Ebisawa Motohiro, Takahashi Kyohei, Takahashi Kento, Yanagida Noriyuki, Sato Sakura, Lieberman Jay, Pistiner Michael, Spergel Jonathan M, Lowenthal Richard, Tanimoto Sarina
Department of Allergy, Clinical Research Center for Allergy and Rheumatology, NHO Sagamihara National Hospital, Kanagawa, Japan.
Department of Pediatrics, University of Tennessee Health Sciences Center, Memphis, Tenn.
J Allergy Clin Immunol Pract. 2025 Jul 8. doi: 10.1016/j.jaip.2025.06.038.
Rapid administration of epinephrine is the only approved first-line treatment for severe allergic reactions or anaphylaxis. Despite its well-established history of safety and efficacy, patients and caregivers have reported significant reluctance to administer epinephrine, largely owing to concerns about the injection. An epinephrine nasal spray (neffy) was recently approved as the first needle-free epinephrine option for the treatment of severe allergic reactions.
This study was conducted to assess neffy's efficacy for the treatment of oral food challenge (OFC)-induced anaphylaxis symptoms in pediatric patients with food allergy.
This was a phase 3 open-label study. Patients aged 6 to 17 years with food allergy (n = 15) were dosed with neffy after the onset of moderate (grade 2) OFC-induced anaphylaxis symptoms. Patients weighing 15 to less than 30 kg received neffy 1 mg, and those weighing 30 kg or more received neffy 2 mg.
All 15 patients exhibited at least one grade 2 anaphylaxis symptom after an OFC. No patients required a second dose of epinephrine for treatment of the initial reaction; however, one patient developed a biphasic reaction 2 hours 45 minutes after neffy administration and was treated with intramuscular epinephrine. Median time to symptom resolution was 16 minutes. Adverse events observed in two or more patients that were not induced by the OFC included tremor (three patients; 20.0%) and nasal mucosal erythema (two patients; 13.3%).
Neffy successfully treated OFC-induced anaphylaxis symptoms. The availability of a needle-free epinephrine delivery device may reduce dosing hesitancy, particularly in patients who are fearful of injections.
快速注射肾上腺素是唯一被批准用于治疗严重过敏反应或过敏性休克的一线治疗方法。尽管其安全性和有效性有着悠久的历史，但患者和护理人员报告称，他们非常不愿意注射肾上腺素，主要是因为担心注射问题。一种肾上腺素鼻喷雾剂（neffy）最近被批准作为治疗严重过敏反应的首个无针肾上腺素选择。
本研究旨在评估neffy治疗食物过敏儿科患者口服食物激发试验（OFC）诱发的过敏反应症状的疗效。
这是一项3期开放标签研究。15名6至17岁的食物过敏患者在中度（2级）OFC诱发的过敏反应症状出现后给予neffy治疗。体重15至30 kg以下的患者接受1 mg neffy，体重30 kg或以上的患者接受2 mg neffy。
所有15名患者在OFC后均出现至少一种2级过敏反应症状。没有患者因初始反应需要第二剂肾上腺素治疗；然而，一名患者在使用neffy后2小时45分钟出现双相反应，并接受了肌肉注射肾上腺素治疗。症状缓解的中位时间为16分钟。两名或更多患者中观察到的非OFC诱发的不良事件包括震颤（3名患者；20.0%）和鼻粘膜红斑（2名患者；13.3%）。
Neffy成功治疗了OFC诱发的过敏反应症状。无针肾上腺素给药装置的可用性可能会减少给药犹豫，特别是在害怕注射的患者中。
