Background: In our recent clinical trial, the addition of omalizumab to oral immunotherapy (OIT) for milk allergy improved safety, but no significant clinical benefit was detected.
Objective: We sought to investigate mechanisms by which omalizumab modulates immunity in the context of OIT and to identify baseline biomarkers that predict subgroups of patients most likely to benefit from omalizumab.
Methods: Blood was obtained at baseline and multiple time points during a placebo-controlled trial of OIT for milk allergy in which subjects were randomized to receive omalizumab or placebo. Immunologic outcomes included measurement of basophil CD63 expression and histamine release and casein-specific CD4 regulatory T-cell proliferation. Biomarkers were analyzed in relationship to measurements of safety and efficacy.
Results: Milk-induced basophil CD63 expression was transiently reduced in whole blood samples from both omalizumab- and placebo-treated subjects. However, IgE-dependent histamine release increased in washed cell preparations from omalizumab- but not placebo-treated subjects. No increase in regulatory T-cell frequency was evident in either group. Subjects with lower rates of adverse reactions, regardless of arm, experienced better clinical outcomes. Pre-OIT basophil reactivity positively associated with occurrence of symptoms during OIT, whereas the baseline milk IgE/total IgE ratio correlated with the likelihood of achieving sustained unresponsiveness. A combination of baseline basophil and serologic biomarkers defined a subset of patients in which adjunctive therapy with omalizumab was associated with attainment of sustained unresponsiveness and a reduction in adverse reactions.
Conclusions: Combining omalizumab therapy with milk OIT led to distinct alterations in basophil reactivity but not T-cell responses. Baseline biomarkers can identify subjects most likely to benefit from adjunctive therapy with omalizumab.
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http://dx.doi.org/10.1016/j.jaci.2017.03.028 | DOI Listing |
Turk J Pediatr
December 2024
Division of Neonatology, Department of Pediatrics, Koç University School of Medicine, İstanbul, Türkiye.
Background: Pneumatosis intestinalis (PI) is a rare radiological finding that may be associated with various diseases. In the neonatal period, it is considered pathognomonic for necrotizing enterocolitis (NEC). Cow's milk protein allergy (CMA) is the main cause of allergy especially in term infants appearing following breastfeeding or consumption of milk-based formulas.
View Article and Find Full Text PDFCurr Allergy Asthma Rep
January 2025
Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Purpose Of Review: There is an increasing awareness among clinicians that industrial and household food processing methods can increase or decrease the allergenicity of foods. Modification to allergen properties through processing can enable dietary liberations. Reduced allergenicity may also allow for lower risk immunotherapy approaches.
View Article and Find Full Text PDFNutrients
January 2025
Independent Researcher, 00100 Rome, Italy.
Cow's milk allergy (CMA) is the most common food allergy among children. An oral food challenge (OFC) remains a mainstay of the diagnosis of CMA, especially for the non-IgE-mediated type; however, this test can be risky and time-consuming. Hence, there is a need to identify biomarkers.
View Article and Find Full Text PDFNutrients
December 2024
Sección de Gastroenterología y Nutrición Infantil, Hospital Regional Universitario de Málaga, 29010 Málaga, Spain.
: Hydrolysed rice formula (HRF) is tolerated by >90% of children with cow's milk protein allergy (CMPA). However, concerns have been raised about potential suboptimal growth in infants fed HRF compared to those fed an extensively hydrolysed milk protein formula (eHF). : To compare growth, safety and tolerance acquisition in infants with CMPA when fed HRF versus eHF.
View Article and Find Full Text PDFNutrients
December 2024
Allergy Unit, Meyer Children's Hospital IRCCS, 50139 Florence, Italy.
: Food protein-induced allergic proctocolitis (FPIAP) is a non-IgE-mediated food allergy, usually presenting as bloody stools in breastfed, well-appearing, and regularly growing infants. The aim of our study was to describe the clinical features of Italian infants affected by FPIAP and their management and natural history in a real-life setting. : A retrospective, observational study was performed at two tertiary pediatric hospitals (Florence and Trieste), including FPIAP-diagnosed infants between 2012 and 2022.
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