BACKGROUND Registries can yield important insights on allergen immunotherapy (AIT) outcomes in daily clinical practice. However, systematic recordings of adverse events (AE) due to AIT in real-life are lacking. METHODS The Allergen Immunotherapy Adverse Events Registry (ADER) is a prospective, multicenter registry on real-life AIT safety. Data on adults (>18 years old) with respiratory allergies receiving AIT with mites, pollens, epithelia, and/or molds were retrieved and analyzed from ADER. The frequency, characteristics and risk factors of AE were investigated. The MedDRA terminology was used to record AE. RESULTS A total of 1545 individuals with a mean age of 33 ± 10 years receiving 1815 AIT courses (n = 1060 sublingual (SLIT); n = 755 subcutaneous (SCIT)) in centers from eight countries were included. Patients had allergic rhinitis (65%) or, asthma only (3.7%) or rhinitis with asthma (31.2%). Grass was the most frequent specific sensitizer (60.7%), followed by mites (45.5%), birch pollen (20.6%), epithelia (16.1%), and molds (8%). There were 296 AE recorded in 115 patients (7.4%). A higher frequency of AE occurred during up-dosing (59%) compared to maintenance. Severe reactions were rare (0.2%), all in the context of SCIT. After 6 weeks of maintenance only one moderate AE was recorded. The most frequently reported symptoms were from the respiratory system and the skin. Having asthma, doing SCIT, AIT with mugwort, cat, or birch were associated with higher risk for AE while the use of allergoids induced lower risk. CONCLUSION In real life clinical practice, AIT-associated AE occur in a minority of patients, while severe reactions are rare. The presence of asthma and use of SCIT are risk factors, while the use of modified allergens lowers the risk.

中文翻译：

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来自呼吸过敏的成人过敏原免疫治疗不良事件：EAACI 工作组报告。


背景 登记处可以在日常临床实践中对过敏原免疫治疗 （AIT） 结果产生重要见解。然而，缺乏现实生活中 AIT 引起的不良事件 （AE） 的系统记录。方法 过敏原免疫治疗不良事件登记处 （ADER） 是一项关于现实生活中 AIT 安全性的前瞻性、多中心登记处。从 ADER 中检索和分析患有呼吸道过敏的成人 （>18 岁） 接受带有螨虫、花粉、上皮和/或霉菌的 AIT 的数据。调查 AE 的发生频率、特征和危险因素。使用 MedDRA 术语记录 AE。结果 共纳入了 1545 名平均年龄为 33 ± 10 岁的个体，在来自 8 个国家的中心接受了 1815 个 AIT 课程 （n = 1060 个舌下含服 （SLIT）;n = 755 个皮下 （SCIT））。患者患有过敏性鼻炎 （65%） 或仅哮喘 （3.7%） 或鼻炎伴哮喘 （31.2%）。草是最常见的特异性致敏剂 （60.7%），其次是螨虫 （45.5%）、桦树花粉 （20.6%）、上皮细胞 （16.1%） 和霉菌 （8%）。115 例患者 （7.4%） 记录了 296 例 AE。与维持治疗相比，增加给药期间 AE 的频率更高 （59%）。严重反应很少见 （0.2%），均在 SCIT 的背景下发生。维持 6 周后，仅记录到一例中度 AE。最常报告的症状来自呼吸系统和皮肤。患有哮喘、进行 SCIT、用艾蒿、猫或桦树进行 AIT 与 AE 风险较高相关，而使用过敏症诱导的风险较低。结论 在实际临床实践中，AIT 相关 AE 发生在少数患者中，而严重反应很少见。哮喘的存在和使用 SCIT 是危险因素，而使用改良的过敏原可降低风险。