BackgroundPeanut allergy is a potentially life‐threatening food allergy in children. This study explored whether dupilumab, a human monoclonal immunoglobulin (Ig)G4 antibody that blocks the activity of interleukin (IL)‐4/IL‐13, improved safety and desensitization to peanut exposure in children with peanut allergy.MethodsA Phase II, 24‐week, multicenter, single‐arm, open‐label, proof‐of‐concept study was conducted in the USA and Canada (NCT03793608). Children/adolescents with peanut allergy received subcutaneous dupilumab 300 mg (≥ 60 kg) or 200 mg (≥ 20 to < 60 kg) every 2 weeks. The primary endpoint was the proportion of participants who passed a double‐blind placebo‐controlled food challenge (DBPCFC) with ≥ 444 mg (cumulative) of peanut protein at week 24. Secondary endpoints included safety measures (Consortium of Food Allergy Research grading system) and change from baseline in peanut‐specific (ps)‐IgG4, total IgE, and ps‐IgE.ResultsTwenty‐four participants enrolled and received dupilumab: 75.0% were male, 79.2% were white, mean (standard deviation) age was 11.7 (3.3) years. Most (95.8%) participants had not received allergen immunotherapy. Two participants (8.3%) achieved the primary endpoint and passed the DBPCFC at week 24. Fifteen participants (62.5%) reported 66 treatment‐emergent adverse events, all being mild or in moderate intensity. At the week 24 DBPCFC, 8 participants (33.3%) had a grade 2 allergic reaction (no grade 3 or above); 10 (41.7%) used adrenaline as a rescue medication. Dupilumab treatment resulted in a median reduction of total and ps‐IgE of −54% and −49%, respectively, and a 0% change in ps‐IgG4.ConclusionsDupilumab monotherapy treatment for 24 weeks did not improve desensitization to peanut exposure after food challenge.

中文翻译：

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Dupilumab 在花生过敏儿童中的疗效和安全性：一项多中心、开放标签、II 期研究


背景花生过敏是一种可能危及儿童生命的食物过敏。本研究探讨了 dupilumab，一种阻断白细胞介素 （IL）-4/IL-13 活性的人单克隆免疫球蛋白 （Ig）G4 抗体，是否能提高花生过敏儿童对花生暴露的安全性和脱敏性。方法在美国和加拿大 （NCT03793608） 进行了一项 II 期、24 周、多中心、单臂、开放标签、概念验证研究。花生过敏的儿童/青少年每 2 周接受皮下注射 300 mg （≥ 60 kg） 或 200 mg （≥ 20 至 < 60 kg）。主要终点是在第 24 周时通过 ≥ 444 mg（累积）花生蛋白的双盲安慰剂对照食物激发试验 （DBPCFC） 的参与者比例。次要终点包括安全措施（食物过敏研究联盟分级系统）和花生特异性 （ps）-IgG4、总 IgE 和 ps-IgE 相对于基线的变化.结果24 名参与者入组并接受 dupilumab：75.0% 为男性，79.2% 为白人，平均（标准差）年龄为 11.7 （3.3） 岁。大多数 （95.8%） 参与者没有接受过敏原免疫治疗。两名参与者 （8.3%） 达到主要终点并在第 24 周通过了 DBPCFC。15 名参与者 （62.5%） 报告了 66 例治疗中出现的不良事件，均为轻度或中等强度。在第 24 周 DBPCFC，8 名参与者 （33.3%） 出现 2 级过敏反应 （无 3 级或以上）;10 人 （41.7%） 使用肾上腺素作为急救药物。Dupilumab 治疗导致总和 ps-IgE 的中位降低分别为 -54% 和 -49%，ps-IgG4 变化为 0.结论Dupilumab 单药治疗 24 周并未改善食物攻击后对花生暴露的脱敏。