Crisaborole Improves Sleep Outcomes in Pediatric Patients with Atopic Dermatitis

New research presented at the American Academy of Pediatrics (AAP) 2021 Virtual Conference suggested that the non-steroidal phosphodiesterase 4 inhibitor crisaborole improved sleep outcomes in pediatric patients with mild-to-moderate atopic dermatitis and their families.

The data were presented this past weekend by Joseph Fowler, MD, Dermatology Specialists Research LLC, Louisville, Kentucky, during the session “Improvements in Sleep Outcomes for Crisaborole-treated Pediatric Patients with Mild-to-Moderate Atopic Dermatitis and Their Families”.

Crisaborole ointment, 2%, has been used in past studies for the treatment of mild-to-moderate atopic dermatitis, and had been approved in the United States and Canada for use in patients aged 3 months and younger.

Data from phase 3 of the CrisADe CORE 1 and CORE 2 studies showed that crisaborole improved signs and symptoms in pediatric patients with mild-to-moderate atopic dermatitis, with similar results being recorded in the phase 4 study CrisADe CARE 1.

Given the data surrounding crisaborole, and the prevalence of atopic dermatitis in pediatric parents and its affect on sleep, Fowler and investigators examined sleep outcomes across the studies in a post hoc analysis.

The Methods

The 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 atopic dermatitis.

Participating children received twice daily crisaborole for 28 days, while others received a vehicle during the CORE 1 and CORE 2 studies.

Baseline and day 29 sleep outcomes were measured in CARE 1 via the sleep item of the Patient-Oriented Eczema Measure (POEM) questionnaire and sleep items from the Children’s Dermatology Life Quality Index (CDLQI) and the Dermatology Family Impact (DFI) questionnaires.

Sleep data from the Patient Oriented Eczema Measure (POEM) were collected for 137 infants in the CARE 1 study, while CDLQI and DFI sleep data were collected for 1199 patients (crisaborole: 796; vehicle: 403) and 1291 families (crisaborole: 860; vehicle: 431), in CORE 1 and 2.

The Findings

Investigators reported that in CARE 1, the POEM sleep item indicated that 60.6% of patients experienced ≥1 night of disturbed sleep during the previous week because of atopic dermatitis at baseline.

At day 29, the number of patients who experienced ≥1 night of disturbed sleep decreased to 28.5%.

In CORE 1 and CORE 2 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) at day 29.

The proportion of families reporting that their sleep was affected by their child’s atopic dermatitis in the preceding week was also significantly lower with crisaborole than with vehicle at day 29 (35.8% vs 43.1%; P=0.02),

At baseline, 60.6% of respondents reported that their child’s sleep had been disturbed because of the child’s condition within the past week. At days 8, 15, and 29 of crisaborole treatment, the proportion was reduced to 40.3%, 32.9%, and 28.5%, respectively.

Overall, Fowler and colleagues felt the data was consistent and representative of the effect of crisaborole treatment for mild-to-moderate atopic dermatitis.

“These results suggest that crisaborole treatment is effective in improving sleep outcomes in children with atopic dermatitis and their broader family units,” the team said.