Omalizumab – A study on kids reveals that the drug can limit dangerous reactions to allergy-triggering foods

A drug that attaches itself to antibodies that cause allergies can save kids from harmful responses when they unintentionally consume foods that cause allergies.

A new study headed by experts at the Stanford School of Medicine suggests that medication might avoid harmful allergic reactions to small amounts of food that trigger allergies, therefore making life safer for children with food allergies.

The research was published in the New England Journal of Medicine on February 25. The results imply that omalizumab, a medication, may shield individuals against severe allergic reactions, including breathing difficulties if they inadvertently consume a tiny quantity of food to which they are allergic.

I’m excited that we have a promising new treatment for multifood allergic patients. This new approach showed really great responses for many of the foods that trigger their allergies

Sharon Chinthrajah, MD, associate professor of medicine and of pediatrics, Stanford Medicine.

Patients impacted by food allergies face a daily threat of life-threatening reactions due to accidental exposures.

The study showed that omalizumab can be a layer of protection against small, accidental exposures.

Robert Wood, MD, professor of pediatrics at Johns Hopkins University School of Medicine.

Omalizumab binds to and deactivates the antibodies that cause a variety of allergic diseases. It was first licenced by the Food and Drug Administration to treat conditions including allergic asthma and persistent hives. On February 16, 2024, the FDA authorised omalizumab to lower the risk of allergic responses to foods based on the evidence obtained in the new trial.

Every research participant had a severe allergy to at least two additional foods as well as peanuts. Two-thirds of the 118 patients who had omalizumab injections on a monthly or biweekly basis were able to safely eat tiny portions of the foods that trigger their allergies after four months of the medication. Interestingly, 38.4% of research participants were less than 6 years old, an age range that is particularly vulnerable to unintentional food allergies.

In the US, 8% of children and 10% of adults suffer from food allergies. It is advisable for those with severe allergies to completely avoid foods that trigger their symptoms, but common allergens like wheat, milk, eggs, and peanuts may be hidden in so many different locations that regular activities like going to parties and dining out can be difficult.

Food allergies have significant social and psychological impacts, including the threat of allergic reactions upon accidental exposures, some of which can be life-threatening.

Families also face economic impacts from purchasing more expensive foods to avoid allergens, she added.

Sharon Chinthrajah

Oral immunotherapy is the greatest treatment now available for food allergies. Under a doctor’s supervision, patients take tiny, progressively increasing quantities of allergy-triggering foods to build tolerance. However, desensitisation to allergens can take months or years, oral immunotherapy itself can cause allergic reactions, and the process is particularly drawn out for those with many food allergies because they are typically treated for one allergy at a time. Patients must also keep eating the meal frequently once they become desensitised to it to maintain their tolerance, but people frequently find that they don’t enjoy things that they have been told to avoid for a long time.

There is a real need for treatment that goes beyond vigilance and offers choices for our food allergic patients.

Sharon Chinthrajah

An injectable antibody called omalizumab binds to and deactivates all forms of immunoglobin E, or IgE, the protein on the body’s immune cells and in the blood that causes allergies. Omalizumab seems to be able to alleviate symptoms of several food allergies simultaneously thus far.

We think it should have the same impact regardless of what food it is.

Sharon Chinthrajah

Of the 177 children with at least three food allergies in the research, 38% were between the ages of one and five, 37% were between the ages of six and eleven, and 24% were older than twelve. Through skin-prick testing and food challenges, the participants’ severe food allergies were confirmed; they responded to fewer than 300 milligrams of each other food and less than 100 milligrams of peanut protein.

The injections took place over 16 weeks, with two-thirds of the individuals randomly allocated to get omalizumab injections and the other third receiving an injected placebo. Depending on the required dosage, injections were administered once every two or four weeks. Medication dosages were determined by taking into account each participant’s body weight and IgE levels. After 16 and 20 weeks, the subjects had another test to determine the maximum amount of each item that triggers an allergy they may safely consume.

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Retest results showed that just four patients (6.8%) who received the placebo could handle at least 600 mg of peanut protein, which is the equivalent of two or three peanuts, but 79 patients (66.9%) who had taken omalizumab could. Comparable percentages of patients reported improved responses to the other meals in the investigation.

A small quantity of at least one allergy-triggering food could be consumed by almost 80% of omalizumab patients without causing an allergic reaction, small amounts of two allergenic foods could be consumed by 69% of patients, and small amounts of all three allergenic foods could be consumed by 47% of patients.

Except for a few small responses at the injection site, omalizumab was safe and did not produce any adverse effects. For the first time, its safety has been evaluated in infants as young as one in this study.

The researchers highlighted that more investigation is required to fully comprehend the potential benefits of omalizumab for individuals with food allergies.

We have a lot of unanswered questions: How long do patients need to take this drug? Have we permanently changed the immune system? What factors predict which people will have the strongest response?

We don’t know yet.

Sharon Chinthrajah

To find out what kind of monitoring would be required to ascertain whether a patient develops a significant tolerance to a meal that triggers an allergy, the team is preparing experiments to address these and other related topics.

According to Chinthrajah, a lot of people with food allergies also have additional allergy illnesses such as eczema, asthma, allergic rhinitis (hay fever and allergies to environmental triggers like mould, dogs, cats, or dust mites), or rhinitis. Omalizumab is used to treat these conditions. “We’re hoping for a single medication that could help with all of their allergy conditions,” she stated.

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She said that because young children prefer to put things in their mouths and may not be aware of the risks associated with their allergies, the medication may be especially beneficial for those with severe food allergies.

Due to the medication’s inability to cause potentially fatal allergic responses, as oral immunotherapy occasionally can, treating patients with food allergies may also be safer for community doctors.

This is something that our food allergy community has been waiting a long time for.

It’s an easy drug regimen to implement in a medical practice, and many allergists are already using this for other allergic conditions.

Sharon Chinthrajah

Source: Stanford Medicine – News Center

Journal Reference: Robert A. Wood, Alkis Togias, Scott H. Sicherer, Wayne G. Shreffler, Edwin H. Kim, Stacie M. Jones, Donald Y.M. Leung, Brian P. Vickery, J. Andrew Bird, Jonathan M. Spergel, Ahmar Iqbal, Julie Olsson, Monica Ligueros-Saylan, Alkaz Uddin, Agustin Calatroni, Charmaine Marquis Huckabee, Nicole H. Rogers, Nancy Yovetich, Jennifer Dantzer, Kim Mudd, Julie Wang, Marion Groetch, David Pyle, Corinne A. Keet, Michael Kulis, Sayantani B. Sindher, Andrew Long, Amy M. Scurlock, Bruce J. Lanser, Tricia Lee, Christopher Parrish, Terri Brown-Whitehorn, Amanda K. Rudman Spergel, Maria Veri, Sanaz Daneshfar Hamrah, Erica Brittain, Julian Poyser, Lisa M. Wheatley, R. Sharon Chinthrajah. Omalizumab for the Treatment of Multiple Food AllergiesNew England Journal of Medicine, 2024; DOI: 10.1056/NEJMoa2312382

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