Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis with prior exposure to oral systemic immunosuppressants or biologic therapies: a post hoc analysis of the JADE clinical trials

Abstract

Background: patients with moderate-to-severe atopic dermatitis (AD) refractory to topical therapy might require treatment with systemic therapies, including biologics. Objectives: To assess the efficacy and safety of abrocitinib monotherapy in patients who previously received systemic therapies. 

Methods: this post hoc analysis included patients receiving abrocitinib (200 mg/100 mg) or placebo in the phase 2b and phase 3 JADE MONO-1 and MONO-2, REGIMEN (abrocitinib 200 mg; open-label period) and EXTEND (patients enrolled from MONO-1 and MONO-2) trials. Patients who were systemic therapy-naive or had received prior oral systemic or biologic therapies were assessed for Investigator's Global Assessment (IGA) response of 0 (clear) or 1 (almost clear) and ≥2-point improvement from baseline, ≥75% or ≥90% improvement in Eczema Area and Severity Index (EASI-75 or EASI-90), ≥4-point improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4), PP-NRS score of 0 or 1 and change from baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) and Patient-Oriented Eczema Measure (POEM) scores. Safety was assessed. 

Results: this analysis included 1579 patients (systemic therapy-naive, n = 997; prior exposure to oral systemic, n = 429; biologic therapies, n = 153). At Week 12, IGA 0/1 response rates (95% confidence intervals) among patients who were systemic therapy-naive, had received prior oral systemic therapy or had received biologic therapy were 44.4% (37.5–51.4), 34.5% (22.3–46.7) and 43.5% (23.2–63.7) with abrocitinib 200 mg, 30.9% (24.2–37.5), 16.4% (7.1–25.7) and 24.1% (8.6–39.7) with abrocitinib 100 mg and 9.6% (4.2–14.9), 5.9% (0.0–13.8) and 0.0% (0.0–23.2) with placebo in the pooled monotherapy trials; and 67.0% (62.8–71.2), 62.2% (56.4–68.0) and 53.5% (42.9–64.0) in REGIMEN. Across subgroups, abrocitinib showed greater improvement in EASI-75, PP-NRS4, EASI-90, PP-NRS 0/1, PSAAD and POEM scores versus placebo. Similar results were seen at Week 48. No new safety signals were observed. 

Conclusions: prior use of oral systemic or biologic therapies did not seem to impact the efficacy and safety of abrocitinib in patients with moderate-to-severe AD.

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