News Release
Monday, March 3, 2025
The high percentage of oral immunotherapy side effects in the NIH trial explains the advantage of omalizumab.
In clinical trials, the drug omalizumab, sold as Xolair, treated polyfood allergies more effectively than oral immunotherapy (OIT) in people with an allergic reaction to very small amounts of common food allergens. The most common approach to treating food allergies in the United States, OIT involves eating gradually increasing food allergens to reduce the allergic reaction to it. Thirty-six percent of study participants who received an extended course of omalizumab were able to withstand more than 2 grams of peanut protein, or about 8 peanuts, and two other food allergens by the end of the treatment period, but only 19% of participants who received a multi-food OIT can do so. Researchers have led to this difference primarily due to a high rate of allergic reactions and other unbearable side effects among participants who received the OIT, leading to a quarter of them discontinuing treatment. However, if participants who discontinued treatment are excluded from the analysis, the same proportion of each group can withstand at least 2 grams of all three food allergens.
The survey results were Published With online supplements Journal of Allergy and Clinical Immunology and Presentation The 2025 American Academy of Allergy, Asthma & Immunology/World Allergy Organizations Joint Conference 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 allergic reactions to moderate amounts of these foods,” said MD, MD, MD, MPH, director of the NIH National Institute of Allergy and Infectious Diseases (NIAID). “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 side effects are not an issue.”
Omalizumab functions by binding to an allergic antibody called immunoglobulin E in the blood, preventing arming of important immune cells that cause allergic reactions. This makes these cells less sensitive to stimulation by any allergen.
The current study is the second stage of a Landmark Clinical Trials Therefore, the 16-week course of omalizumab increased the amount of peanuts, trees, eggs, milk and wheat for children with multi-food allergies that a young child as young as 1 year old could consume without an allergic reaction. This next phase of the study was designed to be a direct comparison of omalizumab with OIT for the first time.
At 10 locations in the US, the research team enrolled 177 children and three adults aged 17 and 18 to 55. After completing the first phase of the trial, 117 people entered the second phase of the trial.
Upon stage 2, all participants received an injection of omalizumab for 8 weeks. Participants were then randomly divided into halves and placed in one of two groups. Group A received omalizumab injection and multi-allergen OIT for 8 weeks, while Group B received omalizumab injection and placebo OIT for 8 weeks. Group A subsequently received placebo injections and multi-allergen OIT for 44 weeks, while Group B continued receiving omalizumab injections and placebo OIT for 44 weeks. Neither participant nor investigators knew who was in which treatment group.
Group A received omalizumab in the early months before and during the early months of OIT. This suggests that data from previous studies would significantly enhance the safety of OITs, and that continuous omalizumab for the early months of OITs would provide additional benefits.
During the study treatment period, 29 of the 59 participants in Group A discontinuation therapy were 15 due to allergic reactions (some severe) or other unbearable symptoms of OIT, and 14 for other reasons including aversion to study foods and burden of participating in the trial. Group B participants discontinued treatment because they did not suffer from allergic reactions or other side effects from omalizumab, while seven participants in Group B left the study primarily due to the burden of participation. In total, 30 of the 59 original members of Group A (51%) and 51 of the 58 original members of Group B (88%) completed treatment.
After the study treatment period, the clinical trial team tested whether participants who completed the treatment could eat at least 2 grams of peanut protein and two other study foods without an allergic reaction. Twenty-one of the original 58 participants in Group B or 36% can tolerate at least 2 grams of all three foods, and only 11 of the original 59 participants in Group A (OIT processing group), or 19% can do so.. However, if we evaluate only participants who have completed treatment, the same percentage in each group can withstand at least 2 grams of all three foods.
These results showed that omalizumab is more effective than OIT in treating multifood allergies in people who had very low tolerance to common food allergens. The researchers attributed this finding primarily to the high rates of allergic reactions and other side effects leading to treatment discontinuation among participants in OIT treatment, despite omalizumab being administered before and after treatment.
The trial is called either monotherapy or as an adjuvant therapy for multi-allergen OIT in children and adults with food allergies, or as adjuvant therapy. NIAID-funded Food Allergy Research (COFAR) is trial under the leadership of Robert Wood, MD, and R. Sharon Scinchiraja. Dr. Chinchillaja is an associate professor of medicine and pediatric allergy and clinical immunology and is co-director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford University School of Medicine in Stanford, California.
Niad is funding the ongoing trial, along with additional financial support from Genentech, a member of the Roche Group, and additional financial support from Novartis Pharmaceuticals Corporation. The two companies work together to develop and promote omalizumab and supply it to court.
Details of the Outmatch Trials are available under the Research Identifier at ClinicalTrials.gov. NCT03881696.
NIAID conducts and supports research across the United States and around the world to study the causes of infectious and immune-mediated diseases and develop better means to prevent, diagnose and treat these diseases. News releases, fact sheets and other NIAID-related materials are Niaid Website.
About the National Institutes of Health (NIH):The national medical research institute, the NIH, includes 27 research institutes and centers, and is a component of the U.S. Department of Health and Human Services. NIH is a leading federal agency that conducts and supports basic, clinical, and translational medical research, investigating the causes, treatments and treatments for both common and rare diseases. For more information about NIH and its programs, please visit www.nih.gov.
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reference
ra wood et al. Treatment of multifood allergies with omalizumab compared to omalizumab-promoted multi-allergen OIT. Journal of Allergy and Clinical Immunology doi: 10.1016/j.jaci.2024.12.1022 (2025).
