Peanut Allergen Threshold Study (PATS): Validation of eliciting doses using a novel single-dose challenge protocol

Giovanni A. Zurzolo, Katrina J. Allen, Steve L. Taylor, Wayne G. Shreffler, Joseph L. Baumert, Mimi L.K. Tang, Lyle C. Gurrin, Michael L. Mathai, Julie A. Nordlee, Audrey DunnGalvin, Jonathan O. Hourihane

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

Background: The eliciting dose (ED) for a peanut allergic reaction in 5% of the peanut allergic population, the ED05, is 1.5 mg of peanut protein. This ED05 was derived from oral food challenges (OFC) that use graded, incremental doses administered at fixed time intervals. Individual patients' threshold doses were used to generate population dose-distribution curves using probability distributions from which the ED05 was then determined. It is important to clinically validate that this dose is predictive of the allergenic response in a further unselected group of peanut-allergic individuals.Methods/Aims: This is a multi-centre study involving three national level referral and teaching centres. (Cork University Hospital, Ireland, Royal Children's Hospital Melbourne, Australia and Massachusetts General Hospital, Boston, U.S.A.) The study is now in process and will continue to run until all centres have recruited 125 participates in each respective centre.A total of 375 participants, aged 1-18 years will be recruited during routine Allergy appointments in the centres. The aim is to assess the precision of the predicted ED05 using a single dose (6 mg peanut = 1.5 mg of peanut protein) in the form of a cookie. Validated Food Allergy related Quality of Life Questionnaires-(FAQLQ) will be self-administered prior to OFC and 1 month after challenge to assess the impact of a single dose OFC on FAQL. Serological and cell based in vitro studies will be performed.Conclusion: The validation of the ED05 threshold for allergic reactions in peanut allergic subjects has potential value for public health measures. The single dose OFC, based upon the statistical dose-distribution analysis of past challenge trials, promises an efficient approach to identify the most highly sensitive patients within any given food-allergic population.

Original languageEnglish (US)
Article number35
JournalAllergy, Asthma and Clinical Immunology
Volume9
Issue number1
DOIs
StatePublished - Sep 12 2013

Fingerprint

Validation Studies
Allergens
Food
Hypersensitivity
Statistical Distributions
Food Hypersensitivity
Arachis
Ireland
General Hospitals
Population
Appointments and Schedules
Teaching
Proteins
Referral and Consultation
Public Health
Quality of Life
Demography

Keywords

  • Eliciting dose (ED)
  • Food Allergy related Quality of Life Questionnaires-(FAQLQ)
  • Oral Food Challenges (OFC)
  • Peanut Allergen Threshold Study (PATS)
  • Peanut thresholds
  • Single dose
  • Voluntary Incidental Trace Allergen Labelling (VITAL)

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pulmonary and Respiratory Medicine

Cite this

Peanut Allergen Threshold Study (PATS) : Validation of eliciting doses using a novel single-dose challenge protocol. / Zurzolo, Giovanni A.; Allen, Katrina J.; Taylor, Steve L.; Shreffler, Wayne G.; Baumert, Joseph L.; Tang, Mimi L.K.; Gurrin, Lyle C.; Mathai, Michael L.; Nordlee, Julie A.; DunnGalvin, Audrey; Hourihane, Jonathan O.

In: Allergy, Asthma and Clinical Immunology, Vol. 9, No. 1, 35, 12.09.2013.

Research output: Contribution to journalArticle

Zurzolo, GA, Allen, KJ, Taylor, SL, Shreffler, WG, Baumert, JL, Tang, MLK, Gurrin, LC, Mathai, ML, Nordlee, JA, DunnGalvin, A & Hourihane, JO 2013, 'Peanut Allergen Threshold Study (PATS): Validation of eliciting doses using a novel single-dose challenge protocol', Allergy, Asthma and Clinical Immunology, vol. 9, no. 1, 35. https://doi.org/10.1186/1710-1492-9-35
Zurzolo, Giovanni A. ; Allen, Katrina J. ; Taylor, Steve L. ; Shreffler, Wayne G. ; Baumert, Joseph L. ; Tang, Mimi L.K. ; Gurrin, Lyle C. ; Mathai, Michael L. ; Nordlee, Julie A. ; DunnGalvin, Audrey ; Hourihane, Jonathan O. / Peanut Allergen Threshold Study (PATS) : Validation of eliciting doses using a novel single-dose challenge protocol. In: Allergy, Asthma and Clinical Immunology. 2013 ; Vol. 9, No. 1.
@article{53ac3d2e50154285a0444441c4cbcaa4,
title = "Peanut Allergen Threshold Study (PATS): Validation of eliciting doses using a novel single-dose challenge protocol",
abstract = "Background: The eliciting dose (ED) for a peanut allergic reaction in 5{\%} of the peanut allergic population, the ED05, is 1.5 mg of peanut protein. This ED05 was derived from oral food challenges (OFC) that use graded, incremental doses administered at fixed time intervals. Individual patients' threshold doses were used to generate population dose-distribution curves using probability distributions from which the ED05 was then determined. It is important to clinically validate that this dose is predictive of the allergenic response in a further unselected group of peanut-allergic individuals.Methods/Aims: This is a multi-centre study involving three national level referral and teaching centres. (Cork University Hospital, Ireland, Royal Children's Hospital Melbourne, Australia and Massachusetts General Hospital, Boston, U.S.A.) The study is now in process and will continue to run until all centres have recruited 125 participates in each respective centre.A total of 375 participants, aged 1-18 years will be recruited during routine Allergy appointments in the centres. The aim is to assess the precision of the predicted ED05 using a single dose (6 mg peanut = 1.5 mg of peanut protein) in the form of a cookie. Validated Food Allergy related Quality of Life Questionnaires-(FAQLQ) will be self-administered prior to OFC and 1 month after challenge to assess the impact of a single dose OFC on FAQL. Serological and cell based in vitro studies will be performed.Conclusion: The validation of the ED05 threshold for allergic reactions in peanut allergic subjects has potential value for public health measures. The single dose OFC, based upon the statistical dose-distribution analysis of past challenge trials, promises an efficient approach to identify the most highly sensitive patients within any given food-allergic population.",
keywords = "Eliciting dose (ED), Food Allergy related Quality of Life Questionnaires-(FAQLQ), Oral Food Challenges (OFC), Peanut Allergen Threshold Study (PATS), Peanut thresholds, Single dose, Voluntary Incidental Trace Allergen Labelling (VITAL)",
author = "Zurzolo, {Giovanni A.} and Allen, {Katrina J.} and Taylor, {Steve L.} and Shreffler, {Wayne G.} and Baumert, {Joseph L.} and Tang, {Mimi L.K.} and Gurrin, {Lyle C.} and Mathai, {Michael L.} and Nordlee, {Julie A.} and Audrey DunnGalvin and Hourihane, {Jonathan O.}",
year = "2013",
month = "9",
day = "12",
doi = "10.1186/1710-1492-9-35",
language = "English (US)",
volume = "9",
journal = "Allergy, Asthma and Clinical Immunology",
issn = "1710-1484",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - Peanut Allergen Threshold Study (PATS)

T2 - Validation of eliciting doses using a novel single-dose challenge protocol

AU - Zurzolo, Giovanni A.

AU - Allen, Katrina J.

AU - Taylor, Steve L.

AU - Shreffler, Wayne G.

AU - Baumert, Joseph L.

AU - Tang, Mimi L.K.

AU - Gurrin, Lyle C.

AU - Mathai, Michael L.

AU - Nordlee, Julie A.

AU - DunnGalvin, Audrey

AU - Hourihane, Jonathan O.

PY - 2013/9/12

Y1 - 2013/9/12

N2 - Background: The eliciting dose (ED) for a peanut allergic reaction in 5% of the peanut allergic population, the ED05, is 1.5 mg of peanut protein. This ED05 was derived from oral food challenges (OFC) that use graded, incremental doses administered at fixed time intervals. Individual patients' threshold doses were used to generate population dose-distribution curves using probability distributions from which the ED05 was then determined. It is important to clinically validate that this dose is predictive of the allergenic response in a further unselected group of peanut-allergic individuals.Methods/Aims: This is a multi-centre study involving three national level referral and teaching centres. (Cork University Hospital, Ireland, Royal Children's Hospital Melbourne, Australia and Massachusetts General Hospital, Boston, U.S.A.) The study is now in process and will continue to run until all centres have recruited 125 participates in each respective centre.A total of 375 participants, aged 1-18 years will be recruited during routine Allergy appointments in the centres. The aim is to assess the precision of the predicted ED05 using a single dose (6 mg peanut = 1.5 mg of peanut protein) in the form of a cookie. Validated Food Allergy related Quality of Life Questionnaires-(FAQLQ) will be self-administered prior to OFC and 1 month after challenge to assess the impact of a single dose OFC on FAQL. Serological and cell based in vitro studies will be performed.Conclusion: The validation of the ED05 threshold for allergic reactions in peanut allergic subjects has potential value for public health measures. The single dose OFC, based upon the statistical dose-distribution analysis of past challenge trials, promises an efficient approach to identify the most highly sensitive patients within any given food-allergic population.

AB - Background: The eliciting dose (ED) for a peanut allergic reaction in 5% of the peanut allergic population, the ED05, is 1.5 mg of peanut protein. This ED05 was derived from oral food challenges (OFC) that use graded, incremental doses administered at fixed time intervals. Individual patients' threshold doses were used to generate population dose-distribution curves using probability distributions from which the ED05 was then determined. It is important to clinically validate that this dose is predictive of the allergenic response in a further unselected group of peanut-allergic individuals.Methods/Aims: This is a multi-centre study involving three national level referral and teaching centres. (Cork University Hospital, Ireland, Royal Children's Hospital Melbourne, Australia and Massachusetts General Hospital, Boston, U.S.A.) The study is now in process and will continue to run until all centres have recruited 125 participates in each respective centre.A total of 375 participants, aged 1-18 years will be recruited during routine Allergy appointments in the centres. The aim is to assess the precision of the predicted ED05 using a single dose (6 mg peanut = 1.5 mg of peanut protein) in the form of a cookie. Validated Food Allergy related Quality of Life Questionnaires-(FAQLQ) will be self-administered prior to OFC and 1 month after challenge to assess the impact of a single dose OFC on FAQL. Serological and cell based in vitro studies will be performed.Conclusion: The validation of the ED05 threshold for allergic reactions in peanut allergic subjects has potential value for public health measures. The single dose OFC, based upon the statistical dose-distribution analysis of past challenge trials, promises an efficient approach to identify the most highly sensitive patients within any given food-allergic population.

KW - Eliciting dose (ED)

KW - Food Allergy related Quality of Life Questionnaires-(FAQLQ)

KW - Oral Food Challenges (OFC)

KW - Peanut Allergen Threshold Study (PATS)

KW - Peanut thresholds

KW - Single dose

KW - Voluntary Incidental Trace Allergen Labelling (VITAL)

UR - http://www.scopus.com/inward/record.url?scp=84887641776&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84887641776&partnerID=8YFLogxK

U2 - 10.1186/1710-1492-9-35

DO - 10.1186/1710-1492-9-35

M3 - Article

C2 - 24028324

AN - SCOPUS:84887641776

VL - 9

JO - Allergy, Asthma and Clinical Immunology

JF - Allergy, Asthma and Clinical Immunology

SN - 1710-1484

IS - 1

M1 - 35

ER -