Omalizumab in food allergy: Risks and benefits.

Omalizumab is approved for the management of immunoglobulin E-mediated food allergy in individuals ages ≥ 1 year. Approval for food allergy followed the Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants (OUtMATCH) study, which demonstrated that omalizumab increases the threshold dose of multiple food allergens needed to elicit an allergic reaction. Despite the demonstrated efficacy in food allergy and favorable safety profile, many questions remain. This review addresses the efficacy of omalizumab for the management of food allergy, as monotherapy, and in conjunction with oral immunotherapy. Safety in children is paramount, and this review addresses noted adverse events of anaphylaxis and malignancy. There is minimal knowledge with regard to the real-world impact on food allergy-related quality of life. Many questions still remain, including identifying who is the ideal patient for omalizumab, determining the role of oral food challenges before and during therapy with omalizumab, evaluating food allergy tolerance while on treatment, and optimizing the cost-effectiveness of this efficacious and well-tolerated management option for food allergy.