Efficacy and safety of dupilumab in children aged 6–11 years with inadequately controlled severe atopic dermatitis: Results from an open-label extension trial up to 1 year

Abstract

Introduction (contexte de la recherche) Atopic dermatitis (AD), a common chronic inflammatory type 2 systemic disease, is characterized by pruritus, disruption of skin barrier function and eczematous lesions. Treatment options are limited, especially for children. To report long-term efficacy and safety of dupilumab in patients (pts) aged 6–11 years with severe AD from the open-label extension (OLE) study ( NCT02612454 ). Children (6–11 years) with severe AD from the 16-week (wk), double-blind, phase 3 LIBERTY AD PEDS study ( NCT03345914 ; parent study) enrolled in the long-term, multicentre OLE study and were treated with 300 mg dupilumab every 4 wks. If treatment response was inadequate (failure to achieve Investigator's Global Assessment [IGA] score of 0/1 within 16 wks) it could be up-titrated to 200 mg/300 mg every 2 wks (< 60 kg/ ≥ 60 kg, respectively). Concomitant topical treatments were permitted. Data are as observed. In the OLE, pts ( n = 321) had a mean (standard deviation [SD]) age of 8.6 (1.7) years and AD duration of 7.4 (2.2) years. Mean percentage change (SD) from parent study baseline (PSBL) to OLE baseline (BL) in Eczema Area and Severity Index (EASI) was −62.5 (34.4). In the OLE, mean percentage change from PSBL in EASI improved at Wk 16 (−79.6 [20.8]) and Wk 52 (−86.0 [13.9]). Relative to PSBL, the proportion of pts achieving ≥ 50% and ≥ 75% reduction in EASI increased from OLE BL (EASI-50: 230/321 [71.7%]; EASI-75: 142/321 [44.2%]) to OLE Wk 52 (EASI-50: 250/257 [97.3%]; EASI-75: 210/257 [81.7%]). The proportion of pts achieving IGA 0/1 increased from OLE BL (62/321 [19.3%]) to Wk 52 (104/257 [40.5%]). 255 (79.4%) pts reported ≥ 1 treatment-emergent adverse events (TEAEs). Most common TEAEs were dermatitis atopic (28.7%), nasopharyngitis (17.1%) and upper respiratory tract infection (15.6%). 15 (4.7%) and 13 (4.0%) pts reported serious and severe TEAEs, respectively. Dupilumab treatment resulted in substantial and sustained long-term reduction in AD signs and symptoms in pts aged 6–11 years with inadequately controlled severe AD. Long-term safety was acceptable and consistent with that previously seen in shorter term, placebo-controlled studies.