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. 2025 Apr 3;18(4):101048.
doi: 10.1016/j.waojou.2025.101048. eCollection 2025 Apr.

Efficacy of omalizumab in food allergic adults - A retrospective analysis

Aikaterina Alexiou  1 , Sofia Carreras-Kàtcheff  2 , Karin Hartmann  3   4 , Regina Treudler  5   6 , Paolo Tassinari  7 , Victoria Cardona  2 , Margitta Worm  1
Affiliations

Efficacy of omalizumab in food allergic adults - A retrospective analysis

Aikaterina Alexiou et al. World Allergy Organ J. .

Abstract

Background: IgE-mediated food allergy poses a significant public health concern, currently with no approved therapies for adults in Europe. Omalizumab (OMA) used as monotherapy or in conjunction with oral immunotherapy (OIT) has been suggested as an efficacious treatment for severe food allergy. The aim of this study was to analyze real-world data from food-allergic patients treated with OMA.

Methods: We included food-allergic patients treated with OMA between 2002 and 2022 throughout Europe. Treatment responders (TR) were identified based on the unresponsiveness to related food allergens (determined by food challenge), reduction in the severity of food allergy and absence of anaphylactic reactions.

Results: Sixty-two patients (female n = 39/62, 62.9%; mean age 30.6 years) were included into this analysis, most of whom were polysensitized to more than 2 food allergens (n = 40/62, 64.5%); 45/62 patients (72.6%) received OMA in conjunction with OIT, while the remaining patients underwent OMA monotherapy. The eliciting food allergens were tree nuts (n = 27/62, 43.5%), cow's milk (n = 26/62, 41.9%), and vegetables (n = 25/62, 40.3%). In most cases, OMA was initiated with 300 mg q4w (n = 51/62, 82.3%) dosing. Treatment was tolerated exceptionally well.Fifty-two (52/62) patients (83.9%) were classified as treatment responders. Six (6/62) patients (9.7%) developed unresponsiveness, 6/62 (9.7%) had a reduction of the severity of food allergy, and 40/62 (64.5%) had no further anaphylactic reactions during treatment. One (1/62) patient (1.6%) undergoing monotherapy was a non-responder, exhibiting repeated anaphylactic reactions to accidental exposures, and 10/62 patients (16.1%) reported anaphylactic reactions during treatment. In most of these cases, cofactors (n = 5/10, 50%) were present.

Conclusion: Our real-world evidence data indicate efficacy and tolerability of OMA for the treatment of IgE-mediated food allergy with and without OIT. As the onset of food related reactions upon treatment was frequently linked to the presence of cofactors, these should be identified and considered in patients with food allergy-not only for diagnosis, but also in treatment settings.

Keywords: Anaphylaxis; Food allergy; Immunotherapy; Omalizumab.

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Conflict of interest statement

AA is a sub investigator in several clinical studies sponsored by pharma including Novartis. SCK and VC have no conflicts of interest to declare. KH and RT received honoraria for lectures, advisory boards and/or research funding from Novartis and other pharmaceutical companies, all outside this research project. MW received compensation for research, advisory and speaker from Novartis and other pharmaceutical companies.

Figures

Fig. 1
Fig. 1
A depicts the eliciting food allergens by frequency. The proportion of cases with LTP sensitization is marked in dark blue. B depicts the number of anaphylactic reactions per case
Fig. 2
Fig. 2
A shows the number of patients per treatment group. B shows the most common dose and treatment intervals used. C shows the indications for treatment with omalizumab
Fig. 3
Fig. 3
A is the outcome flowchart. B shows the treatment response per treatment group. Treatment responders are highlighted, partial responders are marked in grey, and non-responders are marked with a red circle
See this image and copyright information in PMC

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