15517 Eczema Area and Severity Index 90 (EASI-90) responder rates with abrocitinib and relationship with quality of life (QoL) and itch in patients with moderate to severe atopic dermatitis: Results from a randomized phase 3 clinical trial

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Conference Proceeding

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J Am Acad Dermatol


Introduction: Abrocitinib is an oral Janus kinase 1 inhibitor under investigation for the treatment of moderate to severe AD. Design: Randomized, double-blind, placebo-controlled phase 3 trial (NCT03349060; JADE MONO-1). Methods: Patients ≥12 years old with clinical diagnosis of moderate to severe AD were randomly assigned (2:2:1) to once-daily abrocitinib 200 mg, abrocitinib 100 mg, or placebo for 12 weeks. Eczema Area and Severity Index 90 (EASI-90), Dermatology Life Quality Index (DLQI), Children’s DLQI (CDLQI), and peak pruritus numeric rating scale (PP NRS; 0-10) were measured at baseline and weeks 2, 4, 8, and 12. Results: 154, 156, and 77 patients were treated with abrocitinib 200 mg, abrocitinib 100 mg, or placebo, respectively. Proportions of patients achieving ≥ 90% improvement in EASI-90 overall were 38.6% and 18.6% versus 5.3% at week 12 (difference from placebo [95% CI], 33.4% [24.3%-42.5%] and 13.3% [5.4%-21.2%]), with little difference between those with moderate baseline IGA (42.9% and 18.5% vs 6.7%; 36.2% [23.7%-48.7%] and 11.8% [1.0%-22.6%]) and severe baseline IGA (32.3% and 18.8% vs 3.2%; 29.0% [15.8%-42.2%] and 15.5% [4.1%-26.9%]). Greater proportions of week-12 EASI-90 responders versus nonresponders achieved no/mild alteration in QoL (89.0% vs 46.6%; per published [C]DLQI severity bands), ≥4-point improvement in PP-NRS (88.4% vs 25.1%; among those with baseline PP-NRS ≥4), and PP-NRS <2 (70.0% vs 10.2%; among those with baseline PP-NRS ≥2). Conclusions: Abrocitinib therapy was associated with significantly greater EASI-90 responder rates versus placebo, regardless of baseline AD severity. EASI-90 response at week 12 corresponded with patients experiencing low impairment in QoL, clinically meaningful improvement in itch, and/or little-to-no itch.





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