The Role of Omalizumab as an Adjunct to Oral Immunotherapy in Pediatric Food Allergy: A Systematic Review.

Food allergy represents a growing public health concern, particularly among pediatric populations, where it significantly impacts quality of life and carries the risk of severe reactions. Traditional management through allergen avoidance and emergency medications fails to address the underlying immune dysfunction, prompting interest in active treatments like oral immunotherapy (OIT). However, OIT alone is often limited by safety concerns and variable efficacy, leading to the exploration of adjunctive therapies such as omalizumab treatment to enhance outcomes. This systematic review evaluates the role of omalizumab combined with OIT in pediatric food allergy, aiming to synthesize current evidence on its clinical benefits, safety profile, and potential to induce lasting tolerance. A comprehensive search was conducted across four major databases (PubMed, Scopus, Web of Science, and Embase) following PRISMA guidelines. Studies were included if they investigated omalizumab as an adjunct to OIT in children with immunoglobulin E (IgE)-mediated food allergy and reported measurable clinical outcomes. Two independent reviewers screened records, extracted data, and assessed risk of bias using standardized tools. A narrative synthesis was performed due to heterogeneity in study designs and outcome reporting. The results indicate that omalizumab enhances the safety and efficacy of OIT, with consistent improvements in desensitization rates and reductions in adverse events during treatment. The adjunctive use of omalizumab appears particularly beneficial for high-risk patients and those undergoing multi-allergen OIT, facilitating faster dose escalation and better tolerability. However, evidence on sustained unresponsiveness remains inconsistent, and long-term outcomes require further investigation. The safety profile is favorable overall, with most adverse events being mild to moderate in severity. Omalizumab represents a promising adjunct to OIT in pediatric food allergy, offering a more manageable and effective treatment approach for selected patients. While current evidence supports its use in improving short-term outcomes, additional research is needed to establish standardized protocols, evaluate cost-effectiveness, and clarify its role in achieving long-term tolerance. Clinicians should consider this combined therapy as part of a personalized treatment strategy while remaining mindful of uncertainties and individual patient needs.