investigator Global Assessment for AD Success for Zoryve- vs. vehicle-treated patients were observed regardless of race, ethnicity, or Fitzpatrick score. The Fitzpatrick skin type is a scale of I to VI that classifies the skin by its reaction to exposure to sunlight, with skin type I being pale white skin that always burns, does not tan, to VI being dark brown or black skin that never burns, always tans darkly. vIGA-AD Success was defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline. Zoryve-treated patients also achieved a greater improvement in itch as measured by reductions in Worst Itch-Numeric Rating Scale 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, ethnicity, or Fitzpatrick score. 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. The Incidence of Treatment Emergent Adverse Events was low in both Zoryve- and vehicle-treated patients. The incidence of TEAEs in Zoryve-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 were two identical Phase 3, parallel group, double blind, vehicle-controlled trials evaluating the safety and efficacy of Zoryve cream 0.15% in AD.