BackgroundIn Europe, Omalizumab (anti‐IgE) is indicated for the treatment of moderate to severe asthma, but not for IgE‐mediated food allergy (FA).ObjectiveWe 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.MethodsFood‐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.ResultsIn 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.ConclusionsDuring Omalizumab therapy, a safe reintroduction of allergenic foods is feasible.Trial Registration NumberClinicalTrials.gov, NCT06316414.
