scholarly journals Analysis of a Large Standardized Food Challenge Data Set to Determine Predictors of Positive Outcome Across Multiple Allergens

2018 ◽  
Vol 9 ◽  
Author(s):  
Sayantani Sindher ◽  
Andrew J. Long ◽  
Natasha Purington ◽  
Madeleine Chollet ◽  
Sara Slatkin ◽  
...  

Background: Double-blind placebo-controlled food challenges (DBPCFCs) remain the gold standard for the diagnosis of food allergy; however, challenges require significant time and resources and place the patient at an increased risk for severe allergic adverse events. There have been continued efforts to identify alternative diagnostic methods to replace or minimize the need for oral food challenges (OFCs) in the diagnosis of food allergy.Methods: Data was extracted for all IRB-approved, Stanford-initiated clinical protocols involving standardized screening OFCs to a cumulative dose of 500 mg protein to any of 11 food allergens in participants with elevated skin prick test (SPT) and/or specific IgE (sIgE) values to the challenged food across 7 sites. Baseline population characteristics, biomarkers, and challenge outcomes were analyzed to develop diagnostic criteria predictive of positive OFCs across multiple allergens in our multi-allergic cohorts.Results: A total of 1247 OFCs completed by 427 participants were analyzed in this cohort. Eighty-five percent of all OFCs had positive challenges. A history of atopic dermatitis and multiple food allergies were significantly associated with a higher risk of positive OFCs. The majority of food-specific SPT, sIgE, and sIgE/total IgE (tIgE) thresholds calculated from cumulative tolerated dose (CTD)-dependent receiver operator curves (ROC) had high discrimination of OFC outcome (area under the curves > 0.75). Participants with values above the thresholds were more likely to have positive challenges.Conclusions: This is the first study, to our knowledge, to not only adjust for tolerated allergen dose in predicting OFC outcome, but to also use this method to establish biomarker thresholds. The presented findings suggest that readily obtainable biomarker values and patient demographics may be of use in the prediction of OFC outcome and food allergy. In the subset of patients with SPT or sIgE values above the thresholds, values appear highly predictive of a positive OFC and true food allergy. While these values are relatively high, they may serve as an appropriate substitute for food challenges in clinical and research settings.

2021 ◽  
Vol 3 (1) ◽  
pp. 3-7 ◽  
Author(s):  
Justin Greiwe

A verified food allergy can be an impactful life event that leads to increased anxiety and measurable effects on quality of life. Allergists play a key role in framing this discussion and can help alleviate underlying fears by promoting confidence and clarifying safety concerns. Correctly diagnosing a patient with an immunoglobulin E (IgE) mediated food allergy remains a nuanced process fraught with the potential for error and confusion. This is especially true in situations in which the clinical history is not classic, and allergists rely too heavily on food allergy testing to provide a confirmatory diagnosis. A comprehensive medical history is critical in the diagnosis of food allergy and should be used to determine subsequent testing and interpretation of the results. Oral food challenge (OFC) is a critical procedure to identify patients with an IgE-mediated food allergy when the history and testing are not specific enough to confirm the diagnosis and can be a powerful teaching tool regardless of outcome. Although the safety and feasibility of performing OFC in a busy allergy office have always been a concern, in the hands of an experienced and trained provider, OFC is a safe and reliable procedure for patients of any age. With food allergy rates increasing and analysis of recent data that suggests that allergists across the United States are not providing this resource consistently to their patients, more emphasis needs to be placed on food challenge education and hands-on experience. The demand for OFCs will only continue to increase, especially with the growing popularity of oral immunotherapy programs; therefore, it is essential that allergists become familiar with the merits and limitations of current testing modalities and open their doors to using OFCs in the office.


2020 ◽  
Vol 2 (1) ◽  
pp. 31-34
Author(s):  
Amal H. Assa’ad

Oral food challenge (OFC) is a procedure that is conducted most commonly by allergist/immunologists in their office or in food allergy centers to confirm a food allergy or to confirm tolerance to the food. The procedure as conducted in clinical practice is mostly open food challenge and, in research, a double-blind, placebo controlled food challenge. OFC has associated risks that can be minimized by having the challenges conducted by trained personnel who are prepared to treat allergic reactions and who have rescue medications available. However, OFCs have tremendous benefits to the patients and their families, including the potential to determine that a food is no longer an allergen and can be introduced into the diet. Even OFCs that result in clinical reactions have the benefit of confirming the food allergy and demonstrating the therapeutic effect of the rescue medications. The study of the outcomes of OFC has shed light on food allergy reactions and characteristics of the patients with food allergy as well as on the value of other diagnostic tests compared with OFC. OFCs have helped establish food allergy thresholds, confirm that subjects enrolled in research studies have the allergy, and demonstrate the response to the therapies tested in terms of ameliorating the allergic response or raising the reaction threshold. OFCs have also been used to promote the recent guidelines for the prevention of peanut allergy by identifying the infants at risk for peanut allergy but who are not allergic yet.


2019 ◽  
Vol 6 ◽  
pp. 2333794X1989129
Author(s):  
Abdullah Alsaggaf ◽  
James Murphy ◽  
Sydney Leibel

Introduction. Food allergies affect 8% of the pediatric population in the United States with an estimated annual cost of US$25 billion. The low specificity of some of the main food allergy tests used in diagnosis may generate false positives incurring unnecessary costs. We examined the cost-effectiveness of oral food challenges (OFC) as confirmatory tests in the diagnosis of food allergy. Methods. We constructed a decision tree with a Markov model comparing the long-term (15 years) cost and effectiveness—in the form of quality-adjusted life years (QALY)—of confirmatory OFCs compared with immediate allergenic food elimination (FE) after a skin prick test or blood immunoglobulin E (IgE) level in children with suspected food allergy. For costs, we included the costs of OFCs and the reported annual costs of having a food allergy, including direct medical costs and costs borne by families. Results. The cost of OFC strategy was $8671 compared with $18 012 for the FE strategy for the length of the model. Also, the OFC strategy had a total QALY of 21.942 compared with 21.740 for the FE strategy. In the OFC strategy, the total cost was $9341 less than FE and the increase in QALY after OFCs led to a 0.202 higher effectiveness in the OFC strategy. Conclusion. In conclusion, our study shows that the confirmatory OFC strategy dominated the FE strategy and that a confirmatory OFC for children, within a year of diagnosis, is a cost-effective strategy that decreases costs and appears to improve quality of life.


Author(s):  
Umit Murat Sahiner ◽  
Ebru Arik Yilmaz ◽  
Sara Fontanella ◽  
Sadia Haider ◽  
Ozge Soyer ◽  
...  

<b><i>Introduction:</i></b> Children with food allergy are at increased risk for asthma and asthma morbidity. Since leukotrienes are implicated in the pathogenesis of both asthma and probably in food allergies, we hypothesized that asthmatic children with concomitant food allergy may have a favorable response to antileukotriene treatment. <b><i>Methods:</i></b> Asthmatic children aged 6–18 years with and without food allergy were treated with montelukast and placebo in a double-blind, placebo-controlled cross-over parallel-group study. The primary outcome of the study was improvement in FEV1%. Asthma control tests, spirometry and methacholine challenges were performed as well as Fractional Exhaled Nitric Oxide (FeNO) levels. PGD2, CystLT, and lipoxin levels were measured in exhaled breath condensate (EBC). <b><i>Results:</i></b> A total of 113 children were enrolled and 87 completed the study in accordance with the protocol. At baseline, children with food allergy and asthma (FAA) had higher levels of PGD2 and CysLT levels in the EBC than children with asthma alone (AA) (<i>p</i> &#x3c; 0.001 for each). In the montelukast arm, although FEV1% was significantly higher in the FAA group compared to AA (<i>p</i> = 0.005), this effect was linked to the baseline difference of FEV1% between both arms. Montelukast treatment failed to improve FEV1% in both groups compared to the placebo. No effect of montelukast was observed in the remaining study parameters. <b><i>Conclusion:</i></b> Although children with FAA do not show a more favorable response to montelukast treatment compared to AA, a significant difference between baseline PGD2 and CystLT levels between FAA and AA groups may point to a different endotype of childhood asthma.


Author(s):  
Daniela Roehrl ◽  
Susanne Brandstetter ◽  
Linda Siziba ◽  
Dietrich Rothenbacher ◽  
Vincent Gaertner ◽  
...  

Background: The prevalence of food allergies (FA) in children increased rapidly at the turn of the century. The EuroPrevall study identified Germany as a country with very high prevalence of FA at that time. Using two large German birth cohorts we provide an update of the status quo ten years later. Methods: KUNO Kids and Ulm SPATZ Health studies are two ongoing prospective birth cohorts. Information on FA was obtained by questionnaires at birth and after 6, 12 and 24 months. Univariate logistic regression analyses were performed to investigate risk factors during pregnancy, birth and early childhood. Results: In 1139 and 1006 children from KUNO Kids and SPATZ the point prevalence of parent-reported FA symptoms at the ages of 1 and 2 years was 13.2% and 13.9 % in KUNO Kids. Doctor’s diagnosed FA at 1 and 2 years was 2.4% and 2.7% in KUNO Kids and 2.3% and 3% in SPATZ. Cow’s milk and citrus fruits were most frequently suspected by parents to cause FA symptoms. Atopy in the child was associated with a higher frequency of FA at any time, whereas atopy in first degree relatives was only associated with FA at year 1. Smoke exposure during pregnancy was a risk for FA at age 2. Conclusion: The prevalence of food allergy seems to have plateaued in the last 10 years in Germany. FA is often suspected by parents but only rarely diagnosed by oral food challenge. Risk factor analysis may help to establish personalized health approaches.


Author(s):  
C. Nitsche ◽  
C. D. Westerlaken-van Ginkel ◽  
B. J. Kollen ◽  
A. B. Sprikkelman ◽  
G. H. Koppelman ◽  
...  

Abstract Background Tolerance development rates differ between food allergies. Almost all previous studies have not used the gold standard method, the double-blind, placebo-controlled food challenge (DBPCFC), which may affect the reported prevalence rates. Little is known about the association of the eliciting dose (ED) obtained during the initial DBPCFC with later tolerance development. Methods This was a retrospective, tertiary care study of children who had a positive DBPCFC to either peanut, milk or egg, and at least one follow-up food challenge (open or DBPCFC) with the same food. The association between ED and negative (tolerant) follow-up food challenge outcome was analyzed by logistic regression, with adjustment for confounders. Suspected confounders were initial DBPCFC test characteristics, atopic comorbidities and serum specific IgE (sIgE) levels. Results In 47 peanut allergic children, tolerance developed in 27.7% (median follow-up duration of 43 months). In 80 milk (follow-up 23 months) and 55 egg (follow-up 37 months) allergic children, tolerance developed in 55.0% and 65.5%. The ED obtained during the initial DBPCFC was significantly associated with tolerance development in peanut and milk allergy, but not in egg allergy. Conclusion Approximately 1 out of 4 children with DBPCFC confirmed peanut allergy developed tolerance, compared to more than half of the children with milk or egg allergy, respectively. Tolerance development in peanut and milk allergy is significantly associated with ED at initial DBPCFC.


2020 ◽  
Vol 68 (6) ◽  
pp. 1152-1155
Author(s):  
Joan H Dunlop

The US Food and Drug Administration’s approval of a peanut oral immunotherapy product in January 2020 is a landmark development in the field of food allergy therapy. While food allergy prevalence has been increasing, this product is the first approved therapy for food allergy. Oral immunotherapy has many similarities to subcutaneous immunotherapy and drug desensitization protocols, but does not lead to sustained unresponsiveness. The studies leading to approval of the Palforzia product demonstrated increase in the amount of peanut protein able to be consumed, with 67% of subjects randomized to the treatment arm able to consume 600 mg of peanut protein in double-blind placebo-controlled food challenge at study exit. However, side effects are an important consideration, and dropout rates in studies of Palforzia ranged from 11% to 21%. Postmarketing surveillance of this product will be critical in assessing its long-term risks and benefits.


1996 ◽  
Vol 115 (4) ◽  
pp. 312-318 ◽  
Author(s):  
Jacquelynne P. Corey ◽  
Anil Gungor

The role of immunoglobulin E-mediated food allergy in subjects with allergic disorders, especially in patients with rhinitis and sinusitis, is underestimated by clinicians because of the initial attribution of these disorders to immediate-type hypersensitivity reactions. The difficulties of diagnosing food-related reactions have caused further delay in their recognition and incorporation into the daily practice of diagnosing food allergy. Two of the diagnostic methods for food allergy are the in vitro assay of total immunoglobulin E and the measurement of food-specific immunoglobulin E levels in serum with the radioallergosorbent test. Measurement of specific immunoglobulin E level is the most commonly used but also one of the most controversial techniques. We examined 123 patients with rhinitis who were referred to our otolaryngology/allergy clinic between January and April 1995. All patients received an initial radioallergosorbent test screen, which included milk. We determined the positive predictive value of this positive screen and, in particular, of a positive test for milk in the diagnosis of immunoglobulin E-mediated food allergies in these patients. Conclusions were based on comparison with the result of an additional radioallergosorbent test food panel consisting of eight common and two investigational food allergens. (Otolaryngol Head Neck Surg 1996;115:312-8.)


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