R Sharon Chinthrajah1, Natasha Purington2, Sandra Andorf3, Jaime S Rosa4, Kaori Mukai5, Robert Hamilton6, Bridget Marie Smith7, Ruchi Gupta8, Stephen J Galli5, Manisha Desai9, Kari C Nadeau10. 1. Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Stanford, California; Department of Medicine, Stanford University School of Medicine, Stanford, California; Department of Pediatrics, Stanford University School of Medicine, Stanford, California. 2. Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Stanford, California; School of Medicine, Quantitative Sciences Unit, Stanford University School of Medicine, Stanford, California. 3. Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Stanford, California; Department of Medicine, Stanford University School of Medicine, Stanford, California. 4. Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Stanford, California; Department of Pediatrics, Stanford University School of Medicine, Stanford, California. 5. Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Stanford, California; Department of Pathology, Stanford University School of Medicine, Stanford, California; Department of Microbiology and Immunology, Stanford University School of Medicine, Stanford, California. 6. Division of Allergy and Clinical Immunology, Johns Hopkins University School of Medicine, Baltimore, Maryland; Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland. 7. Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Center of Innovation for Complex Chronic Healthcare, Edward Hines Jr. VA Hospital, Hines, Illinois. 8. Department of Pediatrics and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois. 9. Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Stanford, California; School of Medicine, Quantitative Sciences Unit, Stanford University School of Medicine, Stanford, California; Department of Pathology, Stanford University School of Medicine, Stanford, California. 10. Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Stanford, California; Department of Medicine, Stanford University School of Medicine, Stanford, California; Department of Pediatrics, Stanford University School of Medicine, Stanford, California. Electronic address: knadeau@stanford.edu.
Abstract
BACKGROUND: Reliable prognostic markers for predicting severity of allergic reactions during oral food challenges (OFCs) have not been established. OBJECTIVE: To develop a predictive algorithm of a food challenge severity score (CSS) to identify those at higher risk for severe reactions to a standardized peanut OFC. METHODS: Medical history and allergy test results were obtained for 120 peanut allergic participants who underwent double-blind, placebo-controlled food challenges. Reactions were assigned a CSS between 1 and 6 based on cumulative tolerated dose and a severity clinical indicator. Demographic characteristics, clinical features, peanut component IgE values, and a basophil activation marker were considered in a multistep analysis to derive a flexible decision rule to understand risk during peanut of OFC. RESULTS: A total of 18.3% participants had a severe reaction (CSS >4). The decision rule identified the following 3 variables (in order of importance) as predictors of reaction severity: ratio of percentage of CD63hi stimulation with peanut to percentage of CD63hi anti-IgE (CD63 ratio), history of exercise-induced asthma, and ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) ratio. The CD63 ratio alone was a strong predictor of CSS (P < .001). CONCLUSION: The CSS is a novel tool that combines dose thresholds and allergic reactions to understand risks associated with peanut OFCs. Laboratory values (CD63 ratio), along with clinical variables (exercise-induced asthma and FEV1/FVC ratio) contribute to the predictive ability of the severity of reaction to peanut OFCs. Further testing of this decision rule is needed in a larger external data source before it can be considered outside research settings. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02103270.
BACKGROUND: Reliable prognostic markers for predicting severity of allergic reactions during oral food challenges (OFCs) have not been established. OBJECTIVE: To develop a predictive algorithm of a food challenge severity score (CSS) to identify those at higher risk for severe reactions to a standardized peanut OFC. METHODS: Medical history and allergy test results were obtained for 120 peanut allergic participants who underwent double-blind, placebo-controlled food challenges. Reactions were assigned a CSS between 1 and 6 based on cumulative tolerated dose and a severity clinical indicator. Demographic characteristics, clinical features, peanut component IgE values, and a basophil activation marker were considered in a multistep analysis to derive a flexible decision rule to understand risk during peanut of OFC. RESULTS: A total of 18.3% participants had a severe reaction (CSS >4). The decision rule identified the following 3 variables (in order of importance) as predictors of reaction severity: ratio of percentage of CD63hi stimulation with peanut to percentage of CD63hi anti-IgE (CD63 ratio), history of exercise-induced asthma, and ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) ratio. The CD63 ratio alone was a strong predictor of CSS (P < .001). CONCLUSION: The CSS is a novel tool that combines dose thresholds and allergic reactions to understand risks associated with peanut OFCs. Laboratory values (CD63 ratio), along with clinical variables (exercise-induced asthma and FEV1/FVC ratio) contribute to the predictive ability of the severity of reaction to peanut OFCs. Further testing of this decision rule is needed in a larger external data source before it can be considered outside research settings. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02103270.
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