美国约翰斯·霍普金斯大学医学院Robert A. Wood团队研究了奥马珠单抗治疗多种食物过敏的疗效与安全性。2024年2月25日出版的《新英格兰医学杂志》发表了这一最新研究成果。

食物过敏很常见，并与严重的发病率有关；唯一被批准的治疗方法是口服免疫疗法治疗花生过敏。

在这项试验中，研究组评估了单克隆抗IgE抗体奥马珠单抗作为单一疗法对多种食物过敏患者是否有效和安全，对1至55岁对花生和至少两种其他试验指定食品（腰果、牛奶、鸡蛋、核桃、小麦和榛子）过敏的人群进行筛查。包括需要对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。

将参与者以2:1的比例随机分配，每2-4周接受一次奥马珠单抗或安慰剂皮下给药（剂量基于体重和IgE水平），持续16至20周，之后重复挑战。主要终点是以600mg或更多的单剂量摄入花生蛋白，没有剂量限制症状。三个关键次要终点是单次食用腰果、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人为儿童或青少年）参加了为期24周的开放标签扩展试验。

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）。118名接受奥马珠单抗治疗的参与者中，共有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人（7%）符合终点标准（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%；所有比较均<0.001）。除奥马珠单抗组有更多的注射部位反应外，两组之间的安全终点没有差异。

研究结果表明，在1岁以下患有多种食物过敏的人群中，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。

附：英文原文

Title: Omalizumab for the Treatment of Multiple Food Allergies | NEJM

Author: anonymous

Issue&Volume: 2024-02-25

Abstract:

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.

DOI: 10.1056/NEJMoa2312382

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2312382