Sustained On- and Off-Treatment Disease Control in Patients With Moderate-to-Severe Atopic Dermatitis Following 12-Week, Open-Label, Once-Daily Abrocitinib 200 mg: A Post Hoc Analysis of the Phase 3 JADE REGIMEN Study

Abstract

Introduction Outcomes from JADE REGIMEN (NCT03627767) were examined to explore the potential for patients with moderate-to-severe atopic dermatitis to achieve sustained on- and off-treatment disease control with abrocitinib treatment.

Methods Patients received 12 weeks of open-label once-daily induction therapy with abrocitinib 200 mg, achieved a response (Investigator’s Global Assessment [IGA] score of 0/1 with ≥2-point reduction from baseline and ≥75% improvement from baseline in the Eczema Area and Severity Index [EASI]), and were then randomized to double-blind maintenance therapy with once-daily abrocitinib 200/100 mg or placebo for 40 weeks. Outcomes included EASI, IGA, and Peak Pruritus Numerical Rating Scale (PP-NRS) scores. Patients were categorized by whether or not they experienced a disease flare (≥50% loss of initial EASI response at week 12 and IGA score ≥2) during the 40-week maintenance period.

Results Overall, 798 patients (200 mg, 266; 100 mg, 265; and placebo, 267) were responders at the end of the 12-week induction period; of these, 44 (16.5%), 105 (39.6%), and 207 (77.5%) experienced a flare during the 40-week maintenance period, while 222 (83.5%), 160 (60.4%), and 60 (22.5%) did not. Baseline characteristics were similar among patients who did and did not flare. Of patients who did not flare after being randomized to placebo for the maintenance period, mean EASI, IGA, and PP-NRS scores remained stable and either clear/mild for 40 weeks, indicating sustained off-treatment disease control. Of patients who did not flare after continuing abrocitinib 200 mg or down-dosing to 100 mg, average EASI, IGA, and PP-NRS scores also remained stable and either clear/mild for 40 weeks, indicating sustained on-treatment disease control.

Conclusion This post hoc analysis of JADE REGIMEN demonstrated that sustained off-treatment disease control is possible in a proportion of patients following only 12 weeks of active treatment with abrocitinib 200 mg. Sustained on-treatment disease control was also demonstrated among patients down-dosed to abrocitinib 100 mg following induction therapy. For patients who experienced sustained on-treatment disease control, a dose interruption or pause following response to induction therapy might be considered, and future studies may identify patient characteristics or biomarkers that could predict which patients would benefit from doing so.

Funding This study was supported by Pfizer Inc.