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Although omalizumab demonstrated superiority over oral immunotherapy, the treatments had comparable effectiveness when excluding dropouts from the analysis, Wood said at AAAAI.
At the 2025 American Academy of Allergy, Asthma, & Immunology (AAAAI) annual meeting in San Diego, HCPLive spoke with Robert Wood, MD, from Johns Hopkins Medicine, on OUtMATCH—a trial comparing the effectiveness of omalizumab vs oral immunotherapy for food allergies.
OutMATCH had 177 participants (55% males; the median age of 7 years who were allergic to peanuts and ≥ 2 other common food allergens, such as milk, egg, cashew, wheat, walnut, or hazelnut. Participants started with omalizumab injections and at week 9 were randomized to receive oral immunotherapy or placebo oral immunotherapy (maintenance goal: 1,000 mg). At week 16, participants entered the double-blind portion, where they were randomized to receive either omalizumab or a placebo injection for 44 weeks. The therapy was considered successful if participants tolerated 4,044 mg of all 3 of their food allergens post-treatment.
In the intent-to-treat analysis, omalizumab demonstrated superiority over oral immunotherapy (36% vs 19%; odds ratio [OR]; P = .031). However, the per-protocol analysis, which analyzed the treatment’s effectiveness without examining dropouts, found no differences between omalizumab and oral immunotherapy for food allergy management (P = .66).
“When we do an intent to treat analysis, what happens is that anyone who drops out of the treatment for any reason is considered a treatment failure,” Wood told HCPLive. “And in this stage 2 of the outmatch study, there was a very low rate of dropouts in the omalizumab side of the study and quite a high rate of dropouts in the multi-allergen OIT slide of the side of the study. What that did really is drive the results toward the advantage of omalizumab. If we look only at the patients who could stay on oral immunotherapy, the results were very similar, and that's the per-protocol analysis.”
He said the results underline the importance of an individualized treatment approach. A patient may tolerate their food allergen better after omalizumab or oral immunotherapy—it all depends on how the patient reacts.
“What I would take away from this is that oral immunotherapy does have potential benefit, but we need to be very clear with our patients about the high rate of side effects and the possibility that they really won't tolerate that treatment, whereas with omalizumab, we don't see side effect,” Wood said. “While [omalizumab] doesn't have the potential for long-term changes in the immune system that oral immunotherapy has, it's a very effective treatment for most patients with a very low risk of side effects.”
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