Caregiver’s Guide to Monoclonal Antibodies for Food Allergies in Children

When it comes to treating diseases, monoclonal antibodies are nothing new. They’ve been used for years to treat numerous conditions, including other allergies, cancer, inflammatory and autoimmune disorders, and infections such as COVID. “They have revolutionized care for a host of chronic diseases in the last couple of decades,” says Dr. Sammon. “We are excited to see food allergy finally catch the attention of researchers and the exciting developments to come.”

Omalizumab is the only monoclonal antibody currently approved by the FDA for food allergies. “There are a few others currently being studied in various phases for the treatment of food allergy,” says Sammon. They all work in slightly different ways to block IgE antibodies, the primary driver of allergic reactions.

The monoclonal antibodies currently being tested include:

• Dupilumab, which is being studied as a preventive treatment in children with a peanut allergy. It works by blocking the activation of IgE, which can potentially diminish the severity of food allergies. It’s in phase 2 of clinical trials.
• Ligelizumab, which would be for children and adults with food allergies. It also prevents IgE from binding to its receptor on mast cells, which significantly reduces the inflammatory response triggered by food allergies. It is currently in phase 3 of clinical trials.

In the OUtMATCH (Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food Allergic Children and Adults) trial, researchers found that omalizumab increased the reaction threshold for peanuts, eggs, milk, wheat, and some tree nuts (cashews, hazelnuts, and walnuts) to levels that would likely protect against allergic reactions to accidental exposure.

In the study, nearly 70 percent of the children and adolescents treated with the drug could consume at least a single dose of 600 milligrams of peanut protein — approximately 2 and a half peanuts — without a moderate or severe allergic reaction. Many of the study participants could consume closer to 25 peanuts.

“Like OIT, monoclonal antibodies are a ‘safety’ therapy to desensitize or raise the threshold that would trigger reactions,” says Joyce Yu, MD, a pediatric allergist and associate professor of pediatrics at Columbia University Irving Medical Center in New York City. “Anything to decrease the risk for life-threatening reactions and decrease the severity of reactions should improve quality of life by allowing people who are impaired by the fear of exposure to do activities that they might not otherwise.”

But the avoidance of allergens and use of epinephrine in emergency reactions are still a must.

Monoclonal antibodies are given as a preventive shot, unlike epinephrine, which is used in an emergency. “Monoclonal antibodies are typically administered into the subcutaneous tissue via self-injection with a prefilled syringe or auto-injector,” says Sammon. Injections may be given once every 2 to 4 weeks, depending on the prescribed dose.

Because there is currently only one monoclonal antibody on the market for food allergies, further studies are needed to better understand the role they play when used with other therapies. “The OUtMATCH trial will soon provide data on the risk of reaction when using omalizumab in combination with oral immunotherapies versus omalizumab alone,” Sammon says.

In the case of omalizumab, the most common side effects include injection-site reactions and fever, which are temporary and can be treated at home with ice, topical steroids, acetaminophen, or nonsteroidal anti-inflammatory drugs. “Rarely, anaphylaxis or severe allergic reactions have been reported — to omalizumab or its ingredients — and that is why an extended observation period is required for the first few doses,” Sammon notes.