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

نویسندگان

چکیده

Background Patients with moderate-to-severe atopic dermatitis (AD) refractory to topical therapy might require treatment systemic therapies, including biologics. Objectives To assess the efficacy and safety of abrocitinib monotherapy in patients who previously received therapies. Methods This post hoc analysis included receiving (200 mg/100 mg) or placebo phase 2b 3 JADE MONO-1 MONO-2, REGIMEN (abrocitinib 200 mg; open-label period) EXTEND (patients enrolled from MONO-2) trials. were therapy-naive had prior oral biologic therapies assessed for Investigator's Global Assessment (IGA) response 0 (clear) 1 (almost clear) ≥2-point improvement baseline, ≥75% ≥90% Eczema Area Severity Index (EASI-75 EASI-90), ≥4-point Peak Pruritus Numerical Rating Scale (PP-NRS4), PP-NRS score change baseline Symptoms Atopic Dermatitis (PSAAD) Patient-Oriented Measure (POEM) scores. Safety was assessed. Results 1579 (systemic therapy-naive, n = 997; exposure systemic, 429; 153). At Week 12, IGA 0/1 rates (95% confidence intervals) among 44.4% (37.5–51.4), 34.5% (22.3–46.7) 43.5% (23.2–63.7) mg, 30.9% (24.2–37.5), 16.4% (7.1–25.7) 24.1% (8.6–39.7) 100 mg 9.6% (4.2–14.9), 5.9% (0.0–13.8) 0.0% (0.0–23.2) pooled trials; 67.0% (62.8–71.2), 62.2% (56.4–68.0) 53.5% (42.9–64.0) REGIMEN. Across subgroups, showed greater EASI-75, PP-NRS4, EASI-90, 0/1, PSAAD POEM scores versus placebo. Similar results seen at 48. No new signals observed. Conclusions Prior use did not seem impact AD.

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ژورنال

عنوان ژورنال: JEADV Clinical Practice

سال: 2023

ISSN: ['2768-6566']

DOI: https://doi.org/10.1002/jvc2.203