Time to Efficacy Outcomes Among Biologic-Naive and -Exposed Patients With Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of JADE REAL

Abstract

Introduction Abrocitinib, an oral JAK1-selective inhibitor, is approved for treating moderate-to-severe atopic dermatitis (AD) in patients aged ≥12 years. In the real-world, many patients initiating abrocitinib have prior biologic exposure, but this group is under-represented in clinical trials. JADE REAL (NCT04564755), a global, open-label, expanded access protocol study, provided abrocitinib to patients with inadequate response to approved AD therapies. This JADE REAL post-hoc analysis evaluated time to response for efficacy outcomes overall and by prior biologic exposure.

Methods Patients received flexibly-dosed abrocitinib (100 or 200 mg daily) at investigator discretion, with dose adjustments allowed to simulate real-world clinical practice using JAK inhibitors. Time to response for Eczema Area and Severity Index (EASI)-75, EASI-90, EASI-100, and EASI-90 + Peak Pruritus-Numerical Rating Scale (PP-NRS) 0/1 were analyzed overall and by prior biologic exposure (naive vs exposed) up to Week 72 of abrocitinib treatment. Efficacy endpoints in JADE REAL were exploratory.

Results Analyses included 309 patients overall with 220 and 89 in the biologic-naive and - exposed groups, respectively. Median time to EASI-75 response was 78 days overall, 82 days in biologic-naive and 33 days in biologic-exposed patients; overall, 91.6% achieved response by Week 48. Median time to response overall and in the biologic- naive and -exposed groups was 168, 169, and 92 days for EASI-90; 414, 413, and 422 days for EASI-100; and 335, 335, and 419 days for EASI-90 + PP-NRS 0/1. By Weeks 4, 12, and 60, similar proportions of biologic-naive and -exposed patients achieved EASI-75 response (45.5% & 57.3%, 65.3% & 70.8%, and 93.3% & 92.1%, respectively) as well as EASI-90 response (23.2% & 33.7%, 43.6% & 51.7%, and 74.0% & 71.1%). Similar proportions of patients overall and in the biologic-naive and -exposed subgroups achieved EASI-100 response by Weeks 48 (45.6%, 45.8%, and 45.2%, respectively) and 72 (54.5%, 51.4%, and 65.5%) and EASI-90 + PP-NRS 0/1 response by Weeks 48 (49.4%, 50.0%, and 48.1%) and 72 (54.6%, 52.7%, and 61.2%).

Conclusions Among patients with moderate-to-severe AD receiving abrocitinib in JADE REAL, the proportion achieving response was similar and increased over time overall and among biologic-naive and -exposed patients for all efficacy endpoints examined. Additionally, nearly half of all patients achieved the stringent endpoints of EASI-100 response and EASI-90 + PP-NRS 0/1 response before 1 year of abrocitinib treatment.