Omalizumab Alleviates Anaphylactic Food Allergy in Children with Severe
Asthma: A Real-Life Study
Abstract
Background: In Europe, Omalizumab (anti-IgE) is indicated for
the treatment of moderate/severe asthma, but not for IgE-mediated food
allergy (FA). Objective: We prospectively assessed the impact
of Omalizumab for efficacy, safety, and quality of life (FA-QoL) in
patients with moderate/severe asthma and history of anaphylaxis to
peanut, tree nuts, fish, egg, milk, and/or wheat. Methods:
Food-allergic children (6-18yrs) with moderate/severe asthma underwent
oral food challenges (OFCs) to establish the threshold of reaction to
the culprit food(s) at baseline (T0) and at four-month intervals (T1,
T2, T3) during their first year of treatment with Omalizumab. We
recorded the number and severity of food-allergic reactions, Asthma
Control Test (ACT), FA-QoL, and total IgE. Results: In 65
patients allergic to 107 foods, the No Observed Adverse Events Level
(NOAEL) at T1 increased: 243- and 488-fold for raw 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 ad libitum in the diet of
55 patients; the remaining 12 were introduced by 10 patients at least in
traces. Throughout the study, 40/65 children got 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, in
adolescents from 4.68±0.92 to 1.90±1.50. Conclusions:
Omalizumab allows safe reintroduction of allergenic foods. Trial
registration number: ClinicalTrials.gov, NCT06316414