UPADACITINIB EFFECT ON PRURITUS IN MODERATE-TO-SEVERE ATOPIC DERMATITIS; FROM A PHASE 2B RANDOMIZED, PLACEBO-CONTROLLED TRIAL

Abstract

Introduction The effect of the selective JAK-1 inhibitor, upadacitinib, on pruritus was evaluated in patients from the initial 16-week, double-blind portion of a phase 2b, 88-week trial. Methods Adults with moderate-to-severe AD (EASI ≥16, BSA ≥10%, IGA ≥3) not adequately controlled by topical treatment, or for whom topical treatments were not medically advisable, were randomized to once-daily upadacitinib 7.5, 15, or 30mg, or placebo. Patient-reported pruritus measurements utilized the Scoring Atopic Dermatitis (SCORAD) itch Visual Analog Scale (VAS), Patient Oriented Eczema Measure (POEM) itch score (Question #1), and pruritus Numerical Rating Scale (NRS). Missing data were handled by last-observation-carried-forward. Results Of the 167 randomized patients; 166 received study drug (42 in each upadacitinib dose-group; 40 placebo). Mean improvement from baseline at week 16 in SCORAD itch VAS (range 0-10) for upadacitinib 7.5mg/15mg/30mg groups (N=42/41/42) was 3.3/3.4/4.7 vs 1.2 placebo (N=38) (p.05/>.05/.05/>.05/ Conclusions Upadacitinib treatment for 16 weeks resulted in significant improvements in pruritus as early as day 2. The positive benefit/risk profile of upadacitinib supports proceeding to phase-3 trials in AD.