A new clinical trial has found that omalizumab (Xolair) is a more effective and better-tolerated treatment for multi-food allergies than oral immunotherapy (OIT).
The study, funded by the National Institute of Allergy and Infectious Diseases (NIAID), showed that people allergic to even tiny amounts of common foods had better results with omalizumab than with OIT.
How does Omalizumab work?
Omalizumab is a medication that works by blocking the allergy-causing antibody immunoglobulin E (IgE) in the blood. This prevents key immune cells from reacting strongly to allergens, making allergic reactions much less likely.
OIT, on the other hand, involves slowly increasing exposure to food allergens to help the body build tolerance. While this method is widely used in the U.S., it can cause strong allergic reactions, leading many people to stop treatment.
The study included 177 children, teens, and adults with severe food allergies to peanut and at least two other common foods like milk, egg, cashew, wheat, hazelnut, or walnut.
- 36% of participants who took omalizumab could eat at least 2 grams of peanut protein (about 8 peanuts) and two other allergens without a reaction.
- Only 19% of those who took OIT could do the same.
- A major reason for this difference was that many people in the OIT group had allergic reactions or other side effects, causing 25% of them to stop treatment early.
- Among those who completed treatment, both groups had similar success rates.
Dr. Jeanne Marrazzo, director of NIAID, explained: “Omalizumab offers a new option for people with severe multi-food allergies. It’s a safer alternative for those who cannot tolerate OIT’s side effects.”
The study was done in two stages across 10 locations in the U.S..
- First, all participants received omalizumab injections for 8 weeks.
- Then, they were divided into two groups:
- Group A: Took omalizumab and OIT for 8 weeks, followed by 44 weeks of OIT alone.
- Group B: Continued omalizumab for 44 weeks but took a placebo instead of OIT.
- At the end of treatment, researchers tested whether participants could eat at least 2 grams of peanut protein and their two other allergens without an allergic reaction.
Why did so many people stop OIT?
- Half of the OIT group (51%) stopped treatment, with 15 people quitting due to severe allergic reactions or side effects and 14 for other reasons, like dislike of the foods or study participation burden.
- No one in the omalizumab-only group stopped due to allergic reactions.
What this means for people with food allergies
The study suggests that omalizumab could become a safer, more effective alternative to OIT for people with highly sensitive multi-food allergies. While OIT remains an option for those who can tolerate its side effects, omalizumab offers a promising new approach to managing food allergies with fewer risks.
The research was presented at the 2025 American Academy of Allergy, Asthma & Immunology/World Allergy Organization Joint Congress and published in The Journal of Allergy and Clinical Immunology.
For more details on this trial, visit ClinicalTrials.gov (NCT03881696).
Source: KSR.
