Top Trends in Pediatric Dermatology
Dr Eichenfield, professor of dermatology and pediatrics, University of California, San Diego and Rady’s Children’s Hospital in San Diego, highlighted numerous trending topics in pediatric dermatology and offered pearls for dermatologists to take back to their clinic and implement.
“We are moving toward the concept of potential moisturizers being used early as preventative for AD. Two small number studies were conducted—one in Japan and one in the United States and the United Kingdom—with around 150 individuals using products. Those studies showed about a 50% decrease in the development of AD,” he said.
Simpson and colleagues1 performed a randomized controlled trial in the United States and United Kingdom of 124 neonates at high risk for AD. Caregivers in the intervention arm were instructed to apply full-body emollient therapy at least once per day starting within 3 weeks of birth. Caregivers in the control arm used no emollients. The primary clinical outcome was the cumulative incidence of AD at 6 months, as assessed by a trained investigator. Forty-two percent of eligible families agreed to be randomized into the trial and all participating families in the intervention arm found the intervention acceptable. A statistically significant protective effect was found with the use of daily emollient on the cumulative incidence of AD with a relative risk reduction of 50%. There were no emollient-related adverse events. The results demonstrated that emollient therapy from birth represents a feasible, safe, and effective approach for AD prevention.
Another study from Xu and colleagues2 looked at the cost-effectiveness of daily moisturizer as prevention against AD among high-risk newborns. In the analysis, the average cost of total-body moisturization using 7 common moisturizers from birth to 6 months of age was determined for male and female infants. The calculated amount of daily all-body moisturizer needed at birth was 3.6 g (0.12 oz) per application, which increased to 6.6 g (0.22 oz) at 6 months of age. Of the 7 products evaluated, the average price was $1.07/oz (range, $0.13-$2.96/oz). For a 6-month time window, the average incremental quality-adjusted life-years (QALYs) benefit was 0.021. A sensitivity analysis showed that the incremental gain of QALY ranged from 0.0041 to 0.030. Petrolatum was the most cost-effective moisturizer in the cohort. Even assuming the lowest incremental QALYs for the most expensive moisturizer, the intervention was still less than $45,000/QALY. The study researchers concluded daily moisturization may represent a cost-effective, preventive strategy to reduce the burden of AD.
Dr Eichenfield noted that this research has influenced him, and he now suggests early and regular use of moisturization as a potential preventive strategy to families in which there is a child with moderate to severe AD and the mother is pregnant again.
Dr Eichenfield reviewed several recent studies that demonstrate the effectiveness of crisaborole (Eucrisa) for the treatment to AD.3,4 A study by Paller and colleagues3 assessed the efficacy and safety of crisaborole ointment, a phosphodiesterase-4 inhibitor, in 2 phase 3 AD studies. Two identically designed, vehicle-controlled, double-blind studies enrolled and randomly assigned patients aged 2 years or older with an Investigator’s Static Global Assessment (ISGA) score of mild or moderate for twice-daily application for 28 days. The primary endpoint was ISGA score at day 29 of clear (0)/almost clear (1) with 2-grade or greater improvement from baseline. Additional analyses included time to success in ISGA score, percentage of patients achieving clear/almost clear, reduction in severity of AD signs, and time to improvement in pruritus. More crisaborole- vs vehicle-treated patients achieved ISGA score success with a greater percentage with clear/almost clear. Crisaborole-treated patients achieved success in ISGA score and improvement in pruritus earlier than those treated with vehicle. Treatment-related adverse events were infrequent and mild to moderate in severity. Crisaborole demonstrated a favorable safety profile and improvement in all measures of efficacy, including overall disease severity, pruritus, and other signs of AD. The short study duration was a limitation.
Dr Eichenfield shared that he and his colleagues recent study4 found that crisaborole data demonstrated significant improvements in quality of life and pruritus, with low incidence of adverse events. The study assessed the long-term safety results from a multicenter, open-label, 48-week safety study (AD-303) of patients (N=517) ≥2 years of age with mild to moderate AD who continued crisaborole treatment, after completing a 28-day phase 3 pivotal study (AD-301, AD-302). Global disease severity was assessed in patients every 4 weeks, and if assessed as mild or greater, a 28-day treatment period with crisaborole applied twice daily was initiated. During the pivotal studies and AD-303, 65% of patients reported ≥1 treatment-emergent adverse events (TEAEs), most of which were mild (51.2%) or moderate (44.6%) and considered unrelated to treatment (93.1%). The frequency and severity of TEAEs were consistent. The most frequently reported treatment-related adverse events were AD (3.1%), application-site pain (2.3%), and application-site infection (1.2%). Nine patients (1.7%) discontinued the long-term study because of TEAEs. Crisaborole ointment had a low frequency of treatment-related adverse events over 48 weeks of treatment of patients with AD. He added that many factors warrant continued study, including comparative efficacy and cost-efficiency.
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