A phase 3 trial found that 67% of children receiving omalizumab could tolerate at least 600 mg of peanut protein, compared to just 7% in the placebo group, according to a recent study. 

Food allergies are prevalent among children and adults and are associated with significant morbidity, often requiring food avoidance and impacting quality of life. Omalizumab, a monoclonal anti-IgE antibody, has previously shown promise in raising reaction thresholds to food allergens. Researchers conducted a phase 3 trial to evaluate the efficacy and safety of omalizumab as monotherapy for the treatment of multiple food allergies in a pediatric population. 

The study screened 462 participants, out of which 180 were randomized. A total of 177 children and adolescents aged 1-17 years with documented allergies to peanuts and at least two additional food allergens (cashew, milk, egg, walnut, wheat, hazelnut) were enrolled. Participants were randomized in a 2:1 ratio to receive subcutaneous omalizumab or placebo every 2-4 weeks for 16-20 weeks. 

The primary endpoint was the ability to consume at least 600 mg of peanut protein without dose-limiting symptoms. Key secondary endpoints included the ability to tolerate 1000 mg or more of cashew, milk, or egg protein. Of those receiving omalizumab, 67% met the primary endpoint compared to 7% in the placebo group (P<0.001). Results, published in the New England Journal of Medicine, indicated that secondary endpoints demonstrated increased tolerance thresholds to cashew (41% vs 3%), milk (66% vs 10%), and egg (67% vs 0%) in the omalizumab group (P<0.001 for all comparisons), consistent with the primary endpoint. 

Safety profiles were similar between groups, aside from a higher incidence of injection-site reactions in the omalizumab group.

Full disclosures can be found in the published study.