Aimmune Therapeutics, a Nestlé Health Science company, Brisbane, Calif.
Mary H. Weiser Food Allergy Center, University of Michigan, Ann Arbor, Mich.
J Allergy Clin Immunol. 2022 Jun;149(6):2043-2052.e9. doi: 10.1016/j.jaci.2021.12.780. Epub 2021 Dec 29.
Peanut (Arachis hypogaea) allergen powder-dnfp (PTAH; previously known as AR101) is a daily oral immunotherapy approved to mitigate allergic reactions after accidental peanut exposure in peanut-allergic individuals aged 4-17 years.
We sought to comprehensively summarize the PTAH safety profile for up to ∼2 years of treatment.
Safety and adverse event (AE) data from participants aged 4-17 years from 3 controlled, phase 3 and 2 open-label extension trials were pooled and assessed.
Of the 944 individuals receiving ≥1 PTAH dose, median exposure was ∼49 weeks; most participants experienced ≥1 treatment-related AE (TRAE; n = 853; 90.4%). A total of 829 participants experienced TRAEs with a maximum severity of mild (497, 52.6%) or moderate (332, 35.2%); 24 participants (2.5%) experienced TRAEs graded as severe. Overall, 80 participants (9.5%) discontinued as a result of AEs; most experienced gastrointestinal symptoms and discontinued during the first 6 months. When adjusted for exposure, AEs and TRAEs occurred at a rate of 76.4 and 58.7 events per participant-year of exposure (PYE), respectively, during updosing; AEs and TRAEs decreased to 23.0 and 14.2, respectively, during 300 mg maintenance. Overall, exposure-adjusted rates of systemic allergic reactions were 0.12 events/PYE (mild), 0.11 events/PYE (moderate), and 0.01 events/PYE (severe [anaphylaxis]).
The safety profile of PTAH was consistent across trials, manageable, and improved over time. AEs were predominantly mild to moderate, and all grades declined in frequency with continued treatment. These data can be used to facilitate shared decision-making discussions with patients and families considering treatment with PTAH.
花生（Arachis hypogaea）过敏原粉-dnfp（PTAH；以前称为 AR101）是一种每日口服免疫疗法，用于减轻 4-17 岁花生过敏个体在意外接触花生后的过敏反应。
我们旨在全面总结 PTAH 长达约 2 年治疗期间的安全性概况。
汇总并评估了来自 3 项对照、3 期和 2 项开放标签扩展试验中 4-17 岁参与者的 PTAH 安全性和不良事件（AE）数据。
接受≥1 次 PTAH 剂量的 944 名个体中，中位暴露时间约为 49 周；大多数参与者经历了≥1 次与治疗相关的 AE（TRAE；n=853；90.4%）。共有 829 名参与者经历了 TRAE，最大严重程度为轻度（497，52.6%）或中度（332，35.2%）；24 名参与者（2.5%）经历了严重程度为重度的 TRAE。总体而言，80 名参与者（9.5%）因 AE 而停药；大多数参与者在最初 6 个月内出现胃肠道症状并停药。当根据暴露情况调整时，AE 和 TRAE 的发生率分别为暴露患者每年 76.4 和 58.7 例事件；在维持治疗 300mg 时，AE 和 TRAE 分别降至 23.0 和 14.2。总体而言，系统性过敏反应的暴露调整发生率为 0.12 例/患者每年（轻度），0.11 例/患者每年（中度）和 0.01 例/患者每年（严重[过敏反应]）。
PTAH 的安全性概况在各试验中一致，可管理且随时间推移而改善。AE 主要为轻度至中度，所有级别均随着治疗的继续而降低。这些数据可用于促进与考虑接受 PTAH 治疗的患者和家属进行共同决策讨论。
