Food Allergy Monday 03.03.2025
Expert Updates for Pediatric Healthcare Providers
🧭 Your weekly compass in the evolving landscape of pediatric food allergies
This Week's Featured Article
Title: "Treatment of Multi-Food Allergy with Omalizumab Compared to Omalizumab-Facilitated Multi-Allergen OIT"
Authors: Robert A. Wood, M.D. et al
Journal and Year: Abstract presented at the AAAAI 2025
⚡️ Key Points in 30 Seconds
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Xolair® (omalizumab) is a monoclonal antibody that binds to IgE and can raise a patient’s reaction threshold. (Reaction threshold is the amount of an allergen that triggers a reaction.)
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Xolair® increased most subjects’ reaction threshold, i.e. patients treated with four months of Xolair® were able to ingest larger amounts of their allergens without reacting compared to subjects on placebo.
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This abstract presented data from stage two of the three-stage study.
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This study demonstrated that an accelerated multi-food OIT protocol has more adverse reactions than does Xolair®.
👉 Why This Article Matters for Your Practice
This abstract is a bit in-the-weeds for non-allergists since non-allergy clinicians probably are not offering patients Xolair® or OIT as these therapies are offered under an allergist's care. Why this study matters to your practice is because you may have patients ask you your thoughts, e.g. “What do you think is better - Xolair® or OIT?”
It’s important that all of us who care for children with food allergies be somewhat informed about care that we ourselves don’t offer. Given the prevalence of food allergy, it’s particularly important that you have insight into this topic.
📊 Study Overview - Stage 2
Population: cohort of 177 children and adolescents (ages 1-17 years old) with multiple food allergies. This stage included 117 of those initial subjects.
Design: (See this newsletter with the initial study overview, and the diagram is below). In Stage 2, subjects were all treated with Xolair® for 16 weeks (this is in addition to the Xolair they received in Stage 1 of the study, which could have been 16-20 weeks or none, depending on their study group). Halfway through this 16-week period (so after 8 weeks), subjects were started on OIT or placebo-OIT. After each group completed its 16 weeks of Xolair® and were either on OIT or placebo-OIT, the placebo-OIT group continued receiving Xolair® while the real OIT group began receiving placebo-Xolair®. Subjects continued in their groups for a total of 44 weeks after the initial 2 weeks of Xolair®. They then underwent four food challenges to assess the primary endpoint of this stage, which was consuming >/= 4,044mg of all three foods.
Study design of the OUtMATCH study.
It is important to note that the OIT protocol used in this study was more accelerated and reached higher doses than most OIT protocols.
Side-by-side comparison of OUtMATCH OIT protocol versus Palforzia OIT protocol.
Primary Outcome (regarding food allergy): In the Intention-To-Treat analyses, subjects who received Xolair® and placebo-OIT were significantly more likely to meet the primary outcome (i.e. consume >/= 4,044mg of all three foods) compared to subjects who received OIT and placebo-Xolair. This is due to patients in the OIT group stopping the study due to adverse events (i.e. allergic reactions). In the Per-Protocol analyses (which included the subjects who tolerated the OIT and those who tolerated Xolair®), the groups performed fairly similarly.
Key Conclusions by the Authors: ”Xolair® is superior to OIT.” 🤦🏻♀️
Hoyt Commentary
I continue to appreciate Xolair® as a great tool for our toolkit to treat children with IgE-mediated food allergies.
It helps these children stay safe in a world in which they may be exposed to their allergens.
Is Xolair® better than OIT?
No. Despite the conclusions of the authors, I do not see Xolair® as superior to OIT in increasing a child’s reaction threshold. My conclusion is based on my assessment that the study’s OIT protocol was far too aggressive and not consistent with how most OIT allergists practice OIT, and this aggressive OIT protocol made it more likely these children would react compared to a more traditional, well-researched, commonly utilized OIT protocol.
When asked at the AAAAI meeting why this seemingly aggressive protocol was used, Dr. Wood responded that the study team expected the study subjects to tolerate more allergen (than a patient who had not previously been on Xolair®). In my opinion, this is not something that should be assumed. If the study wanted to compare Xolair and OIT, then use an OIT protocol that is commonly used in research studies and is the basis and/or akin to many OIT protocols being used today. To use an aggressive OIT protocol then say Xolair is superior to OIT is an inaccurate comparison.
In other words, of course these OIT kids reacted - the OIT protocol was too aggressive.
Ultimately, Xolair® is a nice way to help raise a child’s reaction threshold, making them less likely to react to their allergens. But is it better than OIT? Looking at the kids who did actually tolerate the OIT protocol, the outcomes were pretty similar, so, no, I don't thinks Xolair® is better, per se, than OIT. I think Xolair® and OIT are two very different ways to help keep kids safe, and that both ways work well in the right patient.
Patient Communication Tips
🗣️ Key Messages for Families
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Xolair® can help prevent children with IgE-mediated food allergies from reacting to their food allergens.
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Xolair® may be compared to OIT because both are treatments for food allergy, but these are two different approaches and both can raise a child’s reaction threshold.
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Whether Xolair® or OIT (or neither!) is right for a child depends on multiple factors and should be discussed and decided via shared decision-making.
Sample Script:
"Have you heard about Xolair®? It’s an FDA-approved injected medication that helps protect patients with food allergies from severe allergic reactions. It can help increase a child’s reaction threshold to an allergen, similar to oral immunotherapy (OIT). Have you and your child’s allergist discussed this?"
🧐 Quick Quiz
After perusing the article, test your knowledge with this single question:
True or false: Xolair® is superior to OIT in treating food allergies.
Answer and explanation provided in next week's newsletter. ✔
Last week’s answer: False. Xolair® can help raise a child’s reaction threshold but will not cure the child’s food allergy.
'Food Allergy Friday' is curated and written by Dr. Alice Hoyt. Dr. Hoyt is board-certified in allergy & immunology, internal medicine, and pediatrics. Her clinical expertise is in food allergies, and she serves patients with her team at the Hoyt Institute of Food Allergy.
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