Threshold dose for peanut: Risk characterization based upon diagnostic oral challenge of a series of 286 peanut-allergic individuals

• Published in: Food and chemical toxicology Vol. 48; no. 3; pp. 814 - 819
• Main Authors: Taylor, Steve L., Moneret-Vautrin, D.A., Crevel, Rene W.R., Sheffield, David, Morisset, Martine, Dumont, P., Remington, Benjamin C., Baumert, Joseph L.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01-03-2010; Elsevier
• Subjects: Adolescent; Adult; allergenicity; allergens; Allergic diseases; Allergy; Antigens, Plant - immunology; Arachis - immunology; Arachis hypogaea; Biological and medical sciences; Child; Child, Preschool; diagnostic oral challenge; Digestive allergic diseases; disease diagnosis; dose response; Dose-Response Relationship, Immunologic; Female; food allergies; France; Humans; Immunopathology; Infant; lowest observed effect level; Male; Medical sciences; Middle Aged; Modeling; Models, Immunological; No-Observed-Adverse-Effect Level; oral administration; patients; Peanut; Peanut Hypersensitivity - diagnosis; Peanut Hypersensitivity - immunology; peanuts; Risk Assessment; Threshold; threshold dose; Toxicology; Young Adult; France; Peanut; Allergy; Modeling; Threshold; Human; Immunopathology; Food allergy; Threshold dose; Characterization; Risk factor; Digestive diseases; Diagnosis; Groundnut; Provocation test
• ISSN: 0278-6915; 1873-6351
• DOI: 10.1016/j.fct.2009.12.013

Clinical records of 286 consecutive patients reacting positively with objective symptoms to double-blind, placebo-controlled oral peanut challenges at University Hospital, Nancy, France were examined for individual No Observed Adverse Effect Levels (NOAELs) and Lowest Observed Adverse Effect Levels (LOAELs). After fitting to a log-normal probability distribution model, the ED10 and ED05 were 14.4 and 7.3mg (expressed as whole peanut), respectively, with 95% lower confidence intervals of 10.7 and 5.2mg, respectively. Compared to results from a previous study where the ED10 was based upon individual peanut thresholds gleaned from 12 publications, a statistically significant difference was observed between the ED50’s, but not the ED10’s of the two probability distribution curves. The Nancy patient group contains more sensitive subjects than the group from the published literature thus contributing to the observed differences. Minimum eliciting dose-distributions for patients with histories of more severe reactions (grade 4 or 5; 40 subjects) did not differ significantly from those of patients with histories of less severe reactions (grades 1–3; 123 subjects). These data and this modeling approach could be used to establish population thresholds for peanut-allergic consumers and thereby provide a sound basis for allergen control measures in the food industry.