P81 Long-term efficacy of abrocitinib in adolescents and adults with moderate-to-severe atopic dermatitis: a post hoc analysis of JADE EXTEND

Abstract

Abstract Differences exist in the manifestation and disease course of atopic dermatitis (AD) between adult and adolescent patients. Long-term efficacy of abrocitinib (an oral, once-daily Janus kinase 1-selective inhibitor) was examined in the phase III extension study JADE EXTEND (NCT03422822). This interim post hoc analysis assessed abrocitinib treatment efficacy up to 96 weeks in adolescents and adults with moderate-to-severe AD who enrolled in JADE EXTEND. Eligible adolescents (aged 12 to < 18 years) and adults (≥ 18 years) from the phase III trials JADE MONO-1 (NCT03349060), MONO-2 (NCT03575871), COMPARE (NCT03720470), TEEN (NCT03796676) and DARE (NCT04345367) were enrolled in JADE EXTEND. Patients randomized to abrocitinib (200 mg or 100 mg) in the parent studies received blinded abrocitinib at the same dose in JADE EXTEND; those receiving placebo or dupilumab were randomized to either abrocitinib dose in JADE EXTEND. Patients from JADE DARE received abrocitinib 200 mg in JADE EXTEND. Analyses assessed the proportions of patients achieving an Investigator’s Global Assessment score of clear or almost clear (IGA 0/1); ≥ 75%, ≥ 90% and ≥ 100% improvement from baseline in Eczema Area and Severity Index (EASI-75, EASI-90 and EASI-100, respectively); ≥ 4-point improvement from baseline in Peak Pruritus Numerical Rating Scale score (PP-NRS4; used with permission from Regeneron Pharmaceuticals and Sanofi); PP-NRS score of no or very little itch (PP-NRS 0/1); and ≥ 4-point improvement from baseline in the Patient Oriented Eczema Measure (POEM ≥ 4). The JADE EXTEND data cutoff date was 25 September 2021. This analysis included 357 adolescents and 1309 adults (excluding patients previously randomized to dupilumab). Age at parent study screening visit determined age categorization. Baseline disease severity was higher in adolescents than adults [IGA 4 (severe); 42.3% vs. 36.7%]. At week 96, responder proportions were comparable for adolescents and adults for EASI-75 (abrocitinib 200 mg: 84.4% vs. 85.7%; abrocitinib 100 mg: 81.3% vs. 76.1%), PP-NRS4 (200 mg: 69.4% vs. 69.3%; 100 mg: 60.3% vs. 59.8%) and POEM ≥ 4 (200 mg: 84.4% vs. 88.6%; 100 mg: 79.2% vs. 80.8%), and largely comparable for the stringent endpoints of EASI-90 (200 mg: 62.3% vs. 61.1%; 100 mg: 50.7% vs. 48.1%), EASI-100 (200 mg: 32.5% vs. 21.8%; 100 mg: 18.7% vs. 18.7%), IGA 0/1 (200 mg: 53.2% vs. 55.9%; 100 mg: 49.3% vs. 45.1%) and PP-NRS 0/1 (200 mg: 42.9% vs. 39.5%; 100 mg: 33.3% vs. 32.3%). Long-term efficacy of abrocitinib treatment up to 96 weeks was comparable for adolescents and adults with moderate-to-severe AD, including substantial proportions achieving stringent endpoints of EASI-90, EASI-100, IGA 0/1 or PP-NRS 0/1. Funding sources: Pfizer Inc.