Novel baseline predictors of adverse events during oral immunotherapy in children with peanut allergy.
Novel baseline predictors of adverse events during oral immunotherapy in children with peanut allergy.
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DOI：
10.1016/j.jaci.2016.07.030
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发表时间：
2017-03
期刊：
影响因子：
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通讯作者：
Vickery BP
中科院分区：
文献类型：
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作者：
Virkud YV;Burks AW;Steele PH;Edwards LJ;Berglund JP;Jones SM;Scurlock AM;Perry TT;Pesek RD;Vickery BP
虽然花生口服免疫疗法（OIT）是一种很有前途的研究性疗法，但其潜力受到大量不良事件（AE）的限制，这些不良事件的研究相对不足。对三项儿科花生OIT试验进行回顾性分析，其中包括迄今为止最大规模的花生OIT安全性分析。我们从三项花生OIT研究中收集了104名花生过敏儿童。我们对来自父母报告、每日症状日记和剂量递增的AE进行分类。我们纳入了可能与OIT相关的事件，并使用广义线性回归模型确定了较高AE发生率的潜在基线预测因素。80%的受试者在OIT期间发生了可能相关的AE（72%在累积期间，47%在维持期间）。在这些AE中，超过90%发生在家中。约42%的受试者发生全身反应，49%的受试者发生胃肠道症状。20%的受试者退出，其中一半（总组的10%）是由于持续的胃肠道症状。基线变应性鼻炎（AR）、哮喘和花生皮肤点刺试验（SPT）是总体AE发生率较高的显著预测因素。SPT预测胃肠道AE增加，AR预测全身反应增加。在OIT过程中，61%的受试者接受了可能相关的AE治疗，59%接受了抗组胺药治疗，12%接受了肾上腺素治疗。花生OIT与频繁发生的AE相关，发生率随时间推移而下降，大多数分级为轻度。然而，全身反应和不可耐受的胃肠道AE确实发生，并且分别与AR和花生SPT显著相关。需要进一步研究预测性生物标志物和OIT的总体风险和益处。
Though peanut oral immunotherapy (OIT) is a promising investigational therapy, its potential is limited by substantial adverse events (AEs), which are relatively understudied. To conduct a retrospective analysis pooling three pediatric peanut OIT trials, comprising the largest analysis of peanut OIT safety to date. We pooled 104 peanut-allergic children from three peanut OIT studies. We catalogued AEs from parental report, daily symptom diaries, and dose escalations. We included events that were likely related to OIT and identified potential baseline predictors of higher AE rates using generalized linear regression models. Eighty percent of subjects experienced likely-related AEs during OIT (72% during buildup and 47% during maintenance). Of these AEs, over 90% occurred while at home. Approximately 42% of subjects experienced systemic reactions, and 49% experienced gastrointestinal symptoms. Twenty percent of subjects dropped out, with half (10% of overall group) due to persistent gastrointestinal symptoms. Baseline allergic rhinitis (AR), asthma, and peanut skin prick test (SPT) were significant predictors of higher overall AE rates. SPT predicted increased gastrointestinal AEs, and AR predicted increased systemic reactions. Over the course of OIT, 61% of subjects received treatment for likely-related AEs, 59% with antihistamines and 12% with epinephrine. Peanut OIT is associated with frequent AEs, with rates declining over time, and most graded mild. However, systemic reactions and intolerable gastrointestinal AEs do occur and are significantly associated with AR and peanut SPT, respectively. Further study is needed of predictive biomarkers and the overall risks and benefits of OIT.