Clinical Trial Eligibility Criteria Limit Pediatric Patients With Hidradenitis Suppurativa Involvement

Eligibility criteria in clinical trials for hidradenitis suppurativa (HS) limit pediatric recruitment, according to results from a recent study published in Pediatric Dermatology.

Researchers aimed to identify potential patient characteristics and inclusion criteria for future pediatric HS studies in a dual analysis, cross-sectional, and descriptive study. A pediatric HS cohort and typical eligibility criteria in adult trials were compared in the dual analysis. Data were collected from an HS clinic, studies from the ClinicalTrials.gov database, and information from interventional systemic HS drug trials.

In a total of 81 pediatric patients, the mean abscess and inflammatory nodule count was 2.3 and mainly Hurley stage I or II. Clinical trials required patients to be Hurley stage II/III, with an abscess and inflammatory nodule count of equal to or above 3.

“When developing clinical trials for pediatric HS, it is imperative to consider how baseline characteristics impact recruitment and disease assessment,” concluded the study authors. “Frequently used eligibility criteria in adult trials may severely limit pediatric recruitment,” they added.

Reference
Bui H, Sayed C. A cross-sectional study of pediatric hidradenitis suppurativa and the value of the International Hidradenitis Suppurativa Severity Score System (IHS4) as a pediatric clinical trial inclusion criteria. Pediatr Dermatol. Published online June 29, 2022. doi:10.1111/pde.15026