PDF(Pubmed)
Abstract：
Food allergies are common and are associated with substantial morbidity; the only approved treatment is oral immunotherapy for peanut allergy.
In this trial, we assessed whether omalizumab, a monoclonal anti-IgE antibody, would be effective and safe as monotherapy in patients with multiple food allergies. Persons 1 to 55 years of age who were allergic to peanuts and at least two other trial-specified foods (cashew, milk, egg, walnut, wheat, and hazelnut) were screened. Inclusion required a reaction to a food challenge of 100 mg or less of peanut protein and 300 mg or less of the two other foods. Participants were randomly assigned, in a 2:1 ratio, to receive omalizumab or placebo administered subcutaneously (with the dose based on weight and IgE levels) every 2 to 4 weeks for 16 to 20 weeks, after which the challenges were repeated. The primary end point was ingestion of peanut protein in a single dose of 600 mg or more without dose-limiting symptoms. The three key secondary end points were the consumption of cashew, of milk, and of egg in single doses of at least 1000 mg each without dose-limiting symptoms. The first 60 participants (59 of whom were children or adolescents) who completed this first stage were enrolled in a 24-week open-label extension.
Of the 462 persons who were screened, 180 underwent randomization. The analysis population consisted of the 177 children and adolescents (1 to 17 years of age). A total of 79 of the 118 participants (67%) receiving omalizumab met the primary end-point criteria, as compared with 4 of the 59 participants (7%) receiving placebo (P<0.001). Results for the key secondary end points were consistent with those of the primary end point (cashew, 41% vs. 3%; milk, 66% vs. 10%; egg, 67% vs. 0%; P<0.001 for all comparisons). Safety end points did not differ between the groups, aside from more injection-site reactions in the omalizumab group.
In persons as young as 1 year of age with multiple food allergies, omalizumab treatment for 16 weeks was superior to placebo in increasing the reaction threshold for peanut and other common food allergens. (Funded by the National Institute of Allergy and Infectious Diseases and others; ClinicalTrials.gov number, NCT03881696.).
In this trial, we assessed whether omalizumab, a monoclonal anti-IgE antibody, would be effective and safe as monotherapy in patients with multiple food allergies. Persons 1 to 55 years of age who were allergic to peanuts and at least two other trial-specified foods (cashew, milk, egg, walnut, wheat, and hazelnut) were screened. Inclusion required a reaction to a food challenge of 100 mg or less of peanut protein and 300 mg or less of the two other foods. Participants were randomly assigned, in a 2:1 ratio, to receive omalizumab or placebo administered subcutaneously (with the dose based on weight and IgE levels) every 2 to 4 weeks for 16 to 20 weeks, after which the challenges were repeated. The primary end point was ingestion of peanut protein in a single dose of 600 mg or more without dose-limiting symptoms. The three key secondary end points were the consumption of cashew, of milk, and of egg in single doses of at least 1000 mg each without dose-limiting symptoms. The first 60 participants (59 of whom were children or adolescents) who completed this first stage were enrolled in a 24-week open-label extension.
Of the 462 persons who were screened, 180 underwent randomization. The analysis population consisted of the 177 children and adolescents (1 to 17 years of age). A total of 79 of the 118 participants (67%) receiving omalizumab met the primary end-point criteria, as compared with 4 of the 59 participants (7%) receiving placebo (P<0.001). Results for the key secondary end points were consistent with those of the primary end point (cashew, 41% vs. 3%; milk, 66% vs. 10%; egg, 67% vs. 0%; P<0.001 for all comparisons). Safety end points did not differ between the groups, aside from more injection-site reactions in the omalizumab group.
In persons as young as 1 year of age with multiple food allergies, omalizumab treatment for 16 weeks was superior to placebo in increasing the reaction threshold for peanut and other common food allergens. (Funded by the National Institute of Allergy and Infectious Diseases and others; ClinicalTrials.gov number, NCT03881696.).
摘要：
背景：食物过敏是常见的，并且与高发病率相关；唯一被批准的治疗方法是花生过敏的口服免疫疗法。
方法：在本试验中，我们评估了奥马珠单抗，单克隆抗IgE抗体,对于多种食物过敏的患者，作为单一疗法是有效和安全的。1至55岁的人对花生和至少两种其他试验指定的食物(腰果，牛奶，鸡蛋,核桃,小麦,和榛子)进行筛选。纳入需要对100毫克或更少的花生蛋白和300毫克或更少的其他两种食物的食物挑战做出反应。参与者被随机分配，以2:1的比例，接受奥马珠单抗或安慰剂皮下给药（剂量基于体重和IgE水平），每2至4周16至20周，之后，挑战不断重复。主要终点是以600mg或更多的单剂量摄入花生蛋白，而没有剂量限制症状。三个关键的次要终点是腰果的消耗，牛奶,和鸡蛋，每次至少1000毫克，没有剂量限制症状。完成第一阶段的前60名参与者（其中59名是儿童或青少年）参加了为期24周的开放标签扩展。
结果：在接受筛查的462人中，180例随机分组。分析人群包括177名儿童和青少年（1至17岁）。118名接受奥马珠单抗的参与者中，共有79名（67%）符合主要终点标准。59名参与者中有4名(7%)接受安慰剂(P<0.001)。关键次要终点的结果与主要终点的结果一致(腰果，41%vs.3%；牛奶，66%vs.10%;鸡蛋,67%vs.0%；所有比较均P<0.001）。两组之间的安全终点没有差异，除了奥马珠单抗组的注射部位反应更多。
结论：在1岁以下患有多种食物过敏的人中，奥马珠单抗治疗16周在提高花生和其他常见食物过敏原的反应阈值方面优于安慰剂。（由国家过敏和传染病研究所等资助；ClinicalTrials.gov编号，NCT03881696。).
方法：在本试验中，我们评估了奥马珠单抗，单克隆抗IgE抗体,对于多种食物过敏的患者，作为单一疗法是有效和安全的。1至55岁的人对花生和至少两种其他试验指定的食物(腰果，牛奶，鸡蛋,核桃,小麦,和榛子)进行筛选。纳入需要对100毫克或更少的花生蛋白和300毫克或更少的其他两种食物的食物挑战做出反应。参与者被随机分配，以2:1的比例，接受奥马珠单抗或安慰剂皮下给药（剂量基于体重和IgE水平），每2至4周16至20周，之后，挑战不断重复。主要终点是以600mg或更多的单剂量摄入花生蛋白，而没有剂量限制症状。三个关键的次要终点是腰果的消耗，牛奶,和鸡蛋，每次至少1000毫克，没有剂量限制症状。完成第一阶段的前60名参与者（其中59名是儿童或青少年）参加了为期24周的开放标签扩展。
结果：在接受筛查的462人中，180例随机分组。分析人群包括177名儿童和青少年（1至17岁）。118名接受奥马珠单抗的参与者中，共有79名（67%）符合主要终点标准。59名参与者中有4名(7%)接受安慰剂(P<0.001)。关键次要终点的结果与主要终点的结果一致(腰果，41%vs.3%；牛奶，66%vs.10%;鸡蛋,67%vs.0%；所有比较均P<0.001）。两组之间的安全终点没有差异，除了奥马珠单抗组的注射部位反应更多。
结论：在1岁以下患有多种食物过敏的人中，奥马珠单抗治疗16周在提高花生和其他常见食物过敏原的反应阈值方面优于安慰剂。（由国家过敏和传染病研究所等资助；ClinicalTrials.gov编号，NCT03881696。).
