Dupilumab treatment improved sleep quality in moderate-to-severe atopic dermatitis in children aged 6 months to 5 years and their caregivers

Sleep disturbance is a major factor leading to reduced quality of life of pediatric patients and their caregivers. LIBERTY AD INFANT/PRESCHOOL (NCT03346434 part B) is a randomized, double blind, placebo controlled study that evaluated sleep quality in children with moderateto‐severe atopic dermatitis, aged 6 months to 5 years and their caregivers. Children (n = 162) inadequately controlled with topical therapies were randomized (1:1) to subcutaneous dupilumab, concomitantly administered with low‐potency topical corticosteroids (TCS), every 4 weeks (200 mg if baseline weight ≥5 to <15 kg; 300 mg if ≥15 to <30 kg) or placebo for 16 weeks. Change in sleep quality in patients and their caregivers from baseline to Week 16 was assessed using sleep quality numerical rating scale (NRS; 0: worst possible sleep, 10: best possible sleep). At baseline, sleep quality NRS scores (±SD) were comparable between dupilumab (4.9 ± 1.9) and placebo (4.6 ± 2.1). The mean caregiver's sleep quality NRS scores in these groups were 4.7 ± 2.1 and 5.1 ± 1.9, respectively. Least squares mean (±SE) change in the weekly average of NRS score was significantly improved as early as Week 4 in dupilumab patients (1.5 ± 0.2 vs. 0.5 ± 0.2; P < 0.0001) and caregivers (1.2 ± 0.2 vs. 0.49 ± 0.2; P = 0.0063) versus placebo. This treatment difference was sustained at Week 16 in both patients (2.0 ± 0.3 vs. 0.3 ± 0.3; P < 0.0001) and their caregivers (1.8 ± 0.3 vs. 0.3 ± 0.3; P < 0.0001). Dupilumab demonstrated an acceptable safety profile. In conclusion, dupilumab + low‐potency TCS for 16 weeks provided significant improvement in sleep quality within 4 weeks in children aged 6 months to 5 years and their caregivers.