Long-term efficacy of abrocitinib in patients with moderate-to-severe atopic dermatitis to 2 years.

BACKGROUND

Abrocitinib treatment previously showed clinically meaningful improvements in skin signs and symptoms in patients with moderate-to-severe atopic dermatitis (AD) up to 48 weeks, with a manageable safety profile.

OBJECTIVE

To further evaluate long-term efficacy and patient-reported outcomes (PROs) with abrocitinib in patients with moderate-to-severe AD up to 112 weeks of treatment.

METHODS

JADE EXTEND (NCT03422822), an ongoing, phase 3, long-term extension study of previous abrocitinib trials, includes patients from qualifying trials MOA (NCT03915496), MONO-1 (NCT03349060), MONO-2 (NCT03575871), COMPARE (NCT03720470), TEEN (NCT03796676) and DARE (NCT04345367). Efficacy assessments include the proportion of patients achieving IGA score of 0 or 1 (IGA 0/1); absolute Eczema Area and Severity Index ≤7 (EASI ≤ 7), ≥75%/≥90%/100% improvement in EASI (EASI-75/-90/-100); ≥4-point improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4); PP-NRS score of 0 or 1 (PP-NRS 0/1); EASI-90 + PP-NRS 0/1. PROs include Dermatology Life Quality Index score of 0 or 1 (DLQI 0/1), Children's Dermatology Life Quality Index score of 0 or 1 (CDLQI 0/1), Patient Global Assessment score of 0 or 1 (PtGA 0/1), and ≥4-point improvement in Patient-Oriented Eczema Measure (POEM ≥ 4). Data cut-off: 5 September 2022.

RESULTS

At data cut-off, 403 (42%) and 425 (56%) patients received abrocitinib 200 mg and abrocitinib 100 mg, respectively, for ≥112 weeks. Week 112 efficacy responses were IGA 0/1 57% and 52%; EASI ≤7 81% and 77%; EASI-75 84% and 78%; EASI-90 61% and 54%; EASI-100 26% and 21%; PP-NRS4 70% and 58%; PP-NRS 0/1 43% and 33%; EASI-90 + PP-NRS 0/1 37% and 30%. Week 112 PROs were DLQI 0/1 43% and 41%; CDLQI 0/1 59% and 39%; PtGA 0/1 75% and 72%; POEM ≥4 88% and 81%.

CONCLUSIONS

Abrocitinib treatment resulted in clinically meaningful outcomes and improvements in PROs, including high-threshold endpoints, in substantial proportions of patients with moderate-to-severe AD up to 2 years.