IgE mediated food allergy poses a significant public health concern, with currently no approved therapies for adults. 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 analyse real-life data from food allergic patients treated with OMA. 

We included food allergic patients treated with OMA between 2002 and 2022 throughout Europe (Barcelona, Spain; Berlin and Leipzig, Germany; and Basel, Switzerland). Treatment responders were identified based on the development of tolerance and/or unresponsiveness to related food allergens (determined with a food challenge), reduction in the severity of food allergy, and absence of anaphylactic reactions.

In total, 61 patients (female n=39/61, median age 27.3 years) were included into this analysis, most of whom were polysensitised to more than two food allergens (n= 40/61, 65.5%). Most patients (n=46/61, 75.4%) received the OMA in conjunction with OIT, while the remaining patients underwent monotherapy. The eliciting food allergens were tree nuts (n=27/61, 44.3%), cow’s milk (n=25/61, 41%) and vegetables (n=25/61, 41%). In most cases OMA was initiated with 300 mg q4w (n=49/61, 80.3%). Treatment was well tolerated. 51/61 (83.6%) were classified as treatment responders. 5/61 (8.2%) developed tolerance/ unresponsiveness, 7/61 (11.5%) had a reduction of the severity of food allergy and 39/61 (63.9%) had no further anaphylactic reactions during treatment. 1/61 (1.6%) patient undergoing monotherapy was a non-responder, exhibiting repeated accidental anaphylactic reactions. 9/61 (14.8%) reported anaphylactic reactions during treatment. In most of cases with food related reactions upon treatment with OMA cofactors (n=5/9, 55.6%) were present, in 3/9 cases (33.3%) the reactions were OIT related.

Our real-world evidence data suggest efficacy and tolerability of OMA in the treatment IgE mediated food allergy with and w/o OIT. Most patients responded to treatment and anaphylaxis was eliminated for most patients. The onset of recurrent reactions upon treatment was often linked to the presence of cofactors. Therefore, cofactors should be identified and considered in patients with food allergy - not only for diagnosis, but also in treatment settings.