Dupilumab Improves Symptoms and Quality of Life in Pediatric Patients With Moderate-to-Severe Atopic Dermatitis in Clinical Practice: RELIEVE-AD-PED Study

Abstract

Introduction Dupilumab significantly improved symptoms and quality of life (QoL) of patients with moderate-to-severe atopic dermatitis (AD) in clinical trials. This analysis evaluated dupilumab effectiveness on AD symptoms and patient QoL based on interim data from a real-world study in pediatric patients with AD.

Methods RELIEVE-AD-PED is an ongoing, prospective, longitudinal survey study of pediatric patients aged 6m – 17y with moderate-to-severe AD who initiated dupilumab, and their caregivers, recruited from DUPIXENT MyWay^®, a patient support program. Eligible pediatric patients from USA and their caregivers completed surveys at baseline and at multiple time points after dupilumab initiation. In this analysis, survey results up to 6m from patients aged 6m – 5y were included. Caregivers completed questions on the patients’ behalf or read questions aloud and recorded their children’s responses when appropriate. Disease control was assessed using Patient-Oriented Eczema Measure (POEM; range 0–28) and Atopic Dermatitis Control Tool (ADCT; range 0–24). Itch symptoms were assessed using a 0–10 Numeric Rating Scale (NRS) with a 1-week recall period, and a 4-point reduction was considered clinically meaningful. QoL and sleep problem were evaluated using the Infants' Dermatitis Quality of Life Index (IDQoL) questionnaire for ≤3-year-olds and Children’s Dermatology Life Quality Index (CDLQI) for 4–5-year-olds, and Patient-Reported Outcomes Measurement Information System (PROMIS) early childhood parent-report sleep problems, respectively.

Results At baseline, 238 patients aged 6m – 5y initiated dupilumab treatment, and 8.4% had clear/almost clear or mild eczema measured by POEM. By Week 2, 45.1% (P<0.001) of patients had clear/almost clear or mild eczema, and half of the patients with itch NRS ≥4 at baseline (96/187; 51.3%) experienced a clinically significant reduction in itch NRS. At Month 6, the percentage of patients with clear/almost clear continued to increase from baseline (70.0% of patients had clear/almost clear or mild eczema; P<0.001), with 67.8% of patients with itch NRS ≥4 at baseline experiencing a clinically significant reduction in itch NRS. Mean ADCT scores significantly decreased from baseline as early as Week 2 (baseline, 15.1 [5.6]; Week 2, 8.0 [5.5]; P<0.001) and were maintained to Month 6 (5.8 [5.8]; P<0.001). 46.1% of patients had controlled disease (ADCT total score <7; P<0.001) at Week 2 and 68.3% (P<0.001) at Month 6, compared with 9.7% at baseline. The proportion of patients with moderate to extremely large effect of AD on QoL decreased from baseline (76.5% and 88.2% for the 6m – 3y group and 4–5y group, respectively) to Month 1 (26.2% and 19.6%; P<0.001 for each). The proportion of patients continued to decrease from baseline at Month 6 (26.2% and 22.3% for 6m – 3y and 4–5y; P<0.001 for each). The proportion of patients aged 6m – 5y with normal sleep increased from baseline (32.8%) to Month 1 (78.6%; P<0.001), and these results were maintained to Month 6 (78.3%; P<0.001).

Conclusions In this real-world study, dupilumab led to significant improvements in QoL by Month 1, with significant reduction in symptoms observed as early as Week 2 in pediatric patients with moderate-to-severe AD. These results were sustained through Month 6.