BackgroundPeanut allergy is a common, life‐threatening food allergy in children. We evaluated whether dupilumab, which blocks the activity of interleukin (IL)‐4/IL‐13, enhances the efficacy of oral immunotherapy (OIT) AR101 in pediatric patients with peanut allergy.MethodsA Phase II, multicenter, randomized, double‐blind study was conducted in the USA (NCT03682770) in pediatric patients (6–≤ 17 years old) with confirmed peanut allergy. Patients were randomized 2:1 to receive dupilumab + OIT or placebo + OIT during a 28–40‐week up‐dosing period. Patients in the dupilumab + OIT group were re‐randomized 1:1 and received dupilumab + OIT or placebo + OIT during 24‐week OIT maintenance, undergoing a 2044 mg (cumulative) of peanut protein double‐blind, placebo‐controlled food challenge (DBPCFC) following up‐dosing, maintenance, and at 12‐week post‐treatment follow‐up.ResultsThe study enrolled 148 patients, 123 of whom were included in the modified full analysis set, with a mean age of 11.1 years. Dupilumab + OIT treatment (n = 84) led to a 20.2% increase (p < 0.05) in the number of patients who passed a DBPCFC to 2044 mg (cumulative) of peanut protein following the up‐dosing period versus placebo (OIT alone, n = 39). Following the OIT maintenance period, continuous dupilumab treatment improved the number of patients who passed a DBPCFC to 2044 mg (cumulative) of peanut protein versus patients continuously on OIT alone (16.6% difference [95% CI −9.7, 42.8], p = 0.2123). Safety was consistent with known dupilumab safety profile.ConclusionsDupilumab provided a modest increase efficacy of OIT in children and adolescents with peanut allergy, though it did not provide protection against OIT‐related anaphylaxis.Trial RegistrationClinicalTrials.gov identifier: NCT03793608

中文翻译：

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Dupilumab 作为花生过敏儿科患者口服免疫治疗的辅助治疗


背景花生过敏是一种常见的、危及生命的儿童食物过敏。我们评估了阻断白细胞介素 （IL）-4/IL-13 活性的 dupilumab 是否能增强口服免疫疗法 （OIT） AR101 对花生过敏儿科患者的疗效。方法在美国 （NCT03682770） 对确诊花生过敏的儿科患者 （6-≤ 17 岁） 进行了一项 II 期、多中心、随机、双盲研究。患者以 2：1 的比例随机分配，在 28-40 周的给药升级期内接受 dupilumab + OIT 或安慰剂 + OIT。dupilumab + OIT 组的患者以 1：1 的比例重新随机分配，并在 24 周的 OIT 维持期间接受 dupilumab + OIT 或安慰剂 + OIT，接受 2044 毫克（累积）花生蛋白双盲、安慰剂对照食物激发试验 （DBPCFC） 在增加给药、维持治疗后和 12 周治疗后随访。结果该研究招募了 148 名患者，其中 123 名被纳入修改后的完整分析集，平均年龄为 11.1 岁。与安慰剂相比，度普利尤单抗 + OIT 治疗 （n = 84） 导致在给药升级期后将 DBPCFC 传递至 2044 毫克（累积）花生蛋白的患者人数增加了 20.2% （p < 0.05） （n = 39）。在 OIT 维持期之后，与单独持续接受 OIT 的患者相比，连续 dupilumab 治疗提高了将 DBPCFC 传递至 2044 mg（累积）花生蛋白的患者数量 （16.6% 差异 [95% CI -9.7， 42.8]，p = 0.2123）。安全性与已知的 dupilumab 安全性特征一致。结论Dupilumab 在花生过敏儿童和青少年中提供了 OIT 的适度疗效增加，尽管它不能提供对 OIT 相关过敏反应的保护。试用 RegistrationClinicalTrials.gov 标识符：NCT03793608