Sicherer Scott H, Bunyavanich Supinda, Berin M Cecilia, Lo Tracy, Groetch Marion, Schaible Allison, Perry Susan A, Wheatley Lisa M, Fulkerson Patricia C, Chang Helena L, Suárez-Fariñas Mayte, Sampson Hugh A, Wang Julie
Department of Pediatrics, Division of Allergy and Immunology, Jaffe Food Allergy Institute, Kravis Children's Hospital, Icahn School of Medicine at Mount Sinai, New York.
Department of Medicine, Division of Allergy and Immunology, Northwestern University Feinberg School of Medicine, Chicago.
NEJM Evid. 2025 Mar;4(3):EVIDoa2400306. doi: 10.1056/EVIDoa2400306. Epub 2025 Feb 10.
Approved therapeutics for peanut allergy are not designed for the many patients with allergic reactions to more than one peanut.
We randomly assigned (1:1) participants 4 to 14 years of age reacting to a challenge of between 443 mg and 5043 mg of peanut protein to peanut oral immunotherapy (P-OIT) using home-measured peanut butter versus peanut avoidance. The primary end point was the difference between groups in the proportion tolerating a two-dose-level increase or 9043 mg of peanut protein. For ingestion participants tolerating 9043 mg, sustained unresponsiveness (tolerance off treatment) was tested after 16 weeks of ad lib ingestion followed by 8 weeks of abstinence.
Of 73 participants, 38 were randomly assigned to P-OIT and 35 to avoidance. Thirty-two of 38 participants in the ingestion group (84.2%) and 30 of 35 in the avoidance group (85.7%) underwent the primary outcome food challenge. The primary analysis with prespecified multiple imputation for missing values showed 100% success for ingestion versus 21.0% for avoidance (between-group difference, 79.0 percentage points; 95% confidence interval [CI], 64.6 to 93.5; P<0.001). All 32 treated and 3 out of 30 avoiders (10%) tolerated 9043 mg. In the intention-to-treat analysis, sustained unresponsiveness occurred in 68.4% (26/38) on P-OIT versus 8.6% (3/35) tolerating 9043 mg among those avoiding (between-group difference, 59.9 percentage points; 95% CI, 42.4 to 77.3). No dosing reactions were greater than grade 1 severity, and no serious adverse events were reported.
In this trial of P-OIT using store-bought, home-measured peanut versus peanut avoidance in high-threshold peanut allergy, those treated achieved significantly higher rates of desensitization with a durable response off treatment. (Funded by the National Center for Advancing Translational Sciences [UL1TR004419] and the National Institute of Allergy and Infectious [U19AI136053]; ClinicalTrials.gov number, NCT03907397.).
已获批的花生过敏治疗方法并非针对对多种花生产生过敏反应的众多患者设计。
我们将4至14岁、对443毫克至5043毫克花生蛋白激发试验有反应的参与者按1:1随机分配至使用家庭自行测量的花生酱进行花生口服免疫疗法（P - OIT）组或避免食用花生组。主要终点是两组在耐受花生蛋白剂量增加两剂水平或9043毫克的比例上的差异。对于耐受9043毫克的摄入组参与者，在随意摄入16周后接着禁食8周后，测试持续无反应性（停止治疗后的耐受性）。
73名参与者中，38人被随机分配至P - OIT组，35人被分配至避免食用花生组。摄入组的38名参与者中有32人（84.2%），避免食用花生组的35人中有30人（85.7%）接受了主要结局食物激发试验。对缺失值进行预先指定的多重填补的主要分析显示，摄入组的成功率为100%，而避免食用花生组为21.0%（组间差异为79.0个百分点；95%置信区间[CI]，64.6至93.5；P<0.001）。所有32名接受治疗者以及30名避免食用花生者中的3人（10%）耐受了9043毫克。在意向性分析中，P - OIT组有68.4%（26/38）出现持续无反应性，而避免食用花生组中耐受9043毫克的比例为8.6%（3/35）（组间差异为59.9个百分点；95%CI，42.4至77.3）。无给药反应的严重程度超过1级，且未报告严重不良事件。
在这项使用市售、家庭自行测量的花生进行P - OIT与避免食用花生治疗高阈值花生过敏的试验中，接受治疗者实现了显著更高的脱敏率，且停止治疗后有持久反应。（由美国国立转化医学推进中心[UL1TR0044;19]和美国国立过敏与传染病研究所[U19AI136053]资助；ClinicalTrials.gov编号，NCT03907397。）
