A pilot study of omalizumab to facilitate rapid oral desensitization in high-risk peanut-allergic patients
A pilot study of omalizumab to facilitate rapid oral desensitization in high-risk peanut-allergic patients
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DOI：
10.1016/j.jaci.2013.09.046
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发表时间：
2013-12-01
影响因子：
14.2
通讯作者：
Umetsu, Dale T.
中科院分区：
文献类型：
--
作者：
Schneider, Lynda C.;Rachid, Rima;Umetsu, Dale T.
背景资料：花生过敏是一个主要的公共卫生问题，影响1%的人口，并没有有效的therapeutic.Objective：为了检查口服脱敏在花生过敏儿童的安全性和有效性，结合一个简短的过程中的抗IgE单克隆抗体（奥马珠单抗[Xolair]）。方法：我们进行了口服花生脱敏花生过敏的儿童在高风险的发展显着花生引起的过敏反应。在口服花生脱敏之前和期间给予奥马珠单抗。我们招收了13名儿童（中位年龄，10岁），具有229 kU（A）/L的中位花生特异性IgE水平和621 kU/L的中位血清总IgE水平，其在100 mg或更少的花生粉剂量下的初始双盲安慰剂对照食物攻击失败。所有13名受试者耐受了在第一天给予的最初11个脱敏剂量，包括最大剂量500 mg花生粉（累积剂量992 mg，相当于>2个花生），需要最少的或不需要补救治疗。然后，12名受试者在8周的中位时间内达到每天4000 mg花生粉的最大维持剂量，此时奥马珠单抗停药。所有12名受试者继续每天服用4000毫克花生粉，随后耐受8000毫克花生粉（相当于约20颗花生）的激发，即脱敏前耐受剂量的160至400倍。在研究过程中，13名受试者中有6名出现轻度或无过敏反应，5名受试者有2级反应，2名受试者有3级反应，所有这些反应迅速treatment.Conclusions：在高危花生过敏儿童中，omalizumab治疗可促进快速口服脱敏和定性改善脱敏过程。
Background: Peanut allergy is a major public health problem that affects 1% of the population and has no effective therapy.Objective: To examine the safety and efficacy of oral desensitization in peanut-allergic children in combination with a brief course of anti-IgE mAb (omalizumab [Xolair]).Methods: We performed oral peanut desensitization in peanut-allergic children at high risk for developing significant peanut-induced allergic reactions. Omalizumab was administered before and during oral peanut desensitization.Results: We enrolled 13 children (median age, 10 years), with a median peanut-specific IgE level of 229 kU(A)/L and a median total serum IgE level of 621 kU/L, who failed an initial double-blind placebo-controlled food challenge at peanut flour doses of 100 mg or less. After pretreatment with omalizumab, all 13 subjects tolerated the initial 11 desensitization doses given on the first day, including the maximum dose of 500 mg peanut flour (cumulative dose, 992 mg, equivalent to >2 peanuts), requiring minimal or no rescue therapy. Twelve subjects then reached the maximum maintenance dose of 4000 mg peanut flour per day in a median time of 8 weeks, at which point omalizumab was discontinued. All 12 subjects continued on 4000 mg peanut flour per day and subsequently tolerated a challenge with 8000 mg peanut flour (equivalent to about 20 peanuts), or 160 to 400 times the dose tolerated before desensitization. During the study, 6 of the 13 subjects experienced mild or no allergic reactions, 5 subjects had grade 2 reactions, and 2 subjects had grade 3 reactions, all of which responded rapidly to treatment.Conclusions: Among children with high-risk peanut allergy, treatment with omalizumab may facilitate rapid oral desensitization and qualitatively improve the desensitization process.