Background Allergen specific IgG4 levels have been monitored as a surrogate marker for the tolerance inducing effect of subcutaneous immunotherapy (SCIT) in many studies. Its accuracy at group level has been well established, but IgG4 has not yet found its place in the daily care of immunotherapy patients. Methods Intralymphatic immunotherapy (ILIT) is a novel route for allergy vaccination against pollen allergy, where an ultrasound-guided injection of 1000 SQ-U Alutard is given directly into a groin lymph node. The suggested standard dosing so far has been one injection with 4 weeks in-between. In total 3000 SQ-U with the treatment completed in 2 months. IgG4 was measured with Immulite technique and rhinoconjunctivitis symptoms were estimated with daily online questionnaires. Mann-Whitney U-test and Wilcoxon Signed Rank test were applied for comparisons between groups and within groups, respectively. Results The present study demonstrates that a single, preseason ILIT booster of 1000 SQ-U Alutard 5-grasses®, re-increases the allergen specific timothy-IgG4 levels, in patients already treated with ILIT before the previous pollen season. It also shows the feasibility of the ILIT-route for allergy vaccination of rhinitis patients, with or without concomitant asthma, with low degree of side effects and reconfirms high and sustained patient satisfaction. Conclusions It is tempting to suggest that the allergen specific IgG4 levels can be used to build an intuitive algorithm for future clinical guidance of ILIT patients.Trial registration Is Intralymphatic Allergen Immunotherapy Effective and Safe?, ClinicalTrials.gov Identifier NCT04210193. Registered 24 December 2019-Retrospectively registered, https://clinicaltrials.gov/ct2/show/study/NCT04210193?term=NCT04210193&draw=2&rank=1.

中文翻译：

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在基本的过敏原淋巴内免疫治疗后，季前加强剂可延长过敏原特异性 IgG4 水平的增加，以对抗草花粉季节性过敏。

背景 在许多研究中，过敏原特异性 IgG4 水平已被监测为皮下免疫疗法 (SCIT) 耐受诱导作用的替代标志物。其在群体水平上的准确性已经确立，但 IgG4 尚未在免疫治疗患者的日常护理中找到自己的位置。方法 淋巴内免疫疗法 (ILIT) 是一种针对花粉过敏的过敏疫苗接种的新途径，在超声引导下将 1000 SQ-U Alutard 直接注射到腹股沟淋巴结。到目前为止，建议的标准剂量是一次注射，间隔 4 周。总共 3000 SQ-U 治疗在 2 个月内完成。用 Immulite 技术测量 IgG4，并通过每日在线问卷评估鼻结膜炎症状。Mann-Whitney U 检验和 Wilcoxon 符号秩检验分别用于组间和组内比较。结果 本研究表明，单次季前 ILIT 加强剂 1000 SQ-U Alutard 5-grasses® 可重新增加在前一个花粉季节之前已经接受 ILIT 治疗的患者的过敏原特异性 timothy-IgG4 水平。它还显示了 ILIT 途径对鼻炎患者进行过敏疫苗接种的可行性，无论是否伴有哮喘，副作用程度低，并再次证实了患者的高度和持续满意度。结 政府标识符 NCT04210193。2019 年 12 月 24 日注册-回顾性注册，https://clinicaltrials.gov/ct2/show/study/NCT04210193?term=NCT04210193&draw=2&rank=1。