Shrimp oral immunotherapy outcomes in the phase 2 clinical trial: MOTIF.

Introduction: Shrimp is a common but understudied food allergen with relatively high rates of emergency department visits. Here we report the shrimp OIT outcomes in the MOTIF (NCT03504774) clinical trial and discuss some of the challenges with performing this study.

Methods: In this phase 2 clinical trial, 12 shrimp allergic participants aged 7-55 years (median age 21.

Emerging Role of Novel Therapeutics.

The recent United States Food and Drug Administration (FDA) approval of omalizumab for the treatment of food allergy has highlighted the potential of targeting the allergic pathways driving food allergy. Many promising therapeutic strategies are emerging that target different aspects of these pathways including immunoglobulin E, interleukin-4 receptor α, alarmins, and Bruton's tyrosine kinase. Several of these novel therapeutics have already been FDA approved for the treatment of other atopic diseases, greatly facilitating their potential translation to food allergy.

A hand-operated microfluidic sample preparation-to-analysis workflow for simplifying the basophil activation test.

Access to the basophil activation test (BAT) has been hindered by the requirement for fresh blood analysis, specialized laboratory equipment, and advanced technical expertise. To address these issues, we have developed a hand-operated microfluidic sample preparation "μF-prep" device to perform the most time sensitive steps of the assay and stabilize the sample, effectively extending the time window before flow cytometry analysis. The μF-prep device performs concurrent basophil stimulation and staining for eight conditions in parallel.

Long-Term Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: An Open-Label Active Treatment (REALISE Study).

Background: Owing to limited treatment options for peanut allergy, patients remain at risk for allergic reactions due to accidental exposure. Epicutaneous immunotherapy (EPIT) is a novel treatment being investigated for peanut allergy.

Objective: This study assessed long-term safety of EPIT with VIASKIN peanut patch 250 μg (VP250) via an open-label extension of the REAL Life Use and Safety of EPIT (REALISE) trial.

Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Toddlers: Open-Label Extension to EPITOPE.

Background: The pivotal phase 3 EPITOPE trial, a 12-month, double-blind, placebo-controlled study of epicutaneous immunotherapy with the VIASKIN patch containing 250 μg of peanut protein (VP250), previously reported significant treatment response versus placebo in peanut-allergic toddlers aged 1 through 3 years.

Objective: To assess the interim efficacy and safety of VP250 from the first year of the EPITOPE open-label extension (OLE) study.

Methods: Eligible participants enrolled in the OLE study for up to 3 years of total treatment with annual double-blind, placebo-controlled food challenges (DBPCFCs) and safety assessments; here we report the first-year OLE (year 2) results.

Challenges in designing interventions for food insecure families with food allergy in a Californian latinx cohort.

Food allergy poses substantial social, economic, and quality of life burdens which are even heavier for families that are struggling with food insecurity. In the United States (US), food insecurity disproportionately affects vulnerable and historically marginalized communities, such as Latino/a/x and Black households. Targeting these disparities via our recent Food Equality Initiative (FEI) research intervention was challenging due to the barriers faced by the target underserved populations, which included poor digital literacy, language barriers, and limited access to necessary resources.

Management of children with food allergies by allergists in the United States.

Background: Management of patients with food allergies is complex, especially in cases of patients with multiple and potentially severe food allergies. Although international guidelines exist for food allergy management, the role of the allergist in the decision-making process is key.

Objective: Our aim was to investigate the management patterns and educational needs of practicing allergists treating patients with food allergies.

Treatment of Food Allergy: Immunotherapy, Omalizumab, or Both.

Food allergy is a common disease that has substantial impacts on the quality of life of patients and their families, and all reactions have the potential for causing life-threatening anaphylaxis. Food-allergic individuals currently have 2 Food and Drug Administration- approved therapeutic options available to them aside from life-long allergen avoidance: oral immunotherapy (OIT) and omalizumab. OIT for food allergy has been extensively studied in clinical trials and currently provides the greatest level of protection; however, it also has a high burden of treatment.

Efficacy and Safety of Dupilumab in Children With Peanut Allergy: A Multicenter, Open-Label, Phase II Study.

Background: Peanut allergy is a potentially life-threatening food allergy in children. This study explored whether dupilumab, a human monoclonal immunoglobulin (Ig)G4 antibody that blocks the activity of interleukin (IL)-4/IL-13, improved safety and desensitization to peanut exposure in children with peanut allergy.

Methods: A Phase II, 24-week, multicenter, single-arm, open-label, proof-of-concept study was conducted in the USA and Canada (NCT03793608).

Dupilumab as an Adjunct to Oral Immunotherapy in Pediatric Patients With Peanut Allergy.

Background: Peanut allergy is a common, life-threatening food allergy in children. We evaluated whether dupilumab, which blocks the activity of interleukin (IL)-4/IL-13, enhances the efficacy of oral immunotherapy (OIT) AR101 in pediatric patients with peanut allergy.

Methods: A Phase II, multicenter, randomized, double-blind study was conducted in the USA (NCT03682770) in pediatric patients (6-≤ 17 years old) with confirmed peanut allergy.

Baseline epitope-specific IgE profiles are predictive of sustained unresponsiveness or high threshold 1-year post oral immunotherapy in the POISED trial.

Background: Results from the POISED trial suggest that discontinuation of peanut oral immunotherapy can increase the risk of regaining clinical reactivity to peanut.

Objective: We sought to determine whether patients who achieved sustained unresponsiveness (SU) or sustained high threshold (SHT) have different baseline sequential epitope-specific IgE profiles than patients who achieved transient desensitization.

Methods: Subjects in the POISED trial (NCT02103270) were randomized to peanut (n = 95) or placebo (n = 25) for 24 months.

HLA-DR regulatory T cells and IL-10 are associated with success or failure of desensitization outcomes.

Background: Omalizumab (XOLAIR®)-assisted multi-food oral immunotherapy (mOIT) has been shown to safely, effectively, and rapidly desensitize patients with multiple food allergies. In our clinical trial (NCT02626611) on omalizumab-assisted mOIT, different desensitization outcomes (success or failure of desensitization) were observed following a period of either continued or discontinued mOIT. However, the association between the immunological changes induced by omalizumab-assisted mOIT and desensitization outcomes has not yet been fully elucidated.

Asthma management in the digital age.

Asthma affects 25 million people in the United States, and its prevalence is increasing. Access to care and adherence to prescribed asthma-treatment programs remain the principal formidable challenges for asthma management. Telemedicine offers substantial opportunities for improved asthma care of patients across the full range of socioeconomic strata.

Fish and shellfish allergy: Presentation and management differences in the UK and US-analysis of 945 patients.

Background: Seafood allergy (SA), including allergy to shellfish (crustacean and mollusks) and fish, is among the 4 most common food allergies causing anaphylaxis, but there are limited data showing SA clinical management in different countries.

Objective: We sought to characterize a large cohort of patients with fish and shellfish allergy and to facilitate standardization of future care for this increasingly common allergic disease.

Methods: We performed a retrospective, observational, noninterventional study from 945 patients from 2015 to 2019 in 7 hospitals in the United States and the United Kingdom to evaluate SA.

Health care resource use and costs in patients with food allergies: a United States insurance claims database analysis.

Aims: Food allergies impose a large clinical and financial burden on patients and the health care system. However, little is known about the factors associated with health care resource use and costs. The aim of this study was to investigate health care resource use and costs in individuals with food allergies utilizing health care in the United States.

Elucidating allergic reaction mechanisms in response to SARS-CoV-2 mRNA vaccination in adults.

Background: During the COVID-19 pandemic, novel nanoparticle-based mRNA vaccines were developed. A small number of individuals developed allergic reactions to these vaccines although the mechanisms remain undefined.

Methods: To understand COVID-19 vaccine-mediated allergic reactions, we enrolled 19 participants who developed allergic events within 2 h of vaccination and 13 controls, nonreactors.

Preparing Patients for Oral Immunotherapy (PPOINT): International Delphi consensus for procedural preparation and consent.

Background: Despite the promise of oral immunotherapy (OIT) to treat food allergies, this procedure is associated with potential risk. There is no current agreement about what elements should be included in the preparatory or consent process.

Objective: We developed consensus recommendations about the OIT process considerations and patient-specific factors that should be addressed before initiating OIT and developed a consensus OIT consent process and information form.

New biologics for food allergy.

Purpose Of Review: This review aims to explore role of emerging biologics, including ligelizumab, UB-221, dupilumab, and antialarmins, in food allergy management. With a focus on recent developments, we evaluate their promise in mitigating adverse events during oral immunotherapy (OIT), reducing allergic reactions, and addressing the limitations of current therapeutic options.

Recent Findings: Antiimmunoglobulin E mAbs, exemplified by omalizumab, demonstrate efficacy in desensitization and safety improvement during multiallergen OIT.

Corrigendum: Advances and potential of omics studies for understanding the development of food allergy.

[This corrects the article DOI: 10.3389/falgy.2023.

Varying Doses of Epicutaneous Immunotherapy With Viaskin Milk vs Placebo in Children With Cow's Milk Allergy: A Randomized Clinical Trial.

Importance: No approved treatment exists for allergen-specific immunoglobulin E (IgE)-mediated cow's milk allergy (CMA), a common childhood food allergy.

Objective: To assess dose, efficacy, and safety of epicutaneous immunotherapy with Viaskin milk in children with IgE-mediated CMA.

Design, Setting, And Participants: A phase 1/2, 2-part, randomized, double-blind, placebo-controlled dose-ranging clinical trial in children aged 2 to 17 years with IgE-mediated CMA was conducted between November 2014 through December 2017.

The Role of Biologics in the Treatment of Food Allergy.

The landscape of food allergy (FA) treatment is poised for a paradigm shift with the emergence of biologic therapies. The Food and Drug Administration approval of a standardized peanut powder for oral immunotherapy in 2020 marked a milestone, signaling a departure from allergen avoidance toward proactive treatment strategies. Although oral immunotherapy has been proven effective in desensitizing patients to specific allergens, there are several limitations such as lacking standardization, a long-time commitment to achieve maintenance, and adverse events.

Combining avidin with CD63 improves basophil activation test accuracy in classifying peanut allergy.

Background: Conventional basophil activation tests (BATs) measure basophil activation by the increased expression of CD63. Previously, fluorophore-labeled avidin, a positively-charged molecule, was found to bind to activated basophils, which tend to expose negatively charged granule constituents during degranulation. This study further compares avidin versus CD63 as basophil activation biomarkers in classifying peanut allergy.

Recent Mechanistic Studies in Allergic Diseases.

Allergic diseases, such as food allergies, asthma, and allergic rhinitis, continue to present a significant challenge for a broad cross-section of the population, despite recent advancements in their treatment and prevention [...