Department of Dermatology and Allergy Centre, Odense Research Centre for Anaphylaxis (ORCA), Odense University Hospital, University of Southern Denmark, Odense, Denmark.
Allergy. 2024 Apr;79(4):964-976. doi: 10.1111/all.16046. Epub 2024 Feb 17.
Food allergy is common in childhood with some children having a low threshold and being difficult to protect from accidental ingestion of the offending food. Therapies for this potentially life-threatening condition are highly needed. The aim of this study was to evaluate the efficacy of Omalizumab in food-allergic children.
This is a single-center, double-blind, placebo-controlled study. Food allergic children with a cumulative threshold ≤443 mg food protein at DBPCFC were randomized to Omalizumab (asthma dose) or placebo (3:1). After 3 months, a second DBPCFC was performed (steps 3, 10, 30, 100, 300, 1000, and 3000 mg food protein), followed by a separate open challenge up to 10,000 and 30,000 mg food protein if negative. Responders were defined as ≥2-step increases in threshold. Non-responders received high-dose Omalizumab. A third DBPCFC was performed after 6 months. Skin testing, blood samples, and the severity of atopic co-morbidity were registered during the study and 3 months after treatment.
In total, 20 children were evaluated at 3 months (14 Omalizumab, 6 placebo). All treated with Omalizumab increased their threshold at least two steps and with a significant difference between the Omalizumab and the placebo group (p = .003), although the intended number of included children was not reached. The threshold before Omalizumab treatment was 13-443 mg food protein while the threshold after 3 months of treatment increased up to 44,000 mg (1143-44,000). In the placebo group, two children improved threshold during the study.
An increase in the threshold level during Omalizumab treatment significantly improve patient safety and protected all children against small amount of allergen.
食物过敏在儿童中很常见，有些儿童的过敏阈值较低，难以避免意外摄入致敏食物。因此，非常需要针对这种潜在危及生命的疾病的治疗方法。本研究旨在评估奥马珠单抗在食物过敏儿童中的疗效。
这是一项单中心、双盲、安慰剂对照研究。在 DBPCFC 中累积阈值≤443mg 食物蛋白的食物过敏儿童随机分为奥马珠单抗（哮喘剂量）或安慰剂（3:1）组。3 个月后进行第二次 DBPCFC（步骤 3、10、30、100、300、1000 和 3000mg 食物蛋白），如果结果为阴性，则单独进行开放挑战，直至 10000 和 30000mg 食物蛋白。应答者定义为阈值增加≥2 步。未应答者接受高剂量奥马珠单抗治疗。6 个月后进行第三次 DBPCFC。在研究期间和治疗后 3 个月记录皮肤测试、血液样本和特应性合并症的严重程度。
共有 20 名儿童在 3 个月时进行了评估（奥马珠单抗 14 名，安慰剂 6 名）。所有接受奥马珠单抗治疗的儿童阈值至少增加了 2 步，且奥马珠单抗组与安慰剂组之间差异有统计学意义（p=0.003），尽管未达到纳入儿童的预期数量。奥马珠单抗治疗前的阈值为 13-443mg 食物蛋白，而治疗 3 个月后的阈值增加至 44000mg（1143-44000）。在安慰剂组中，有 2 名儿童在研究期间阈值有所改善。
奥马珠单抗治疗期间阈值水平的增加显著提高了患者安全性，并使所有儿童免受少量过敏原的侵害。
