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This document summarizes a study on the relationship between atopic dermatitis (AD) and IgE-mediated food allergy (FA) in children. The study found that children with AD were more likely to develop FA, and vice versa. However, the study had limitations, such as not assessing the severity of AD and having a small sample size for cases of FA. The findings suggest that AD and FA may be related and further research is needed to understand and address these conditions. [Extracted from the article]

BACKGROUND No approved treatment for peanut allergy exists for children younger than 4 years of age, and the efficacy and safety of epicutaneous immunotherapy with a peanut patch in toddlers with peanut allergy are unknown. METHODS We conducted this phase 3, multicenter, double-blind, randomized, placebo-controlled trial involving children 1 to 3 years of age with peanut allergy confirmed by a double-blind, placebo-controlled food challenge. Patients who had an eliciting dose (the dose necessary to elicit an allergic reaction) of 300 mg or less of peanut protein were assigned in a 2:1 ratio to receive epicutaneous immunotherapy delivered by means of a peanut patch (intervention group) or to receive placebo administered daily for 12 months. The primary end point was a treatment response as measured by the eliciting dose of peanut protein at 12 months. Safety was assessed according to the occurrence of adverse events during the use of the peanut patch or placebo. RESULTS Of the 362 patients who underwent randomization, 84.8% completed the trial. The primary efficacy end point result was observed in 67.0% of children in the intervention group as compared with 33.5% of those in the placebo group (risk difference, 33.4 percentage points; 95% confidence interval, 22.4 to 44.5; P<0.001). Adverse events that occurred during the use of the intervention or placebo, irrespective of relatedness, were observed in 100% of the patients in the intervention group and 99.2% in the placebo group. Serious adverse events occurred in 8.6% of the patients in the intervention group and 2.5% of those in the placebo group; anaphylaxis occurred in 7.8% and 3.4%, respectively. Serious treatment-related adverse events occurred in 0.4% of patients in the intervention group and none in the placebo group. Treatment-related anaphylaxis occurred in 1.6% in the intervention group and none in the placebo group. CONCLUSIONS In this trial involving children 1 to 3 years of age with peanut allergy, epicutaneous immunotherapy for 12 months was superior to placebo in desensitizing children to peanuts and increasing the peanut dose that triggered allergic symptoms. (Funded by DBV Technologies; EPITOPE ClinicalTrials.gov number, NCT03211247. opens in new tab.) [ABSTRACT FROM AUTHOR]

Purpose of Review: To discuss if all patients who use self-injectable epinephrine outside the hospital setting require immediate emergency care., Recent Findings: Prior to 2023, anaphylaxis management guidance universally recommended that patients who use self-injectable epinephrine outside of the hospital or clinic setting immediately activate emergency medical services and seek further care. Additional food-induced anaphylaxis management recommendations specified that all patients always carry 2 auto-injector devices and give a second dose of epinephrine if there was not immediate response within 5 min of injection. Patients presenting for emergency care after epinephrine are often observed for up to 4-6 h afterwards, even when completely asymptomatic. These management steps have lacked evidence for improving outcomes, and universal implementation of these approaches is not cost-effective as guidance for food allergic patients. Epinephrine pharmacokinetics and pharmacodynamics suggest that peak physiologic response is more likely to occur closer to 15 min than before 5 min, that few patients require a second dose of epinephrine as most stabilize within 15 min of use, that 60 min of observation after a patient stabilizes after epinephrine use may be adequate as patients infrequently have further sequelae, and that not everyone needs to carry 2 epinephrine auto-injectors on their person at all times. The most recent anaphylaxis practice parameter promotes a contextualized approach to these management questions, outlining the option for watchful waiting to gauge response to epinephrine before seeking emergency care, which has been proven as a more cost-effective management strategy. The recent updated anaphylaxis care guidelines support the evolution of anaphylaxis care, in that universal, immediate activation of emergency services is not required for using self-injectable epinephrine outside the hospital setting., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Standard of care for anaphylaxis treatment is intramuscular (IM) epinephrine. An epinephrine nasal spray (ENS) is under development as an alternative form of administration., Objective: To compare the pharmacokinetic (PK) and pharmacodynamic (PD) profile of 13.2 mg ENS with 0.3 mg IM epinephrine auto-injector., Methods: Data from 4 open-label phase 1 crossover studies conducted in healthy adults were pooled to determine the PK and PD profile of a single 13.2 mg ENS dose delivered by 2 consecutive sprays of 6.6 mg each in opposite (n=224 doses) or the same nostril (n=75 doses) compared with the 0.3 mg IM auto-injector (n=215 doses). Each participant served as their own control. Blood samples and vital signs were collected pre-dose and at multiple intervals from 0-360 minutes post-dose., Results: ENS rapidly increased the plasma epinephrine concentration, with levels that were overall greater than IM auto-injector. Median (range) time to maximum plasma epinephrine concentration with ENS opposite nostrils, ENS same nostril, and IM auto-injector was 25.1 (1.3, 362.1), 20.1 (3.0, 120.2), and 20.0 (1.0, 121.3) minutes, respectively. The area under the plasma concentration-time curve for 0-360 minutes was significantly higher with ENS than the IM auto-injector (geometric mean ratio [90% CI]=155% [140%, 172%] with ENS opposite nostrils, 159% [138%, 182%] with ENS same nostril). The PD effects on heart rate and blood pressure were similar in pattern and magnitude among all 3 treatment groups., Conclusions: ENS rapidly achieved plasma epinephrine levels greater and more sustained than the IM auto-injector and with a similar PD effect., (Copyright © 2024. Published by Elsevier Inc.)

Shared decision-making (SDM) is an increasingly implemented patient-centered approach to navigating patient preferences regarding diagnostic and treatment options and supported decision-making. This therapeutic approach prioritizes the patient's perspectives, considering current medical evidence to provide a balanced approach to clinical scenarios. In light of numerous recent guideline recommendations that are conditional in nature and are clinical scenarios defined by preference-sensitive care options, there is a tremendous opportunity for SDM and validated decision aids. Despite the expansion of the literature on SDM, formal acceptance among clinicians remains inconsistent. Surprisingly, a significant disparity exists between clinicians' self-reported adherence to SDM principles and patients' perceptions of its implementation during clinical encounters. This discrepancy underscores a fundamental issue in the delivery of health care, where clinicians may overestimate their integration of SDM, while patients' experiences suggest otherwise. This review critically examines the factors contributing to this inconsistency, including barriers within the health care system, clinician attitudes and behaviors, and patient expectations and preferences. By elucidating these factors in the fields of food allergy, asthma, eosinophilic esophagitis, and other allergic diseases, this review aims to provide insights into bridging the gap between clinician perception and patient experience in SDM. Addressing this discordance is crucial for advancing patient-centered care and ensuring that SDM is not merely a theoretical concept but a tangible reality in the., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Limited decision-support tools are available to help shared decision-making (SDM) regarding food oral immunotherapy (OIT) initiation. No current tool covers all foods, forms, and pediatric ages for which OIT is offered., Methods: In compliance with International Patient Decision Aid Standards criteria, this pediatric decision-aid comparing OIT versus avoidance was developed in three stages. Nested qualitative data assessing OIT decisional needs were supplemented with evidence-synthesis from the OIT literature to create the prototype decision-aid content. This underwent iterative development with food allergy experts and patient advocacy stakeholders until unanimous consensus was reached regarding content, bias, readability, and utility in making a choice. Lastly, the tool underwent validated assessment of decisional acceptability, decisional conflict, and decisional self-efficacy., Results: The decision-aid underwent 5 iterations, resulting in a 4-page written aid (Flesch-Kincaid reading level 6.1) explaining therapy choices, risks and benefits, providing self-rating for attribute importance for the options and self-assessment regarding how adequate the information was in decision-making. A total of n = 135 caregivers of food-allergic children assessed the decision-aid, noting good acceptability, high decisional self-efficacy (mean score 85.9/100) and low decisional conflict (mean score 20.9/100). Information content was rated adequate and sufficient, the therapy choices wording balanced, and presented without bias for a "best choice." Lower decisional conflict was associated with caregiver-reported anaphylaxis., Conclusions: This first pediatric OIT decision-aid, agnostic to product, allergen, and age has good acceptability, limited bias, and is associated with low decisional conflict and high decisional self-efficacy. It supports SDM in navigating the decision to start OIT or continue allergen avoidance., (© 2024 European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.)

Background: Consumption of ultra-processed foods [UPFs] may be associated with negative health outcomes. Limited data exist regarding the potential role of UPFs in the occurrence of allergic diseases. The underlying mechanisms underpinning any such associations are also poorly elucidated., Methods: We performed a systematic review and narrative evidence synthesis of the available literature to assess associations between UPF consumption and pediatric allergy outcomes (n = 26 papers), including data on the association seen with the gut microbiome (n = 16 papers) or immune system (n = 3 papers) structure and function following PRISMA guidelines., Results: Dietary exposure to fructose, carbonated soft drinks, and sugar intake was associated with an increased risk of asthma, allergic rhinitis, and food allergies in children. Commercial baby food intake was associated with childhood food allergy. Childhood intake of fructose, fruit juices, sugar-sweetened beverages, high carbohydrate UPFs, monosodium glutamate, UPFs, and advanced glycated end-products (AGEs) was associated with the occurrence of allergic diseases. Exposure to UPFs and common ingredients in UPFs seem to be associated with increased occurrence of allergic diseases such as asthma, wheezing, food allergies, atopic dermatitis, and allergic rhinitis, in many, but not all studies., Conclusion: More preclinical and clinical studies are required to better define the link between UPF consumption and the risk of allergies and asthma. These observational studies ideally require supporting data with clearly defined UPF consumption, validated dietary measures, and mechanistic assessments to definitively link UPFs with the risk of allergies and asthma., (© 2024 European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.)

Background: Cow's milk and egg allergy affect approximately 1.9% and 0.9% of children, respectively. Dietary advancement therapies (DATs), including milk (ML) and egg (EL) ladders, and baked milk (BM-OIT) and baked egg (BE-OIT) oral immunotherapy, are potential therapeutic options for these patients., Objective: To perform systematic review and meta-analysis of the safety and efficacy of DATs in children with IgE-mediated milk or egg allergy., Methods: A systematic literature review was conducted, exploring 22 potential outcomes, with meta-analysis performed where ≥3 studies reported data. The GRADE approach was used to determine the certainty of evidence for each outcome, and the Johanna Briggs Institute tools were used for determining risk of bias., Results: Twenty-nine studies met inclusion criteria among 9946 titles screened. Tolerance occurred in 69% of EL, 58% of ML, 49% of BE-OIT, and 29% of BM-OIT patients. All-severity allergic reactions occurred in 21% of EL, 25% of ML, 20% of BE-OIT, and 61% of BM-OIT patients, with epinephrine use in 3% of EL, 2% of ML, and 9% of BM-OIT patients. At-home reactions occurred in 19% of BE-OIT and 10% of BM-OIT patients. Discontinuation occurred in 14% of EL, 17% of ML, 17% of BE-OIT, and 20% of BM-OIT patients. The mean time to BE egg and BE-OIT tolerance was 13.25 months (4 studies) and 19.1 months (3 studies). Certainty of evidence was very low, and risk of bias high. Study heterogeneity was high, attributable to multiple factors., Conclusions: There is very low certainty of evidence supporting DAT safety and efficacy. We cannot conclude that DAT accelerates tolerance development., (Copyright © 2024 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Omalizumab is an anti-IgE therapy newly approved by the Food and Drug Administration for allergen agnostic treatment of single or multiple food allergies in patients aged 1 year or older., Objective: Evaluate the cost-effectiveness of omalizumab as a food allergy treatment., Methods: We evaluated health and economic outcomes in Markov cohorts of simulated food allergic infants randomized to receive omalizumab using a 15-year horizon. Monte Carlo simulation was used (n = 40,000 subjects) to evaluate cost-effectiveness from a societal perspective, incorporating both a family-level and individual-level analysis. We included family-level analysis to incorporate a broad perspective for health utility change, given treatment effects likely benefit all parties at home (eg, caregivers, siblings), not just the patient, representing the sum of changes in all such persons. Supplemental analyses explored lower omalizumab cost and home initiation. We performed deterministic and probabilistic sensitivity analyses., Results: In the family-level cohort analysis, omalizumab exceeded cost-effectiveness thresholds ($185,183/quality-adjusted life-years [QALY]). In a comparison of the omalizumab strategy (OMA) with the non-omalizumab strategy, the cost of OMA exceeded the non-omalizumab strategy ($315,020 vs $136,609) with greater incremental effectiveness (12.668 vs 11.699 QALY). In the individual-level analysis, the cost-effectiveness of OMA was $573,698/QALY. In base-case assessments, OMA was cost-effective (willingness to pay, $100,000/QALY) at a health state utility (HSU) improvement of 0.265. The value-based cost of OMA ranged from $14,166 to $23,791 when it was considered at the individual and family-unit levels. Requiring OMA administration in the clinic was not cost-effective (incremental cost-effectiveness ratio, $260,239)., Conclusions: In the base case and at current pricing, omalizumab is not cost-effective, but it could be at a lower retail price or when use creates large health utility shifts in the family and patient., (Copyright © 2024 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Food allergy management has greatly evolved in the last several years, moving from passive approaches, such as strict food allergen avoidance, to more active treatments, including regulatory approval of the first specifically indicated immunotherapy product (for peanut) in 2020. In 2024, a second therapy, omalizumab, received regulatory approval for the treatment of 1 or more IgE-mediated food allergies, providing clinicians with multiple treatment options to offer patients and families. With this expanded armamentarium of food allergy treatment options, the practicing clinician requires detailed knowledge of benefits and risks of omalizumab, how omalizumab fits into the management landscape, and how to use shared decision-making to optimize therapy. This yardstick aims to provide the clinician with a review of data leading to omalizumab's food allergy indication and an evidence-based expert opinion approach regarding on how best to use this and other therapies available to optimize patient management., Competing Interests: Disclosures Dr Anagnostou reports receiving institutional funding from Novartis; serving as advisory board member of Genentech, Novartis, Bryn, and Ready. Set. Food!; and receiving consultation/speaker fees from ALK, Adelphi, Novartis, Genentech, Medscape, FARE, MHJ, and EPG Health. Dr Greenhawt is a consultant for Aquestive; is a member of physician/medical advisory boards for DBV Technologies, Takeda, Griffols, Nutricia, Novartis, Aquestive, Allergy Therapeutics, AstraZeneca, ALK-Abello, Bryn, Genentech, and Prota; is a speaker for Genentech; is an unpaid member of the scientific advisory council for the National Peanut Board and medical advisory board of the International Food Protein Induced Enterocolitis Syndrome Association; is a member of the Brighton Collaboration Criteria Vaccine Anaphylaxis 2.0 working group; is the senior associate editor for the Annals of Allergy, Asthma & Immunology; and is member of the Joint Taskforce on Allergy Practice Parameters. He has received honorarium for lectures from ImSci, Red Nucleus, Medscape, Paradigm Medical Communications, Kaplan, Food Allergy Research and Education, and multiple state/local allergy societies. Dr Shaker is a member and co-chair of the Joint Task Force on Practice Parameters, serves on the editorial board of The Journal of Allergy and Clinical Immunology In Practice, is an associate editor of Annals of Allergy, Asthma & Immunology, and serves on the board of directors of the American Academy of Allergy, Asthma & Immunology (views expressed are his own). Dr Vickery reports receiving grants from Alladapt, AstraZeneca, Genentech, National Institute of Allergy and Infectious Diseases (NIAID)/National Institutes of Health (NIH), and Siolta; personal fees from Allergenis, Aravax, Reacta Biosciences, and Sanofi Regeneron; both grants and personal fees from Aimmune, DBV, FARE, Novartis, and Regeneron; and stock options from Moonlight Therapeutics outside the submitted work. Dr Wang is a member of the Joint Task Force on Practice Parameters; receives research support from NIAID, Aimmune, DBV, and Siolta; and receives consultancy fees from ALK-Abello, DBV, and Novartis., (Copyright © 2024 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Food allergy has been increasing in prevalence in most westernised countries and poses a significant burden to patients and families; dietary and social limitations as well as psychosocial and economic burden affect daily activities, resulting in decreased quality of life. Food oral immunotherapy (food-OIT) has emerged as an active form of treatment, with multiple benefits such as increasing the threshold of reactivity to the allergenic food, decreasing reaction severity on accidental exposures, expanding dietary choices, reducing anxiety and generally improving quality of life. Risks associated with food immunotherapy mostly consist of allergic reactions during therapy. While the therapy is generally considered both safe and effective, patients and families must be informed of the aforementioned risks, understand them, and be willing to accept and hedge these risks as being worthwhile and outweighed by the anticipated benefits through a process of shared decision-making. Food-OIT is a good example of a preference-sensitive care paradigm, given candidates for this therapy must consider multiple trade-offs for what is considered an optional therapy for food allergy compared with avoidance. Additionally, clinicians who discuss OIT should remain increasingly aware of the growing impact of social media on medical decision-making and be prepared to counter misconceptions by providing clear evidence-based information during in-person encounters, on their website, and through printed information that families can take home and review., Competing Interests: Competing interests: AA reports institutional funding from Aimmune Therapeutics, Novartis and FARE (Food Allergy Research and Education), and personal fees (consultation and speaker services) from DBV Technologies, ALK and FARE. MG is a consultant for Aquestive; is a member of physician/medical advisory boards for DBV Technologies, Sanofi/Regeneron, Nutricia, Novartis, Aquestive, Allergy Therapeutics, AstraZeneca, ALK-Abello and Prota; is an unpaid member of the scientific advisory council for the National Peanut Board and medical advisory board of the International Food Protein Induced Enterocolitis Syndrome Association; is a member of the Brighton Collaboration Criteria Vaccine Anaphylaxis 2.0 working group; is the senior associate editor for the Annals of Allergy, Asthma, and Immunology; and is member of the Joint Taskforce on Allergy Practice Parameters. He has received honorarium for lectures from ImSci, MedLearningGroup, RMEI Medical Education and multiple state/local allergy societies. He received past research support ending in 2020 from the Agency for Healthcare Quality and Research (K08-HS024599). PRdR reports research grant from Aimmune Therapeutics and FAES; speakers honoraria from GSK, FAES, Novartis, ALK, LETI, Aimmune Therapeutics, Sanofi, Stallergenes and DBV. DS reports consultant fees from ARS Pharmaceuticals, Before Brands, Novartis and ParentMD; research support from DBV Technologies; is a social media editor for the American Academy of Allergy, Asthma and Immunology; is a member of the Board of Regents for the American College of Allergy, Asthma and Immunology; is a member of the Joint Task Force on Practice Parameters for Allergy/Immunology; and is an associate editor of Annals of Allergy, Asthma and Immunology. EMA is an employee of Public Health Agency of Canada. GP and VS report no conflicts of interest., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)