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Background Methods Results Conclusions 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.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.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.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. [ABSTRACT FROM AUTHOR]

The field of food allergy has seen tremendous change over the past 5–10 years with seminal studies redefining our approach to prevention and management and novel testing modalities in the horizon. Early introduction of allergenic foods is now recommended, challenging the previous paradigm of restrictive avoidance. The management of food allergy has shifted from a passive avoidance approach to active interventions that aim to provide protection from accidental exposures, decrease allergic reaction severity and improve the quality of life of food‐allergic patients and their families. Additionally, novel diagnostic tools are making their way into clinical practice with the goal to reduce the need for food challenges and assist physicians in the—often complex—diagnostic process. With all the new developments and available choices for diagnosis, prevention and therapy, shared decision‐making has become a key part of medical consultation, enabling patients to make the right choice for them, based on their values and preferences. Communication with patients has also become more complex over time, as patients are seeking advice online and through social media, but the information found online may be outdated, incorrect, or lacking in context. The role of the allergist has evolved to embrace all the above exciting developments and provide patients with the optimal care that fits their needs. In this review, we discuss recent developments as well as the evolution of the field of food allergy in the next decade. [ABSTRACT FROM AUTHOR]

Objective: This research sought to explore health care providers' (HCPs) experiences of delivering the first US Food and Drug Administration (FDA) and European Commission (EC) approved peanut oral immunotherapy (peanut OIT; Palforzia). Semi-structured qualitative interviews with HCPs who had initiated treatment with ≥ 3 patients in the first nine months following FDA approval sought to identify challenges faced and successful implementation strategies. Results: Eight allergists and three nurse practitioners from eight sites based in the United States participated. The HCPs included in this research were motivated to implement this novel treatment, however, entered the process with some reservations. HCPs described how successful implementation of peanut OIT requires them to be thoughtful about their clinic's abilities to integrate complex, time-consuming treatments into their daily practice. Prior experience of OIT was deemed beneficial, but not essential for implementation and learning from others' experience was suggested as a way of helping new prescribers overcome perceived and actual implementation challenges. Delivering licensed peanut OIT during the COVID-19 pandemic posed both challenges and unexpected opportunities for implementation. The experiences described have the potential to benefit the wider allergy community by providing practical solutions, successful implementation strategies and opportunities to enhance training and resources. [ABSTRACT FROM AUTHOR]

Food allergies are common,1,2 and as practicing physicians, we regularly see food allergy sufferers in our clinics. This approach has the potential to minimize the number of hospital patient visits and the overall cost of treatment, as OIT to more than one food allergen can be time-consuming and expensive if the allergens are to be administered sequentially, one at a time. Rapid oral desensitization in combination with omalizumab therapy in patients with cow's milk allergy. Allergy Eur J Allergy Clin Immunol. 2018; 73 (4): 799 - 815. [Extracted from the article]

The article offers a study that reveals increasing Peanut allergy in prevalence in the United States. Topics discussed include connection of peanut allergy with an increased risk of sesame sensitization and allergy; mentions the introduction for prevention of tree nut allergy, with proactive approach; and information on the children with negative Standard penetration test (SPT) that suggests 82 percent of sesame in their diet.

The article discusses the use of omalizumab, a biologic, in the treatment of food allergies. The OUtMATCH study evaluated the efficacy and safety of omalizumab in a multi-food allergic population, and found that it significantly increased the threshold of reactivity to peanut and other food allergens compared to a placebo. The study raises questions about the optimal candidate for omalizumab use, the combination of omalizumab with an avoidance diet, the optimal dosage, monitoring of therapy, and the cost and availability of the treatment. Further research and real-world studies are needed to answer these questions and determine the optimal therapy for food-allergic individuals. [Extracted from the article]

Immunoglobulin E (IgE)‐mediated food allergies are the most common type of food allergy, often causing rapid symptoms after exposure to allergens posing a serious health risk and a high impact on patient's and caregiver's quality of life. Omalizumab, a humanized anti‐IgE monoclonal antibody, reduces allergic reactions by binding to circulating IgE. Omalizumab has been successfully used in allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic urticaria, and was recently approved for treating IgE‐mediated food allergies by the US Food and Drug Administration (FDA). This GA2LEN ANACARE Consensus Statement presents our position on the use of omalizumab for treating IgE‐mediated food allergies, based on a systematic review and meta‐analysis, experience with use for other conditions, and expert consensus achieved via an eDelphi process. Following publication of the recent OUtMATCH study (stage 1) results and subsequent FDA approval, we propose that there is now sufficient evidence to recommend omalizumab as the only drug currently available that can mechanistically reduce IgE‐mediated food allergic reactions. We acknowledge that the evidence does not reach the highest level of evidence which would be needed for a guideline recommendation. [ABSTRACT FROM AUTHOR]

Additionally, age and levels of baseline peanut-specific IgE and Arah 2 were significantly different between the group experiencing anaphylaxis compared with the non-anaphylaxis group, with older subjects, and those with higher baseline levels, being more likely to experience anaphylaxis. Peanut Oral Immunotherapy (POIT) is shown to be a safe and efficacious therapeutic option for peanut-allergic patients corroborated by multiple published studies.[[1], [3]] Limited data exist on anaphylaxis risk and long-term therapy.[[4], [6]] The aim of our study was to investigate anaphylaxis episodes during dose escalation and maintenance, and identify potential risk factors and avoidable triggers for these. [Extracted from the article]

Peanut allergy rates have nearly tripled in the last decade.1-3 Initial guidelines, promoting avoidance of allergenic foods in infants, had no effect on the rising prevalence of food allergies, and the recommendations were reversed based on new evidence4. At 6 months of age, peanut SPT was negative and she passed a peanut butter oral challenge, subsequently consuming peanut at least three times a week for 2 weeks. Five of our patients developed IgE-mediated peanut allergy, whereas two developed FPIES to peanut. [Extracted from the article]

Abstract: Background: Intestinal microbes have been shown to influence predisposition to atopic disease, including food allergy. The intestinal microbiome of food‐allergic children may differ in significant ways from genetically similar non‐allergic children and age‐matched controls. The aim was to characterize fecal microbiomes to identify taxa that may influence the expression of food allergy. Methods: Stool samples were collected from children with IgE‐mediated food allergies, siblings without food allergy, and non‐allergic controls. Stool microbiome characterization was performed via next‐generation sequencing (Illumina) of the V1V3 and V4 variable regions of the 16S rRNA gene. Bacterial diversity, evenness, richness, and relative abundance of the operational taxonomic units (OTUs) were evaluated using QIIME. ANOVA and Welch's t test were utilized to compare groups. Results: Sixty‐eight children were included: food‐allergic (n = 22), non‐food‐allergic siblings (n = 25), and controls (n = 21). When comparing fecal microbial communities across groups, differences were noted in Rikenellaceae (P = .035), Actinomycetaceae (P = .043), and Pasteurellaceae (P = .018), and nine other distinct OTUs. Food‐allergic subjects had enrichment for specific microbes within the Clostridia class and Firmicutes phylum (Oscillobacter valericigenes, Lachnoclostridium bolteae, Faecalibacterium sp.) compared to siblings and controls. Identification of Clostridium sp. OTUs revealed differences in specific Clostridia drive the separation of the allergic from the siblings and controls. Alistipes sp. were enriched in non‐allergic siblings. Conclusions: Comparisons in the fecal microbiome of food‐allergic children, siblings, and healthy children point to key differences in microbiome signatures, suggesting the role of both genetic and environmental contributors in the manifestation of food‐allergic disease. [ABSTRACT FROM AUTHOR]

National asthma guidelines recommend an outpatient follow-up after hospitalization for asthma. Our aim is determine if a follow-up visit within 30 days after an asthma hospitalization impacts risk for re-hospitalization and emergency department visits for asthma within the following year. This was a retrospective cohort study of claims data of Texas Children's Health Plan (a Medicaid managed care program) members age 1 to <18 years and hospitalized for asthma between January 1, 2012, and December 31, 2018. Primary outcomes were days to re-hospitalization and emergency department visit between 30 days and 365 days following the index hospitalization. We identified 1,485 children age 1 to <18 years hospitalized for asthma. Comparing those with a 30 day follow-up to those without, there was no difference in days to re-hospitalization (adjusted hazard ratio 1.23, 95% Confidence Interval (CI) 0.74–2.06) or emergency department visit for asthma (aHR 1.08, 95% CI 0.88–1.33). Inhaled corticosteroid and short acting beta agonist dispensing were greater in the group completing the 30 day follow-up (means of 2.8 and 4.8 respectively for those with follow-up, 1.6 and 3.5 respectively for those without, p < 0.0001). Having a follow-up outpatient visit within 30 days of an asthma hospitalization is not associated with a decrease in asthma re-hospitalization or emergency department visit in the 30–365 day period following the index hospitalization. Non-adherence to regular use of inhaled corticosteroid medication was high in both groups. These findings suggest need for improvement in the quality and quantity of post hospital asthma follow-up. [ABSTRACT FROM AUTHOR]

Purpose: Peanut allergy and its current management, involving peanut avoidance and use of rescue medication during instances of accidental exposure, are burdensome to patients and their caregivers and can be a source of stress, uncertainty, and restriction. Physicians may also be frustrated with a lack of effective and safe treatments other than avoidance in the current management of peanut allergy. Efficacy, determined using double-blind, placebo-controlled food challenges (DBPCFCs), of oral immunotherapy with peanut (Arachis hypogaea) allergen powder-dnfp (PTAH; Palforzia®) was demonstrated versus placebo in children and adolescents aged 4 to 17 years in multiple phase 3 trials; continued benefit of PTAH was shown in a follow-on trial. The DBPCFC is a reproducible, rigorous, and clinically meaningful assessment accepted by regulatory authorities to evaluate the level of tolerance as an endpoint for accidental exposures to peanut in real life. It also provides useful clinical and patient-relevant information, including the amount of peanut protein an individual with peanut allergy can consume without experiencing dose-limiting symptoms, severity of symptoms, and organs affected upon ingestion of peanut protein. We explored symptoms of peanut exposure during DBPCFCs from phase 3 and follow-on trials of PTAH to further characterize treatment efficacy from a perspective relevant to patients, caregivers, and clinicians. Methods: Symptom data recorded during screening and/or exit DBPCFCs from participants aged 4 to 17 years receiving PTAH or placebo were examined post hoc across three PTAH trials (PALISADE [ARC003], ARC004 [PALISADE follow-on], and ARTEMIS [ARC010]). The maximum peanut protein administered as a single dose during DBPCFCs was 1000 mg (PALISADE and ARTEMIS) and 2000 mg (ARC004). Symptoms were classified by system organ class (SOC) and maximum severity. Endpoints were changes in symptom severity and freedom from symptoms (ie, asymptomatic) during DBPCFC. Relative risk (RR) was calculated for symptom severity by SOC and freedom from symptoms between groups; descriptive statistics were used to summarize all other data. Results: The risk of any respiratory (RR 0.42 [0.30–0.60], P < 0.0001), gastrointestinal (RR 0.34 [0.26–0.44], P < 0.0001), cardiovascular/neurological (RR 0.17 [0.08–0.39], P < 0.001), or dermatological (RR 0.33 [0.22–0.50], P < 0.0001) symptoms was significantly lower in participants treated with PTAH versus placebo upon exposure to peanut at the end of the PALISADE trial (ie, exit DBPCFC). Compared with placebo-treated participants (23.4%), the majority (76.3%) of PTAH-treated participants had no symptoms at the exit DBPCFC when tested at the peanut protein dose not tolerated (ie, reactive dose) during the screening DBPCFC. Significantly higher proportions of PTAH-treated participants were asymptomatic at doses ≤ 100 mg in the exit DBPCFC compared with placebo-treated participants (PALISADE: 69.35% vs 12.10%, RR 5.73 [95% confidence interval (CI) 3.55–9.26]; P < 0.0001; ARTEMIS: 67.42% vs 13.95%, RR 4.83 [95% CI 2.28–10.25]; P < 0.0001); findings were similar at peanut protein doses ≤ 1000 mg (PALISADE: RR 15.56 [95% CI 5.05–47.94]; P < 0.0001; ARTEMIS: RR 34.74 [95% CI 2.19–551.03]; P < 0.0001). In ARC004, as the period of PTAH maintenance became longer, greater proportions of participants were asymptomatic at doses of peanut protein ≤ 1000 mg in the exit DBPCFC (from 37.63% after ~ 6 months of maintenance treatment [exit DBPCFC of PALISADE] to 45.54% after ~ 13 months and 58.06% after ~ 20 months of overall PTAH maintenance treatment). Conclusions: PTAH significantly reduced symptom severity due to exposure to peanut, which is clinically relevant. When exposed to peanut, participants with peanut allergy treated with PTAH rarely had moderate or severe respiratory or cardiovascular/neurological symptoms. Oral immunotherapy with PTAH appears to reduce frequency and severity of allergic reactions in individuals with peanut allergy after accidental exposure to peanut and may enable them and their families to have an improved quality of life. Trial registration ClinicalTrials.gov, NCT02635776, registered 17 December 2015, https://clinicaltrials.gov/ct2/show/NCT02635776?term=AR101&draw=2&rank=7; ClinicalTrials.gov, NCT02993107, registered 08 December 2016, https://clinicaltrials.gov/ct2/show/NCT02993107?term=AR101&draw=2&rank=6; ClinicalTrials.gov, NCT03201003, registered 22 June 2017, https://clinicaltrials.gov/ct2/show/NCT03201003? term = AR101&draw = 2&rank = 9 [ABSTRACT FROM AUTHOR]

Background: Health‐related quality of life (HRQoL) is significantly and substantially reduced in individuals with peanut allergy due to many factors associated with unanticipated or potentially fatal reactions. Further insight on the impact of peanut oral immunotherapy in managing peanut allergy on HRQoL is needed. The aim of this analysis was to assess effects of peanut (Arachis hypogaea) allergen powder‐dnfp (PTAH), a biologic drug for peanut oral immunotherapy, on HRQoL from three phase 3 and two follow‐on trials of PTAH. Methods: HRQoL assessments from participants aged 4–17 in the PALISADE (ARC003), ARC004 (PALISADE follow‐on), ARTEMIS (ARC010), RAMSES (ARC007), and ARC011 (RAMSES follow‐on) trials were included in this analysis. Responses on the Food Allergy Quality of Life Questionnaire (FAQLQ) and Food Allergy Independent Measure (FAIM) were evaluated by age group and respondent (self or caregiver proxy). Data were analyzed with descriptive statistics and Student t tests. Results: Baseline FAQLQ and FAIM total scores appeared comparable between PTAH‐ and placebo‐treated participants. Self and caregiver proxy‐reported total scores on the FAQLQ for PTAH‐treated participants generally improved at trial exit versus baseline; FAIM total scores improved throughout all trials. The tendency for improvement in FAQLQ total scores from baseline for PTAH appeared larger in self versus caregiver proxy‐reports. Between treatment groups, PTAH was generally favored in the PALISADE and ARTEMIS trials; differences varied in the RAMSES trial based on age and respondent types. Conclusions: PTAH for the management of peanut allergy in children appeared to have a beneficial effect on HRQoL in trials. Improvements were seen despite rigors of trial participation. [ABSTRACT FROM AUTHOR]

Dendritic cells are important mediators in the early presentation of antigen and regulation of the differentiation of T cells. Peanut oral immunotherapy (POIT) results in desensitization in most peanut allergic individuals (responders), but not in others due to allergic reactions (non-responders). Delineation of early immunologic changes contributing to desensitization would help clarify the POIT mechanism of action. We analyzed dendritic cells in 15 pediatric subjects (5–12 years) undergoing a phase 1 single-center POIT study. We examined dendritic cells at baseline, 6-, 12-, 18- and 24-weeks after initiation of POIT and responders of therapy were compared to non-responders and healthy controls. The distribution frequency of myeloid DCs (mDCs) and plasmacytoid DCs (pDCs) from peripheral blood samples were measured in vitro. A general linear mixed model was used, and included fixed effects for cohort (responder, non-responder, or healthy control), time (0-, 6-, 12-, 18-, and 24-weeks), and the cohort-time interaction term. P-values were adjusted for multiple hypothesis testing using Tukey's method. We observed that POIT responders had reduced TNFa producing myeloid dendritic cells (mDCs) compared to non-responders. Additionally, non-responders had increased OX40L expressing mDCs at 18-weeks compared to responders. In conclusion, our findings suggest that a reduced pro-inflammatory phenotype in DCs could potentially serve as a predictor of early outcome and success of POIT desensitization. [ABSTRACT FROM AUTHOR]

The food preparations were prepared by placing either 0.5g of fresh food, 1g dry food mixed with 1mL of isotonic saline until paste, or using commercial liquid food extract (please see Appendix S1 for information on where allergens and extracts were obtained from). A pairwise comparison of SPT wheal size between fresh-powder, fresh-extract, and powder-extract forms of food allergens showed no significant difference ( I P i > .05) (Table). A significant difference in APT skin reactivity ( I P i < .05) was seen between extract-fresh and extract-powder for all food allergens, where skin reactivity was more pronounced in the fresh and powder forms compared to the extract. 4 Zivanovic M, Atanaskovic-Markovic M, Medjo B. Evaluation of food allergy in children by skin prick tests with commercial extracts and fresh foods, specific IgE and open oral food challenge-our five years experience in food allergy work-up. [Extracted from the article]

Key Clinical Message: Mechanical complications of acute myocardial infarction include ventricular septal rupture (VSR), free wall rupture, and ischemic mitral regurgitation. Postinfarction VSR is a rare but serious complication of myocardial infarction. VSR has a lower incidence in the era of new reperfusion therapies. However, clinicians should be aware of this potentially fatal complication as the mortality remains extremely high. Early diagnosis and treatment are the cornerstones of achieving a better outcome. Mechanical complications of acute myocardial infarction include ventricular septal rupture (VSR), free wall rupture, and ischemic mitral regurgitation. Post infarction VSR is a rare but serious complication of myocardial infarction. VSR has a lower incidence in the era of new reperfusion therapies. However, clinicians should be aware of this potentially fatal complication as the mortality remains extremely high. Early diagnosis and treatment are the cornerstones of achieving a better outcome. [ABSTRACT FROM AUTHOR]

Key Clinical Message: Fluoroscopy permits rapid and straightforward assessment of mechanical valve function and allows a distinction between normal and malfunctional prostheses, acting as a complementary diagnostic step. [ABSTRACT FROM AUTHOR]