Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
UNC School of Medicine, University of North Carolina, Chapel Hill, NC.
J Allergy Clin Immunol. 2021 Mar;147(3):992-1003.e5. doi: 10.1016/j.jaci.2020.11.027. Epub 2020 Dec 5.
Consortium for Food Allergy Research investigators previously reported 52-week outcomes from a randomized controlled trial of peanut epicutaneous immunotherapy, observing modest and statistically significant induction of desensitization, highest in children ages 4 to 11 years.
We sought to evaluate changes in efficacy, safety, and mechanistic parameters following extended open-label peanut epicutaneous immunotherapy.
Peanut-allergic participants (4-25 years) received 52 weeks of placebo (PLB), Viaskin Peanut 100 μg (VP100) or 250 μg (VP250), and then crossed over to VP250 for PLB (PLB-VP250) and VP100 (VP100-VP250) participants and continued treatment for VP250 participants (total = 130 weeks of active epicutaneous immunotherapy). Efficacy was assessed by double-blind, placebo-controlled food challenge (5044 mg peanut protein), and adherence, safety, and mechanistic parameters were evaluated.
At week 130, desensitization success was achieved in 1 of 20 (5%) PLB-VP250, 5 of 24 (20.8%) VP100-VP250, and 9 of 25 (36%) VP250 participants, with median successfully consumed dose change from baseline of 11.5 mg, 141.5 mg, and 400 mg, respectively. Median age (years) for week 130 desensitization success was 6.2 years (interquartile range, 5.2-9.1) versus 9.4 years (interquartile range, 7.6-12.8) for failures (P < .001). Adherence was 96%. Adverse reactions were predominantly local patch-site reactions. Significant increases in peanut- and Ara h2-specific IgG observed at week 52 persisted to week 130. By a post hoc analysis, there were no statistically significant increases from week 52 to week 130 in either desensitization success or successfully consumed dose.
Extended treatment with VP250 was well tolerated, and desensitization observed at week 52 persisted between weeks 52 and 130. Treatment success was observed predominantly in younger participants, with younger age at initiation of active therapy an important predictor of success.
食品过敏研究联合会的研究人员之前报告了花生经皮免疫治疗的随机对照试验的 52 周结果，观察到脱敏作用适度且具有统计学意义，在 4 至 11 岁的儿童中最高。
我们旨在评估延长的开放性标签花生经皮免疫治疗后的疗效、安全性和机制参数变化。
花生过敏参与者（4-25 岁）接受 52 周安慰剂（PLB）、Viaskin 花生 100 μg（VP100）或 250 μg（VP250），然后交叉到 VP250 用于 PLB（PLB-VP250）和 VP100（VP100-VP250）参与者，并继续接受 VP250 参与者的治疗（总= 130 周的活性经皮免疫治疗）。通过双盲、安慰剂对照食物挑战（5044 mg 花生蛋白）评估疗效，评估依从性、安全性和机制参数。
在第 130 周，20 名 PLB-VP250 参与者中有 1 名（5%）、24 名 VP100-VP250 参与者中有 5 名（20.8%）和 25 名 VP250 参与者中有 9 名（36%）实现脱敏成功，中位基线成功摄入剂量分别变化 11.5 mg、141.5 mg 和 400 mg。第 130 周脱敏成功的中位年龄（岁）为 6.2 岁（四分位距，5.2-9.1），而失败的中位年龄为 9.4 岁（四分位距，7.6-12.8）（P<.001）。依从性为 96%。不良反应主要为局部贴剂部位反应。第 52 周观察到的花生和 Ara h2 特异性 IgG 显著增加持续至第 130 周。通过事后分析，脱敏成功或成功摄入剂量从第 52 周到第 130 周均无统计学意义上的增加。
延长 VP250 治疗耐受性良好，第 52 周观察到的脱敏作用在第 52 周至第 130 周之间持续存在。治疗成功主要见于年龄较小的参与者，起始主动治疗的年龄较小是成功的重要预测因素。
