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.
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.
复制标题
儿科化脓性汗腺炎的横断面研究以及国际化脓性汗腺炎严重程度评分系统 (IHS4) 作为儿科临床试验纳入标准的价值。
DOI：
10.1111/pde.15026
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发表时间：
2022
影响因子：
1.5
通讯作者：
Sayed,Christopher
中科院分区：
文献类型：
--
作者：
Bui,Helen;Sayed,Christopher
背景化脓性汗腺炎（HS）通常发生在儿科，但很少有干预性研究包括儿科患者。目的这种对儿科HS队列和成人试验中典型资格标准的双重分析旨在确定潜在的患者特征和未来儿科HS研究的入选标准。方法这项横断面和描述性研究基于HS诊所前瞻性收集的数据登记。我们还查询了125 HS的研究从Clinicaltrials.gov数据库和信息从61干预系统HS药物trials.ResultsThe平均脓肿和炎性结节（AN）计数在81名儿科受试者为2.3相比，5.0在成人与大多数是赫尔利阶段I（39.5%，32/81）或II（55.6%，45/81）。大多数临床试验要求患者为Hurley II/III期，AN计数≥ 3。结论在开展儿童HS临床试验时，必须考虑基线特征如何影响招募和疾病评估。成人试验中经常使用的合格性标准可能严重限制儿科招募。虽然我们的登记研究有较大的成人样本量，但本研究的主要局限性是儿科样本量相对较小。
BackgroundHidradenitis suppurativa (HS) often develops in pediatrics, but few interventional studies include pediatric patients.ObjectivesThis 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.MethodsThis 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 Clinicaltrials.gov database and information from 61 interventional systemic HS drug trials was analyzed.ResultsThe 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.ConclusionWhen 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.