Abstract：
Peanut allergy affects 1%-3% of children in Western countries. Boiling peanuts has been demonstrated to result in a hypoallergenic product that may provide a safer way of inducing desensitization in peanut-allergic patients by first inducing tolerance to boiled peanut. We aimed to assess the efficacy and safety of oral immunotherapy (OIT) using sequential doses of boiled peanuts followed by roasted peanuts for treating peanut allergy in children.
In this open-label, phase 2, single-arm clinical trial, children aged 6-18 years with a positive history of peanut allergy and positive peanut skin prick test ≥ 8 mm and/or peanut-specific IgE ≥ 15 kU/L at screening underwent OIT involving sequential up-dosing with 12-hour boiled peanut for 12 weeks, 2-hour boiled peanut for 20 weeks and roasted peanut for 20 weeks, to a target maintenance dose of 12 roasted peanuts daily.
proportion of children passing open-label oral food challenge involving cumulative administration of 12 roasted peanuts (12 g peanuts; approximately 3000 mg peanut protein) 6-8 weeks after reaching the target maintenance dose. Secondary outcomes included treatment-related adverse events and use of medications for treating allergy symptoms.
Between 1 July 2017 and 22 June 2018, 70 participants were enrolled and commenced OIT. Desensitization was successfully induced in 56 of 70 (80%) participants. Withdrawal due to treatment-related adverse events was infrequent (n = 3). Treatment-related adverse events were reported in 43 (61%) participants, corresponding to a rate of 6.58 per 1000 OIT doses. Medication use associated with treatment-related adverse events was infrequent, with rescue epinephrine use reported by three (4%) participants (0.05 per 1000 doses).
Oral immunotherapy using boiled followed by roasted peanuts represents a pragmatic approach that appears effective in inducing desensitization and is associated with a favourable safety profile.
In this open-label, phase 2, single-arm clinical trial, children aged 6-18 years with a positive history of peanut allergy and positive peanut skin prick test ≥ 8 mm and/or peanut-specific IgE ≥ 15 kU/L at screening underwent OIT involving sequential up-dosing with 12-hour boiled peanut for 12 weeks, 2-hour boiled peanut for 20 weeks and roasted peanut for 20 weeks, to a target maintenance dose of 12 roasted peanuts daily.
proportion of children passing open-label oral food challenge involving cumulative administration of 12 roasted peanuts (12 g peanuts; approximately 3000 mg peanut protein) 6-8 weeks after reaching the target maintenance dose. Secondary outcomes included treatment-related adverse events and use of medications for treating allergy symptoms.
Between 1 July 2017 and 22 June 2018, 70 participants were enrolled and commenced OIT. Desensitization was successfully induced in 56 of 70 (80%) participants. Withdrawal due to treatment-related adverse events was infrequent (n = 3). Treatment-related adverse events were reported in 43 (61%) participants, corresponding to a rate of 6.58 per 1000 OIT doses. Medication use associated with treatment-related adverse events was infrequent, with rescue epinephrine use reported by three (4%) participants (0.05 per 1000 doses).
Oral immunotherapy using boiled followed by roasted peanuts represents a pragmatic approach that appears effective in inducing desensitization and is associated with a favourable safety profile.
摘要：
背景：花生过敏影响西方国家1%-3%的儿童。已证明煮花生可产生低变应原性产品，该产品可通过首先诱导对煮花生的耐受性，为花生过敏患者提供更安全的脱敏方法。我们旨在评估口服免疫疗法（OIT）的有效性和安全性，该疗法使用顺序剂量的煮花生，然后烤花生治疗儿童花生过敏。
方法：在此开放标签中，第二阶段，单臂临床试验，6-18岁有花生过敏史阳性，花生皮肤点刺试验阳性≥8mm和/或花生特异性IgE≥15kU/L的儿童在筛查时接受了OIT，包括连续加药12小时煮花生12周，2小时煮花生20周，烤花生20周，每天12份烤花生的目标维持剂量。
方法：在达到目标维持剂量后6-8周，通过开放标签口服食物挑战的儿童的比例涉及12个烤花生（12克花生；约3000毫克花生蛋白）的累积给药。次要结果包括治疗相关的不良事件和使用药物治疗过敏症状。
结果：在2017年7月1日至2018年6月22日期间，70名参与者被登记并开始OIT。70名参与者中有56名（80％）成功诱导脱敏。由于治疗相关的不良事件而停药的情况很少见（n=3）。43名（61%）参与者报告了与治疗相关的不良事件，对应于每1000个OIT剂量6.58的比率。与治疗相关的不良事件相关的药物使用很少，3名(4%)参与者报告使用了急救肾上腺素(0.05/1000剂量).
结论：使用煮沸后烤花生的口服免疫疗法代表了一种实用的方法，该方法似乎可有效诱导脱敏，并具有良好的安全性。
方法：在此开放标签中，第二阶段，单臂临床试验，6-18岁有花生过敏史阳性，花生皮肤点刺试验阳性≥8mm和/或花生特异性IgE≥15kU/L的儿童在筛查时接受了OIT，包括连续加药12小时煮花生12周，2小时煮花生20周，烤花生20周，每天12份烤花生的目标维持剂量。
方法：在达到目标维持剂量后6-8周，通过开放标签口服食物挑战的儿童的比例涉及12个烤花生（12克花生；约3000毫克花生蛋白）的累积给药。次要结果包括治疗相关的不良事件和使用药物治疗过敏症状。
结果：在2017年7月1日至2018年6月22日期间，70名参与者被登记并开始OIT。70名参与者中有56名（80％）成功诱导脱敏。由于治疗相关的不良事件而停药的情况很少见（n=3）。43名（61%）参与者报告了与治疗相关的不良事件，对应于每1000个OIT剂量6.58的比率。与治疗相关的不良事件相关的药物使用很少，3名(4%)参与者报告使用了急救肾上腺素(0.05/1000剂量).
结论：使用煮沸后烤花生的口服免疫疗法代表了一种实用的方法，该方法似乎可有效诱导脱敏，并具有良好的安全性。
