Estimated risk reduction to packaged food reactions by epicutaneous immunotherapy (EPIT) for peanut allergy

Benjamin C. Remington, Tanja Krone, Edwin H. Kim, J. Andrew Bird, Todd D. Green, Gideon Lack, David M. Fleischer, Stef J. Koppelman

Research output: Contribution to journalArticle

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. 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. 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. 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. 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

Original languageEnglish (US)
JournalAnnals of Allergy, Asthma and Immunology
DOIs
StateAccepted/In press - Jan 1 2019
Externally publishedYes

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Peanut Hypersensitivity
Risk Reduction Behavior
Immunotherapy
Food
Hypersensitivity
Food Hypersensitivity
Placebos
Population
Aptitude
Therapeutics
Arachis
Proteins
Eating
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pulmonary and Respiratory Medicine

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Estimated risk reduction to packaged food reactions by epicutaneous immunotherapy (EPIT) for peanut allergy. / Remington, Benjamin C.; Krone, Tanja; Kim, Edwin H.; Bird, J. Andrew; Green, Todd D.; Lack, Gideon; Fleischer, David M.; Koppelman, Stef J.

In: Annals of Allergy, Asthma and Immunology, 01.01.2019.

Research output: Contribution to journalArticle

Remington, Benjamin C. ; Krone, Tanja ; Kim, Edwin H. ; Bird, J. Andrew ; Green, Todd D. ; Lack, Gideon ; Fleischer, David M. ; Koppelman, Stef J. / Estimated risk reduction to packaged food reactions by epicutaneous immunotherapy (EPIT) for peanut allergy. In: Annals of Allergy, Asthma and Immunology. 2019.
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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. 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. 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. 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. 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",
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