Abrocitinib effect on patient-reported outcomes in patients with moderate-to-severe atopic dermatitis: Results from phase 3 studies, including the long-term extension JADE EXTEND study

Document Type

Journal Article

Publication Date

6-15-2023

Journal

Journal of the European Academy of Dermatology and Venereology : JEADV

DOI

10.1111/jdv.19254

Abstract

BACKGROUND: Abrocitinib improved signs and symptoms of moderate-to-severe atopic dermatitis (AD) at 12/16 weeks in phase 3 studies, with a manageable safety profile. Patient-reported outcomes with long-term abrocitinib treatment were not reported. OBJECTIVE: To evaluate patient-reported outcomes with long-term abrocitinib treatment in patients with moderate-to-severe AD. METHODS: JADE EXTEND (NCT03422822) is an ongoing phase 3 long-term extension study that enrolled patients from previous abrocitinib AD trials. This analysis includes patients from the phase 3 JADE MONO-1 (NCT03349060), JADE MONO-2 (NCT03575871), and JADE COMPARE (NCT03720470) trials who completed the full treatment period of placebo or abrocitinib (200 mg or 100 mg once-daily) and subsequently entered JADE EXTEND and were randomized to receive once-daily abrocitinib 200 mg or 100 mg. Patient-reported endpoints to week 48 included the proportion of patients who achieved Dermatology Life Quality Index (DLQI) scores of 0/1 (no effect of AD on quality of life [QoL]) and a ≥4-point improvement in Patient-Oriented Eczema Measure (POEM) score (clinically meaningful improvement). Data cutoff: April 22, 2020. RESULTS: Baseline DLQI mean scores were 15.4 and 15.3 in the abrocitinib 200 mg and 100 mg groups, respectively, which corresponded to a "very large effect" on QoL; at week 48, mean DLQI scores were lower with abrocitinib 200 mg (4.6; "small effect" on QoL) and abrocitinib 100 mg (5.9; "moderate effect" on QoL). Baseline POEM mean scores were 20.4 and 20.5 in the abrocitinib 200 mg and 100 mg groups, respectively; at week 48, mean POEM scores were 8.2 and 11.0. Week 48 patient-reported responses with abrocitinib 200 mg and abrocitinib 100 mg were 44% and 34% for DLQI 0/1, and 90% and 77% for a ≥4-point reduction in POEM score. CONCLUSION: In patients with moderate-to-severe AD, long-term abrocitinib treatment resulted in clinically meaningful improvement in patient-reported symptoms of AD, including QoL.

Department

Dermatology

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