Biologics
Omalizumab
Omalizumab is an anti-IgE monoclonal antibody previously indicated for moderate to severe allergic asthma, nasal polyposis and chronic spontaneous urticaria. Its mechanism of action involves binding to IgE antibodies, thereby preventing their interaction with mast cell and basophil surface receptors. This action effectively prevents degranulation and subsequent release of allergic response mediators. In February 2024, Omalizumab gained FDA approval for the treatment of IgE-mediated food allergies in February 2024. The prescribing information states that omalizumab is indicated “for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy” and that omalizumab is “to be used in conjunction with food allergen avoidance.” This prescribing information also notes that omalizumab “is not indicated…
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Omalizumab
Omalizumab is an anti-IgE monoclonal antibody previously indicated for moderate to severe allergic asthma, nasal polyposis and chronic spontaneous urticaria. Its mechanism of action involves binding to IgE antibodies, thereby preventing their interaction with mast cell and basophil surface receptors. This action effectively prevents degranulation and subsequent release of allergic response mediators. In February 2024, Omalizumab gained FDA approval for the treatment of IgE-mediated food allergies in February 2024. The prescribing information states that omalizumab is indicated “for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy” and that omalizumab is “to be used in conjunction with food allergen avoidance.” This prescribing information also notes that omalizumab “is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.” This indication was approved on the basis of positive results from a phase 3, multi-center, randomized, double-blind, placebo-controlled Food Allergy trial. The trial assessed the efficacy and safety of omalizumab as monotherapy in a total of 177 children and adolescents (1 to 17 years of age) with multiple allergies (peanut allergy and at least 2 of the following: cashew, milk, egg, walnut, wheat and hazelnut), of which 118 received omalizumab and 59 received a placebo. Omalizumab demonstrated superiority to the placebo in increasing the reaction threshold for peanut, cashew, milk and egg (P <0.001 for all comparisons).
Omalizumab has also been evaluated as an adjunct to OIT, showing the ability to reduce its side effects, and even prevent anaphylaxis. It has been shown that omalizumab can reduce the number and severity of reactions during the allergen dosage-increasing phase of milk, egg and peanut OIT, as well as help achieve desensitization more quickly. The modulation of immune responses using anti-IgE treatments as an adjunct to OIT is shown in Figure 3-1.
Other Biologics
Other biologics and targeted molecules, including etokimab, dupilumab, ligelizumab, abrocitinib, abatacept and remibrutinib are currently under investigation for the treatment of food allergies.
References
- Bégin P, Dominguez T, Wilson SP, et al. Phase 1 results of safety and tolerability in a rush oral immunotherapy protocol to multiple foods using Omalizumab. All Asth Clin Immun. 2014;10(1):7.
- Dantzer JA, Wood RA. Omalizumab as an adjuvant in food allergen immunotherapy. Curr Opin Allergy Clin Immunol. 2021;21(3):278–285
- Macginnitie AJ, Rachid RA, Cianferoni A, et al. Omalizumab Facilitates Rapid Oral Desensitization for Peanut Allergy. J Allergy Clin Immunol. 2016;137(2):AB194
- Nadeau KC, Schneider LC, Hoyte L, et al. Rapid oral desensitization in combination with omalizumab therapy in patients with cow’s milk allergy. J Allergy Clin Immunol. 2011;127(6):1622-1624.
- Schneider LC, Rachid R, LeBovidge J, et al. A pilot study of omalizumab to facilitate rapid oral desensitization in high-risk peanut-allergic patients. J Allergy Clin Immunol. 2013;132(6):1368-1374.
- Wood RA, Togias A, Sicherer SH, et al. Omalizumab for the Treatment of Multiple Food Allergies. N Engl J Med. 2024;390(10):889-899.
- Xolair [package insert]. South San Francisco, CA: Genentech Inc.; February 2024.
- Yu L, Zhang H, Pan J, Ye L. Pediatric usage of Omalizumab: A promising one. World Allergy Organ J. 2021;14(12):100614.
- Zuberbier T, Wood RA, Bindslev-Jensen C, et al. Omalizumab in IgE-Mediated Food Allergy: A Systematic Review and Meta-Analysis. J Allergy Clin Immunol: In Practice. 2023;11(4):1134-1146.
