A randomized, double‐blind placebo‐controlled study on the efficacy of Omalizumab on food allergy threshold in children with severe food allergy

Abstract Background Food allergy is common in childhood with some children having a low threshold and being difficult to protect from accidental ingestion of the offending food. Therapies for this potentially life‐threatening condition are highly needed. The aim of this study was to evaluate the efficacy of Omalizumab in food‐allergic children. Methods This is a single‐center, double‐blind, placebo‐controlled study. Food allergic children with a cumulative threshold ≤443 mg food protein at DBPCFC were randomized to Omalizumab (asthma dose) or placebo (3:1). After 3 months, a second DBPCFC was performed (steps 3, 10, 30, 100, 300, 1000, and 3000 mg food protein), followed by a separate open challenge up to 10,000 and 30,000 mg food protein if negative. Responders were defined as ≥2‐step increases in threshold. Non‐responders received high‐dose Omalizumab. A third DBPCFC was performed after 6 months. Skin testing, blood samples, and the severity of atopic co‐morbidity were registered during the study and 3 months after treatment. Results In total, 20 children were evaluated at 3 months (14 Omalizumab, 6 placebo). All treated with Omalizumab increased their threshold at least two steps and with a significant difference between the Omalizumab and the placebo group ( p = .003), although the intended number of included children was not reached. The threshold before Omalizumab treatment was 13–443 mg food protein while the threshold after 3 months of treatment increased up to 44,000 mg (1143–44,000). In the placebo group, two children improved threshold during the study. Conclusion An increase in the threshold level during Omalizumab treatment significantly improve patient safety and protected all children against small amount of allergen.