Omalizumab treats multiple food allergies better than oral immunotherapy

Press release

Monday, March 3, 2025

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High rate of side effects of oral immunotherapy in NIH trial explains superiority of omalizumab.

Participants in the OUtMATCH trial are allergic to peanuts and at least two other foods including milk, eggs, wheat, cashews, walnuts, and hazelnuts. NIAID

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A clinical trial found that the drug omalizumab, marketed as Xolair, treated multi-food allergies more effectively than oral immunotherapy (OIT) in people with allergic reactions to very small amounts of common food allergens. OIT, the most common approach to treating food allergies in the United States, involves eating gradually increasing doses of a food allergen to reduce the allergic response to it. Thirty-six percent of study participants who received extended omalizumab treatment could tolerate 2 grams or more of peanut protein, or about eight peanuts and two other food allergens, at the end of the treatment period, but only 19% of participants who received multi-food OIT could tolerate this. The researchers attributed this difference primarily to the high rate of allergic reactions and other intolerable side effects among participants who received OIT, which led a quarter of them to discontinue treatment. When participants who discontinued treatment were excluded from the analysis, however, the same proportion of each group could tolerate at least 2 grams of all three food allergens.

The results were published in an online supplement of the Journal of Allergy and Clinical Immunology And presented at the 2025 American Academy of Allergy, Asthma & Immunology/World Allergy Organization Joint Meeting in San Diego on Sunday, March 2, 2025. “People with highly sensitive multi-food allergies previously had only one treatment option—oral immunotherapy—to reduce their allergic response to moderate amounts of these foods,” said Jeanne Marrazzo, MD, MPH, director of the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), the study’s funder and regulatory sponsor. “This study shows that omalizumab is a good alternative because most people tolerate it very well. Oral immunotherapy remains an effective option if treatment-related adverse effects are not a concern.”

Omalizumab works by binding to the allergen antibody called immunoglobulin E in the blood and preventing it from arming the key immune cells responsible for allergic reactions. This makes these cells much less susceptible to stimulation by an allergen.

The current study is the second stage of a

benchmark clinical trial which found that 16 weeks of treatment with omalizumab increased the amount of peanuts, tree nuts, eggs, milk, and wheat that children with multiple food allergies as young as one year old could consume without an allergic reaction. This next stage of the trial was designed to directly compare omalizumab to OIT for the first time. At 10 sites across the United States, the study team recruited 177 children and adolescents aged 1 to 17 years and three adults aged 18 to 55 years, all with a confirmed allergy to less than half a peanut and similarly small amounts of at least two other common foods: milk, egg, cashew, wheat, hazelnut, or tree nut. After completing the first stage of the trial, 117 people entered the second stage of the trial.

At the start of the second stage, all participants received omalizumab injections for eight weeks. The participants were then randomly divided into two groups. Group A received omalizumab injections and multi-allergen OIT for eight weeks, while Group B received omalizumab injections and placebo OIT for eight weeks. Subsequently, Group A received placebo injections and multi-allergen OIT for 44 weeks, while Group B continued to receive omalizumab injections and placebo OIT for 44 weeks. Neither the participants nor the investigators knew who was in which treatment group.

Group A received omalizumab before and during the first months of OIT because data from previous studies suggested that pretreatment with the drug would significantly increase the safety of OIT, and that continuing omalizumab during the first months of OIT would provide additional benefit.

During the study treatment period, 29 of the 59 participants in Group A discontinued treatment: 15 due to allergic reactions, some severe, or other intolerable symptoms of OIT, and 14 for other reasons, including aversion to the study foods or coercion into participating in the trial. No participants in Group B had allergic reactions or other omalizumab-related side effects that caused them to discontinue treatment, but seven participants in Group B left the study primarily due to coercion into participation. Overall, 30 of the original 59 members of Group A (51 %) and 51 of the original 58 members of Group B (88 %) completed treatment.

After the study treatment period, the clinical trial team checked whether participants who completed treatment could eat at least 2 grams of peanut protein and their two other study foods without an allergic reaction. Twenty-one of the original 58 participants in Group B, or 36 %, could tolerate at least 2 grams of all three foods, while only 11 of the original 59 participants in Group A (the OIT group), or 19 %, could do so.

.However, when assessing only participants who completed treatment, the same proportion of each group could tolerate at least 2 grams of all three foods. These results showed that omalizumab was more effective than OIT in treating multi-food allergy in people who initially had a very low tolerance to common food allergens. The researchers attributed this result mainly to the high rate of allergic reactions and other side effects that led to treatment discontinuation in participants treated with OIT, despite receiving omalizumab before and during the first few months of treatment.

The trial is called Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults, or OUTMATCH. The NIAID-funded Consortium for Food Allergy Research (CoFAR) is conducting the trial under the direction of Dr. Robert Wood and Dr. R. Sharon Chinthrajah. Dr. Wood is the Julie and Neil Reinhard Professor of Pediatric Allergy and Immunology and director of the Pediatric Clinical Research Unit at the Johns Hopkins University School of Medicine, Baltimore. Dr. Chinthrajah is an associate professor of medicine and of pediatric clinical allergy and immunology and co-director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford University School of Medicine, Stanford, California.

NIAID is funding the ongoing trial with additional financial support and collaboration from Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation. The two companies are collaborating to develop and promote omalizumab and are supplying it for the trial.

Further information about the OUtMATCH trial is available at ClinicalTrials.gov under the study identifier

NCT03881696 .NIAID conducts and supports research—at the NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better ways to prevent, diagnose, and treat these diseases. Press releases, fact sheets, and other NIAID-related materials are available at

NIAID website .About the National Institutes of Health (NIH):

NIH, the nation's medical research agency, comprises 27 institutes and centers and is part of the U.S. Department of Health and Human Services. NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research, studying the causes, treatments, and cures for common and rare diseases. For more information about NIH and its programs, visit www.nih.gov .NIH…Turning Discovery Into Health

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