Faculty Bibliography

INTRODUCTION/BACKGROUND:Introducing baked milk into the diet of children with cow's milk protein allergy (CMPA) has been shown to potentially accelerate the development of tolerance to non-heated milk. However, there is no standardised milk ladder (ML) protocol, and different scientific societies across countries recommend varying versions. This study aims to assess the effectiveness and safety of the four-step ML (4-ML) compared with the six-step ML (6-ML) in children with IgE-mediated CMPA. METHODS AND ANALYSIS/METHODS:We will perform an open-label randomised trial with two parallel arms in two departments of the same academic hospital. A total of 92 children with IgE-mediated CMPA will be allocated in a 1:1 ratio to introduce cow's milk into their diet according to either 4-ML or 6-ML with a 4-week break period between subsequent steps. Oral food challenge (OFC) with tested products at each subsequent step of the ML will be conducted in hospital settings. The primary outcome will be the percentage of children with tolerance to non-heated cow's milk proteins defined as no allergic reaction to raw cow's milk (120-240 mL depending on the age of the patient) during the last OFC; measured at the end of the 12-week observation period for the 4-ML and 20-week observation period for the 6-ML. Secondary outcomes will include the percentage of children with a negative OFC to each ML step; the percentage of children with anaphylaxis (both those who were treated and those who were not treated with epinephrine); the percentage of children with exacerbation of atopic dermatitis; growth; compliance; and quality of life of the caregivers and parents' anxiety about adverse events during their child's OFC. ETHICS AND DISSEMINATION/BACKGROUND:The bioethics committee of the Medical University of Warsaw, Poland, approved this protocol (KB/107/2024). The findings will be published in a peer-reviewed journal and submitted to relevant conferences no later than 1 year after data collection. TRIAL REGISTRATION NUMBER/BACKGROUND:NCT06664918.

BACKGROUND/UNASSIGNED: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/UNASSIGNED:Our aim was to investigate the management patterns and educational needs of practicing allergists treating patients with food allergies. METHODS/UNASSIGNED:An online survey was e-mailed to United States-based practicing allergists (N = 2833) in November-December 2021. The allergists were screened for managing 1 or more patients (including ≥25% pediatric patients) with food allergies per month. The allergists responded to questions regarding food allergy management in response to 2 hypothetical pediatric case studies, their familiarity with available guidelines and emerging treatments, and their future educational preferences. A descriptive analysis of outcomes was conducted. RESULTS/UNASSIGNED:A total of 125 responding allergists (4.4%) met the eligibility criteria and completed the survey. The allergists prioritized written exposure action plans, patient-caregiver communication, prevention of serious reactions, and consideration of both food allergy severity and allergic comorbidities in the management of patients with food allergies. With regard to recommending biologics in the future, the allergists identified patient history of anaphylaxis and hospitalizations, food allergy severity, and allergic comorbidities as all being important factors to consider when deciding on appropriate treatment options. The allergists noted their ongoing educational needs, especially for current and emerging treatments for food allergies. CONCLUSION/UNASSIGNED:With the treatment landscape for food allergies evolving rapidly, the decision-making priorities and continuing educational needs of allergists will be important in optimizing the management of patients with food allergies.

Food Protein-Induced Enterocolitis (FPIES) is a non-IgE mediated GI food allergy characterized by delayed, protracted vomiting, accompanied by lethargy and pallor, usually 1-4 hours following ingestion of the food allergen. The pathophysiology of FPIES remains unknown and currently there are no diagnostic biomarkers available to assess disease activity or its resolution. Over the last two decades, FPIES has become increasingly recognized in both pediatric and adult patients. Forty years later after the initial FPIES description, the first international classification of diseases (ICD-10) code for FPIES was established and the first international consensus guidelines for diagnosis and management of FPIES was published. On June 22, 2022, the National Institute of Allergy and Infectious Diseases (NIAID) held its first virtual multidisciplinary workshop on FPIES. Various clinical and translational aspects of FPIES, as well as the important areas of unmet needs were discussed as priorities for future research during this 2-day virtual workshop. The following report provides a summary of content of the workshop, including updated literature on the topic areas, as well as providing a critical commentary on the state of FPIES.

Omalizumab was recently approved by the US Food and Drug Administration for treatment of any single food allergy or multiple food allergies in children aged 1 year and older and adults. There is currently no formal guidance regarding recommended best practices for omalizumab use in food allergy, including patient selection, anticipated goals and outcomes of therapy, procedure for monitoring patients who elect to start omalizumab therapy, and ways in which omalizumab can be incorporated into the landscape of food allergy management and daily clinical practice. This work group report was developed by the food allergy therapies subcommittee of the Adverse Reactions to Foods Committee within the American Academy of Allergy, Asthma & Immunology. Consensus, evidence-based guidance regarding experts' recommendations for using omalizumab to treat children and adults with food allergy was developed by using modified Delphi methodology. In iterative fashion, a total of 8 statements regarding how to use omalizumab to treat patients with food allergy were developed by 16 clinical experts. This guidance provides the clinician with a suggested approach to patient selection, initiation of therapy, monitoring of efficacy, and long-term follow-up care. The role of preference-sensitive care is emphasized, with most statements offering care recommendations relevant to the culture and values of a particular practice setting.

BACKGROUND:Pollen-food allergy syndrome (PFAS) is common among patients with allergic rhinitis. Treatment recommendations for patients with PFAS remain variable. OBJECTIVE:To develop consensus recommendation statements for managing patients with PFAS. METHODS:An international panel of allergists, researchers, and nutritionists with an interest in PFAS from 25 different institutions across 11 countries convened and a list of statements was written by 3 authors. The RAND/University of California Los Angeles methodology was adopted to establish consensus on the statements. RESULTS:After 2 Delphi rounds, a consensus was reached on 14 statements. The panel agreed that patients with PFAS would benefit from counseling on the nature and basis of PFAS and the rare chance of more severe systemic reactions and their recognition. The panel agreed on avoiding the raw food responsible for the index reaction, but not potentially cross-reactive fruits/vegetables based on the responsible food of the index reaction. Epinephrine autoinjectors should be recommended for patients with PFAS who experienced severe symptoms (beyond the oropharynx) or for patients considered at risk for severe reactions. The panel agreed that the benefit of allergen immunotherapy remains unclear and that PFAS should not be considered the primary indication for such intervention. CONCLUSIONS:We developed consensus statements regarding counselling patients about the nature and severity of PFAS, potential risk factors, dietary avoidance, epinephrine autoinjector prescription, and allergen immunotherapy consideration for patients with PFAS.