Omalizumab Enhances Oral Immunotherapy for Pediatric Food Allergies

A study showed that omalizumab enables rapid, effective desensitization in pediatric food allergy, improving the safety of oral immunotherapy.1

“While omalizumab significantly enhances the safety and efficacy of [oral immunotherapy], its widespread clinical implementation is currently hindered by uncertainties related to optimal treatment duration, long-term efficacy, cost-effectiveness, and standardization of treatment protocols,” wrote investigators, led by Enrico Vito Buono, from the pediatric clinic, department of medicine and surgery, at the University Hospital of Parma in Italy. “If these barriers are overcome, this approach has the potential to transform food allergy treatment, improving patient outcomes and quality of life for affected individuals.”

According to FARE, approximately 1 in 13 children have food allergies, with 40% experiencing a severe reaction, such as anaphylaxis.2 Allergies to peanuts, tree nuts, fish, and shellfish often begin in childhood and persist into adulthood. Conversely, milk, eggs, wheat, and soy allergies frequently emerge during childhood but may be outgrown over time.

Despite the life-threatening nature of food allergies, treatment options for children remain extremely limited, and no cure exists. Children with peanut allergies can turn to oral immunotherapy with peanut allergen powder-dnfp (Palforiza), approved by the US Food and Drug Administration (FDA) for ages 4 – 17 years, to reduce the risk and severity of allergic reactions to peanuts.3 However, oral immunotherapy is not yet approved for other food allergies, and right now, all children can do is avoid food allergens and take emergency treatments when needed.

Oral immunotherapy has recently been studied for multiple food allergies; however, trials have had high rates of allergic reactions and non-compliance. A study published in February found that the investigational oral immunotherapy ADP101 increased the relative threshold in pediatric patients with single or multiple food allergies but did not meet its primary endpoint of a certain proportion of participants tolerating a ≥ 600 mg challenge dose without dose-limiting symptoms at week 40.4

OutMATCH’s intent-to-treat analysis showed the superiority of omalizumab over oral immunotherapy (36% vs 19%; odds ratio [OR], P = .031) for allergies to peanuts with ≥ 2 other common food allergens, such as milk, egg, cashew, wheat, walnut, or hazelnut.5 However, the per-protocol analysis found no differences between omalizumab and oral immunotherapy for food allergy management (P = .66).

It has been proposed that omalizumab could be a helpful adjunct to oral immunotherapy to improve safety and efficacy. Investigators conducted a systematic review and meta-analysis to assess the efficacy and safety of omalizumab in combination with oral immunotherapy for IgE-mediated food allergy in children.1

While searching through PubMed/MEDLINE and Cochrane Central databases, the team identified randomized controlled trials, controlled clinical trials, and observational studies evaluating omalizumab as an adjunct to oral immunotherapy in children with food allergies. Studies also assessed desensitization rates, immunological changes, adverse events, and quality of life improvements.

The study discovered that omalizumab as an adjunct to oral immunotherapy led to significantly greater rates of desensitization. With treatment, participants could tolerate greater doses of allergens in a shorter timeframe than if they were just to have oral immunotherapy alone.

One study on peanut allergies showed patients on omalizumab could tolerate greater peanut doses than those on placebo on the first day of desensitization (250 mg vs 22.5 mg). Six weeks after discontinuing omalizumab, 79% randomized to omalizumab vs 12% randomized to placebo tolerated 2000 mg of peanut protein. The 4000 mg oral food challenge was completed by 23 participants on omalizumab and 1 on placebo.

The analysis showed omalizumab was linked to a reduction in adverse reactions, including anaphylaxis, and improved treatment adherence. Despite these positive findings, the long-term sustainability of tolerance after concluding omalizumab treatment is uncertain. Only 1 study assessed long-term sustained unresponsiveness after omalizumab discontinuation.

“To address this, future research should incorporate extended follow-up periods to evaluate the persistence of tolerance and the need for ongoing maintenance therapy,” investigators wrote.

References

1. Buono EV, Giannì G, Scavone S, Esposito S, Caffarelli C. Omalizumab and Oral Immunotherapy in IgE-Mediated Food Allergy in Children: A Systematic Review and a Meta-Analysis. Pharmaceuticals (Basel). 2025 Mar 20;18(3):437. doi: 10.3390/ph18030437. PMID: 40143213.

2. Facts and Statistics. Food Allergy Research & Education. https://www.foodallergy.org/resources/facts-and-statistics. Accessed March 27, 2025.

3. Peanut Oral Immunotherapy (OIT). ACAAI. https://acaai.org/health-care-providers/peanut-oral-immunotherapy-oit/. Accessed March 27, 2025.

4. Derman, C. ADP101 Immunotherapy Increases Food Allergy Threshold but Misses Primary Endpoint. HCPLive. February 7, 2025. https://www.hcplive.com/view/adp101-immunotherapy-increases-food-allergy-threshold-but-misses-primary-endpoint. Accessed March 27, 2025.

5. Derman, C. Omalizumab Performs Better Than Oral Immunotherapy for Food Allergy, with Robert Wood, MD. HCPLive. March 2, 2025. https://www.hcplive.com/view/omalizumab-performs-better-than-oral-immunotherapy-food-allergy-with-robert-wood-md. Accessed March 27, 2025.