27915 Rapid skin improvement with upadacitinib with or without topical corticosteroids (TCS) in moderate-to-severe atopic dermatitis (AD): Results from 3 phase 3 studies (Measure Up 1, Measure Up 2, and AD Up)

Abstract

Upadacitinib safety and efficacy in adults and adolescents with moderate-to-severe AD is being evaluated in 3 phase 3, double-blind, placebo-controlled, multicenter studies; patients received once-daily oral upadacitinib 15mg, 30mg, or placebo (1:1:1) as monotherapy (Measure Up 1 [NCT03569293]; Measure Up 2 [NCT03607422]) or combined with TCS (AD Up [NCT03568318]). At the first postbaseline measurement (week 1; not multiplicity controlled) in Measure Up 1|Measure Up 2, upadacitinib vs placebo (P < .001) showed significant skin improvement as assessed by least squares mean percent change in Eczema Area and Severity Index (EASI; 15mg, –39.3%|–36.4%; 30mg, –44.3%|–42.2%; placebo, –9.1%|–5.6%), and proportions of patients achieving ≥75% reduction in EASI from baseline (EASI 75; 15mg, 16.0%|8.3%; 30mg, 15.1%|14.5%; placebo, 2.1%|1.1%). Similar results were observed at the first assessment (week 2) in AD Up for change in EASI|EASI 75 (15mg, –57.6%|31.0%; 30mg, –65.9%|44.1%; placebo, –25.0%|6.9%; P<.001 for all). At week 16 in Measure Up 1|Measure Up 2|AD Up, the change in EASI (15mg: –80.2%|–74.1%|–78.0%; 30mg: –87.7%|–84.7%|–87.3%; placebo: –40.7%|–34.5%|–45.9%), and EASI 75 (15mg: 69.6%|60.1%|64.6%; 30mg: 79.7%|72.9%|77.1%; placebo: 16.3%|13.3%|26.4%) were significantly higher for upadacitinib vs placebo (P < .001). Similar results were seen for higher stringency endpoints (EASI 90, EASI 100, and proportions of patients achieving validated Investigator Global Assessment for Atopic Dermatitis score 0/1) from week 1 or 2 through 16. No new safety signals were observed vs other upadacitinib trials. Upadacitinib treatment results in significant skin improvement from the first assessment (week 1 or 2) with continued improvement through week 16.