Real-life lessons on omalizumab and food allergy: The potential for unexplored outcomes

Lo Scalzo, Lucia, Galletta, Francesca, Cafarotti, Arianna, Nurmatov, Ulugbek ORCID: https://orcid.org/0000-0002-9557-8635, Klimek, Ludger, Fiocchi, Alessandro and Arasi, Stefania 2026. Real-life lessons on omalizumab and food allergy: The potential for unexplored outcomes. World Allergy Organization Journal 19 (5) , 101390. 10.1016/j.waojou.2026.101390

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Abstract

Introduction IgE-mediated food allergy (FA) represents an increasing global health burden, with rising prevalence and limited therapeutic options beyond allergen avoidance and emergency management. The approval of omalizumab as the first biologic to reduce reactions after accidental food exposure marks a turning point in FA care. While randomized controlled trials (RCTs) have demonstrated its efficacy in raising reaction thresholds and reducing allergic responses, real-world studies provide complementary evidence capturing outcomes relevant to everyday life. Methods This review integrates evidence from sources of observational studies, including cohort, case series, and case reports evaluating omalizumab in patients with FA, including complex phenotypes and populations typically excluded from RCTs. Discussion Real-world data demonstrate that omalizumab can prevent severe reactions in atypical and non-ingestive FA phenotypes, increase reaction thresholds as monotherapy, and enable dietary liberalization in a substantial proportion of patients. Observational cohorts consistently report improvements in food allergy–related quality of life, reduced anxiety, and enhanced confidence in food management. Omalizumab appears effective and well tolerated across complex populations, including patients with multiple comorbidities and very high total IgE levels, even beyond currently approved dosing limits. Emerging evidence also suggests that FA may require disease-specific dosing paradigms distinct from those used in asthma. Conclusions Real-world evidence complements RCTs findings by highlighting the multidimensional benefits of omalizumab in FA, encompassing clinical protection, dietary freedom, and psychosocial well-being as well as dose fine-tuning and off-label scenarios. These data support its broader clinical value and inform future research, dosing strategies, and personalized application in routine care.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Schools > Medicine
Publisher:	Elsevier
ISSN:	1939-4551
Date of First Compliant Deposit:	5 May 2026
Date of Acceptance:	3 April 2026
Last Modified:	05 May 2026 11:46
URI:	https://orca.cardiff.ac.uk/id/eprint/186780

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