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

Abstract

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.

Trial registration number: ClinicalTrials.gov, NCT06316414.

Keywords: IgE; allergy; anti IgE; asthma; children; food; immunologic desensitization; omalizumab.

FIGURE 1

Study design.

FIGURE 2

Consort Flow diagram of the population screened and included.

FIGURE 3

Box and whisker plots showing NOAEL before (t0) and during Omalizumab treatment at individual level for: (I) All food challenges (n = 107, cumulative of baked milk, milk, baked egg, egg, hazelnut, peanut, wheat and cod); and (II) by single food: (A) peanut challenges (n = 6); (B) hazelnut challenges (n = 12); (C) baked egg challenges (n = 13); (D) egg challenges (n = 23); (E) milk challenges (n = 11); (F) baked milk challenges (n = 36).

FIGURE 4

Episodes of food reactions 12 and 6 months before, and during omalizumab treatment (6 and 12 months). (***p < .001).

FIGURE 5

Box and whisker plots showing score of FAQLQ‐PF and FAQLQ‐TF before and during Omalizumab treatment.

FIGURE 6

Concentration of serum total IgE (kUI/L) over treatment. The figure shows the geometric mean of IgE and the confidence intervales.