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Impact of Crisaborole on Sleep Outcomes in Pediatric Patients with Mild-to-Moderate Atopic Dermatitis
Joseph Fowler1, Jeffrey Sugarman2, Lawrence Sher3
1Dermatology Specialists Research LLC and University of Louisville School of Medicine, Louisville, KY, USA.
Insights
Crisaborole ointment significantly improved sleep for children with atopic dermatitis (AD) and their families. Treatment reduced sleep disruption in pediatric patients and affected households.
Area of Science:
- Dermatology
- Pediatrics
- Sleep Medicine
Background:
- Atopic dermatitis (AD) significantly impacts sleep quality in pediatric patients and their families.
- Evaluating the effect of topical treatments on non-dermatological outcomes like sleep is crucial for comprehensive patient care.
Purpose of the Study:
- To assess the impact of crisaborole ointment on sleep outcomes in pediatric patients with mild-to-moderate atopic dermatitis.
- To evaluate the effect of crisaborole treatment on the sleep of families with children diagnosed with atopic dermatitis.
Main Methods:
- Analysis of data from three clinical trials (CORE 1, CORE 2, CARE 1) involving pediatric patients with atopic dermatitis.
- Patients aged 2 to <16 years (CORE 1 & 2) and 3 months to <2 years (CARE 1) received crisaborole ointment 2% or vehicle twice daily for 28 days.
- Sleep outcomes were measured using validated questionnaires including the Children's Dermatology Life Quality Index, Dermatitis Family Impact, and Patient-Oriented Eczema Measure.
Main Results:
- Crisaborole treatment resulted in a significantly lower proportion of patients reporting sleep disruption compared to vehicle treatment (48.5% vs 57.7%, p=0.001).
- A significantly lower proportion of families reported sleep affected by their child's AD in the crisaborole group (35.8% vs 43.1%, p=0.02).
- In the CARE 1 study, crisaborole treatment led to a 32.1% decrease in disturbed sleep nights from baseline in pediatric patients.
Conclusions:
- Crisaborole ointment demonstrates efficacy in improving sleep outcomes for pediatric patients suffering from mild-to-moderate atopic dermatitis.
- The findings suggest that crisaborole treatment positively impacts the sleep quality of both affected children and their families.
Introduction:
Using data from three clinical trials, the effect of crisaborole treatment on sleep outcomes for pediatric patients with atopic dermatitis (AD) and their families was examined.
Methods:
This analysis comprised patients aged 2 to < 16 years from the double-blind phase 3 CrisADe CORE 1 (NCT02118766) and CORE 2 (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 (NCT03356977), all with mild-to-moderate AD who received crisaborole ointment 2% twice daily for 28 days. Sleep outcomes were assessed via the Children's Dermatology Life Quality Index and Dermatitis Family Impact questionnaires in CORE 1 and CORE 2 and the Patient-Oriented Eczema Measure questionnaire in CARE 1.
Results:
In CORE 1 and CORE 2, a significantly lower proportion of crisaborole-treated patients than vehicle-treated patients reported sleep disruption at day 29 (48.5% versus 57.7%, p = 0.001). The proportion of families whose sleep was affected by their child's AD in the preceding week was also significantly lower in the crisaborole group (35.8% versus 43.1%, p = 0.02) at day 29. At day 29 in CARE 1, the proportion of crisaborole-treated patients who experienced ≥ 1 night of disturbed sleep in the previous week decreased by 32.1% from baseline.
Conclusion:
These results suggest that crisaborole improves sleep outcomes in pediatric patients with mild-to-moderate AD and their families.
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