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
Yosipovitch G, Bieber T, Gold LS, Kwatra S, Tatulych S, Nduaka C, Cameron MC, Williams D, Biswas P, and Valdez H. 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. Journal of the American Academy of Dermatology 2020; 83(6):AB41.
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.