Time-to-Efficacy Outcomes by Observed Abrocitinib Dosing Patterns Among 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 the treatment of moderate-to-severe atopic dermatitis (AD) in patients aged ≥12 years. JADE REAL (NCT04564755), an open-label, expanded-access-protocol study, provided abrocitinib to patients with inadequate response to approved AD therapies. Patients received 100 or 200 mg daily at investigator discretion, with dose adjustments allowed to simulate real world clinical practice. Patients could up-titrate from 100 mg to 200 mg if clinical response was inadequate after ≥4 weeks of treatment and they did not experience dose-limiting adverse events. Conversely, patients could down-titrate at investigator discretion for safety reasons, or if the investigator considered that disease maintenance could occur at a lower dose. This analysis evaluated time-to-efficacy outcomes overall and by flexible dosing strategy.

Methods Time to achieve Eczema Area and Severity Index (EASI)-75, EASI-90, EASI-100, and EASI-90 + Peak Pruritus-Numerical Rating Scale (PP-NRS) 0/1 was analyzed overall, and by abrocitinib dosing: 100 mg consistent dose (initiated 100 mg without dose escalation), 200 mg consistent dose (initiated 200 mg and continued the high dose), dose escalation (initiated 100 mg and increased dose, with ≥1 dose change), and dose reduction (initiated 200 mg and reduced dose, with ≥1 dose change), up to Week 72 of abrocitinib treatment. Patients were censored if they did not achieve response by the end of follow-up in the study.

Results Analyses included 77, 117, 42, and 73 patients in the 100 mg consistent dose, 200 mg consistent dose, dose escalation, and dose reduction groups, respectively. Median time to achieve EASI-75 response was 85, 43, 85, and 30 days for 100 mg consistent dose, 200 mg consistent dose, dose escalation, and dose reduction groups, respectively. Median time to EASI-90 response was 169, 169, 254, and 84 days; to EASI-100, 327, not evaluable (NE), 427 and 182 days; and to EASI-90 + PP-NRS 0/1, 253, 684, NE and 167 days in the 100 mg consistent dose, 200 mg consistent dose, dose escalation, and dose reduction groups, respectively.

Conclusions Patients across all dosing groups demonstrated achievement of all efficacy endpoints over time. Patients with clinical response to abrocitinib 200 mg may switch to the lowest effective dose, while continuous 200 mg dosing may also be an option based on provider decision and patients’ clinical needs. Patients with lower response to 100 mg may benefit from up-dosing to 200 mg, and patients who respond well to the 100 mg dose may continue on the lowest effective dose. Among patients with moderate-to-severe AD receiving abrocitinib in JADE REAL, flexible dosing enabled individualized management of moderate-to-severe AD.

Funding This study was funded by Pfizer.