TY - JOUR
T1 - Threshold dose for peanut
T2 - Risk characterization based upon published results from challenges of peanut-allergic individuals
AU - Taylor, Steve L.
AU - Crevel, Rene W.R.
AU - Sheffield, David
AU - Kabourek, Jamie
AU - Baumert, Joseph
PY - 2009/6
Y1 - 2009/6
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
C2 - 19232533
AN - SCOPUS:67349265163
VL - 47
SP - 1198
EP - 1204
JO - Food and Chemical Toxicology
JF - Food and Chemical Toxicology
SN - 0278-6915
IS - 6
ER -