Improvements in Sleep Outcomes for Crisaborole-treated Pediatric Patients with Mild-to-moderate Atopic Dermatitis and Their Families

Background: Pediatric patients with atopic dermatitis (AD) often experience pruritus that results in sleep disruption for themselves and their families. Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate AD that is approved in the United States and Canada for use in patients aged ≥3 months. Crisaborole improved signs and symptoms of mild-to-moderate AD in pediatric patients in the double-blind phase 3 studies CrisADe CORE 1 (NCT02118766) and CORE 2 (NCT02118792) and the open-label phase 4 study CrisADe CARE 1 (NCT03356977). This post hoc analysis examined sleep outcomes across these studies for pediatric patients and their families.

Methods: This analysis included patients aged 3 to <24 months (CARE 1), patients aged 2 to <16 years (pooled CORE 1/CORE 2), and families of patients aged 2 to <18 years (pooled CORE 1/CORE 2) with mild-to-moderate AD who received twice-daily crisaborole (or vehicle in CORE 1/CORE 2) for 28 days. Baseline and day 29 sleep outcomes were measured in CARE 1 via the sleep item of the Patient-Oriented Eczema Measure (POEM) questionnaire and via sleep items from the Children’s Dermatology Life Quality Index (CDLQI) and the Dermatology Family Impact (DFI) questionnaires for patients and their families, respectively, in CORE 1 and CORE 2.

Results: POEM sleep data were collected for 137 infants in CARE 1, all of whom were treated with crisaborole. CDLQI and DFI sleep data were collected for 1199 patients (crisaborole: 796; vehicle: 403) and 1291 families (crisaborole: 860; vehicle: 431), respectively, in CORE 1 and 2. For patients in CARE 1, baseline mean age was 1.1 years and baseline mean %BSA was 28.1. For CORE 1 and CORE 2 patients aged 2 to <16 years, baseline mean age (crisaborole and vehicle) was 7.7 and 7.8 years, respectively, and baseline mean %BSA was 19.2 and 19.1. In patients aged 2 to <18 years in CORE 1 and CORE 2, these were 8.3 and 8.4 years, respectively, and 18.9 and 18.5. In CARE 1, the POEM sleep item indicated that, at baseline, 60.6% of patients experienced ≥1 night of disturbed sleep during the previous week because of AD. At day 29, the number of patients who experienced ≥1 night of disturbed sleep decreased to 28.5%. In CORE 1 and CORE 2 at day 29, a significantly lower proportion of crisaborole-treated patients than vehicle-treated patients reported sleep disruption due to AD (48.5% vs 57.7%; P=0.001). The proportion of families reporting that their sleep was affected by their child’s AD in the preceding week was also significantly lower with crisaborole than with vehicle at day 29 (35.8% vs 43.1%; P=0.02).

Conclusion: These results suggest that crisaborole improves sleep outcomes in pediatric patients with mild-to-moderate AD and their families.