奥马珠单抗可减少重度哮喘儿童的过敏反应，并允许引入食物治疗:一项观察性研究
2024/09/29
摘要
背景与目的：在欧洲，奥马珠单抗用于治疗中重度哮喘，但不适用于IgE介导的食物过敏(FA)。
目的：评估奥马珠单抗对有花生、树坚果、鱼、鸡蛋、牛奶和/或小麦过敏史的中重度哮喘患者的疗效、安全性和生活质量(FA-QoL)的影响。
方法：中重度哮喘的食物过敏儿童(6-18岁)在奥马珠单抗治疗的第一年，在基线(T0)和每隔4个月(T1, T2和T3)进行口服食物激发试验(OFCs)，以建立对致敏食物的反应阈值。记录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例对107种食物过敏的患者中，T1时无观察到的不良事件水平(NOAEL)增加：新鲜牛奶和烘焙牛奶分别增加243倍和488倍；生蛋和烤蛋分别是172和134倍；榛子245倍；花生是55倍；小麦为31倍；鱼是10倍。完全耐受率T1为66.4%，T2为58.3%，T3为75%。55例患者饮食中放开95种食物;其余12例由至少10例患者在追踪时介绍。在整个研究过程中，65人中有40人能够得到免费的饮食。ACT从17 (q1 ~ q3: 15 ~ 17)上升至23.6 (q1 ~ q3: 23 ~ 25)。≤12岁儿童FA-QoL评分由4.63±0.74降至2.02±1.13，青少年FA-QoL评分由4.68±0.92降至1.90±1.50。
结论：在奥马珠单抗治疗期间，安全重新摄入过敏性食物是可行的。
Omalizumab reduces anaphylactic reactions and allows food introduction in food-allergic in children with severe asthma: An observational study
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
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.
背景与目的：在欧洲，奥马珠单抗用于治疗中重度哮喘，但不适用于IgE介导的食物过敏(FA)。
目的：评估奥马珠单抗对有花生、树坚果、鱼、鸡蛋、牛奶和/或小麦过敏史的中重度哮喘患者的疗效、安全性和生活质量(FA-QoL)的影响。
方法：中重度哮喘的食物过敏儿童(6-18岁)在奥马珠单抗治疗的第一年，在基线(T0)和每隔4个月(T1, T2和T3)进行口服食物激发试验(OFCs)，以建立对致敏食物的反应阈值。记录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例对107种食物过敏的患者中，T1时无观察到的不良事件水平(NOAEL)增加：新鲜牛奶和烘焙牛奶分别增加243倍和488倍；生蛋和烤蛋分别是172和134倍；榛子245倍；花生是55倍；小麦为31倍；鱼是10倍。完全耐受率T1为66.4%，T2为58.3%，T3为75%。55例患者饮食中放开95种食物;其余12例由至少10例患者在追踪时介绍。在整个研究过程中，65人中有40人能够得到免费的饮食。ACT从17 (q1 ~ q3: 15 ~ 17)上升至23.6 (q1 ~ q3: 23 ~ 25)。≤12岁儿童FA-QoL评分由4.63±0.74降至2.02±1.13，青少年FA-QoL评分由4.68±0.92降至1.90±1.50。
结论：在奥马珠单抗治疗期间，安全重新摄入过敏性食物是可行的。
(中日友好医院呼吸与危重症医学科 顾宪民 摘译 林江涛 审校)
(Allergy. 2024 Sep 16. doi: 10.1111/all.16314.)
(Allergy. 2024 Sep 16. doi: 10.1111/all.16314.)
Omalizumab reduces anaphylactic reactions and allows food introduction in food-allergic in children with severe asthma: An observational study
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
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.
上一篇：
CAPTAIN 研究中中度和重度哮喘加重的特征描述
下一篇：
LPG 18：0是哮喘的一般生物标志物，可抑制调节性T细胞的分化和功能
