奥马珠单抗可减少过敏反应并使重度哮喘合并食物过敏的儿童能够引入食物：一项观察性研究。
Omalizumab reduces anaphylactic reactions and allows food introduction in food-allergic in children with severe asthma: An observational study.
作者信息
Arasi Stefania, Cafarotti Arianna, Galletta Francesca, Panetta Valentina, Riccardi Carla, Calandrelli Veronica, Fierro Vincenzo, Dahdah Lamia, Artesani Maria Cristina, Valluzzi Rocco Luigi, Pecora Valentina, Tallarico Valeria, Dinardo Giulio, Lo Scalzo Lucia, Fiocchi Alessandro
机构信息
Allergy Division, Pediatric Hospital Bambino Gesu IRCCS, Rome, Italy.
Department of Human Pathology of Adult and Childhood Gaetano Barresi, Pediatric Unit, University of Messina, Messina, Italy.
出版信息
Allergy. 2025 Apr;80(4):1074-1085. doi: 10.1111/all.16314. Epub 2024 Sep 16.
BACKGROUND
In Europe, Omalizumab (anti-IgE) is indicated for the treatment of moderate to severe asthma, but not for IgE-mediated food allergy (FA).
OBJECTIVE
We assessed the impact of Omalizumab on efficacy, safety, and quality of life (FA-QoL) in patients with moderate to severe asthma and who have a history of anaphylaxis to peanut, tree nuts, fish, egg, milk, and/or wheat.
METHODS
Food-allergic children (6-18 years) with moderate to severe asthma underwent oral food challenges (OFCs) to establish the threshold of reaction to the culprit food(s) at baseline (T0) and at 4-month intervals (T1, T2, and T3) during their first year of treatment with Omalizumab. We recorded the number and severity of food-allergic reactions, Asthma Control Test (ACT) scores, FA-QoL, and total IgE levels.
RESULTS
In 65 patients allergic to 107 foods, the No Observed Adverse Events Level (NOAEL) at T1 increased: 243- and 488-fold for fresh and baked milk, respectively; 172- and 134-fold for raw and baked egg; 245-fold for hazelnut; 55-fold for peanut; 31-fold for wheat; and 10-fold for fish. Full tolerance was achieved in 66.4% of OFCs at T1, 58.3% at T2, and 75% at T3. Ninety-five foods were liberalized in the diet of 55 patients; the remaining 12 were introduced by 10 patients at least in traces. Throughout the study, 40 out of 65 were able to get a free diet. ACT increased from 17 (Q1-Q3: 15-17) to 23.6 (Q1-Q3: 23-25). The FA-QoL score in children ≤12 years decreased from 4.63 ± 0.74 to 2.02 ± 1.13, and in adolescents from 4.68 ± 0.92 to 1.90 ± 1.50.
CONCLUSIONS
During Omalizumab therapy, a safe reintroduction of allergenic foods is feasible.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov, NCT06316414.
背景
在欧洲，奥马珠单抗（抗IgE）被用于治疗中度至重度哮喘，但未用于IgE介导的食物过敏（FA）。
目的
我们评估了奥马珠单抗对中度至重度哮喘且有花生、坚果、鱼、蛋、牛奶和/或小麦过敏反应病史患者的疗效、安全性及生活质量（FA-QoL）的影响。
方法
患有中度至重度哮喘的食物过敏儿童（6 - 18岁）在接受奥马珠单抗治疗的第一年，于基线期（T0）以及每隔4个月（T1、T2和T3）进行口服食物激发试验（OFC），以确定对致敏食物的反应阈值。我们记录了食物过敏反应的数量和严重程度、哮喘控制测试（ACT）分数、FA-QoL及总IgE水平。
结果
在65名对107种食物过敏的患者中，T1期的未观察到不良事件水平（NOAEL）有所提高：新鲜牛奶和烘焙牛奶分别提高了243倍和488倍；生鸡蛋和烘焙鸡蛋分别提高了172倍和134倍；榛子提高了245倍；花生提高了55倍；小麦提高了31倍；鱼提高了10倍。T1期66.4%的OFC达到完全耐受，T2期为58.3%，T3期为75%。55名患者的饮食中95种食物放宽了限制；其余12种食物至少有10名患者微量摄入。在整个研究过程中，65名患者中有40名能够实现自由饮食。ACT评分从17（第一四分位数 - 第三四分位数：15 - 17）提高到23.6（第一四分位数 - 第三四分位数：23 - 25）。12岁及以下儿童的FA-QoL评分从4.63±0.74降至2.02±1.13，青少年从4.68±0.92降至1.90±1.50。
结论
在奥马珠单抗治疗期间，安全地重新引入致敏食物是可行的。
试验注册号
ClinicalTrials.gov，NCT06316414。
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