Exploratory analyses of predictors and correlates of response to omalizumab therapy in patients with multiple food allergies - 12/12/25

Doi : 10.1016/j.jaci.2025.10.031

R. Sharon Chinthrajah, MD ^a,^⁎ , Michael Kulis, PhD ^b, Stacie M. Jones, MD ^c, Scott Sicherer, MD ^d, Julie Wang, MD ^d, Wayne Shreffler, MD, PhD ^e, Caitlin M. Burk, MD ^e, Edwin Kim, MD ^b, Corinne Keet, MD, PhD ^b, Sayantani Sindher, MD ^a, Andrew J. Long, PharmD ^a, Amy M. Scurlock, MD ^c, Bruce J. Lanser, MD, MPH ^f, Jessica W. Hui-Beckman, MD ^f, Brian Vickery, MD ^g,^h, Idil D. Ezhuthachan, MD ^g, J. Andrew Bird, MD ⁱ, Christopher Parrish, MD ⁱ, Jonathan M. Spergel, MD, PhD ^j, Terri Brown-Whitehorn, MD ^j, Jennifer Dantzer, MD ^k, Monica Ligueros-Saylan, MD ^l, Paolo Tassinari, MD ^l, Julie Olsson, MD ^m, Ahmar Iqbal, MD ^m, Marie Ozanne, PhD ⁿ, Charmaine Huckabee, MS ⁿ, Nicole Rogers, BS ⁿ, Nancy Yovetich, PhD ⁿ, Adora Lin, MD, PhD ^o, Erica Brittain, PhD ^o, Lisa M. Wheatley, MD ^o, Alkis Togias, MD ^o, Robert A. Wood, MD ^k

^a Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Palo Alto, Calif

^b Division of Pediatric Allergy and Immunology, Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC

^c Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark

^d Department of Pediatrics, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY

^e Division of Pediatric Allergy & Immunology and Food Allergy Center, Massachusetts General Hospital, Boston, Mass

^f Department of Pediatrics, National Jewish Health, Denver, Colo

^g Department of Pediatrics, Emory University, Atlanta, Ga

^h Children’s Healthcare of Atlanta, Atlanta, Ga

ⁱ Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Tex

^j Division of Allergy and Immunology, Children's Hospital of Philadelphia, Department of Pediatrics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pa

^k Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Md

^l Novartis, Emeryville, Calif

^m Genentech/Roche, South San Francisco, Calif

ⁿ Rho, Inc, Chapel Hill, NC

^o National Institute of Allergy and Infectious Diseases, Bethesda, Md

^∗ Corresponding author: R. Sharon Chinthrajah, MD, Departments of Medicine and Pediatrics, 750 Welch Rd, Suite 114, Palo Alto, CA 94304. Departments of Medicine and Pediatrics 750 Welch Rd Suite 114 Palo Alto CA 94304

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Abstract

Background

Stage 1 of the Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults (OUtMATCH) study demonstrated that treatment with omalizumab for 16 to 20 weeks significantly increased the reaction threshold for peanut and other common food allergens in participants with multiple food allergies. However, the degree of this protection is variable across participants, and there are no known markers to predict or assess individual response to omalizumab.

Objective

Our aim was to evaluate clinical and laboratory-based variables as predictors or correlates of response to omalizumab treatment.

Methods

Cumulative tolerated dose (CTD) as a continuous variable and thresholds of 444 mg and 1044 mg of individual food proteins were selected as definitions of positive treatment response. Clinical and immunologic variables were evaluated as predictors of response.

Results

Omalizumab treatment reduced the level of free IgE. In this exploratory analysis (N = 116), although not definitive, higher total IgE level at baseline was the most consistent predictor of a positive response to omalizumab treatment (peanut CTD: r = 0.25; q = 0.047). Omalizumab dosing frequency (every 2 weeks) was also associated with higher peanut CTD outcomes ( r = 0.25; q = 0.047). Medical history of allergy, level of allergen-specific IgE, skin prick test result, and basophil activation did not consistently correlate with response to omalizumab treatment. Concomitant peanut and milk allergy was positively correlated with outcomes of omalizumab treatment ( r = 0.34; q = 0.003), whereas peanut allergy concomitant with either cashew allergy ( r = -0.43; q = 0.003) or walnut allergy ( r = –0.26; q = 0.042) was inversely correlated with outcomes of omalizumab treatment.

Conclusion

Of the food allergy biomarkers and omalizumab dosing assessed in this analysis, a higher baseline total IgE level was the most consistent, albeit modest, predictor of successful peanut threshold protection with omalizumab treatment, thus warranting further study.

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Key words : Predictors, correlates, basophil activation, food challenges, omalizumab, food allergy, IgE, anti-IgE

Abbreviations used : BAT, CTD, DBPCFC, FDR, NPV, OUtMATCH, sIgE, SPT, tIgE