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• W2160881330 abstract "Recent studies published in the Journal1Allen K.J. Remington B.C. Baumert J.L. Crevel R.W. Houben G.F. Brooke-Taylor S. et al.Allergen reference doses for precautionary labeling (VITAL 2.0): clinical implications.J Allergy Clin Immunol. 2014; 133: 156-164Abstract Full Text Full Text PDF PubMed Scopus (154) Google Scholar, 2Blumchen K. Beder A. Beschomer J. Ahrens F. Gruebl A. Hamelmann E. et al.Modified oral food challenge used with sensitization biomarkers provides more real-life clinical thresholds for peanut allergy.J Allergy Clin Immunol. 2014; 134: 390-398.e4Abstract Full Text Full Text PDF Scopus (86) Google Scholar have shed important light on the understanding of thresholds for patients with food allergy. In most clinical contexts, a threshold can be viewed as “the level that must be reached for an effect to be produced.”3Dorland's illustrated medical dictionary. 32nd ed. Saunders, Philadelphia2011Google Scholar Because the effect in question for a subject with food allergy might be a potentially life-threatening reaction for which no preventative treatments are available, understanding threshold responses to allergen exposure undoubtedly benefits the management of patients. Thresholds have diagnostic importance as measures of allergen desensitization or therapeutic effect to immunotherapy and for identifying suitable candidates for therapy. Importantly, knowledge of thresholds might improve quality of life for patients by helping them understand their potential risk for reactions to everyday allergen exposures and helping them to make informed choices in their food avoidance practices.4Hattersley S. Ward R. Baka A. Crevel R.W. Advances in the risk management of unintended presence of allergenic foods in manufactured food products—an overview.Food Chem Toxicol. 2014; 67: 255-261Crossref PubMed Scopus (30) Google Scholar, 5Hourihane J.O. Knulst A.C. Thresholds of allergenic proteins in foods.Toxicol Appl Pharmacol. 2005; 207: 152-156Crossref PubMed Scopus (43) Google Scholar To date, however, deciphering what an allergen threshold clearly represents for individual patients has remained elusive. There are no simple diagnostic tests other than challenge to predict thresholds, and evidence shows that individual thresholds can be affected by various factors, such as exercise and infections,6Crevel R.W. Baumert J.L. Baka A. Houben G.F. Knulst A.C. Kruizinga A.G. et al.Development and evolution of risk assessment for food allergens.Food Chem Toxicol. 2014; 67: 262-276Crossref PubMed Scopus (58) Google Scholar, 7Varshney P. Steele P.H. Vickery B.P. Bird J.A. Thyagarajan A. Scurlock A.M. et al.Adverse reactions during peanut oral immunotherapy home dosing.J Allergy Clin Immunol. 2009; 124: 1351-1352Abstract Full Text Full Text PDF PubMed Scopus (162) Google Scholar and might not be reproducible from one challenge to the next.8Leung D.Y. Sampson H.A. Yunginger J.W. Burks Jr., A.W. Schneider L.C. Wortel C.H. et al.Effect of anti-IgE therapy in patients with peanut allergy.N Engl J Med. 2003; 348: 986-993Crossref PubMed Scopus (607) Google Scholar Risk assessment approaches are being proposed to estimate thresholds for populations of allergic patients.1Allen K.J. Remington B.C. Baumert J.L. Crevel R.W. Houben G.F. Brooke-Taylor S. et al.Allergen reference doses for precautionary labeling (VITAL 2.0): clinical implications.J Allergy Clin Immunol. 2014; 133: 156-164Abstract Full Text Full Text PDF PubMed Scopus (154) Google Scholar, 6Crevel R.W. Baumert J.L. Baka A. Houben G.F. Knulst A.C. Kruizinga A.G. et al.Development and evolution of risk assessment for food allergens.Food Chem Toxicol. 2014; 67: 262-276Crossref PubMed Scopus (58) Google Scholar, 9Taylor S.L. Moneret-Vautrin D.A. Crevel R.W. Sheffield D. Morisset M. Dumont P. et al.Threshold dose for peanut: risk characterization based upon diagnostic oral challenge of a series of 286 peanut-allergic individuals.Food Chem Toxicol. 2010; 48: 814-819Crossref PubMed Scopus (128) Google Scholar For some allergens (ie, peanut, egg, milk, and hazelnut), there are now more than 200 individual data points on eliciting doses (EDs) from double-blind, placebo-controlled food challenge studies using low-dose allergen protocols (of a few milligrams of protein or lower) from which to make population threshold risk predictions. Determining thresholds to lie within the interval between the ED and the highest challenge dose not to elicit a reaction, Allen et al1Allen K.J. Remington B.C. Baumert J.L. Crevel R.W. Houben G.F. Brooke-Taylor S. et al.Allergen reference doses for precautionary labeling (VITAL 2.0): clinical implications.J Allergy Clin Immunol. 2014; 133: 156-164Abstract Full Text Full Text PDF PubMed Scopus (154) Google Scholar modeled threshold dose distribution data from various population data sets to estimate reference doses, which are derived from the ED of allergen predicted to elicit a reaction in 1% (ED01) or 5% (ED05) of the population, for most major food allergens. Although the main focus of this analysis was to establish thresholds for precautionary allergen-labeling purposes, these data can also provide prognostic reaction-risk information for patients. For example, these data demonstrate that the majority of allergic patients might not be sensitive to minute allergen exposures, with more than 70% of patients not expected to react to 60 mg of peanut protein (a dose equivalent to 1 whole peanut). Communicating this risk has value in patient education and addressing consumer fears about trivial allergen exposures.10Crevel R.W. Baumert J.L. Luccioli S. Baka A. Hattersley S. Hourihane J.O. et al.Translating reference doses into allergen management practice: challenges for stakeholders.Food Chem Toxicol. 2014; 67: 277-287Crossref PubMed Scopus (23) Google Scholar, 11Luccioli S. Food allergy guidelines and assessing allergic reaction risks: a regulatory perspective.Curr Opin Allergy Clin Immunol. 2012; 12: 323-330Crossref PubMed Scopus (14) Google Scholar Despite progress in estimating population thresholds, limitations in analyzed ED data that could affect final threshold determinations need to be highlighted. Because threshold data derive from studies from geographic areas with varying sensitization patterns, subject recruitment requirements, dosing protocols, and criteria for establishing EDs, overrepresentation or underrepresentation of certain qualitative factors in the data set could skew threshold estimations in one direction or another. For example, Allen et al1Allen K.J. Remington B.C. Baumert J.L. Crevel R.W. Houben G.F. Brooke-Taylor S. et al.Allergen reference doses for precautionary labeling (VITAL 2.0): clinical implications.J Allergy Clin Immunol. 2014; 133: 156-164Abstract Full Text Full Text PDF PubMed Scopus (154) Google Scholar found significant ED distribution variability when population age, geographic origin, starting dose, and challenge material type were analyzed separately. The authors also acknowledged that thresholds based on ED data from controlled studies might not capture the effect of other factors (eg, exercise and medications) on thresholds in the community. In this issue of the Journal, Blumchen et al2Blumchen K. Beder A. Beschomer J. Ahrens F. Gruebl A. Hamelmann E. et al.Modified oral food challenge used with sensitization biomarkers provides more real-life clinical thresholds for peanut allergy.J Allergy Clin Immunol. 2014; 134: 390-398.e4Abstract Full Text Full Text PDF Scopus (86) Google Scholar raise additional questions about the accuracy of current population threshold estimations by presenting threshold data in German children with peanut allergy using a modified challenge protocol with a prolonged interval of 2 hours between incremental doses. The authors argue that this longer dosing interval mimics more discrete real-life encounters with single allergen exposures and captures late ED responses that might be missed in studies using shorter dose intervals of 15 to 30 minutes. Indeed, the authors found that more than 70% of subjects had objective EDs occurring 30 minutes or more (median, 50 minutes) after challenge. Because Allen et al1Allen K.J. Remington B.C. Baumert J.L. Crevel R.W. Houben G.F. Brooke-Taylor S. et al.Allergen reference doses for precautionary labeling (VITAL 2.0): clinical implications.J Allergy Clin Immunol. 2014; 133: 156-164Abstract Full Text Full Text PDF PubMed Scopus (154) Google Scholar based thresholds on EDs derived from studies with shorter time intervals, it is possible that true ED responses occurred at doses 2- or 3-fold lower than those reported; thus actual thresholds would be lower than those reported. Although no differences were found comparing peanut ED05 data from Blumchen et al2Blumchen K. Beder A. Beschomer J. Ahrens F. Gruebl A. Hamelmann E. et al.Modified oral food challenge used with sensitization biomarkers provides more real-life clinical thresholds for peanut allergy.J Allergy Clin Immunol. 2014; 134: 390-398.e4Abstract Full Text Full Text PDF Scopus (86) Google Scholar with ED05 data from studies using shorter dose intervals,9Taylor S.L. Moneret-Vautrin D.A. Crevel R.W. Sheffield D. Morisset M. Dumont P. et al.Threshold dose for peanut: risk characterization based upon diagnostic oral challenge of a series of 286 peanut-allergic individuals.Food Chem Toxicol. 2010; 48: 814-819Crossref PubMed Scopus (128) Google Scholar this does not exclude the possibility for ED differences caused by an interval-length effect. ED05 differences between the 2 data sets might have been overshadowed by differing ED sensitivities at the population level. Moreover, interval differences might not be prominent at low EDs, at which dose increments are relatively smaller. In any case these data reveal a need to re-examine population threshold data based on studies with shorter or longer dose-interval length to determine how this factor affects final threshold distributions. It is also notable that Blumchen et al2Blumchen K. Beder A. Beschomer J. Ahrens F. Gruebl A. Hamelmann E. et al.Modified oral food challenge used with sensitization biomarkers provides more real-life clinical thresholds for peanut allergy.J Allergy Clin Immunol. 2014; 134: 390-398.e4Abstract Full Text Full Text PDF Scopus (86) Google Scholar challenged a patient population with asthma and prior anaphylaxis who are arguably at heightened risk for severe reactions to dose challenge.12Boyce J.A. Assa'ad A. Burks A.W. Jones S.M. Sampson H.A. Wood R.A. et al.Guidelines for the diagnosis and management of food allergy in the United States: report of the NIAID-sponsored expert panel.J Allergy Clin Immunol. 2010; 126: S1-S58PubMed Google Scholar, 13Vander Leek T.K. Liu A.H. Stefanski K. Blacker B. Bock S.A. The natural history of peanut allergy in young children and its association with serum peanut-specific IgE.J Pediatr. 2000; 137: 749-755Abstract Full Text Full Text PDF PubMed Scopus (222) Google Scholar Although demonstrating that low-dose challenges can be safely performed in populations at high risk for severe reactions, the authors found that patients with prior anaphylaxis had significantly lower thresholds. This finding supports14Wensing M. Penninks A.H. Hefle S.L. Koppelman S.J. Bruijnzeel-Koomen C.A. Knulst A.C. The distribution of individual threshold doses eliciting allergic reactions in a population with peanut allergy.J Allergy Clin Immunol. 2002; 110: 915-920Abstract Full Text Full Text PDF PubMed Scopus (186) Google Scholar and refutes9Taylor S.L. Moneret-Vautrin D.A. Crevel R.W. Sheffield D. Morisset M. Dumont P. et al.Threshold dose for peanut: risk characterization based upon diagnostic oral challenge of a series of 286 peanut-allergic individuals.Food Chem Toxicol. 2010; 48: 814-819Crossref PubMed Scopus (128) Google Scholar, 15van der Zee T. Dubois A. Kerkhof M. van der Heide S. Vlieg-Boerstra B. The eliciting dose of peanut in double-blind, placebo-controlled food challenges decreases with increasing age and specific IgE level in children and young adults.J Allergy Clin Immunol. 2011; 128: 1031-1036Abstract Full Text Full Text PDF PubMed Scopus (41) Google Scholar prior observations and renews debate over whether study populations that exclude patients with prior anaphylaxis from challenge represent the most sensitive patients in the population. Because most data analyzed by Allen et al1Allen K.J. Remington B.C. Baumert J.L. Crevel R.W. Houben G.F. Brooke-Taylor S. et al.Allergen reference doses for precautionary labeling (VITAL 2.0): clinical implications.J Allergy Clin Immunol. 2014; 133: 156-164Abstract Full Text Full Text PDF PubMed Scopus (154) Google Scholar came from study populations that excluded these subjects, there is concern that resultant thresholds might not represent patients at highest risk for severe consequences from dose challenge. Inclusion of more ED data from such patients would benefit the risk characterization of population threshold data. Understanding the relative severity of responses in relation to threshold doses is another issue not clearly addressed by population threshold data. This understanding would help alleviate stakeholder fears (ie, Does ED01 predict that reactions in sensitive subjects will all be severe?), as well as address other public health threshold questions.10Crevel R.W. Baumert J.L. Luccioli S. Baka A. Hattersley S. Hourihane J.O. et al.Translating reference doses into allergen management practice: challenges for stakeholders.Food Chem Toxicol. 2014; 67: 277-287Crossref PubMed Scopus (23) Google Scholar For example, the US Food Allergen Labeling and Consumer Protection Act established a safety standard of “does not cause an allergic response that poses a risk to human health” for granting labeling exemptions. This implies some need to address reaction severity.11Luccioli S. Food allergy guidelines and assessing allergic reaction risks: a regulatory perspective.Curr Opin Allergy Clin Immunol. 2012; 12: 323-330Crossref PubMed Scopus (14) Google Scholar Although the expert panel in Allen et al1Allen K.J. Remington B.C. Baumert J.L. Crevel R.W. Houben G.F. Brooke-Taylor S. et al.Allergen reference doses for precautionary labeling (VITAL 2.0): clinical implications.J Allergy Clin Immunol. 2014; 133: 156-164Abstract Full Text Full Text PDF PubMed Scopus (154) Google Scholar contends that low dose thresholds are expected to be associated with milder reactions, this remains unproved. Few studies that examined this question found no significant correlation between lower EDs and lower reaction severity.14Wensing M. Penninks A.H. Hefle S.L. Koppelman S.J. Bruijnzeel-Koomen C.A. Knulst A.C. The distribution of individual threshold doses eliciting allergic reactions in a population with peanut allergy.J Allergy Clin Immunol. 2002; 110: 915-920Abstract Full Text Full Text PDF PubMed Scopus (186) Google Scholar, 16Rolinck-Werninghaus C. Niggemann B. Grabenhenrich L. Wahn U. Beyer K. Outcome of oral food challenges in children in relation to symptom-eliciting allergen dose and allergen-specific IgE.Allergy. 2012; 67: 951-957Crossref PubMed Scopus (77) Google Scholar Likewise, although Blumchen et al2Blumchen K. Beder A. Beschomer J. Ahrens F. Gruebl A. Hamelmann E. et al.Modified oral food challenge used with sensitization biomarkers provides more real-life clinical thresholds for peanut allergy.J Allergy Clin Immunol. 2014; 134: 390-398.e4Abstract Full Text Full Text PDF Scopus (86) Google Scholar found that lower EDs correlated with biological markers of sensitization (eg, higher IgE levels, skin prick test responses, and basophil activity), a promising finding that supports recent observations regarding high IgE levels and lower EDs15van der Zee T. Dubois A. Kerkhof M. van der Heide S. Vlieg-Boerstra B. The eliciting dose of peanut in double-blind, placebo-controlled food challenges decreases with increasing age and specific IgE level in children and young adults.J Allergy Clin Immunol. 2011; 128: 1031-1036Abstract Full Text Full Text PDF PubMed Scopus (41) Google Scholar and merits further study, the authors found no correlation between ED and response severity. More research is needed to understand the relationship between low-dose allergen exposures and severity. The results of Blumchen et al2Blumchen K. Beder A. Beschomer J. Ahrens F. Gruebl A. Hamelmann E. et al.Modified oral food challenge used with sensitization biomarkers provides more real-life clinical thresholds for peanut allergy.J Allergy Clin Immunol. 2014; 134: 390-398.e4Abstract Full Text Full Text PDF Scopus (86) Google Scholar provide important insights. However, some limitations should be considered. Although the authors focused on objective reactions and controlled for various confounders, the study was an open challenge and is inherently subject to false-positive results. The length of time between challenges likely increased opportunities for nonspecific allergic-type responses to manifest; thus observations of delayed ED responses should be further validated by using double-blind, placebo-controlled food challenges. Moreover, the authors' proposed protocol might not be feasible for establishing thresholds in clinical practice because the requirement to hospitalize patients over a minimum of a few days would be impractical in most health care settings. Nonetheless, it is hoped that the results of Blumchen et al2Blumchen K. Beder A. Beschomer J. Ahrens F. Gruebl A. Hamelmann E. et al.Modified oral food challenge used with sensitization biomarkers provides more real-life clinical thresholds for peanut allergy.J Allergy Clin Immunol. 2014; 134: 390-398.e4Abstract Full Text Full Text PDF Scopus (86) Google Scholar and Allen et al1Allen K.J. Remington B.C. Baumert J.L. Crevel R.W. Houben G.F. Brooke-Taylor S. et al.Allergen reference doses for precautionary labeling (VITAL 2.0): clinical implications.J Allergy Clin Immunol. 2014; 133: 156-164Abstract Full Text Full Text PDF PubMed Scopus (154) Google Scholar will further expand research and encourage more diagnostic food challenges to help patients understand where their threshold lies on a reaction-risk continuum. This information has potential to significantly improve clinical management and quality of life of patients. Modified oral food challenge used with sensitization biomarkers provides more real-life clinical thresholds for peanut allergyJournal of Allergy and Clinical ImmunologyVol. 134Issue 2PreviewThreshold levels for peanut allergy determined by using oral challenges are important for the food industry with regard to allergen labeling. Moreover, the utility of biological markers in predicting threshold levels is uncertain. Full-Text PDF Understanding food allergen thresholds requires careful analysis of the available clinical dataJournal of Allergy and Clinical ImmunologyVol. 135Issue 2PreviewThe recent editorial by Luccioli and Kwegyir-Afful1 appropriately highlights the potential benefits derived from understanding food allergen thresholds across the spectrum of patients with specific food allergies. That editorial highlighted the study of Blumchen et al,2 which contributes to our knowledge of peanut thresholds and especially identified several biomarkers that appear useful in the identification of the most sensitive patients with peanut allergy. The editorial by Luccioli and Kwegyir-Afful1 offered additional comments on the limitations in estimating population thresholds, although we would assert that they overlooked some published evidence and mischaracterized other evidence, including the study by our own consortium. Full-Text PDF" @default.
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