Crisaborole therapy among pediatric patients with mild-to-moderate atopic dermatitis (AD) improves sleep disruption and resulted in a reduction in patients with disturbed nightly sleep, according to post hoc analysis findings published in Dermatology and Therapy (Heidelb).
Researchers conducted a post hoc analysis using data from the double-blind phase 3 CrisADe CORE 1 (ClinicalTrials.gov Identifier: NCT02118766) and CORE 2 (ClinicalTrials.gov Identifier: NCT02118792) studies, families of patients aged 2 to 18 years from CORE 1 and CORE 2, and patients aged 3 months to 2 years from the open-label phase 4 CrisADe CARE 1 study (ClinicalTrials.gov Identifier: NCT03356977). All participants were treated with crisaborole ointment 2% twice daily for 28 days for mild-to-moderate AD.
Safety and efficacy of crisaborole vs vehicle (ointment without medication) were compared in patients with mild-to-moderate AD aged 2 to 18 years in CORE 1 and CORE 2.
The Children’s Dermatology Life Quality Index (CDLQI) and Dermatitis Family Impact (DFI) questionnaires were used to assess sleep outcomes in CORE 1 and CORE 2 at baseline and day 29. These questionnaires were completed by patients or with parental assistance, and a proxy version of the Patient-Oriented Eczema Measure (POEM) questionnaire completed by parents or guardians was used for assessment in CARE 1 at baseline and days 8, 15, and 29.
Researchers collected CDLQI and DFI sleep data from CORE 1 and CORE 2, respectively (1199 patients [crisaborole, n=796; vehicle, n=403] and 1291 families [crisaborole, n=860; vehicle, n=431]). In CARE 1, POEM sleep data was collected for infants (crisaborole-treated participants, n=137).
Participants in CORE 1 and CORE 2 aged 2 to 16 years and those aged 2 to 18 years had similar baseline and disease characteristics. At baseline, participants in CARE 1 had higher median and mean percent body surface area than those in CORE 1 and CORE 2. There were comparable proportions of patients with Investigator Static Global Assessment scores of mild and moderate in all 3 studies. The percentage of White participants in CORE 1 and CORE 2 was similar to the percentage in CARE 1, but the proportion of girls was lower in CARE 1 (36% vs 53%).
Participants’ sleep had been affected by the skin condition in the week before baseline in 72.4% of those treated with crisaborole and 71.2% of those treated with vehicle. There was a significantly lower proportion of participants treated with crisaborole (48.5%) reported sleep disruption at day 29 vs vehicle-treated participants (57.7%; P =.001).
At baseline, 58.3% of families of participants treated with crisborole and 55.2% of families of participants treated with vehicle reported sleep of other family members had been affected by their child’s AD in the previous week. In the week preceding day 29, the researchers noted a significantly lower proportion of families of participants treated with crisborole whose sleep was affected by their child’s AD (35.8%) vs vehicle-treated participants’ families (43.1%; P =.02).
The proportion of participants treated with crisaborole who experienced at least 1 night of disturbed sleep in the previous week before day 29 decreased by 32.1% from baseline. There were no sleep-related adverse events reported in CORE 1, CORE 2, or CARE 1.
Limitations of the study include the nature of post hoc analysis design, a lack of objective measurements of sleep quality, and possible recall bias in patient self-report or parent or guardian proxy report.
Researchers conclude, “After twice-daily use for 28 days to treat mild-to moderate AD in pediatric patients, crisaborole improved sleep outcomes in both the patients and their families. Future trials are warranted to investigate the improvements in sleep associated with PDE4 inhibition in AD.”
Disclosure: This research was supported by Pfizer Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Fowler J, Sugarman J, Sher L, et al. Impact of crisaborole on sleep outcomes in pediatric patients with mild-to-moderate atopic dermatitis. Dermatol Ther (Heidelb)Published online February 22, 2023. doi:10.1007/s13555-023-00899-y