2024-02-27| Trials & Approvals

Breakthrough Study Shows Anti-IgE Antibody Safeguards Children with Multiple Food Allergies

by Richard Chau
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A recent study led by scientists at the Stanford School of Medicine has unveiled promising results regarding the use of omalizumab in safeguarding children with multiple food allergies from severe allergic reactions. Published in the New England Journal of Medicine on February 25, the Phase 3 OUtMATCH trial suggests that regular administration of this anti-IgE monoclonal antibody could effectively prevent life-threatening responses, such as difficulty breathing, triggered by accidental ingestion of food allergens. 

Related article: Aimmune’s PALFORZIA™ Scores FDA Win, Becomes the First Ever Treatment For Peanut Allergy 

Food Allergies: The Growing Global Challenge

Epidemiological studies have shown that the prevalence of food allergies ranges from 1.1% to 10.8% globally, depending on different types of food, regions and ethnic groups, and the estimated number of people affected worldwide stands at about 220 million. There are more than 160 known food items that may trigger allergies, with some of the more common ones including crustacean shellfish, fish, tree nuts (e.g. walnuts, almonds, cashews, etc.), peanuts, milk, eggs, soybeans, wheat, and sesame.

It is worth noting that the number of food allergy cases has been on the rise since the beginning of the 21st century, and there has been a significant increase in the number of cases of severe systemic allergic reactions requiring emergency room visits, hospitalization, and even fatal conditions. In the United States, for example, statistics show that number of people with a peanut allergy quadrupled between 1997-2010, hospitalization of children with food allergy has more than doubled since the mid-1990s, and it is estimated that caring for children with food allergies costs U.S. families nearly $25 billion annually, including medical treatment and missed work in the event of an incident.

“Food allergies have significant social and psychological impacts, including the threat of allergic reactions upon accidental exposures, some of which can be life-threatening,” said Sharon Chinthrajah, MD, senior author of the OUtMATCH study.

A New Layer of Protection Against Allergic Responses

There is presently no cure for food allergy and patients can only rely on strict abstinence from allergenic foods to avoid allergy. The standard treatment, oral immunotherapy, although effective, presents challenges such as lengthy desensitization processes and the need for continuous consumption of allergenic foods. Lead author of the study, Dr. Robert Wood from Johns Hopkins University School of Medicine, highlighted the crucial role of omalizumab in providing a layer of protection against small, inadvertent exposures to allergenic foods. By targeting and inactivating the allergy-causing immunoglobulin E (IgE), omalizumab offers a novel approach to mitigating severe allergic responses, such as respiratory difficulties and anaphylactic shock.  

The population for the OUtMATCH study consisted of 177 children with at least three food allergies, including severe allergic reactions to peanuts plus at least two other trial-specified foods (cashews, milk, eggs, walnuts, wheat and hazelnuts). Over a period of 16 weeks, two-thirds of the participants (118) received omalizumab injections and one-third received an injected placebo. 

Study results showed that 79 patients (67%) treated with omalizumab tolerated at least 600 mg of peanut protein without moderate to severe allergic symptoms, compared to 4 patients (6.8%) in the placebo group. This amount is equivalent to approximately two and a half peanuts or half a teaspoon of regular peanut butter. Besides, a statistically significant higher proportion of patients treated with the anti-IgE antibody compared to placebo tolerated at least 1,000 mg of protein from milk (66% vs. 11%), egg (67% vs. 0%) or cashew (42% vs. 3%) without moderate to severe allergic symptoms. This amount is equivalent to about two tablespoons of 1% milk, one-quarter of an egg or three and a half cashews. 

Transforming Allergy Management with the Latest FDA Approval

Apart from the publication in an international medical journal, these compelling findings were featured in a late-breaking symposium at the 2024 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI) on February 25, and paved the way for the FDA approval of omalizumab in treating multiple food allergies. 

Co-developed by Genentech (a member of the Roche Group) and Novartis and sold under the brand name Xolair, omalizumab received its first FDA green light in June 2003 for the treatment of moderate to severe allergic asthma in patients 12 years of age or older (later expanded to include children 6 to 11 years of age). Subsequent approvals were granted in 2014 and 2020 for treating patients aged 12 years or older with chronic hives (idiopathic urticaria) and adult patients with nasal polyps. On February 16, the antibody medication secured its fourth FDA approval for alleviating allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy.

Notably, Xolair is currently the only IgE-targeting drug available for food allergy management, and the only drug available that can be prescribed for two or more food allergies at the same time. Before this, the agency only ever approved a drug to relieve a single type of food allergy (peanut allergy) in 2020.

Future Directions and Implications

While the OUtMATCH study heralds a significant advancement in food allergy management, there remain unanswered questions on the long-term implications and optimal usage of omalizumab. Dr. Chinthrajah highlighted unanswered questions regarding the duration of treatment, permanent changes to the immune system, and predictors of treatment response. The research team plans to conduct further studies to address these queries and determine the appropriate monitoring protocols for patients. 

It is also worth mentioning that Xolair can only help relieve allergic symptoms caused by accidental ingestion of food allergens, rather than being used as an emergency treatment for food allergies. Furthermore, while taking the medication, patients are advised to continue avoiding all foods to which they are allergic.

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