Omalizumab for the Treatment of Multiple Food Allergies

To evaluate the use of Omalizumab, a monoclonal IgE antibody, as monotherapy for the treatment of patients with multiple food allergies.The study population included 180 persons between 1 and 55 years of age with a history of allergy to peanuts and at least 2 other foods. Inclusion eligibility required dose-limiting symptoms, occurring at predefined thresholds (a single dose of 100 mg or less of peanut protein and 300 mg or less of the other allergens) during double-blind, placebo-controlled oral food challenges. Inclusion also required a body weight and serum IgE level suitable for Omalizumab dosing. Key exclusion criteria included poorly controlled or severe asthma, history of severe anaphylaxis to specific foods, previous immunotherapy for prespecified foods, or monoclonal antibody therapy within 6 months before screening.The study was a double-blind randomized controlled trial conducted at 10 centers in the United States. Participants underwent randomization, in a 2:1 ratio, to receive omalizumab or placebo. Treatment was rendered every 2 to 4 weeks for a total of 16 to 20 weeks, followed by a repetition of the 4 food challenges (3 allergens plus placebo). The first 60 participants who completed this stage were enrolled in a 24-week open-label extension to further assess the safety and durability of the treatment response. The primary end point was the consumption of a single dose of at least 600 mg of peanut protein without dose-limiting symptoms. The secondary endpoints included the consumption of cashew, milk, and egg in single doses of at least 1000 mg without dose-limiting symptoms.The analysis population consisted of 177 children and adolescents (1 to 17 years of age). A total of 79 of the 118 participants (67%) receiving omalizumab were able to consume a single dose of 600 mg of peanut protein (cumulative dose of 1044 mg, equivalent to approximately 4 peanuts) as compared with 7% of participants receiving placebo. Results for the key secondary endpoints, or ability to tolerate a single dose of 1000 mg of protein, showed similar trends as the primary endpoint (cashew, 41% versus 3%; milk 66% versus 10%; egg, 68% versus 0%; <0.001 for all comparisons).Omalizumab is superior to placebo in increasing the reaction threshold for peanut and other common food allergens in children as young as 1 year of age.For many years, there has been a paucity of treatment options for patients with multiple IgE-mediated food allergies. Although peanut-specific oral immunotherapy has received Food and Drug Administration-approval for peanut allergy treatment, many patients with multiple food allergies continue with strict avoidance practices, which can be difficult to maintain. This pivotal study proves that Omalizumab can significantly raise the reaction threshold in two-thirds of patients with peanut, cow’s milk, and egg allergies. Omalizumab is now the first, and only, biologic agent approved in the treatment of food allergies. Shared decision-making remains imperative, as treatment with this agent is suspected to be indefinite.