Background: Cow's milk allergy (CMA) is one of the most common food allergies in children and may persist into later childhood. Oral immunotherapy (OIT) is an effective treatment option; however, the optimal timing of initiation and the mechanisms underlying age-related differences in safety remain uncertain.
Objective: To evaluate the safety and efficacy of cow's milk OIT initiated at different ages and to explore the relationship between age, baseline immunologic markers, and adverse reactions in a real-world pediatric cohort.
Methods: We retrospectively analyzed 145 children with IgE-mediated CMA who completed OIT between 2009 and 2024. Patients were grouped by age at OIT initiation (<24 months, 24-48 months, and >48 months). Baseline clinical and laboratory characteristics and OIT-related adverse events (AEs) were compared. Multivariable logistic regression analyses were performed adjusting for relevant clinical covariates to assess the independent effects of age and cow's milk-specific IgE (CM-spIgE) on AEs.
Results: Older children (>48 months) had significantly higher baseline total IgE and CM-spIgE levels and more frequent pre-OIT anaphylaxis and respiratory symptoms. The use of omalizumab and epinephrine was more common in older patients. In multivariable analyses, age and CM-spIgE were each associated with adverse reactions. Early OIT (<24 months) was associated with fewer severe reactions and no anaphylaxis during the maintenance phase.
Conclusion: Earlier initiation of cow's milk OIT seems to be associated with a more favorable safety profile, highly correlated with the baseline immunologic profile. These findings support personalized decision-making that includes age and immunologic markers when determining OIT timing.
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