Sleep disturbance is a significant factor in reduced quality of life for children and adolescents. A study at a poster session for the SPD 2022 47th Annual Meeting was presented on treating this population with dupilumab (Dupixent) to help with sleep quality showed positive results.
Investigators Amy S. Paller, MD, PhD, Eric L. Simpson, PhD, and Elaine C. Siegfried, PhD, et al shared the results of their study on the treatment of dupilumab for atopic dermatitis (AD) in a poster session at the SPD 2022 47th Annual Meeting.
The Liberty Ad Infant/Preschool (NCT03346434 part B) is a randomized, double-blind, placebo controlled study for children aged 6 months to 5 years, with moderate to severe AD. The change in sleep quality in both the patients and their caregivers from baseline to week 16 was assessed using an 11-point sleep quality numerical rating scale, with 0 indicating the worse possible sleep and 10 the best. The assessment of the sleep quality of the patients was completed by the parents and caregivers.
In the study, 162 patients were randomized to dupilumab (n = 83) and placebo (n = 79), with the majority of the patients (93.2%) in the older group (children aged 2 to 5 years), and 6.8% in the 6 months to 1 year group.
An overwhelming majority (96.9 %) completed 16 weeks of treatment. At baseline, the mean daily average worst scratch/itch NRS score was (7.6 [1.40]) and the sleep quality NRS scores were similar in both the placebo (4.6[2.1]) and dupilumab (4.9 [1.9]) treatment arms, with caregiver’s sleep quality NRS scores in these groups 4.7 and 5.1 respectively.
Results showed that sleep quality was significantly improved with dupilumab treatment as early as week 4 compared with the placebo group. This treatment group difference was sustained at week 16 in both patients and their caregivers, with dupilumab demonstrating an acceptable safety profile.
Researchers concluded that dupilumab plus low-potency topical corticosteroids offered significant improvement in sleep quality within 4 weeks for children aged 6 months to 5 years and their caregivers.
Paller AS, Simpson EL, Siegfried EC. Dupilumab treatment improved sleep quality in moderate-to-severe atopic dermatitis in children aged 6 months to 5 years and their caregivers. SPD 2022 47th Annual Meeting. Poster presentation. July 7, 8, 2022. Indianapolis, Indiana.