Asllani Julijana, Mitsias Dimitrios, Konstantinou George, Qirko Etleva, Hitaj Mirela, Musollari Sybi, Christoff George, Novakova Silviya, Makris Michael, Radulovic Pevec Mira, Pevec Branko, Muntean Adriana, Tomic-Spiric Vesna, Stosovic Rajica, Kosnik Mitja, Mungan Dilsad, Popov Todor A, Calderon Moises, Papadopoulos Nikolaos G
Faculty of Medicine, University of Medicine, Tirana, Albania.
Allergy and Asthma Medical Clinic, Tirana, Albania.
Allergy. 2025 Mar;80(3):775-784. doi: 10.1111/all.16286. Epub 2024 Aug 22.
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.
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.
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.
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.
登记系统可以提供有关日常临床实践中变应原免疫疗法（AIT）结果的重要见解。然而，现实生活中缺乏对AIT所致不良事件（AE）的系统记录。
变应原免疫疗法不良事件登记系统（ADER）是一项关于现实生活中AIT安全性的前瞻性多中心登记系统。从ADER中检索并分析了接受螨、花粉、上皮和/或霉菌AIT治疗的成年（>18岁）呼吸道过敏患者的数据。研究了AE的发生频率、特征和危险因素。使用MedDRA术语记录AE。
纳入了来自八个国家中心的1545名平均年龄为33±10岁的个体，他们接受了1815个AIT疗程（n = 1060个舌下（SLIT）；n = 755个皮下（SCIT））。患者患有过敏性鼻炎（65%）、仅哮喘（3.7%）或鼻炎伴哮喘（31.2%）。草是最常见的特异性致敏原（60.7%），其次是螨（45.5%）、桦树花粉（20.6%）、上皮（16.1%）和霉菌（8%）。115名患者（7.4%）记录了296起AE。与维持期相比，剂量增加期AE的发生频率更高（59%）。严重反应很少见（0.2%），均发生在SCIT治疗过程中。维持6周后仅记录到1起中度AE。最常报告的症状来自呼吸系统和皮肤。患有哮喘、进行SCIT治疗、使用艾蒿、猫或桦树进行AIT治疗与AE发生风险较高相关，而使用变应原疫苗则降低了风险。
在现实生活临床实践中，少数患者会发生与AIT相关的AE，而严重反应很少见。哮喘的存在和SCIT的使用是危险因素，而使用改良变应原可降低风险。
