Peanut Allergen Threshold Study (PATS): Novel single-dose oral food challenge study to validate eliciting doses in children with peanut allergy

Hourihane, Jonathan; Allen, Katrina J.; Shreffler, Wayne G.; DunnGalvin, Gillian; Nordlee, Julie A.; Zurzolo, G.; DunnGalvin, Audrey; Gurrin, Lyle C.; Baumert, Joseph L.; Taylor, Steve L.

doi:10.1016/j.jaci.2017.01.030

Cited by 120 publications

(116 citation statements)

References 17 publications

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“…However, a mathematical risk is not predictive of a reaction for an individual patient and questions still remain when faced with patients in clinical practice. Clearly, even severely allergic patients can tolerate higher thresholds than previously expected, with the ED 05 being sufficiently high of a threshold to avoid allergic reactions in even severely allergic individuals, as shown by the PATS study …”

Section: Resultsmentioning

confidence: 76%

“…Osterballe et al found no relationship between egg sIgE levels and threshold dose during OFC . Furthermore, sIgE and SPT size did not correlate with objective reactions after the single‐dose peanut challenge in the PATS study . However, a recent randomized controlled trial by Reier‐Nilson et al demonstrated that SPT size and peanut sIgE/total IgE ratio were significantly associated with reaction threshold.…”

Section: Factors Affecting Food Allergen Thresholdmentioning

confidence: 97%

“…The Europrevall low‐dose challenge protocol starts at 3 μg of protein with doses increased following a half‐logarithmic progression up to a maximum of a single serving . Recently, Hourihane et al performed a novel single‐dose challenge with 1.5 mg of peanut protein (6 mg of whole peanut) in the Peanut Allergen Threshold Study (PATS), based on previous peanut ED 05 estimates . Only 8 of 378 subjects (2.1%) reacted to this dose.…”

Section: Factors Affecting Food Allergen Thresholdmentioning

confidence: 99%

“…The mathematical risk of an accidental reaction by “may contain” foods has been calculated, and the benchmark dose for a reaction in 10% of the population in the studies considered was 87 mg of peanut protein, with a 95% lower confidence interval at 31.4 mg . In the PATS study, 378 peanut‐allergic children were challenged with 1.5 mg of peanut protein (6 mg of whole peanut). Only 8 patients presented with an objective reaction, and all were mild.…”

Section: Food Allergy Threshold and Clinical Implicationsmentioning

confidence: 99%

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Clinical implications of food allergen thresholds

Graham

Eigenmann

2018

Clin Experimental Allergy

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Food allergy has increased in recent decades and has a major impact on patients' quality of life. There is currently no treatment in routine clinical practice, and patients are often faced with accidental reactions. Precautionary allergen labelling (PAL) has been used by the food industry to attempt to minimize this risk, although not standardized and often ambiguous. Estimating the risk of reacting to traces in foods is complicated by heterogeneous amounts of allergens in foods with precautionary labelling and individual variability in reaction thresholds. In recent years, oral food challenge studies have shown that low individual reaction thresholds do not necessarily correlate with severe reactions, and current understanding of thresholds is evolving with novel low-dose challenge protocols better adapted to estimate them. Future tools to provide a better estimation of minimal eliciting doses, including basophil activation tests, may improve our management of food-allergic patients.

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Section: Resultsmentioning

confidence: 76%

Section: Factors Affecting Food Allergen Thresholdmentioning

confidence: 97%

Section: Factors Affecting Food Allergen Thresholdmentioning

confidence: 99%

Section: Food Allergy Threshold and Clinical Implicationsmentioning

confidence: 99%

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Clinical implications of food allergen thresholds

Graham

Eigenmann

2018

Clin Experimental Allergy

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“…Dose distribution data are now available for many priority allergenic foods. Single dose challenge studies, recently completed for peanut will be extremely useful to characterize the risk associated with ingestion of a known low dose of an allergenic food. They would not only confirm what proportion of people with the specific allergy would react to that dose (as established by dose distributions) but would also reveal the spectrum of reactions experienced.…”

Section: A New Approach To Precautionary Allergen Labelling: the Healmentioning

confidence: 99%

Evidence‐based approaches to the application of precautionary allergen labelling: Report from two iFAAM workshops

Galvin

Roberts

Schnadt³

et al. 2019

Clin Experimental Allergy

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Food allergy is a major public health concern with avoidance of the trigger food(s) being central to management by the patient. Food information legislation mandates the declaration of allergenic ingredients; however, the labelling of the unintentional presence of allergens is less defined. Precautionary allergen labelling (PAL) was introduced by the food industry to help manage and communicate the risk of reaction from the unintended presence of allergens in foods. In its current form, PAL is counterproductive for consumers with food allergies as there is no standardized approach to applying PAL. Foods with a PAL often do not contain the identified food allergen while some products without a PAL contain quantities of common food allergens that are capable of inducing an allergic reaction. Integrated Approaches to Food Allergen and Allergy Risk Management (iFAAM) was an EU‐funded project that aimed to improve the management of food allergens by the food industry for the benefit of people with food allergies. Within iFAAM, a clinically validated tiered risk assessment approach for food allergens was developed. Two cross‐stakeholder iFAAM workshops were held on 13‐14 December 2016 and 19‐20 April 2018. One of the objectives of these workshops was to develop a proposal to make PAL effective for consumers. This paper describes the outcomes from these workshops. This provides the basis for the development of more informative and transparent labelling that will ultimately improve management and well‐being in consumers with food allergy.

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Eliciting and stop dose during oral food challenges for peanut and common tree nuts in different age groups

de Weger,

Jansen,

van Lente

et al. 2024

Immunity Inflam & Disease

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BackgroundOral food challenges (OFCs) are used to confirm or reject a diagnosis of food allergy. However, younger children may encounter difficulties in consuming all offered doses during an OFC in the absence of symptoms, resulting in inconclusive outcomes. Our aim is to assess the eliciting dose for objective symptoms among various age groups and determine the necessity of consuming the final dose step during an uneventful OFC to avoid false negative outcomes.MethodsOFCs for common food allergens performed between 2012 and 2019 were analyzed retrospectively. The primary outcome was the association of age with stop dose for OFCs with inconclusive outcome. Secondary outcome measures were the association of age with eliciting dose and the potential number of false negative outcomes.ResultsA total of 1327 OFCs were performed in 707 patients. Of these, 514 (38.7%) were positive, 589 (44.4%) negative, and 224 (16.9%) inconclusive. In OFCs with inconclusive outcome, age appeared to be a significant predictor of the stop dose only for almond (p = .005). Objective symptoms occurred after the last dose step in 2%–13% of all OFCs with positive outcome. In our cohort, potential false negative outcomes may have been drawn in 27.6% of uneventful OFCs.ConclusionsTwo third of children under 6 years of age successfully consumed all the provided doses during OFCs with a negative outcome. The eliciting dose for objective symptoms was not associated with age, and in a substantial number of OFCs with positive outcome, symptoms occurred after eating the final dose. These findings suggest that in case of an uneventful OFC, the outcome should be drawn only after a cumulative dose of 4.4 g has been consumed to avoid the risk of a potential false negative outcome.

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Peanut Allergen Threshold Study (PATS): Novel single-dose oral food challenge study to validate eliciting doses in children with peanut allergy

Cited by 120 publications

References 17 publications

Clinical implications of food allergen thresholds

Clinical implications of food allergen thresholds

Evidence‐based approaches to the application of precautionary allergen labelling: Report from two iFAAM workshops

Eliciting and stop dose during oral food challenges for peanut and common tree nuts in different age groups

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