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. 2025 Aug;156(2):394-405.
doi: 10.1016/j.jaci.2025.05.014. Epub 2025 May 28.

Introduction of allergenic foods after treatment with omalizumab

Jennifer Dantzer  1 , Yamini Virkud  2 , Julie Wang  3 , Scott Sicherer  3 , Marion Groetch  3 , Wayne Shreffler  4 , David Pyle  4 , Edwin Kim  2 , Corinne Keet  2 , Michael Kulis  2 , Kim Mudd  5 , Sayantani Sindher  6 , Andrew Long  6 , Amy M Scurlock  7 , Stacie M Jones  7 , Donald Leung  8 , Bruce Lanser  8 , Brian Vickery  9 , Idil D Ezhuthachan  9 , J Andrew Bird  10 , Christopher Parrish  10 , Jonathan M Spergel  11 , Terri Brown-Whitehorn  11 , Monica Ligueros-Saylan  12 , Paolo Tassinari  12 , Ahmar Iqbal  13 , Dawn Sibanda  13 , Charmaine Huckabee  14 , Nancy Yovetich  14 , Nicole Rogers  14 , Adora Lin  15 , Lisa M Wheatley  15 , Alkis Togias  15 , R Sharon Chinthrajah  6 , Robert A Wood  5
Affiliations

Introduction of allergenic foods after treatment with omalizumab

Jennifer Dantzer et al. J Allergy Clin Immunol. 2025 Aug.

Abstract

Background: Omalizumab has been shown to increase reaction thresholds to allergenic foods during treatment. Little is known about its potential to permit introduction of allergenic foods.

Objective: The aim of this study was to examine introduction of allergenic foods after stopping treatment with omalizumab.

Methods: The first 60 participants completing OUtMATCH (Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants) stage 1 entered a 24-week open label extension, followed by entry into protocol stage 3, which could include dietary consumption (DC) of retail allergenic foods, rescue oral immunotherapy, or allergen avoidance, depending on the results of the final food challenges and participant preferences.

Results: A total of 60 participants were included (58% male, median age 8.5 years, age range 1-20 years). The study foods included peanut (n = 60), cashew (n = 28), egg (n = 27), milk (n = 25), walnut (n = 23), wheat (n = 9), and hazelnut (n = 8). Of the initial treatment plans, 82% included DC. DC success was defined as a median daily consumption of at least 300 mg of food protein over 12 months, with the data analyzed in quarterly intervals. Overall, greater success was observed for milk, egg, or wheat (61%-70%) than for peanut or tree nuts (38%-56%). Allergenic food consumption generally declined over time, except in the cases of wheat, with greater variability in median consumption for egg and milk relative to nuts. Reduced consumption appeared to be related to both symptoms and patient preference. The only predictor of DC success was a higher screening challenge threshold. Adverse events included episodes of anaphylaxis, epinephrine use, and 2 diagnoses of eosinophilic esophagitis related to DC.

Conclusions: In this first study of introduction of retail food following omalizumab treatment, most participants were able to introduce allergenic foods in a dietary form, although adverse reactions did occur and many participants returned to avoidance.

Keywords: Omalizumab; anti-IgE; food allergy.

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Conflict of interest statement

Disclosure statement Supported by the National Institute of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences, both part of the National Institutes of Health (grants UM2AI130836, UM1AI130838, UL1TR003098, UM1TR004408, UM1Al130570, UM1AI130839, UM2AI13083605, UM1AI130936, UL1TR002535, UM1TR004399, UL1TR001878, UM1Al130781, UM1TR004406, UM1AI130839, UL1TR003107, and UL1TR002378), the Claudia and Steve Stange Family Fund, and Genentech/Novartis (which provided the investigational and monetary support to Johns Hopkins University and collaborated on the study design). Disclosure of potential conflict of interest: J. Dantzer reports grants from the National Institutes of Health/National Institute of Allergy and Infectious Diseases (NIH/NIAID). Y. Virkud reports grants from NIH/NIAID. J. Wang reports clinical trials support (money to her institution) from the NIH, Aimmune, DBV Technologies, and Siolta; consulting fees from DBV Technologies and Novartis outside the submitted work; and royalties from UpToDate. S. Sicherer reports royalty payments from UpToDate and from Johns Hopkins University Press; grants to his institution from the NIAID, Food Allergy Research and Education (FARE), and Pfizer; and personal fees from the American Academy of Allergy, Asthma & Immunology as deputy editor of the Journal of Allergy and Clinical Immunology: In Practice, outside of the submitted work. M. Groetch receives royalties from UpToDate and the Academy of Nutrition and Dietetics, as well as and consulting fees from FARE; in addition, she serves on the medical advisory board of the International Food Protein–Induced Enterocolitis Syndrome Associations, as a senior advisor to FARE, as a health sciences advisor for the American Partnership for Eosinophilic Disorders, and on the editorial board of Journal of Food Allergy. W. Shreffler reports research support to MGH from NIH/NIAID, Genentech, DBC, Novartis, ALK, Allergy Therapeutics, FARE, FASI and consultation fees from Allerfund, Allergy Therapeutics, FARE, Mabylon, Novartis, Paraxel, Phylaxis, RAPT, Third Rock Ventures. E. Kim reports grants from the NIH/NIAID and grants from Genentech during the conduct of the study, as well as grants from FARE, personal fees from ALK, Kenota Health, Ukko Inc, AllerGenis, DBV Technologies, Genentech, and Novartis, and personal fees from Nutricia, Revolo Biotherapeutics outside the submitted work. C. Keet reports royalty payments from UptoDate, grants to her institution from the NIAID, the National Institute of Environmental Health Sciences, and FARE and from Genentech (for this study), as well as personal fees from the American Academy of Allergy, Asthma & Immunology as associate editor of the Journal of Allergy and Clinical Immunology outside of the submitted work. S. Sindher reports funding (money to her institution) from the NIH, Regeneron, DBV Technologies, Aimmune, Novartis, Consortium of Food Allergy Research (CoFAR), and FARE, and consulting fees from Genentech and DBV Technologies. A. Long reports funding (money to his institution) from the NIH, Regeneron, DBV Technologies, Aimmune, Novartis, CoFAR, and FARE, as well as consulting fees from Genentech and DBV Technologies. S. M. Jones reports grant support from the NIH-NIAID, FARE, Genentech, ALK-Abelló, Aravax Pty, DBV Technologies, Genentech, Novartis, and Regeneron Pharmaceuticals, as well as and personal fees from LAmAb Bio. A. M. Scurlock reports grants from the NIH/NIAID, during the conduct of the study, as well as grants from FARE, Aimmune Therapeutics, DBV Technologies, Regeneron Pharmaceuticals, Astellas Pharma, Genentech, Aravax Pty, ALK-Abelló, Novartis, and Siolta Therapeutics and personal fees from DBV Technologies, Aimmune Therapeutics, and Vindico CME outside the submitted work. D. Leung reports grants from the NIAID, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Sanofi, and Genentech, as well as personal fees from the American College of Allergy, Asthma, and Immunology (ACAAI). B. Lanser reports grants from Aimmune, DBV Technologies, Genentech, Regeneron, and thew NIH/NIAID, as well as personal fees from Bryn Pharma, DBV Technologies, and Genentech. J. A. Bird reports grants to his institution from Aimmune, Astellas, DBV technologies, FARE, Genentech, the NIH/NIAID, Novartis, Regeneron, and Siolta, as well as consulting fees from Allakos, AllergGenis, Allergy Therapeutics, DBV Technologies, FARE, Genentech, HAL Allergy, Novartis, Nutricia, and Parexel. J. M. Spergel reports grants from the NIH/NIAID and Novartis during the conduct of the study; grants and personal fees from Regeneron and Sanofi; personal fees from the ACAAI, Syneos, UptoDate Readysetfood; and grants from Allakos outside the submitted work. A. Iqbal and D. Sibanda are employees of Genentech/Roche. P. Tassinari and M. Ligueros-Saylan are employees of Novartis Pharmaceuticals Corporation. N. Yovetich reports employer, Rho, received funding through grants from the NIH/NIAID and from Genentech for support of Stage 1 interim analysis and clinical study report writing. C. Huckabee reports employer, Rho, received funding through grants from the NIH/NIAID and from Genentech for support of Stage 1 interim analysis and clinical study report writing. N. Rogers reports employer, Rho, received funding through grants from the NIH/NIAID and from Genentech for support of Stage 1 interim analysis and clinical study report writing. C. Parrish reports research support (funds to his institution) from the NIH-NIAID, Regeneron Pharmaceuticals, and DBV Technologies; consulting fees from Magellan Rx; speaking fees from Sanofi Genzyme; and advisory board participation for Sanofi Genzyme and Takeda Pharmaceuticals. D. Pyle reports grants from the NIH/NIAID and Genentech during the conduct of the study. M. Kulis receives research support through his institution from the NIH and Department of Defense. B. Vickery reports grants and personal fees from Aimmune, Aravax, DBV, FARE, Genentech, Regeneron, and Novartis; grants from Alladapt, AstraZeneca the NIH-NIAID, and Siolta; personal fees from Allergenis, IgGenix, Reacta Biosciences, Revolo, Sanofi, Stallergenes Greer, and Parexel; and stock options from Moonlight Therapeutics. R. S. Chinthrajah reports grants from NIAID, CoFAR, FARE, the Stanford Maternal and Child Health Research Institute, Genentech, and Regeneron, as well as personal fees from Alladapt Therapeutics, Novartis, Genentech, Allergenis, Intrommune Therapeutics, and IgGenix during the conduct of the study. R. A. Wood reports grants from the NIAID and Genentech during the conduct of the study, as well as grants from Aimmune, ALK, DBV, the NIAID, Novartis, Siolta, and FARE and royalties from Up To Date. The rest of the authors declare that they have no relevant conflicts of interest. The coauthorship of this report by A. Togias, L. M. Wheatley, and A. Lin does not constitute official endorsement by the NIAID, NIH, or any other agency of the United States government.

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