Efficacy and safety of abrocitinib in biologic-exposed versus biologic-naive patients with moderate-to-severe atopic dermatitis

Abstract

Abrocitinib, an oral once-daily Janus kinase 1 selective inhibitor, is being investigated for the treatment of moderate-to-severe atopic dermatitis (AD). This post hoc analysis evaluated if prior treatment with biologic therapy affects response to abrocitinib. Data from patients (pts) with/without previous biologic therapy from each treatment arm (abrocitinib 200 mg or 100 mg, or placebo) of the phase 2b (NCT02780167) and phase 3 JADE MONO-1 (NCT03349060) and MONO-2 (NCT03575871) studies were pooled and evaluated separately from the phase 3 JADE REGIMEN (NCT03627767) open-label induction phase (abrocitinib 200 mg). Investigator’s Global Assessment score of 0/1 (IGA 0/1) with ≥2-grade improvement from baseline and ≥75% improvement from baseline in Eczema Area and Severity Index (EASI-75) were assessed. IGA 0/1 response rates among 67/867 pts with/without prior biologic therapy were 43.5%/41.4% (abrocitinib 200 mg), 24.1%/26.7% (abrocitinib 100 mg), and 0%/8.5% (placebo) in the pooled population, and 53.5%/66.9% (abrocitinib 200 mg) among 86/1147 pts in REGIMEN. EASI-75 response rates in pts with/without prior biologic therapy were 65.2%/62.4% (abrocitinib 200 mg), 34.5%/42.7% (abrocitinib 100 mg), and 7.1%/12.7% (placebo) in the pooled population, and 64.0%/76.4% in REGIMEN. Treatment-emergent adverse event rates in pts with/without prior biologic therapy were 71.7%/69.9% (abrocitinib 200 mg + 100 mg arms) in the pooled population, and 66.3%/66.5% (abrocitinib 200 mg) in REGIMEN. Abrocitinib efficacy and safety were consistent in pts with moderate-to-severe AD regardless of prior biologic therapy.

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ORCID for M. Ardern-Jones: orcid.org/0000-0003-1466-2016

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