Tapinarof Improves Pediatric Sleep and Family Sleep Impact in ADORING Trial Analysis
Key Takeaways
- Post hoc pooled analyses of the phase 3 ADORING 1 and 2 trials found improvements in patient-reported sleep disruption with once-daily tapinarof cream 1% versus vehicle among children with atopic dermatitis.
- At week 8, Patient-Oriented Eczema Measure (POEM) sleep subdomain improvements with tapinarof versus vehicle were −1.9 versus −0.9 points in children aged 2–6 years, −1.5 versus −1.0 in those aged 7–11 years, and −1.2 versus −0.6 in those aged 12–17 years.
- Family sleep impact also improved, but the analyses were post hoc, based on observed cases, and limited to an eight-week treatment period.
Once-daily tapinarof cream 1% was associated with greater improvements in sleep-related symptoms than vehicle among children with atopic dermatitis (AD), according to a post hoc analysis of the phase 3 ADORING 1 and ADORING 2 trials.
Mark Boguniewicz, MD, and colleagues evaluated pooled data from two randomized, double-blind, vehicle-controlled trials (NCT05014568 and NCT05032859). The studies enrolled 813 participants, including 654 children aged 2 to 17 years, who received tapinarof or vehicle once daily for eight weeks.
Investigators assessed changes in the sleep subdomains of the Patient-Oriented Eczema Measure (POEM) and Dermatitis Family Impact (DFI) questionnaires. Pediatric analyses were stratified by age.
Sleep Outcomes Across Pediatric Age Groups
At week 8, mean POEM sleep subdomain changes with tapinarof versus vehicle were −1.9 versus −0.9 points among children aged 2 to 6 years (P < .0001), −1.5 versus −1.0 among those aged 7 to 11 years (P = .0029), and −1.2 versus −0.6 among those aged 12 to 17 years (P < .0001). Significant between-group differences appeared by week 1 in the youngest and oldest cohorts and by week 4 in children aged 7 to 11 years.
Family sleep scores also improved at week 8: DFI sleep subdomain changes were −1.1 versus −0.6 in children aged 2 to 6 years (P = .0002), −0.6 versus −0.4 at ages 7 to 11 years (P = .0049), and −0.4 versus −0.2 at ages 12 to 15 years (P = .0283).
“Tapinarof cream 1% QD monotherapy demonstrated early and consistent improvements in POEM sleep subdomain in pediatric patients down to age 2 years with AD,” the authors concluded.