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Estimated risk reduction to packaged food reactions by epicutaneous immunotherapy (EPIT) for peanut allergy.
- Source :
-
Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology [Ann Allergy Asthma Immunol] 2019 Nov; Vol. 123 (5), pp. 488-493.e2. Date of Electronic Publication: 2019 Aug 20. - Publication Year :
- 2019
-
Abstract
- Background: Peanut allergy is a generally persistent, sometimes life-threatening food allergy. With no treatments demonstrating the ability to cure a food allergy, the focus of drugs in development has been on providing a level of protection against accidental exposure reactions. However, no study has estimated the relative risk reduction of a food-allergic population receiving a specific immunotherapeutic treatment for their allergies.<br />Objective: To estimate the relative risk reduction when consuming peanut-contaminated packaged food products in a double-blind, placebo-controlled Phase 3 study population of children treated with epicutaneous immunotherapy (EPIT) for 12 months with either a patch containing 250 μg peanut protein (250-μg patch) or a placebo patch.<br />Methods: The probability of an allergic reaction due to the unintended presence of peanut protein in packaged food products was modeled per study group and food category combination using Monte Carlo simulations. Risks per eating occasion of a contaminated packaged food product and the number of individuals per study population predicted to react on a yearly basis were investigated.<br />Results: The population treated with the 250-μg patch demonstrated a significantly increased dose-response distribution after 12 months of treatment, which resulted in a relative risk reduction of 73.2% to 78.4% when consuming peanut-contaminated packaged food products. In contrast, no statistically significant change was observed for the placebo group at the 12-month point.<br />Conclusion: Our study estimates a substantial relative risk reduction for allergic reactions among peanut-allergic children after 12 months of EPIT with the 250-μg patch, supporting the potential real-world clinical relevance of this investigational immunotherapy and its possible role as a future therapy for peanut-allergic children. ClinicalTrials.gov Identifier: NCT02636699.<br /> (Copyright © 2019 The Netherlands Organisation for Applied Scientific Research TNO. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Administration, Cutaneous
Allergens adverse effects
Antigens, Plant adverse effects
Child
Child, Preschool
Double-Blind Method
Food Contamination
Humans
Plant Proteins, Dietary adverse effects
Risk Reduction Behavior
Allergens administration & dosage
Antigens, Plant administration & dosage
Arachis adverse effects
Desensitization, Immunologic
Peanut Hypersensitivity therapy
Plant Proteins, Dietary administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1534-4436
- Volume :
- 123
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology
- Publication Type :
- Academic Journal
- Accession number :
- 31442495
- Full Text :
- https://doi.org/10.1016/j.anai.2019.08.007