Omalizumab reduces anaphylactic reactions and allows food introduction in food-allergic in children with severe asthma: An observational study

Background: In Europe, Omalizumab (anti- IgE) is indicated for the treatment of moderate to severe asthma, but not for IgE- mediated food allergy (FA). Objective: We assessed the impact of Omalizumab on efficacy, safety, and quality of life (FA- QoL) in patients with moderate to severe asthma and who have a history of anaphylaxis to peanut, tree nuts, fish, egg, milk, and/or wheat. Methods: Food- allergic children (6-18 years) with moderate to severe asthma underwent oral food challenges (OFCs) to establish the threshold of reaction to the culprit food(s) at baseline (T0) and at 4- month intervals (T1, T2, and T3) during their first year of treatment with Omalizumab. We recorded the number and severity of food- allergic reactions, Asthma Control Test (ACT) scores, FA- QoL, and total IgE levels. Results: In 65 patients allergic to 107 foods, the No Observed Adverse Events Level (NOAEL) at T1 increased: 243- and 488- fold for fresh and baked milk, respectively; 172- and 134- fold for raw and baked egg; 245- fold for hazelnut; 55- fold for peanut; 31- fold for wheat; and 10- fold for fish. Full tolerance was achieved in 66.4% of OFCs at T1, 58.3% at T2, and 75% at T3. Ninety- five foods were liberalized in the diet of 55 patients; the remaining 12 were introduced by 10 patients at least in traces. Throughout the study, 40 out of 65 were able to get a free diet. ACT increased from 17 (Q1- Q3: 15-17) to 23.6 (Q1- Q3: 23-25). The FA- QoL score in children <= 12 years decreased from 4.63 +/- 0.74 to 2.02 +/- 1.13, and in adolescents from 4.68 +/- 0.92 to 1.90 +/- 1.50. Conclusions: During Omalizumab therapy, a safe reintroduction of allergenic foods is feasible.