Dupilumab Reduces Itch in Children with Moderate-to-Severe Atopic Dermatitis Aged 6 Months to 5 Years
Author(s)
Paller AS1, Siegfried EC2, Yosipovitch G3, Kwatra SG4, Praestgaard A5, Prescilla R5, Wang Z6
1Northwestern University Feinberg School of Medicine, Chicago, IL, USA, 2Saint Louis University, Saint Louis, MO, USA, 3University of Miami, Miami, FL, USA, 4Johns Hopkins University School of Medicine, Baltimore, MD, USA, 5Sanofi, Cambridge, MA, USA, 6Regeneron Pharmaceuticals Inc, Tarrytown, USA
Presentation Documents
OBJECTIVES:
Considered the most burdensome symptom of atopic dermatitis (AD), intense itch has a negative impact on quality of life, sleep, and mental health. Dupilumab treatment led to sustained reduction of itch in studies involving adults, adolescents, and school-age children with AD. This analysis studied the impact of dupilumab treatment on itch in preschool-age children with moderate-to-severe AD.METHODS:
In the phase 3 study LIBERTY AD PRESCHOOL, patients aged 6 months to 5 years with moderate-to-severe AD were randomized 1:1 to dupilumab 200/300mg + low-potency topical corticosteroids (TCS) every 4 weeks (q4w), or placebo + TCS. Caregiver-reported improvement in weekly average of daily Worst Scratch/Itch NRS scores (WSI-NRS; 0–10), SCORing Atopic Dermatitis Pruritus Visual Analog Scale (SCORAD Pruritus VAS; 0–10), and the proportion of patients with ≤2 days of itchy skin over the previous 7 days were assessed at Week 16.RESULTS:
At Week 16, 49.4% of patients treated with dupilumab 200/300mg q4w + TCS achieved ≥4‑point improvement in WSI-NRS, compared with 12.7% of the placebo + TCS group (p<0.0001), with a mean cumulative number of days with ≥4-point improvement /mean duration of treatment of 40.0/113.1 (35.4%) in the dupilumab group and 14.7/111.7 (13.2%) in the placebo group (p<0.0001). The proportion of patients with ≤2 days of itchy skin over the past week was of 37.3% in the dupilumab group, compared with 6.3% in the placebo group. Patients treated with dupilumab had a significant (p<0.0001) reduction in mean percentage change from baseline in SCORAD Pruritus VAS (−61.0%), compared with the placebo group (−23.9%), an effect which was observed from Week 1 (−22.8% vs −9.7%; p=0.006). Overall safety was consistent with the known dupilumab safety profile.CONCLUSIONS:
Dupilumab treatment leads to rapid and sustained improvements in itch in children aged 6 months to 5 years with moderate-to-severe AD.Conference/Value in Health Info
2023-05, ISPOR 2023, Boston, MA, USA
Value in Health, Volume 26, Issue 6, S2 (June 2023)
Code
CO224
Topic
Patient-Centered Research, Study Approaches
Topic Subcategory
Clinical Trials, Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas