Treatment Patterns and Efficacy in Biologic-Exposed and Biologic-Naive Patients With Moderate-to-Severe Atopic Dermatitis: JADE REAL Post Hoc Analysis

Abstract

Introduction Abrocitinib, an oral Janus kinase (JAK) 1-selective inhibitor, is approved to treat moderate-to-severe atopic dermatitis (AD) in patients aged ≥12 years. Many patients initiating abrocitinib in the real world have received prior biologic therapy but are under-represented in clinical trials. The primary objective of JADE REAL (NCT04564755), a global, open-label, expanded access protocol study, was to provide early access to abrocitinib for patients for whom available and approved medications for AD were inadequate. This post-hoc analysis of JADE REAL examined treatment patterns and exploratory efficacy outcomes by prior biologic exposure.

Methods Patients initiated daily abrocitinib 100 or 200 mg, per investigator discretion, with dose switching allowed to simulate the real-world use of JAK inhibitors. Baseline patient characteristics, prior biologic use (exposed and naive), and use of concomitant rescue medications were collected. Treatment patterns and Eczema Area and Severity Index (EASI) total score, percentage body surface area (%BSA) involvement, Peak Pruritus Numerical Rating Scale (PP-NRS), and Patient-Oriented Eczema Measure (POEM) at Week 72 were described.

Results Overall, 89 biologic-exposed and 223 biologic-naive patients were included. Demographic and disease characteristics were similar between groups. A higher proportion of exposed patients initially received abrocitinib 200 mg (61 [68.5%]) than naive patients (131 [58.7%]) and had ≥1 dose change in both initial dose groups (initial dose 100 mg, 15 [53.6%]; 200 mg, 27 [44.3%]) than naive patients (100 mg, 27 [29.3%]; 200 mg, 46 [35.1%]). Median (IQR) abrocitinib treatment duration was similar among exposed and naive patients (351.0 [259.0-500.0] & 378.0 [246.0-510.0] days). Exposed and naive patients demonstrated improvements in the mean (SD) from baseline to Week 72 for EASI total score (20.1 [12.3]-3.0 [6.6] & 23.3 [12.8]-3.9 [7.8]), %BSA involvement (32.5 [21.4]-4.6 [9.5] & 35.1 [21.4]-8.2 [16.0]), PP-NRS (7.2 [2.2]-1.6 [1.6] & 7.5 [2.0]-2.4 [2.4]) and POEM (19.7 [5.7]-4.3 [4.0] & 20.2 [5.6]-7.0 [7.7]).  Few exposed and naive patients required concomitant rescue treatments (6 [6.7%]; 10 [4.5%]).

Conclusions Biologic-exposed and -naive patients with moderate-to-severe AD receiving abrocitinib in JADE REAL experienced improvements in EASI total score, %BSA involvement, PP-NRS, and POEM; few required concomitant rescue medications. Abrocitinib flexible dosing enables optimized treatment for biologic-naive patients and biologic-exposed patients, which are a difficult-to-treat population.

Funding This study was funded by Pfizer.