Threshold dose for peanut

Risk characterization based upon published results from challenges of peanut-allergic individuals

Stephen L Taylor, Rene W R Crevel, David Sheffield, Jamie Kabourek, Joseph L Baumert

Research output: Contribution to journalArticle

81 Citations (Scopus)

Abstract

Population thresholds for peanut are unknown. However, lowest- and no-observed adverse effect levels (LOAELs and NOAELs) are published for an unknown number of peanut-allergic individuals. Publications were screened for LOAELs and NOAELs from blinded, low-dose oral challenges. Data were obtained from 185 peanut-allergic individuals (12 publications). Data were analyzed by interval-censoring survival analysis and three probability distribution models fitted to it (Log-Normal, Log-Logistic, and Weibull) to estimate the ED10. All three models described the data well and provided ED10's in close agreement: 17.6, 17.0, and 14.6 mg of whole peanut for the Log-Normal, Log-Logistic, and Weibull models, respectively. The 95% lower confidence intervals for the ED10's were 9.2, 8.1, and 6.0 mg of whole peanut for the Log-Normal, Log-Logistic, and Weibull models, respectively. The modeling of individual NOAELs and LOAELs identified from three different types of published studies - diagnostic series, threshold studies, and immunotherapy trials - yielded significantly different whole peanut ED10's of 11.9 mg for threshold studies, 18.0 mg for diagnostic series and 65.5 mg for immunotherapy trials; patient selection and other biases may have influenced the estimates. These data and risk assessment models provide the type of information that is necessary to establish regulatory thresholds for peanut.

Original languageEnglish (US)
Pages (from-to)1198-1204
Number of pages7
JournalFood and Chemical Toxicology
Volume47
Issue number6
DOIs
StatePublished - Jun 1 2009

Fingerprint

risk characterization
lowest observed effect level
peanuts
No-Observed-Adverse-Effect Level
no observed adverse effect level
Logistics
dosage
immunotherapy
Immunotherapy
Publications
Logistic Models
Risk assessment
Probability distributions
Selection Bias
probability distribution
Survival Analysis
Arachis
Patient Selection
risk assessment
confidence interval

Keywords

  • Allergy
  • Modeling
  • Peanut
  • Threshold

ASJC Scopus subject areas

  • Food Science
  • Toxicology

Cite this

Threshold dose for peanut : Risk characterization based upon published results from challenges of peanut-allergic individuals. / Taylor, Stephen L; Crevel, Rene W R; Sheffield, David; Kabourek, Jamie; Baumert, Joseph L.

In: Food and Chemical Toxicology, Vol. 47, No. 6, 01.06.2009, p. 1198-1204.

Research output: Contribution to journalArticle

@article{ac12d299a9e946579485055d90dd01e3,
title = "Threshold dose for peanut: Risk characterization based upon published results from challenges of peanut-allergic individuals",
abstract = "Population thresholds for peanut are unknown. However, lowest- and no-observed adverse effect levels (LOAELs and NOAELs) are published for an unknown number of peanut-allergic individuals. Publications were screened for LOAELs and NOAELs from blinded, low-dose oral challenges. Data were obtained from 185 peanut-allergic individuals (12 publications). Data were analyzed by interval-censoring survival analysis and three probability distribution models fitted to it (Log-Normal, Log-Logistic, and Weibull) to estimate the ED10. All three models described the data well and provided ED10's in close agreement: 17.6, 17.0, and 14.6 mg of whole peanut for the Log-Normal, Log-Logistic, and Weibull models, respectively. The 95{\%} lower confidence intervals for the ED10's were 9.2, 8.1, and 6.0 mg of whole peanut for the Log-Normal, Log-Logistic, and Weibull models, respectively. The modeling of individual NOAELs and LOAELs identified from three different types of published studies - diagnostic series, threshold studies, and immunotherapy trials - yielded significantly different whole peanut ED10's of 11.9 mg for threshold studies, 18.0 mg for diagnostic series and 65.5 mg for immunotherapy trials; patient selection and other biases may have influenced the estimates. These data and risk assessment models provide the type of information that is necessary to establish regulatory thresholds for peanut.",
keywords = "Allergy, Modeling, Peanut, Threshold",
author = "Taylor, {Stephen L} and Crevel, {Rene W R} and David Sheffield and Jamie Kabourek and Baumert, {Joseph L}",
year = "2009",
month = "6",
day = "1",
doi = "10.1016/j.fct.2009.02.011",
language = "English (US)",
volume = "47",
pages = "1198--1204",
journal = "Food and Chemical Toxicology",
issn = "0278-6915",
publisher = "Elsevier Limited",
number = "6",

}

TY - JOUR

T1 - Threshold dose for peanut

T2 - Risk characterization based upon published results from challenges of peanut-allergic individuals

AU - Taylor, Stephen L

AU - Crevel, Rene W R

AU - Sheffield, David

AU - Kabourek, Jamie

AU - Baumert, Joseph L

PY - 2009/6/1

Y1 - 2009/6/1

N2 - Population thresholds for peanut are unknown. However, lowest- and no-observed adverse effect levels (LOAELs and NOAELs) are published for an unknown number of peanut-allergic individuals. Publications were screened for LOAELs and NOAELs from blinded, low-dose oral challenges. Data were obtained from 185 peanut-allergic individuals (12 publications). Data were analyzed by interval-censoring survival analysis and three probability distribution models fitted to it (Log-Normal, Log-Logistic, and Weibull) to estimate the ED10. All three models described the data well and provided ED10's in close agreement: 17.6, 17.0, and 14.6 mg of whole peanut for the Log-Normal, Log-Logistic, and Weibull models, respectively. The 95% lower confidence intervals for the ED10's were 9.2, 8.1, and 6.0 mg of whole peanut for the Log-Normal, Log-Logistic, and Weibull models, respectively. The modeling of individual NOAELs and LOAELs identified from three different types of published studies - diagnostic series, threshold studies, and immunotherapy trials - yielded significantly different whole peanut ED10's of 11.9 mg for threshold studies, 18.0 mg for diagnostic series and 65.5 mg for immunotherapy trials; patient selection and other biases may have influenced the estimates. These data and risk assessment models provide the type of information that is necessary to establish regulatory thresholds for peanut.

AB - Population thresholds for peanut are unknown. However, lowest- and no-observed adverse effect levels (LOAELs and NOAELs) are published for an unknown number of peanut-allergic individuals. Publications were screened for LOAELs and NOAELs from blinded, low-dose oral challenges. Data were obtained from 185 peanut-allergic individuals (12 publications). Data were analyzed by interval-censoring survival analysis and three probability distribution models fitted to it (Log-Normal, Log-Logistic, and Weibull) to estimate the ED10. All three models described the data well and provided ED10's in close agreement: 17.6, 17.0, and 14.6 mg of whole peanut for the Log-Normal, Log-Logistic, and Weibull models, respectively. The 95% lower confidence intervals for the ED10's were 9.2, 8.1, and 6.0 mg of whole peanut for the Log-Normal, Log-Logistic, and Weibull models, respectively. The modeling of individual NOAELs and LOAELs identified from three different types of published studies - diagnostic series, threshold studies, and immunotherapy trials - yielded significantly different whole peanut ED10's of 11.9 mg for threshold studies, 18.0 mg for diagnostic series and 65.5 mg for immunotherapy trials; patient selection and other biases may have influenced the estimates. These data and risk assessment models provide the type of information that is necessary to establish regulatory thresholds for peanut.

KW - Allergy

KW - Modeling

KW - Peanut

KW - Threshold

UR - http://www.scopus.com/inward/record.url?scp=67349265163&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=67349265163&partnerID=8YFLogxK

U2 - 10.1016/j.fct.2009.02.011

DO - 10.1016/j.fct.2009.02.011

M3 - Article

VL - 47

SP - 1198

EP - 1204

JO - Food and Chemical Toxicology

JF - Food and Chemical Toxicology

SN - 0278-6915

IS - 6

ER -