Omalizumab reduces anaphylactic reactions and allows food introduction in food-allergic in children with severe asthma: An observational study.

IF 12.6 1区医学 Q1 ALLERGY Allergy Pub Date : 2024-09-16 DOI:10.1111/all.16314

Stefania Arasi, Arianna Cafarotti, Francesca Galletta, Valentina Panetta, Carla Riccardi, Veronica Calandrelli, Vincenzo Fierro, Lamia Dahdah, Maria Cristina Artesani, Rocco Luigi Valluzzi, Valentina Pecora, Valeria Tallarico, Giulio Dinardo, Lucia Lo Scalzo, Alessandro Fiocchi

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Abstract

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.

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奥马珠单抗可减少过敏反应，并允许对食物过敏的重症哮喘患儿进食：一项观察性研究。

背景：在欧洲，奥马珠单抗（抗 IgE）适用于治疗中重度哮喘，但不适用于 IgE 介导的食物过敏（FA）：在欧洲，奥马珠单抗（抗 IgE）适用于治疗中重度哮喘，但不适用于 IgE 介导的食物过敏（FA）：我们评估了奥马珠单抗对中重度哮喘患者的疗效、安全性和生活质量（FA-QoL）的影响，这些患者曾对花生、树坚果、鱼、蛋、牛奶和/或小麦过敏：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期间，分别在基线（T0）和每隔 4 个月（T1、T2 和 T3）接受口服食物挑战（OFC），以确定对罪魁祸首食物的反应阈值。我们记录了食物过敏反应的次数和严重程度、哮喘控制测试（ACT）评分、FA-QoL 和总 IgE 水平：结果：在 65 位对 107 种食物过敏的患者中，T1 的无明显不良反应水平（NOAEL）分别为：鲜牛奶和烤牛奶分别增加 243 倍和 488 倍；生鸡蛋和烤鸡蛋分别增加 172 倍和 134 倍；榛子增加 245 倍；花生增加 55 倍；小麦增加 31 倍；鱼增加 10 倍。66.4% 的 OFCs 在 T1、58.3% 的 OFCs 在 T2 和 75% 的 OFCs 在 T3 时达到完全耐受。55 名患者的饮食中放宽了 95 种食物的限制，其余 12 种食物至少有 10 名患者在微量摄入后才开始摄入。在整个研究过程中，65 名患者中有 40 人能够获得免费饮食。ACT 从 17（Q1-Q3：15-17）增加到 23.6（Q1-Q3：23-25）。12岁以下儿童的FA-QoL评分从4.63±0.74分降至2.02±1.13分，青少年的FA-QoL评分从4.68±0.92分降至1.90±1.50分：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。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Allergy 医学-过敏

CiteScore

26.10

自引率

9.70%

发文量

393

审稿时长

2 months

期刊介绍： Allergy is an international and multidisciplinary journal that aims to advance, impact, and communicate all aspects of the discipline of Allergy/Immunology. It publishes original articles, reviews, position papers, guidelines, editorials, news and commentaries, letters to the editors, and correspondences. The journal accepts articles based on their scientific merit and quality. Allergy seeks to maintain contact between basic and clinical Allergy/Immunology and encourages contributions from contributors and readers from all countries. In addition to its publication, Allergy also provides abstracting and indexing information. Some of the databases that include Allergy abstracts are Abstracts on Hygiene & Communicable Disease, Academic Search Alumni Edition, AgBiotech News & Information, AGRICOLA Database, Biological Abstracts, PubMed Dietary Supplement Subset, and Global Health, among others.