44180 Influence of Baseline Disease Severity Defined by Investigator’s Global Assessment on Abrocitinib Efficacy for up to 96 Weeks in Patients With Moderate-to-Severe Atopic Dermatitis: Interim Analysis of JADE EXTEND, a Long-Term Extension Study

Background: Long-term efficacy with 48 weeks of abrocitinib treatment has been demonstrated to be comparable to efficacy at week 12 in patients with moderate-to-severe atopic dermatitis (AD). Longer- term efficacy data stratified by baseline disease severity are needed. Patients from JADE-MONO-1, JADE- MONO-2, JADE-COMPARE, JADE-TEEN, and JADE-DARE who were randomly assigned to abrocitinib or placebo and subsequently enrolled into phase 3 long-term extension study JADE-EXTEND (NCT03422822) were analyzed. Data cutoff: September 25, 2021. At the relevant qualifying parent study baseline, Investigator’s Global Assessment (IGA) was moderate in 61% (n=574) and severe in 39% (n=367) of patients treated with abrocitinib 200 mg once daily (QD), and moderate in 64% (n=461) and severe in 36% (n=264) of patients treated with abrocitinib 100 mg QD . After 96 weeks of treatment with abrocitinib 200 mg QD, IGA clear/almost clear was achieved by 61% and 46% of patients in the moderate and severe baseline IGA subgroups, Eczema Area and Severity Index 2:75% improvement (EASI-75) by 86% and 84%, and Peak Pruritus Numerical Rating Scale 2:4-point improvement (PP-NRS4) by 66% and 74%, respectively (as observed). After 96 weeks of treatment with abrocitinib 100 mg QD, IGA clear/almost clear was achieved by 51% and 36% of patients in the moderate and severe baseline IGA subgroups, EASI-75 by 77% and 77%, and PP-NRS4 by 61% and 59%, respectively (as observed). Long- term treatment with abrocitinib to week 96 resulted in clinically meaningful improvement in signs and symptoms of AD for patients with moderate or severe disease at baseline.