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

Background Hidradenitis suppurativa (HS) often develops in pediatrics, but few interventional studies include pediatric patients. Objectives This dual analysis of a pediatric HS cohort and typical eligibility criteria in adult trials aims to identify potential patient characteristics and inclusion criteria for future pediatric HS studies. Methods This cross-sectional and descriptive study is based on a prospectively collected data registry from an HS clinic. We also queried 125 HS studies from the database and information from 61 interventional systemic HS drug trials was analyzed. Results The mean abscess and inflammatory nodule (AN) count in 81 pediatric subjects was 2.3 compared to 5.0 in adults with majority being Hurley stage I (39.5%, 32/81) or II (55.6%, 45/81). Most clinical trials required patients to be Hurley stage II/III with AN count of >= 3. Conclusion When developing clinical trials for pediatric HS, it is imperative to consider how baseline characteristics impact recruitment and disease assessment. Frequently used eligibility criteria in adult trials may severely limit pediatric recruitment. Although our registry had a large adult sample size, the main limitation of this study was the relatively smaller pediatric sample size.

Automated summary

This study analyzed the characteristics of pediatric Hidradenitis suppurativa (HS) patients and the eligibility criteria in adult trials, providing reference for future pediatric HS studies. The study found that pediatric patients had fewer abscesses and inflammatory nodules, with the majority being Hurley stage I or II. The commonly used criteria in adult trials may severely limit the recruitment of pediatric patients.