Kinetics of early peanut allergy development and resolution in the EAT, LEAP, and PAS cohorts.

Background: Little is known about the development and resolution of early peanut allergy (PA).

Objective: We examined the natural history and biomarkers of PA longitudinally in 3 cohorts.

Methods: PA development was examined in the Enquiring About Tolerance (EAT), Learning Early About Peanut (LEAP), and Peanut Allergy Sensitization (PAS) cohorts.

Kinetics of epitope-specific IgE and IgG in early peanut allergy development and resolution.

Background: The development and resolution of peanut allergy (PA) was evaluated in children enrolled or screened for the Learning Early About Peanut (LEAP) intervention trial. The development of epitope-specific (es) IgE and es-IgG antibodies was evaluated in a subset of these children to determine whether their PA status could be predicted at 4-11 months of age.

Methods: Sera from 386 children enrolled or screened as part of the LEAP trial were assayed at 4-11 months (baseline) and 60 months of age, and final allergy status was established by oral food challenge at 60 months.

Timing of repeat epinephrine to inform paediatric anaphylaxis observation periods: a retrospective cohort study.

Background: Children presenting to the emergency department with anaphylaxis typically receive at least one dose of epinephrine and are observed in the emergency department or monitored for recurrent (biphasic anaphylaxis) or persistent symptoms on hospital wards for variable durations before discharge is considered safe. We aimed to calculate the incidence rate and timing of repeat epinephrine dosing to determine the observation threshold at which the cumulative incidence of repeat epinephrine was less than 2% for every 1 h increase in observation time.

Methods: This multicentre, retrospective cohort study across 30 emergency departments in the USA and one emergency department in Canada included children aged 6 months to 17 years who, according to electronic medical records, presented to one of the participating emergency departments with an acute allergic reaction that was treated with intramuscular, subcutaneous, or intravenous epinephrine before arrival at the emergency department or in the emergency department between Jan 1, 2016, and Dec 31, 2019.

Towards a common approach for managing food allergy and serious allergic reactions (anaphylaxis) at school. GALEN and EFA consensus statement.

GALEN and EFA propose minimum specifications for all industrialised countries/regions to work towards to support students with food allergies in educational settings. We reviewed research and legislation and gained feedback from over 100 patient and professional groups. We built shared expectations around: 1.

Barriers and Solutions to Optimal Food Allergy Prevention, Diagnostic, and Management Strategies.

Food allergy (FA) remains a significant public health issue, posing challenges for patients, families, clinicians, researchers, and policymakers. Despite advancements in FA diagnosis and treatment, substantial unmet needs remain. Clinicians, researchers, and representatives from governmental organizations (National Institutes of Health and Food and Drug Administration) and industry convened at the 2023 Clinical Development Day hosted by Food Allergy Research & Education to discuss current challenges and propose collaborative solutions for comprehensive FA management.

Efficacy and safety of epicutaneous immunotherapy in children with peanut allergy with atopic comorbidities.

Background: There is a high prevalence rate of atopic comorbidities, including atopic dermatitis (AD), asthma, and concomitant food allergy (CFA), in children with peanut allergy.

Objective: To evaluate whether concomitant atopic comorbidities affect the safety and efficacy of VIASKIN peanut patch (patch containing 250 µg peanut protein [VP250]).

Methods: EPITOPE was a phase 3, double-blind, placebo-controlled trial designed to assess treatment response to VP250, as measured by eliciting dose at 12 months, in children with peanut allergy aged 1 to 3 years.

Biomarker-driven drug development for allergic diseases and asthma: An FDA public workshop.

The US Food and Drug Administration (FDA) hosted a workshop on February 22, 2024, to discuss the status of biomarkers in drug development for allergic asthma and food allergy. The workshop provided a forum for open discussion among regulators, academicians, National Institutes of Health staff and industry to inform stakeholders of the requirements for the FDA to adopt a biomarker as a surrogate end point for a clinical trial, and to inform FDA of the status of various biomarkers in development. The workshop was divided into 3 sessions: (1) FDA and European Union regulators discussing regulatory perspectives on use of biomarkers in drug development programs, (2) investigators discussing biomarkers for pediatric and adult asthma, and (3) investigators discussing biomarkers for food allergy.

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.

Just scratching the surface: A review of pediatric skin allergies.

The skin is a large and sophisticated organ populated by innate and adaptive immune effector cells. These immune cells provide a critical first line of defense against pathogens, but genetic and environmental factors can lead to inappropriate signaling that may manifest as hypersensitivity. The most common cutaneous allergic disorders in children include atopic dermatitis, urticaria/angioedema, and contact dermatitis.

Peanut Oral Immunotherapy in Children with High-Threshold Peanut Allergy.

Background: Approved therapeutics for peanut allergy are not designed for the many patients with allergic reactions to more than one peanut.

Methods: We randomly assigned (1:1) participants 4 to 14 years of age reacting to a challenge of between 443 mg and 5043 mg of peanut protein to peanut oral immunotherapy (P-OIT) using home-measured peanut butter versus peanut avoidance. The primary end point was the difference between groups in the proportion tolerating a two-dose-level increase or 9043 mg of peanut protein.

Anaphylaxis definition, overview, and clinical support tool: 2024 consensus report-a GALEN project.

Background: The 2006 National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network anaphylaxis criteria are widely used in clinical care and research. In 2020, the World Allergy Organization published modified criteria that have not been uniformly adopted. Different criteria contribute to inconsistent care and research outcomes.

Roads to remission: evolving treatment concepts in type 2 inflammatory diseases.

Unlabelled: Non-communicable diseases (NCDs) characterised by type 2 inflammation, including asthma, allergic rhinitis, chronic rhinosinusitis with nasal polyps, atopic dermatitis, food allergies and eosinophilic esophagitis, are increasing in prevalence worldwide. Currently, there is a major paradigm shift in the management of these diseases, towards the concept of disease modification and the treatment goal remission, regardless of severity and age. Remission as a treatment goal in chronic inflammatory NCDs was first introduced in rheumatoid arthritis, and then adopted in other non-type 2 inflammatory diseases.

Antigenic determinants underlying IgE-mediated anaphylaxis to peanut.

Background: Studies of human IgE and its targeted epitopes on allergens have been very limited. We established a method to immortalize IgE-encoding B cells from patients with allergy.

Objective: We sought to develop an unbiased and comprehensive panel of peanut-specific human IgE mAbs to characterize key immunodominant antigenic regions and epitopes on peanut allergens to map molecular interactions responsible for inducing anaphylaxis.

10 practical priorities to prevent and manage serious allergic reactions: GALEN ANACare and EFA Anaphylaxis Manifesto.

This Anaphylaxis Manifesto calls on communities to prioritise 10 practical actions to improve the lives of people at risk of serious allergic reactions. The Global Allergy and Asthma European Network and the European Federation of Allergy and Airways Diseases Patients' Associations (EFA) compiled patient-centric priorities. We used qualitative consensus methods, research evidence and feedback from over 200 patient groups, stakeholder organisations and healthcare professionals.

AAAAI-EAACI PRACTALL: Standardizing oral food challenges-2024 Update.

This common statement of the American Academy of Allergy, Asthma and Immunology (AAAAI) and The European Academy of Allergy and Clinical Immunology (EAACI) provides an update of the 2012 published guidelines on food challenges. The guidelines equally address food challenges in the research and the clinical settings. They first address the diagnostic tests which can guide the decision to conduct a challenge.

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.

Differential T follicular helper cell phenotypes distinguish IgE-mediated milk allergy from eosinophilic esophagitis in children.

Background: IgE-mediated food allergy and eosinophilic esophagitis (EoE) are diseases commonly triggered by milk. Milk-responsive CD4 T cells producing type 2 cytokines are present in both diseases, yet the clinical manifestation of disease in milk allergy (MA) and EoE are distinct.

Objective: We sought to identify differences in CD4 T cells between EoE and MA that may be responsible for distinct disease manifestations.

A Streamlined Strategy for Basophil Activation Testing in a Multicenter Phase III Clinical Trial.

Background: The basophil activation test (BAT) has been limited to research settings owing to technical issues. Novel approaches using dry, ready-to-use reagents and streamlined protocols offer greater flexibility and may open opportunities for easier implementation in clinical research.

Objective: Using a streamlined basophil activation test (sBAT) strategy and the settings of the baseline study of the Epicutaneous Immunotherapy in Toddlers with Peanut Allergy (EPITOPE) trial of EPicutaneous ImmunoTherapy, we aimed to assess the feasibility of implementing BAT in a multicenter trial and to evaluate its utility in predicting the outcomes of peanut double-blind placebo-controlled food challenge (DBPCFC).