학술논문
The Allergen Immunotherapy Adverse Events Registry: Setup & methodology of a European Academy of Allergy and Clinical Immunology taskforce project.
Document Type
Article
Author
Asllani, Julijana; Mitsias, Dimitrios; Konstantinou, George; Priftanji, Alfred; Hoxha, Mehmet; Sinani, Gerta; Christoff, George; Zlatko, Dimitrov; Makris, Michael; Aggelidis, Xenofon; Stipic, Asja; Popovic‐Grle, Sanja; Deleanu, Diana; Tomic‐Spiric, Vesna; Plavsic, Aleksandra; Mungan, Dilsad; Kosnik, Mitja; Popov, Todor A.; Papadopoulos, Nikolaos G.; Calderon, Moises
Source
Subject
*CLINICAL immunology
*ALLERGENS
*ITCHING
*ALLERGIES
*DEGLUTITION
*VENOM hypersensitivity
*MEDICAL terminology
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Language
ISSN
2045-7022
Abstract
To the Editor, Over the last decades, systematic reviews and meta analyses of multiple double-blind randomized placebo-controlled trials have demonstrated the efficacy and safety of both subcutaneous (SCIT) and sublingual (SLIT) allergen immunotherapy (AIT) for respiratory and insect venom allergy.[1] However, there is a wide range of AIT preparations used around the globe, and AEs are not always uniformly recorded, limiting the capability to draw safe conclusions or compare reports. Though various clinical development programs[2] have generated substantial knowledge on different AIT preparations, they have been conducted in pre-defined clinical conditions, not reflecting real-life and therefore the results may not have generalized applicability.[3] Very few pragmatic trials and observational studies have evaluated AIT safety in real-life. Adverse Events Registry is the first AIT Registry for AE piloted in different countries in Europe that uses the harmonized MedDRA terminology[9] (Table 1). [Extracted from the article]