Comparison of allergenic extracts from different origins: the value of the FDA's bioequivalent allergy unit (BAU). (2nd July 2016)

• Record Type: Journal Article
• Authors: Passalacqua, Giovanni; Sastre, Joaquín; Pfaar, Oliver; Wahn, Ulrich; Demoly, Pascal
• Is Part Of: Expert review of clinical immunology. Volume 12:Number 7(2016)
• Page Start: 733
• Page End: 739
• Publication Date: 2016-07-02
• Subjects: Allergy immunotherapy -- bioequivalent allergy unit -- grass pollen allergy -- index of reactivity -- standardized quality tablet unit; Clinical immunology -- Periodicals; 616.079
• DOI: 10.1080/1744666X.2016.1187561
• Languages: English
• ISSNs: 1744-666X

Abstract

ABSTRACT: Introduction : Allergy immunotherapy (AIT) is the only disease-modifying intervention for the treatment of allergic diseases. The clinical effectiveness of AIT is clearly dose-dependent, so it is important that clinicians can assess and compare the potency of the various products available. However, this is not possible in practice, because manufacturers use different methods to determine potency. Therefore, a clear need exists for adoption of a 'gold-standard' measure of allergenicity. The bioequivalent allergy unit (BAU) is thus far the only allergen unit approved by a regulatory agency (the US Food and Drug Administration), with European regulatory authorities yet to adopt a common unit. Areas covered : Using PubMed, we performed a review of the literature on measures of allergen extract potency, use of the BAU, and BAU assessment for grass pollen tablets. Expert commentary : There is an obvious benefit to allergists and patients for having a single, comparable unit across products, and we strongly support the adoption of a single, 'gold-standard' unit of measurement for all products. Use of the BAU allows a clear comparison of the potency of allergen products from different manufacturers, and enables better understanding of the potential reasons for any differences in administration and dosing protocols between these products.