According to Food Allergy Research and Education (FARE), 200,000 people require medical care for allergic reactions to food each year. A once monthly injection currently in Phase 3 of its clinical trial may become available as soon as early 2024 that can help those suffering from serious food allergies.

OUtMATCH Study

The Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy (OIT) in Food Allergic Children and Adults (CoFAR-11), also known as the OutMATCH study came to a close at the end of December and is getting the green light to priority review from the United States Food and Drug Administration (FDA). If passed, the use of this medication, currently used in other applications, will be approved as a preventative therapy for accidental ingestion of certain common food allergens.

This study was a multi-center, randomized, double-blind, placebo-controlled study in participants between the ages of 1 and 56 years of age with peanut and at least two other food allergies (including milk, egg, wheat, cashew, hazelnut, or walnut.

The objective of the study was to compare the subject’s ability to consume certain amounts of foods that they are allergic to after treatment with either omalizumab or a placebo for omalizumab. The study was double-blind, so neither the study participants nor the investigators will know until the completion of the study which group the subjects were randomly assigned to.

There were three stages to the study that took place over the course of 56 months (4 years and 8 months).

Stage 1

In Stage 1 the investigators were looking at whether omalizumab stops or decreases allergic reactions after taking the drug for a particular length of time. This phase was called the “open label extension” because both the investigators and study participants were aware of who was administered the drug.

During this stage, investigators offered participants the drug for an extended length to see if prolonged treatment with omalizuab would stop or decrease allergic response to peanut and other food allergens.

Stage 2

The second stage of the study compared the effectiveness of extended course of omalizumab to that of a short course of omalizumab combined with multi-allergen oral immunotherapy.

During this stage, investigators are interested in seeing if long-term use of omalizumab is more effective at stopping or reducing allergic response to peanut and other food allergens.

Stage 3

The third stage involves stopping both treatments of omalizumab and multi-allergen oral immunotherapy and having participants consume peanuts and the other 2 foods they are allergic to in the form it is normally eaten.

During this stage, investigators hope to see if there is long-term effectiveness of omalizumab and/or multi-allergen oral immunotherapy.

How Does Omalizumab Work?

The drug, omalizumab (also known as XOLAIR) has been used since 2003 to treat allergic asthma.

Allergic asthma occurs when the immune system encounters and overreacts to an allergen, prompting the body to make too much of a particular protein called immunoglobulin E (or IgE). This excess protein may lead to asthma symptoms or even an asthma attack.

This drug is only approved for this condition. It is not approved to treat other allergic conditions.

This study could change that.

The intended use in the study is a once-a-month injection. As a monoclonal antibody, it binds to free immunoglobulin E antibodies that prevent it from activating mast cells and basophils. This could help prevent a life-threatening allergic reaction known as anaphylaxis.

If a once-a-month injection can reduce excess immune response in instances of accidental exposure to allergens, it can reduce risk of anaphylaxis and other serious consequences.

Why is This Study Important?

Food allergies are a serious and widespread health concern. It affects about 15 million people in the United States – 6 million of which are children. In some cases, these reactions are life-threatening and treatment/prevention measures are far from perfect.

For those with serious food allergies, there really are only 3 options. Avoid eating foods that may cause allergic reactions, oral immunotherapy, and epinephrine.

Avoiding Food Allergens

For those with food allergies, you know how difficult it can be to completely avoid them, particularly if you are allergic to multiple foods or a common food. Every day there is a recall because a food product was not appropriately labeled with ingredients or allergen warnings. Unless you prepare the food yourself, you cannot be sure that cross-contamination has not occurred.

Even worse, a misunderstanding could have dire results. For example, an unknowing neighbor may you’re your child peanut-free muffins. “The muffins do not have peanuts in them. Just peanut butter.”

Having a child with a serious food allergy is particularly stressful. Educating the child is obviously a first step, but you also have to hope that those who are trusted to take care of you child when they are away from you, such as school or daycare or at their friends’ houses, are also as vigilant as you are about ensuring trigger foods are not consumed.

Oral Food Allergen Immunotherapy

Oral food allergen immunotherapy involves providing small amounts of trigger food on a regular basis to raise the baseline for an allergic response reaction.

This can be effective in some people for some trigger foods. However, it is not all-inclusive.

Epinephrine to Treat Anaphylaxis

Those with severe food allergies should have epinephrine, commonly referred to as an epi-pen on hand in case of anaphylaxis for immediate treatment.

Anaphylaxis often involves constriction of the throat and an unsafe drop in blood pressure. Without appropriate countermeasures, anaphylaxis can result in death in as little as 15 minutes.

Epinephrine is essentially the hormone known as adrenaline in medicine form. It dilates airways and helps to reduce swelling. It causes the heart to pump faster and harder to raise blood pressure and circulate blood more quickly through the body. It also diverts blood to major organs and muscles.

When used immediately after an allergic response, it can reduce or reverse severe symptoms quickly. It reduces throat swelling, opens airways, and helps to maintain heart function and blood pressure. It may even reduce hives and itching as it diverts blood away from the skin to major organs and muscles. Additionally, it can prevent further release of histamine, the chemical that the body uses to respond to allergens that in excess will result in allergic response reactions.

Omalizumab May Be Available as Early as March 2024

According to reports, the drug is in the fast lane for FDA review for this label. If approved, it may be available as early as the first quarter of 2024.

While the drug is already available for allergic asthma, this new label will allow health care providers to prescribe the drug for prophylactic treatment for accidental ingestion of food allergens in cases of severe or common food allergies.

Your health care provider can discuss options with you for use of this medication with oral immunotherapy treatment.

Want to Know More?

If you’d like to know more, check out the Make Food Safe Blog. We regularly update trending topics, foodborne infections in the news, recalls, and more! Stay tuned for quality information to help keep your family safe, while The Lange Law Firm, PLLC strives to Make Food Safe!

By: Heather Van Tassell