Omalizumab Outperforms Oral Immunotherapy for Food Allergies in Johns Hopkins Study

Robert Wood, MD

Credit: Johns Hopkins Medicine

New research at Johns Hopkins Children’s Center found that omalizumab performed better than oral immunotherapy for food allergies.¹ Another phase of the study showed that patients may be able to introduce allergenic foods into their diets after stopping omalizumab.

The findings of the comparison analysis were presented as a late-breaker on Sunday, March 2 at the 2025 American Academy of Allergy, Asthma, & Immunology (AAAAI) annual meeting in San Diego.² In the second stage of OUtMATCH, investigators compared omalizumab with oral immunotherapy among a sample of 117 participants (55% male; 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.¹

“This is the first time we’ve been able to directly compare these two treatments for multiple food allergies, and our study shows omalizumab was superior to oral immunotherapy,” said lead investigator Robert Wood, from Johns Hopkins Medicine, in a press release. “This is an important distinction for clinicians who are weighing which treatment to recommend to their patients.”

All participants received 8 weeks of omalizumab injections. At week 9, approximately half received oral immunotherapy and half received placebo oral immunotherapy. Participants’ specific food allergen dose escalated to the maintenance goal of 1,000 mg.

At week 16, participants started the double-blind portion of the trial, where they were randomized to receive either omalizumab or a placebo injection for 44 weeks. After this 44-week mark, participants were challenged to consume 8,044 mg of protein for their food allergen.

Participants were required to tolerate 4,044 mg of all 3 of their food allergens for the treatment to be considered successful. This was equivalent to approximately 20 peanuts or ½ cup of milk.

Omalizumab demonstrated superiority over oral immunotherapy in the intent-to-treat analysis (36% vs 19%; odds ratio [OR], P = .031). When excluding dropouts in the per-protocol analysis, investigators found no differences between treatments (P = .66).

Differences in omalizumab and oral immunotherapy were largely driven by more patients on oral immunotherapy dropping out due to adverse events. In total 88% in the omalizumab group and 51% in the oral immunotherapy and placebo injection group completed this part of the trial. No participants in the omalizumab group experienced serious adverse reactions, whereas > 30% did in the oral immunotherapy group.

Investigators shared preliminary results for stage 3 of the study, where 60 participants who completed stage 1 received an additional 24 weeks of omalizumab and then stopped the medication. The third stage of the trial is still ongoing, with an expected completion in the summer of 2025.

The early data shows the number of allergens consumed reduced throughout the study, excluding wheat. Success was defined as eating > 300 mg of food protein each day over 12 months.

After stopping omalizumab, consumption of milk, eggs, and wheat had a greater success rate (61% to 70%) than peanuts and tree nuts (38% to 56%). Investigators observed the reduced consumption was due to adverse events, such as anaphylaxis, or taste. After this phase, many participants returned to avoiding their food allergens.

“While the results of Stage 3 are still preliminary, the majority of the first 60 participants were able to successfully introduce allergenic foods into their diet after stopping omalizumab,” said Jennifer Dantzer, MD, a pediatric allergist at Johns Hopkins Children’s Center, in the statement. “Omalizumab is currently approved in the US for the reduction of allergic reactions that may occur with accidental exposures. These results indicate that omalizumab may have additional uses that may be valuable for patients, but the potential risks should be recognized.”

References

1. Johns Hopkins Medicine Study Shows How Recently Approved Drug for Food Allergies Compares to Oral Immunotherapy, Whether It Allows Patients to Eat Their Food Allergens. NewsWise. March 2, 2025. https://www.newswise.com/articles/johns-hopkins-medicine-study-shows-how-recently-approved-drug-for-food-allergies-compares-to-oral-immunotherapy-whether-it-allows-patients-to-eat-their-food-allergens. Accessed March 2, 2025.

2. Wood, R, Jones, S, Dantzer, J, et al. Treatment of Multi-Food Allergy with Omalizumab Compared to Omalizumab-Facilitated Multi-Allergen OIT. Journal of Allergy and Clinical Immunology, Volume 155, Issue 2, AB444. https://www.jacionline.org/article/S0091-6749(24)02309-1/fulltext