本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2312382

摘要内容如下：

背景

食物过敏是常见的，并与相当大的发病率有关。唯一批准的治疗方法是口服免疫疗法治疗花生过敏。

方法

在该试验中，我们评估了奥马珠单抗（一种单克隆抗IgE抗体）作为单一疗法对多种食物过敏患者是否有效和安全。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）过敏的1至55岁的人进行筛查。包含需要对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的反应。参与者以2:1的比例被随机分配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周一次，持续16至20周，之后重复激发。主要终点是单剂量摄入600 mg或更多的花生蛋白，无剂量限制性症状。三个关键的次要终点是单次食用腰果、牛奶和鸡蛋，每次至少1000mg，没有剂量限制性症状。完成第一阶段的前60名参与者（其中59名为儿童或青少年）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人接受了随机分组。分析人群包括177名儿童和青少年（1至17岁）。接受奥马珠单抗治疗的118名参与者中有79名（67%）符合主要终点标准，而接受安慰剂治疗的59名参与者中有4名（7%）符合主要终点标准（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%对3%；牛奶，66%对10%；鸡蛋，68%对0%；所有比较P<0.001）。除了奥马珠单抗组有更多的注射部位反应外，安全性终点在两组之间没有差异。

结论

在1岁的多种食物过敏患者中，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和其他机构资助；ClinicalTrials.gov编号，NCT03881696。）

英文原文如下：

Abstracts

BACKGROUND  Food allergies are common and are associated with substantial morbidity; the only approved treatment is oral immunotherapy for peanut allergy.

METHODS  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.

RESULTS  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, 68% 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.

CONCLUSIONS  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.).

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