Omalizumab Shows Stronger Efficacy, Less Allergic Reactions Compared to Oral Immunotherapy
Patients in the study could tolerate food allergens more, with fewer adverse events or reactions, compared with multi-allergen oral immunotherapy.
In new data from the OUtMATCH (NCT03881696) study, omalizumab (Xolair) showed more effectiveness with fewer adverse events (AEs) compared with multi-allergen oral immunotherapy (OIT). In stage 3 of the study, there was also early data on introducing allergenic foods into a patient’s diet after stopping omalizumab.1
The investigators of the study aimed to determine if omalizumab alone or in combination with OIT could help those with multiple food allergies. | Image Credit: doucefleur | stock.adobe.com
“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, co-lead study investigator and associate professor of medicine at the Stanford School of Medicine, said in a news release.1 “These findings equip health care 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.”
The OUtMATCH trial is a multi-center, randomized, double-blind study that included individuals aged 1 to 56 years of age who were allergic to peanuts and at least 2 other foods, including milk, egg, wheat, cashew, hazelnut, or walnut. The investigators of the study aimed to determine if omalizumab alone or in combination with OIT could help those with multiple food allergies, especially eating foods that they are allergic to. OIT is the ingesting of the food allergen, initially in small amounts and gradually increasing.1,2
In stage 1 of the study, the investigators aimed to learn if omalizumab stopped or decreased the allergic reactions after taking the therapy for a length of time. There were 60 individuals included, and this potion was open label. In stage 2, investigators aimed to determine how short a course of omalizumab combined with OIT was compared with the longer course of omalizumab in reducing allergic reactions. Lastly, in stage 3, after individuals stopped both treatments, investigators aimed to see if they could eat the foods in the form they would normally be eaten.
The primary study outcome included the number of individuals by stage 1 that successfully consumed a single dose of 600 mg of more peanut protein without dose-limiting symptoms.2
The primary end point was met, showing 36% of patients treated with omalizumab monotherapy could tolerate at least 2000 mg of peanut protein, which is equivalent to 8 peanuts compared with 19% in the OIT group. They could also withstand 2 other food allergens without an allergic reaction. After stage 1, 117 patients were moved to stage 2 and received an additional 8 weeks of therapy with omalizumab. Patients either received OIT or placebo OIT while continuing omalizumab for another 8 weeks. The OIT group switched to the placebo injection for an additional 44 weeks, and the omalizumab group continued with the drug and placebo OIT. After treatment, patients received the 3 study foods, including peanut, with the primary end point of 2000 mg or more of all 3 foods being met.1
Further, investigators reported that superiority was met for secondary end points, which included tolerating 2 or more foods, and the rates of serious AEs in the OIT group were higher at 30.5% compared with 0% for omalizumab. AEs leading to discontinuation were 22% and 0%, respectively, and AEs leading to treatment with epinephrine were 37.3% and 6.9%, respectively.1
Finally, in stage 3, the first 60 patients from stage 1 were included in a 24-week open-label extension, which included dietary consumption of allergenic foods, rescue oral immunotherapy, or food avoidance. In this stage, patients no longer received omalizumab. After the 12 months of follow-up, investigators reported that many patients could eat the allergenic foods in their dietary form, but the rates varied. Milk, eggs, and wheat ranged from 61% to 70% compared with peanuts and tree nuts at 38% to 56%, according to the data. This stage is still ongoing, and investigators will continue to analyze data from patients who completed stage 2 and entered stage 3.1
“These latest data provide additional evidence demonstrating the importance of Xolair as a treatment option for the food allergy community,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Roche, said in the news release.1 “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.”
In February 2024, omalizumab was approved by the FDA for immunoglobin E-mediated food allergy for adults and children 1 year and older for the reduction of type 1 allergic reactions due to accidental exposure to certain foods. Allergic reactions included the risk of anaphylaxis. The approval was based on data previously announced for the OutMATCH study. The FDA also granted priority review to omalizumab for the same indication in 2023.3,4
READ MORE: Allergy Resource Center
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