Senti G, von Moos S, Tay F, Graf N, Johansen P, Kündig T M
Clinical Trials Center, University of Zurich, Zurich, Switzerland.
Department of Internal Medicine, University Hospital Zurich, Zurich, Switzerland.
Allergy. 2015 Jun;70(6):707-10. doi: 10.1111/all.12600. Epub 2015 Mar 13.
The results of our third trial on epicutaneous allergen-specific immunotherapy (EPIT) will be presented and discussed in the context of our previous trials. This monocentric, placebo-controlled, double-blind phase I/IIa trial included 98 patients with grass pollen rhinoconjunctivitis. Prior to the pollen season 2009, patients received six patches (allergen extract: n = 48; placebo: n = 50) with weekly intervals, administered onto tape-stripped skin. Allergen EPIT produced a median symptom improvement of 48% in 2009 and 40% in the treatment-free follow-up year 2010 as compared to 10% and 15% improvement after placebo EPIT (P = 0.003). After allergen EPIT but not placebo EPIT, conjunctival allergen reactivity was significantly decreased and allergen-specific IgG4 responses were significantly elevated (P < 0.001). In conclusion, our three EPIT trials found that allergen EPIT can ameliorate hay fever symptoms. Overall, treatment efficacy appears to be determined by the allergen dose. Local side-effects are determined by the duration of patch administration, while risk of systemic allergic side-effects is related to the degree of stratum corneum disruption.
我们关于经皮过敏原特异性免疫疗法（EPIT）的第三次试验结果将在我们之前试验的背景下进行展示和讨论。这项单中心、安慰剂对照、双盲的I/IIa期试验纳入了98例患有草花粉性鼻结膜炎的患者。在2009年花粉季节之前，患者每周接受六次贴片治疗（过敏原提取物组：n = 48；安慰剂组：n = 50），贴片敷于胶带去除角质后的皮肤上。与安慰剂EPIT治疗后10%和15%的改善相比，2009年过敏原EPIT使症状改善中位数达到48%，在无治疗的随访年2010年为40%（P = 0.003）。在接受过敏原EPIT而非安慰剂EPIT后，结膜过敏原反应性显著降低，过敏原特异性IgG4反应显著升高（P < 0.001）。总之，我们的三项EPIT试验发现，过敏原EPIT可改善花粉热症状。总体而言，治疗效果似乎由过敏原剂量决定。局部副作用由贴片给药持续时间决定，而全身过敏副作用风险与角质层破坏程度有关。
