Efficacy of omalizumab in food allergic adults - A retrospective analysis

Abstract

Anaphylaxis; Food allergy; Immunotherapy

Anafilaxi; Al·lèrgia alimentària; Immunoteràpia

Anafilaxia; Alergia alimentaria; Inmunoterapia

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.

A. Alexiou is funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) as part of the clinical research unit (CRU339): Food allergy and tolerance (FOOD@) – project-number 428447634.