“These findings equip healthcare providers with valuable data on omalizumab and oral immunotherapy, enabling them to continue to address the diverse needs and treatment goals of their food allergy patients.”
Omalizumab Efficacy and Safety Shown Superior to OIT in First Head-to-Head Multi-Food Allergy Trial
Safety findings from the phase 3 OUtMATCH trial were notable, including no adverse events for omlizumab vs 30.5% for OIT and epinephrine use for 0% vs 37.3%, respectively.
Omalizumab (Zolair; Roche) demonstrated superior efficacy and a better safety profile compared to multi-allergen oral immunotherapy (OIT) in the first-ever head-to-head trial of the 2 treatment approaches to food allergy, according to new findings from the NIH-sponsored phase 3 OUtMATCH study.1
The results were featured as late-breakers at the 2025 American Academy of Allergy, Asthma, and Immunology meeting, February 28 - March 3, in San Diego, CA.
OUtMATCH stage 2 results showed that 36% of patients treated with omalizumab monotherapy could tolerate at least 2,000 mg of peanut protein and the same amount of 2 additional food allergens without an allergic reaction, compared to 19% in the OIT group (OR 2.6, P =.031). Omazlizumab-treated participants also showed the ability to tolerate at least 2 allergenic foods (P =.004).
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Described as a "key finding," investigators reported significantly higher rates of adverse events (AEs) in the OIT group, including serious AEs (30.5% vs 0% for omalizumab), AEs leading to treatment discontinuation (22% vs 0%), and AEs requiring epinephrine (37.3% vs 6.9%). The tolerability outcome suggests a safety profile for omalizumab that is superior to OIT for persons with multiple food allergies, according to a news release from Roche.1
The Stage 2 study 117 participants (median age 7 years) who had completed Stage 1 and had initially received 8 weeks of open-label treatment with omalizumab, according to Novartis. The group was then randomly assigned to receive multi-allergen OIT or placebo OIT while continuing omalizumab injections for 8 more weeks. The OIT group then switched to placebo injections for 44 weeks while the omalizumab group continued receiving the study drug with placebo OIT.
Stage 3 of the OUtMATCH study provided preliminary data on introducing allergenic foods after discontinuing omalizumab. Among 60 participants, 82% (n=148) were initially advised to consume allergenic foods. After 12 months of follow-up, many participants were able to introduce allergenic foods, with higher success rates for milk, egg, and wheat (61% to 70%) compared to peanuts and tree nuts (38% to 56%). Success for the study was defined as the ability to tolerate a median 300 mg daily of allergenic protein, Novartis said. Many participants, however, returned to avoidance due to symptoms, taste aversion, or other factors. Adverse events, including anaphylaxis and eosinophilic esophagitis, were reported in some cases. Stage 3 is ongoing, with further analysis expected, including of Stage 2 completers who entered Stage 3.1
“Food allergies are becoming more common, leaving millions of families to grapple with constant vigilance, strict dietary restrictions and disruptions to everyday activities,” R Sharon Chinthrajah, MD, OUtMATCH co-lead study investigator and associate professor of medicine, Stanford School of Medicine, Sean N. Parker Center for Allergy and Asthma Research, said in the company news release. “These findings equip healthcare providers with valuable data on omalizumab and oral immunotherapy, enabling them to continue to address the diverse needs and treatment goals of their food allergy patients.”
“These latest data provide additional evidence demonstrating the importance of [omalizumab] as a treatment option for the food allergy community,” Levi Garraway, MD, PhD, Roche's chief medical officer and head of global product development, said. “We are deeply grateful to the leading research institutions who partnered with us on this groundbreaking study, along with the inspiring dedication of the study’s participants and their families.”
Stage 1 of the OUtMATCH study served as the basis for the FDA approval of omalizumab for children and adults with one or more food allergies, and the data were published in the New England Journal of Medicine in February 2024.
Omalizumab is the first and only FDA-approved medication to reduce allergic reactions to reduce allergic reactions, including anaphylaxis, from accidental exposure to 1 or more foods in patients aged 1 year and older with IgE-mediated food allergy. Avoidance of allergenic foods is still highly recommended as omalizumab is not intended for emergency treatment of anaphylaxis, the company stated.
References
1. Phase III study shows Xolair may be more effective with fewer side effects than oral immunotherapy for the treatment of food allergies. News release. Roche. March 1, 2025. Accessed March 3, 2025. https://www.roche.com/media/releases/med-cor-2025-03-02
2. Omalizumab for the treatment of multiple food allergies. N Engl J Med. 2024;390(10):889-899. doi:10.1056/NEJMoa2312382
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