The Journal of allergy and clinical immunology
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J. Allergy Clin. Immunol. · Mar 2019
Review Comparative StudyUnderstanding differences in allergen immunotherapy products and practices in North America and Europe.
Allergen immunotherapy (AIT) is thought to be clinically effective and safe in treating allergic rhinitis, asthma, and stinging insect allergy in Europe and North America. However, there are intercontinental differences in AIT therapeutic products in terms of their application and regulation. In North America unmodified standardized and nonstandardized aqueous aeroallergen extracts are approved and used almost exclusively for subcutaneous immunotherapy, whereas more product options are available in Europe, including adsorbed allergens, chemically modified allergens, or both. ⋯ Moreover, the regulatory approach differs between the European Union and United States. In contrast to the United States, where common allergen standards exist based on biologic activity, no common standards exist in Europe. In terms of development of new investigational products, the United States has followed the European example for phase II and III studies; no formal US Food and Drug Administration guidance has been issued.
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J. Allergy Clin. Immunol. · Mar 2019
Letter Controlled Clinical TrialEpicutaneous immunotherapy for peanut allergy modifies IgG4 responses to major peanut allergens.