Section of Allergy and Immunology, Department of Pediatrics, Children's Hospital Colorado, University of Colorado Denver School of Medicine, Aurora, Colo.
Food Allergy Center, Departments of Pediatrics and Medicine, Massachusetts General Hospital, Boston, Mass.
J Allergy Clin Immunol. 2020 Oct;146(4):863-874. doi: 10.1016/j.jaci.2020.06.028. Epub 2020 Jul 10.
The PEPITES (Peanut EPIT Efficacy and Safety) trial, a 12-month randomized controlled study of children with peanut allergy and 4 to 11 years old, previously reported the safety and efficacy of epicutaneous immunotherapy (EPIT) for peanut allergy (250 μg, daily epicutaneous peanut protein; DBV712 250 μg).
We sought to assess interim safety and efficacy of an additional 2 years of EPIT from the ongoing (5-year treatment) PEOPLE (PEPITES Open-Label Extension) study.
Subjects who completed PEPITES were offered enrollment in PEOPLE. Following an additional 2 years of daily DBV712 250 μg, subjects who had received DBV712 250 μg in PEPITES underwent month-36 double-blind, placebo-controlled food challenge with an optional month-38 sustained unresponsiveness assessment.
Of 213 eligible subjects who had received DBV712 250 μg in PEPITES, 198 (93%) entered PEOPLE, of whom 141 (71%) had assessable double-blind, placebo-controlled food challenge at month 36. At month 36, 51.8% of subjects (73 of 141) reached an eliciting dose of ≥1000 mg, compared with 40.4% (57 of 141) at month 12; 75.9% (107 of 141) demonstrated increased eliciting dose compared with baseline; and 13.5% (19 of 141) tolerated the full double-blind, placebo-controlled food challenge of 5444 mg. Median cumulative reactive dose increased from 144 to 944 mg. Eighteen subjects underwent an optional sustained unresponsiveness assessment; 14 of those (77.8%) maintained an eliciting dose of ≥1000 mg at month 38. Local patch-site skin reactions were common but decreased over time. There was no treatment-related epinephrine use in years 2 or 3. Compliance was high (96.9%), and withdrawals due to treatment-related adverse events were low (1%).
These results demonstrate that daily EPIT treatment for peanut allergy beyond 1 year leads to continued response from a well-tolerated, simple-to-use regimen.
PEPITES（花生 EPIT 疗效和安全性）试验是一项为期 12 个月的随机对照研究，入组年龄为 4 至 11 岁的花生过敏儿童，此前报道了每日经皮免疫治疗（EPIT）治疗花生过敏（250μg，每日经皮花生蛋白；DBV712 250μg）的安全性和有效性。
我们旨在评估正在进行的（5 年治疗）PEOPLE（PEPITES 开放标签扩展）研究中 EPIT 额外 2 年的中期安全性和有效性。
完成 PEPITES 的受试者被纳入 PEOPLE。在接受额外 2 年的每日 DBV712 250μg 治疗后，在 PEPITES 中接受 DBV712 250μg 治疗的受试者接受了第 36 个月的双盲、安慰剂对照食物挑战，并可选地进行了第 38 个月的持续无反应评估。
在 213 名符合条件的接受 PEPITES 中 DBV712 250μg 治疗的受试者中，有 198 名（93%）进入 PEOPLE，其中 141 名（71%）在第 36 个月可进行双盲、安慰剂对照食物挑战。在第 36 个月时，51.8%（73/141）的受试者达到了≥1000mg 的激发剂量，而在第 12 个月时为 40.4%（57/141）；75.9%（107/141）与基线相比，激发剂量增加；13.5%（19/141）耐受了 5444mg 的完整双盲、安慰剂对照食物挑战。累积反应剂量中位数从 144mg 增加到 944mg。18 名受试者进行了可选的持续无反应评估；其中 14 名（77.8%）在第 38 个月时保持了≥1000mg 的激发剂量。局部贴片部位皮肤反应常见，但随时间推移而减少。在第 2 年和第 3 年没有与治疗相关的肾上腺素使用。依从性很高（96.9%），因治疗相关不良事件导致的停药率很低（1%）。
这些结果表明，花生过敏的 EPIT 治疗持续 1 年以上可导致可耐受、使用简便的方案继续产生反应。
