New Treatment for Food Allergies
Immunoglobulin E (IgE) is an antibody that mediates allergic reactions. It interacts with the proteins (i.e., antigens, allergens) during an allergic reaction causing various chemicals and substances to be released into the bloodstream. It is those chemicals and mediators such as histamine, leukotrienes, prostaglandins, etc. that are responsible for the clinical manifestations of allergic reactions. The allergic reactions range in severity from mild itching to life-threatening anaphylactic emergencies. The offending antigens can be present in a host of different settings ranging from environmental allergens such as dust mites, animal dander, pollen, etc., to food allergies, to insect venoms allergies as well as to other allergic situations.
Xolair (i.e., omalizumab) is an antibody that blocks the actions of the IgE antibody. Xolair is classified as a “biologic” medication. It has an anti-IgE quality where it blocks the action of IgE antibodies, thus reducing the risks of allergic reactions. We have been successfully using Xolair to control allergic asthma for more than 20 years. It has also proved to be very successful in controlling chronic unexplained hives (i.e., chronic urticaria) inadequately responsive to various antihistamines in high doses. It was also approved in 2020 to treat chronic sinusitis with nasal polyps.
Millions of Americans have food allergies. Approximately 40% of children with food allergies are allergic to more than one food according to Food Allergy Research & Education (FARE). Until recently, the management of a food allergy only included the complete avoidance of the offending food, as well as to always carry an epinephrine auto-injector (e.g., EpiPen, Auvi-Q, Adrenaclick) for emergency use in case of a severe allergic reaction triggered by an accidental exposure to the offending food. A form of inducing tolerance to the allergic food (i.e., oral immunotherapy) has been approved by the U.S. Food and Drug Association (FDA) only for peanut in children between 4 and 17 years of age.
The results of a landmark clinical trial called OUtMATCH (i.e., Omalizumab as monotherapy and as adjunct therapy to multi-allergen OIT in food allergic children and adults) were presented at the annual scientific meeting of the American Academy of Allergy, Asthma and Immunology on February 25, 2024 in Washington, DC. The study was also simultaneously published online by the New England Journal of Medicine.
The first stage of the phase 3 OUtMATCH trial was designed to see if taking omalizumab increased the threshold for the amount of food that caused allergic reactions, thereby reducing the likelihood of reactions that might occur as a result of accidental exposures. The study team enrolled 177 children and adolescents ages 1 to 17 years and three adults ages 18 to 55 years, all with confirmed allergy to peanut and at least two other common foods among milk, egg, cashew, wheat, hazelnut or walnut.
The study participants who reacted to small amounts of these food allergens during oral food challenges were assigned at random to receive injections of either omalizumab or placebo. After 16 to 20 weeks of treatment, the participants were challenged again in a carefully controlled setting to see if they could tolerate a greater amount of food than they did at the outset.
The study results revealed that a 16-20-week course of the monoclonal antibody omalizumab increased the amount of peanut, tree nuts (cashew, hazelnut and walnut), egg, milk and wheat that multi-food allergic children as young as one-year could consume without a moderate or severe allergic reaction.
Nearly 67% of the participants who completed the treatment could consume a single dose of 600 milligrams (mg) or more of peanut protein, compared to less than 7% of participants who received placebo with 600 mg representing approximately 2.5 peanuts. This was at least 6 times the amount of peanut protein that participants could tolerate at the start of the trial. Treatment with omalizumab also yielded similar outcomes for egg, milk, wheat, cashew, walnut, and hazelnut at a threshold dose of 1,000 mg protein or more.
Based on these results, the FDA recently approved Xolair as a treatment for the reduction of Type I allergic reactions which are IgE-mediated, which includes anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients age 1 year and older with IgE-mediated food allergy. Xolair is to be used in conjunction with food allergen avoidance. Xolair is not however indicated for the emergency treatment of allergic reactions, including anaphylaxis.
In reality, the total avoidance of allergic foods is not always successful and many children and their families live in constant fear of a life-threatening reaction caused by an inadvertent exposure to the food(s) they are sensitized to. The condition may cause considerable psychosocial problems and may also negatively impact the nutrition of the patient.
This new treatment is not a license to eat the foods that one is allergic to, but it can be reassuring to families because the treatment substantially reduces the risks of severe reactions after accidental food exposures.
The board certified allergy doctors at Black & Kletz Allergy have 3 convenient office locations in the Washington, DC, Northern Virginia, and Maryland metropolitan area and are very experienced in the diagnosis and treatment of food allergies. Black & Kletz Allergy treat both adults and children and have offices in Washington, DC, McLean, VA (Tysons Corner, VA), and Manassas, VA. We offer on-site parking at each location and the Washington, DC and McLean, VA offices are Metro accessible. There is a free shuttle that runs between the McLean, VA office and the Spring Hill metro station on the silver line. Please call our office to make an appointment or alternatively, you can click Request an Appointment and we will respond within 24 hours by the next business day. Black & Kletz Allergy has been serving the Washington, DC metropolitan area for more than 5 decades and we pride ourselves in providing outstanding allergy and asthma care in a professional and pleasing environment.