Sustained unresponsiveness to peanut in subjects who have completed peanut oral immunotherapy
Sustained unresponsiveness to peanut in subjects who have completed peanut oral immunotherapy
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DOI：
10.1016/j.jaci.2013.11.007
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发表时间：
2014-02-01
影响因子：
14.2
通讯作者：
Burks, A. Wesley
中科院分区：
文献类型：
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作者：
Vickery, Brian P.;Scurlock, Amy M.;Burks, A. Wesley
背景资料：虽然花生口服免疫疗法（OIT）已被证明会导致脱敏，目前尚不清楚是否临床保护持续后停止therapy.Objective：我们的主要目标是确定是否花生OIT可以诱导持续无反应后撤回OIT.Methods：我们进行了一项试点临床试验，花生OIT在2个美国中心。招募了1至16岁的受试者，并用花生OIT治疗长达5年。随着时间的推移对方案进行了修改，以允许剂量增加至最大4000 mg/d花生蛋白。在多个时间点采集血液。临床终点测定5000毫克双盲，安慰剂对照的食物挑战，一旦特定的criteria were meeted.Results：最初招募的39名受试者，24完成了协议，并有可评估的结果。24例患者中有12例（50%）在停止OIT后1个月成功通过了挑战，并实现了持续无反应。饮食中添加了花生。在基线和激发时，与未通过的受试者相比，这些受试者的皮试结果较小，花生、Ara h 1和Ara h 2特异性IgE水平较低，花生特异性IgE/总IgE比值较低。在研究结束时，花生IgG（4）水平或功能活动没有差异。结论：这是首次证明花生OIT后持续无反应，发生在一半的受试者治疗长达5年。OIT有利地改变了完成方案的所有受试者的花生特异性免疫应答。较小的皮肤试验结果和较低的过敏原特异性IgE水平预测成功的结果。
Background: Although peanut oral immunotherapy (OIT) has been conclusively shown to cause desensitization, it is currently unknown whether clinical protection persists after stopping therapy.Objective: Our primary objective was to determine whether peanut OIT can induce sustained unresponsiveness after withdrawal of OIT.Methods: We conducted a pilot clinical trial of peanut OIT at 2 US centers. Subjects age 1 to 16 years were recruited and treated for up to 5 years with peanut OIT. The protocol was modified over time to permit dose increases to a maximum of 4000 mg/d peanut protein. Blood was collected at multiple time points. Clinical end points were measured with 5000-mg double-blinded, placebo-controlled food challenges once specific criteria were met.Results: Of the 39 subjects originally enrolled, 24 completed the protocol and had evaluable outcomes. Twelve (50%) of 24 successfully passed a challenge 1 month after stopping OIT and achieved sustained unresponsiveness. Peanut was added to the diet. At baseline and the time of challenge, such subjects had smaller skin test results, as well as lower IgE levels specific for peanut, Ara h 1, and Ara h 2 and lower ratios of peanut-specific IgE/total IgE compared with subjects not passing. There were no differences in peanut IgG(4) levels or functional activity at the end of the study.Conclusions: This is the first demonstration of sustained unresponsiveness after peanut OIT, occurring in half of subjects treated for up to 5 years. OIT favorably modified the peanut-specific immune response in all subjects completing the protocol. Smaller skin test results and lower allergen-specific IgE levels were predictive of successful outcome.