Zurück zur Übersicht
| Journal of investigational allergology & clinical immunology. 2022 May 6. doi: 10.18176/jiaci.0822 |
| Major Allergen Content In Allergen Immunotherapy Products: The Limited Value of Numbers. |
| Becker S1, Fassio F2, Muñoz-Cano R3, Klimek L4, Vidal C5, Heath MD6, Kündig TM7, Vogelberg C8, Toran C9, Jensen-Jarolim E10, Heffler E11, Tomazic PV12, Feindor M13, Hewings S14, Carreno T15, Morales M16, Mösges R17, Skinner MA18, Graessel A19, Hernandez D20, Kramer MF21 |
 Author information
|
|
Abstract The prevalence of allergic disorders drastically increased over the last 50 years that today they can be considered epidemic. At present, allergen-specific immunotherapy (AIT) is the only therapy targeting the underlying cause of allergic disorders, and its superior evidence is based on accumulated data from clinical trials and observational studies demonstrating efficacy and safety. However, several aspects remain unsolved, such as harmonization and standardization of manufacturing and quantification procedures across manufacturers, homogeneous reporting of strength, and also the establishment of international reference standards for many allergens. This article discusses the issues related to the measurement of major allergen content in AIT extracts, raising the question of whether comparison of products by different manufacturers are appropriate as basis to choose among the different AIT products. Allergen standardization in immunotherapy products is critical to ensure quality and thereby safety and efficacy. However, lack of harmonization in manufacturing process, allergen quantification (methodologies and references), national regulatory differences, clinical practice, and labeling shows that the comparison of AIT products solely based on major allergen amounts is not rationale and, in fact, impossible. Moreover, further inherent characteristics of products and their clinical use such as their state of extract modification, addition of adjuvant or adjuvant-system, route of administration (sublingual/subcutaneous) and cumulative dose as per posology (including the volume per administration) need to be taken into account, when rating the information given for a specific product. Finally, only convincing clinical data can serve as the product-specific evaluation, or the basis for cross-product comparability, for individual products. |
|
KEYWORDS: AIT, Adjuvants, Immunotherapy, Major allergen content, Product comparability, Quality, Standardization methods |
|
Publikations ID: 35522054 Quelle: öffnen |
Author information
Schnellinfo
-- Cancer Care
-- Kliniken und Partner
-- CCC Cancer School
-- Young CCC
-- CCC Tumorboards
-- CCC Forschungscluster
-- CCC Units
-- CCC Platforms
-- SOPs / Leitlinien
-- Kontakt
Featured
