INTEGUMENT-1 and INTEGUMENT-2 pivotal Phase III studies of Zoryve meet primary endpoints in atopic dermatitis.- Arcutis Biotherapeutics

Both studies met the primary endpoint of IGA Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at Week 4 (INTEGUMENT-1: 32.0% roflumilast cream vs. 15.2% vehicle, P<0.0001; integument-2: 28.9% roflumilast cream vs. 12.0% vehicle, p><0.0001). in addition, rapid and significant improvements in v-iga success were demonstrated as early as week 2 (integument-1: 21.2% for roflumilast cream vs. 6.4% for vehicle; p><0.0001; integument-2: 17.7% for roflumilast cream vs 5.3% for vehicle; p>< 0.0001).</0.0001;></0.0001).></0.0001;>

Over 30% of individuals treated with roflumilast cream in each study achieved Worst Itch Numeric Scale (WI-NRS) Success at Week 4. In addition, a daily improvement in itch was observed in those treated with roflumilast cream with a significant improvement at 24 hours following the first application (P<0.05) as measured by wi-nrs. roflumilast cream also demonstrated rapid and statistically significant improvements compared to vehicle on key secondary endpoints, with more than 40% of children age 6 and older and adults treated with roflumilast cream achieving a 75% reduction in eczema area and severity index (easi-75) at week 4 compared to vehicle (integument-1: 43.2% vs. 22.0%, p><0.0001; integument-2: 42.0% vs. 19.7%, p><0.0001). additionally, significant improvements in easi-75 were observed with roflumilast cream as early as week 1 in both studies compared to vehicle (integument-1: 14.0% vs. 5.5%, p="0.0006;" integument-2: 13.3% vs. 7.8%, p="0.0329)." in both studies, approximately 40% of children and adults treated with roflumilast cream achieved a viga-ad score of clear (0) or almost clear (1) at week 4 (integument-1: 41.5% vs. 25.2%, p><0.0001; integument-2: 39% vs. 16.9%, p><0.0001). roflumilast cream 0.15% was well tolerated. the incidence of treatment emergent adverse events (teaes) was low in both active treatment and vehicle arms, with most teaes assessed as mild to moderate in severity, and no adverse event occurring in more than 3.5% of subjects in either arm. results were presented in a late-breaking clinical trial session at the american academy of dermatology (aad) annual meeting (new orleans, la, march 17-21).></0.0001).></0.0001;></0.0001).></0.0001;></0.05)>