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The FDA initiated a study in the Sentinel System to estimate the prevalence of prurigo nodularis in order to assess the feasibility of conducting studies on products indicated for prurigo nodularis in pediatric patients. There is limited knowledge about age-specific incidence and prevalence of prurigo nodularis, particularly in pediatric age groups.
Sentinel System results described prurigo nodularis as a rare condition among children that is diagnosed much less frequently in children than adults. Prurigo nodularis prevalence (in 2022) increased progressively by age, 0.02-0.17 per 1,000 in pediatric age groups (age <18 years) to 3.12 per 1,000 in older adults (age ≥65 years). These results suggest that the feasibility of studies of new prurigo nodularis treatments in pediatric patients may be low as prurigo nodularis in children is rare. These findings informed the FDA’s decisions on sponsor-required studies in pediatric patients.