Skin pain is a common symptom in patients with atopic dermatitis (AD). A novel 11-point caregiver-reported instrument to assess skin pain by numeric rating scale (NRS; from 0 [no pain] to 10 [worst pain possible]), in young patients with moderate-to-severe AD was developed and evaluated. Caregivers (n=24) of children aged 6 months to <6 years with AD provided feedback on the skin pain NRS during combined concept elicitation/cognitive debriefing interviews. The majority of caregivers (23/24; 96%) reported that skin pain or discomfort were AD-related symptoms for their child. All caregivers understood and were able to provide a response on the skin pain NRS. Psychometric properties were evaluated using data from a Phase 3 study of dupilumab in children (aged 6 months to <6 years) with moderate-to-severe AD (NCT03346434). The test-retest reliability intraclass correlation coefficient (95% CI) was 0.68 (0.50, 0.80). The ability to detect change was shown by significant correlation with changes in anchor clinical outcome assessments (p<0.05), including Caregiver Global Impression of Disease (CGID; correlation coefficient [95% CI], 0.64 [0.52, 0.73]), Children’s Dermatology Life Quality Index (CDLQI; 0.60 [0.42, 0.73]), and Patient-Oriented Eczema Measure (POEM; 0.63 [0.51, 0.72]). Anchor-based methods suggest an at least 2 to 5-point change in skin pain NRS as clinically meaningful. The caregiver completed skin pain NRS is a valid, reliable, and responsive instrument to assess skin pain in children aged 6 months to <6 years with moderate-to-severe AD.
