Using data from food challenges to inform management of consumers with food allergy: A systematic review with individual participant data meta-analysis

Patel, Nandinee; Adelman, Daniel C.; Anagnostou, Aikaterini; Baumert, Joseph L.; Blom, W. Marty; Campbell, Dianne E.; Chinthrajah, R. Sharon; Mills, E. N. Clare; Javed, Bushra; Purington, Natasha; Remington, Benjamin C.; Sampson, Hugh A.; Smith, Alexander D.; Yarham, Ross A.R.; Turner, Paul J.

doi:10.1016/j.jaci.2021.01.025

Cited by 44 publications

(37 citation statements)

References 48 publications

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“…Patel et al 19 recently published a systematic review of over 3000 DBPCFCs to peanut. This analysis found that approximately 4.5% (95% CI: 1.9%-10.1%) of individuals who reacted to ≤5 mg of peanut protein and 4.2% (95% CI: 0.7%-22.3%) of individuals who reacted to ≤1 mg with objective symptoms experienced anaphylaxis (exposures that approximate to the upper limit of the 95% CI for the amount of allergen expected to cause objective symptoms in 1% of the population with that allergy [ED 01 ] and ED 05 for peanut, respectively).…”

Section: Peanutmentioning

confidence: 99%

“…Patel et al 19 analyzed data from 534 individuals who underwent at least 2 peanut-DBPCFCs over time, to assess the reproducibility of thresholds and recurrence of anaphylaxis in peanut-allergic individuals. Although the intraindividual variability in ED varied by up to 3-log, in the majority 71.2% (95% CI: 56.2%-82.6%) of individuals, this was limited to a half-log change—equivalent to a single dosing interval when using a PRACTALL-style semilogarithmic dosing regimen.…”

Section: Reproducibility Of Thresholds and Likelihood Of Anaphylaxismentioning

confidence: 99%

“…Estimates refer to occurrence of allergic symptoms at ED 05 levels of exposure in food-allergic individuals. 15 , 16 , 17 , 18 , 19 ED 05 , Amount of allergen expected to cause objective symptoms in 5% of the population with that allergy. …”

mentioning

confidence: 99%

“…For example, after an exposure to an ED 05 amount of peanut (an amount which would, by definition, not cause an objective allergic reaction in 95% of peanut-allergic individuals), one would expect 2.3 episodes of anaphylaxis per 1000 exposures in the peanut-allergic population. 19 At least 80% of these are mild reactions (which, in reality, resolve spontaneously when allergic individuals choose not to follow medical advice and treat), whereas 97% of the remainder would respond to first-line treatment (with epinephrine/adrenaline). 18 In those reporting anaphylaxis to any level of exposure for a food allergen, the risk of fatal outcome is estimated to be <1:10,000 15 ; it is likely that this rate would be even lower after an ED 05 level of exposure.…”

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confidence: 99%

“…For peanut, there are now published data relating to over 3000 double-blind, placebo-controlled challenges in allergic individuals to inform a reference dose and characterize the hazard associated with an ED 05 exposure. 19 However, for other priority allergens currently defined by the Food and Agriculture Organization/World Health Organization (FAO/WHO) Codex Alimentarius (cereals containing gluten; crustacea, egg, fish, soybean, milk, tree nuts), this level of evidence (both quantity and quality; eg, from double-blind challenges) is lacking, which results in more uncertainty in the estimate of the rate of anaphylaxis to low-level allergen exposures to these allergens. If peanut can be considered a “worst-case” allergen in terms of hazard and risk characterization at low levels of exposure, then this would greatly facilitate attempts to define reference doses and introduce a consistent regulatory framework for the use of PAL acceptable at an international level.…”

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confidence: 99%

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Peanut Can Be Used as a Reference Allergen for Hazard Characterization in Food Allergen Risk Management: A Rapid Evidence Assessment and Meta-Analysis

Turner

Patel

Ballmer‐Weber

et al. 2022

The Journal of Allergy and Clinical Immunology: In Practice

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Regional and national legislation mandates the disclosure of “priority” allergens when present as an ingredient in foods, but this does not extend to the unintended presence of allergens due to shared production facilities. This has resulted in a proliferation of precautionary allergen (“may contain”) labels (PAL) that are frequently ignored by food-allergic consumers. Attempts have been made to improve allergen risk management to better inform the use of PAL, but a lack of consensus has led to variety of regulatory approaches and nonuniformity in the use of PAL by food businesses. One potential solution would be to establish internationally agreed “reference doses,” below which no PAL would be needed. However, if reference doses are to be used to inform the need for PAL, then it is essential to characterize the hazard associated with these low-level exposures. For peanut, there are now published data relating to over 3000 double-blind, placebo-controlled challenges in allergic individuals, but a similar level of evidence is lacking for other priority allergens. We present the results of a rapid evidence assessment and meta-analysis for the risk of anaphylaxis to a low-level allergen exposure for priority allergens. On the basis of this analysis, we propose that peanut can and should be considered an exemplar allergen for the hazard characterization at a low-level allergen exposure.

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Section: Peanutmentioning

confidence: 99%

Section: Reproducibility Of Thresholds and Likelihood Of Anaphylaxismentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Peanut Can Be Used as a Reference Allergen for Hazard Characterization in Food Allergen Risk Management: A Rapid Evidence Assessment and Meta-Analysis

Turner

Patel

Ballmer‐Weber

et al. 2022

The Journal of Allergy and Clinical Immunology: In Practice

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Exploratory immunogenicity outcomes of peanut oral immunotherapy: Findings from the PALISADE trial

Nilsson,

Vereda,

Borres

et al. 2024

Clinical & Translational All

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BackgroundImmunoglobulin E (IgE) and immunoglobulin G4 (IgG4) to peanut and its components may influence the clinical reactivity to peanut. Allergen‐specific immunotherapy is known for modifying both IgE and IgG4. Peanut oral immunotherapy may influence these serological parameters.MethodsExploratory analyses of serological data from participants receiving peanut (Arachis hypogaea) allergen powder‐dnfp (PTAH) and placebo in the double‐blind, randomized, phase 3 PALISADE trial were conducted to evaluate potential relationships between peanut‐specific and peanut component–specific (Ara h 1, Ara h 2, Ara h 3, Ara h 6, Ara h 8, and Ara h 9) IgE and IgG4 levels and clinical outcomes.ResultsA total of 269 participants (PTAH, n = 202; placebo, n = 67) were analyzed. No relationship was observed between specific IgE and IgG4 levels at screening and maximum tolerated peanut protein dose during screening or response status during exit double‐blind placebo‐controlled food challenge (DBPCFC). In PTAH‐treated participants, no relationship was observed between IgE and IgG4 levels at screening and maximum symptom severity during exit DBPCFC. Postscreening ratios (ie, postscreening/screening) in the PTAH group were significant at the end of updosing and exit visit for most components. Postscreening changes in specific IgE levels were more pronounced with PTAH versus placebo for most components.ConclusionsSpecific IgE and IgG4 levels at screening are not correlated with screening or exit DBPCFC results, and are not predictive of clinical response to PTAH. Peanut (Arachis hypogaea) allergen powder‐dnfp contains the relevant and immunodominant allergens, inducing immunological changes with the treatment.Clinical Trial RegistrationClinicalTrials.gov identifier: NCT02635776.

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Peanut thresholds in peanut‐allergic children are related to dietary composition

Luiten,

Biezeveld,

van Doorn

et al. 2023

Immunity Inflam & Disease

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Background: There is no clear explanation for the large variation in threshold levels among peanut-allergic children. We hypothesized that diet composition can partly explain this variation in thresholds, as nutrients and foods influence the intestinal barrier function and microbiota.Aim: to explore the relationship between the threshold levels for peanut and nutritional intake and gut microbial composition in peanut-allergic children.Methods: In this explorative cross-sectional study the cumulative threshold levels for peanut were determined by oral food challenge tests. Data on

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Using data from food challenges to inform management of consumers with food allergy: A systematic review with individual participant data meta-analysis

Cited by 44 publications

References 48 publications

Peanut Can Be Used as a Reference Allergen for Hazard Characterization in Food Allergen Risk Management: A Rapid Evidence Assessment and Meta-Analysis

Peanut Can Be Used as a Reference Allergen for Hazard Characterization in Food Allergen Risk Management: A Rapid Evidence Assessment and Meta-Analysis

Exploratory immunogenicity outcomes of peanut oral immunotherapy: Findings from the PALISADE trial

Peanut thresholds in peanut‐allergic children are related to dietary composition

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