PURPOSE OF THE STUDY:
This study addresses the effect of omalizumab on the threshold of reactivity to food allergens in children with severe asthma undergoing treatment with this monoclonal antibody against IgE.
STUDY POPULATION:
This observational study includes 15 patients (median age, 12 years) with severe asthma undergoing treatment with omalizumab and having allergy to ≥2 foods (37 total) or failed oral immunotherapy to one food. Twenty percent of patients also had atopic dermatitis, and all were sensitized to ≥1 perennial allergen. The total IgE maximum was 1500 kU/L. Threshold challenges were performed in 12/15 patients (three were deferred due to recent anaphylaxis).
METHODS:
In this retrospective observational study, patients were given omalizumab as add-on therapy 2–3 days after their initial oral food challenges. Challenges were performed to one or two of the following allergens: egg, milk, wheat, baked egg, baked milk, or hazelnut. The eliciting dose (ED) was determined by food challenge. EDs were reassessed two days prior to an omalizumab dose after four months of treatment. Statistical analyses included the Wilcoxon signed-rank test, odds ratios, and confidence intervals.
RESULTS:
After four months of treatment, accidental reactions decreased from a total of 47 to 2, eczematous skin was clear, asthma control test scores increased from 16 to 22, EDs increased from 8 to 164 times, and quality of life scores for parents and children increased significantly. Full desensitization was achieved in 70% of the foods tested. Increased EDs were significant for egg (P = .04), baked milk (P = .04), milk (P = .001) and wheat (P = .01). The average monthly cost per patient was 1311.63 Euro. Partial tolerance was achieved in 4 children.
CONCLUSIONS:
Omalizumab treatment improved outcomes for all children in this study. Patients benefitted from free introduction of over 70% of tested food allergens, improved quality of life, asthma, and eczema symptoms.
REVIEWER COMMENTS:
This study took the opportunity to evaluate the impact of omalizumab treatment of asthma on the children’s concomitant food allergy. The outcome of this study is supportive of the ability of omalizumab to raise the threshold of reactivity to multiple food allergens, adding to observations in a few prior studies. The inclusion of severe asthmatic children also addresses an understudied subset of food allergic patients. Despite the use of open food challenges and the possible overestimation of ED in some participants, these results demonstrate an exciting potential treatment option for patients. Omalizumab has been given breakthrough designation for food allergy by the Food and Drug Administration, and we await the result of randomized studies to better understand the risks and benefits of this approach.
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