Multiomics approach to evaluating personalized biomarkers of allergen immunotherapy.

Recent advancements in genomics and "omic" technologies have ushered in a transformative era referred to as personalized or precision medicine. This innovative approach considers the unique genetic profiles of individuals, along with a range of variability factors, to devise tailored disease treatments and prevention strategies that cater to the distinct needs of each patient. Although the terms personalized medicine and precision medicine are frequently utilized interchangeably, it is essential to delineate the subtle distinctions between them.

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.

A regulator's view on AIT clinical trials in the United States and Europe: Why successful studies fail to support licensure.

Clinical studies demonstrate that efficacy and safety in allergen immunotherapy (AIT) are linked to a multiplicity of factors decisively influencing success or failure. In recent years, numerous trials were performed with correspondent study results published. Yet, the number of AIT products successfully obtaining licensure in the analogous time frame is comparably limited.

Specific IgG antibodies to cow's milk proteins in pediatric patients with eosinophilic esophagitis.

Background: Allergen-specific IgG (sIgG) antibodies are often associated with tolerance, but sIgG antibodies to causally relevant foods have been reported recently in adults with eosinophilic esophagitis (EoE). Prevalence and levels of food sIgG are not well established in the general pediatric population.

Objective: We sought to investigate serum food sIgG with component diagnostics in children with EoE and children from an unselected birth cohort and to explore the effects of sex, age, and milk consumption on sIgG levels.

IgE Antibody Detection and Component Analysis in Patients with Eosinophilic Esophagitis.

Background: Although IgE antibodies to cow's milk and wheat are common in patients with eosinophilic esophagitis (EoE), titers are low and responses to diet are not dependent on having IgE antibodies.

Objective: To better define specific IgE antibody responses to foods, focusing on those foods that appear to play a role in EoE.

Methods: Adult (n = 46) and pediatric (n = 51) patients with EoE were recruited for skin prick testing and serum measurement (whole and diluted) of IgE antibodies specific for aeroallergens, food extracts, and component allergens by ImmunoCAP.

Anaphylaxis to the carbohydrate side chain alpha-gal.

In 2007, the monoclonal antibody cetuximab caused severe hypersensitivity reactions during the first infusion in a region of the southeastern United States. Investigation of pretreatment sera established that they contained immunoglobulin (Ig) E against the oligosaccharide galactose-alpha-1,3-galactose (alpha-gal), which is present on the Fab of cetuximab. Alpha-gal is a blood group substance of nonprimate mammals.

Delayed anaphylaxis to red meat masquerading as idiopathic anaphylaxis.

Anaphylaxis is traditionally recognized as a rapidly developing combination of symptoms that often includes hives and hypotension or respiratory symptoms. Furthermore, when a specific cause is identified, exposure to this cause is usually noted to have occurred within minutes to 2 hours before the onset of symptoms. This case is of a 79-year-old woman who developed a severe episode of anaphylaxis 3 hours after eating pork.

Galactose-α-1,3-galactose and delayed anaphylaxis, angioedema, and urticaria in children.

Background And Objective: Despite a thorough history and comprehensive testing, many children who present with recurrent symptoms consistent with allergic reactions elude diagnosis. Recent research has identified a novel cause for "idiopathic" allergic reactions; immunoglobulin E (IgE) antibody specific for the carbohydrate galactose-α-1,3-galactose (α-Gal) has been associated with delayed urticaria and anaphylaxis that occurs 3 to 6 hours after eating beef, pork, or lamb. We sought to determine whether IgE antibody to α-Gal was present in sera of pediatric patients who reported idiopathic anaphylaxis or urticaria.