Pediatric Clinic, Department of Surgical and Biomedical Sciences, Università degli Studi di Perugia, Piazza Menghini 1, 06129, Perugia, Italy.
J Transl Med. 2018 Nov 27;16(1):329. doi: 10.1186/s12967-018-1701-6.
Epicutaneous immunotherapy (EPIT) is a new way of allergen administration that has a high rate of adherence and safety. The aim of this manuscript is to review clinical trials on EPIT for respiratory and food allergies published in the last 10 years, taking into account how different variables (i.e., dose, patch application duration, skin preparation, and efficacy and safety evaluation) have influenced study results.
From a review of the literature, we identified eight placebo-controlled, double-blind trials conducted on children and adults, including four studies on grass pollen rhino-conjunctivitis, one on cow's milk allergy and three on peanut allergy. Different methods for skin pre-treatment, such as skin abrasion and tape stripping or stratum corneous hydration by an occlusive system, different endpoints and cumulative allergen doses, and different durations of patch application and tape stripping, were used in the rhino-conjunctivitis studies. A visual analogue system was used for the efficacy evaluation. Several local skin reactions (eczema) and some systemic adverse reactions were reported at higher rates in the active group compared to placebo in one study, but this was not shown by other authors. Local eczema reactions were correlated to the times for applying the tape stripping, while systemic side effects were correlated to the deepness of scraping. In the food allergy trials, differences in the food challenge thresholds, endpoints and allergen sites of the cutaneous patch application influenced the study results. A slight dose-dependent efficacy was found in the peanut allergy studies, which was confirmed by a more significant increase in the following progressive open study. Few adverse events and high adherence in all of the food allergen trials were reported.
Overall, the EPIT study results, even if they were affected by great heterogeneity among the methodologies applied, have shown not only the high safety and adherence with this kind of immunotherapy but also suggested the possibility for obtaining definitive evidence of the efficacy of EPIT, especially for food allergies.
表皮免疫疗法（EPIT）是一种新的过敏原给药方式，具有较高的依从性和安全性。本文旨在综述过去 10 年中发表的关于呼吸道和食物过敏的 EPIT 临床试验，同时考虑到不同变量（即剂量、贴片应用持续时间、皮肤准备以及疗效和安全性评估）如何影响研究结果。
通过文献回顾，我们确定了八项针对儿童和成人的安慰剂对照、双盲试验，其中包括四项关于草花粉鼻炎结膜炎的研究、一项关于牛奶过敏的研究和三项关于花生过敏的研究。在鼻炎结膜炎研究中，使用了不同的皮肤预处理方法，如皮肤擦伤和胶带剥离，或通过封闭系统使角质层水化，不同的终点和累积过敏原剂量，以及不同的贴片应用和胶带剥离持续时间。疗效评估采用视觉模拟系统。在一项研究中，与安慰剂组相比，活性组报告了更高的局部皮肤反应（湿疹）和一些全身性不良反应的发生率，但其他作者并未显示出这一结果。局部湿疹反应与应用胶带的次数相关，而全身性副作用与刮擦的深度相关。在食物过敏试验中，食物挑战阈值、终点和皮肤贴片应用部位的差异影响了研究结果。在花生过敏研究中发现了轻微的剂量依赖性疗效，在随后的更具挑战性的开放性研究中得到了更显著的增加。在所有食物过敏原试验中，报告的不良事件较少且患者的依从性较高。
总体而言，EPIT 研究结果，即使受到应用方法之间存在较大异质性的影响，不仅显示了这种免疫疗法的高度安全性和依从性，而且还表明有可能获得 EPIT 疗效的明确证据，特别是在食物过敏方面。
