Q&A: FDA-approved omalizumab ‘not a cure’ for food allergy

Key takeaways:

• Patients who used omalizumab could tolerate small amounts of allergen proteins.
• Omalizumab does not modulate immune responses to allergens.
• Treatment is only appropriate for IgE-modulated disease.

The FDA has approved omalizumab for use in building tolerance to accidental ingestion of allergens among patients with IgE-mediated food allergy.

Patients who used the biologic tolerated 600 mg of peanut protein and at least 1,000 mg of protein from milk, egg or cashew without any moderate to severe allergic symptoms after 16 to 20 weeks of treatment.

However, this treatment comes with caveats. Healio spoke with Zachary E. Rubin, MD, pediatric allergist and spokesperson for the American College of Allergy, Asthma & Immunology, to find out more.

Healio: Could you summarize how omalizumab would be used in food allergy treatment?

Rubin: Omalizumab (Xolair; Genentech, Novartis) is now the first FDA-approved medication to treat food allergies. It is not a cure. The purpose of the medication is to significantly reduce the chances for having a severe, potentially life-threatening allergic reaction, also known as anaphylaxis, if there is accidental ingestion of a particular food allergen. It has been approved for children and adults aged as young as 1 year for other applications. It is an injectable medicine given subcutaneously based on body weight and total IgE antibody levels, either every 2 weeks or every 4 weeks.

In the OUtMATCH study, patients had significant improvements in their ability to tolerate small amounts of the proteins that they were allergic to after about 16 to 20 weeks of treatment. So, it doesn’t work right away, and it’s not a cure. It’s not going to modulate the immune response or change it enough so that people can freely eat these foods.

Also, omalizumab is specific for a type of food allergy called IgE-mediated food allergy. People who are prescribed epinephrine autoinjector devices such as EpiPens (Mylan/Viatris) are typically going to benefit the most from this approval. It is not going to be helpful for other forms of food reactions such as celiac disease, food protein induced enterocolitis syndrome, or eosinophilic esophagitis. It is specifically for IgE-mediated disease.

Another potential benefit to this medication is that it may decrease anxiety that results from living with food allergy because it may reduce the risk of anaphylaxis not only from accidental ingestion but also from cross-contamination of food allergens touching surfaces that may come into contact with people. It may allow some people to consume foods that have precautionary allergen labels such as “may contains,” “processed in a facility that contains,” “may contain trace elements of,” and so on.

Prior to this approval, the only other treatments we had for food allergy were reading labels carefully, avoiding foods and treating reactions if they occurred. Or, there’s something called oral immunotherapy. There is an FDA-approved OIT called Palforzia (Aimmune Therapeutics) specifically for peanuts, but there are no FDA-approved OIT treatments for other foods.

OIT is something that is constantly being studied and given in clinics experimentally. That’s something that also can help reduce the chances of a severe allergic reaction. It involves daily dosing, which requires a lot of work, although it might help with long-term immune responses. But there really is no wide FDA approval for that type of therapy.

Healio: Is there anything specifically about this approval that allergists need to know before incorporating it into their care?

Rubin: Allergists have been using this medication since 2003. Most allergists are familiar with this medication. It is nothing new. It was approved for asthma back in 2003, but it also has been approved for chronic urticaria or hives, as well as for chronic rhinosinusitis with nasal polyps. So, allergists are very, very experienced with this medication.

The question is going to become how we are going to be able to accommodate the potential growing need for this medication. We have millions of people in the United States living with food allergies who might be interested in something like this. That’s the challenge that we have to figure out with insurance companies. How well are they going to cover this? Access to this medication is going to be the main question for allergists going forward.

Healio: Do you anticipate any risks with this medication?

Rubin: This medication has a small risk for anaphylaxis. People who take it to reduce risks for reactions potentially could have an allergic reaction to the medication itself. Most allergists like myself only feel comfortable prescribing it for in-office use, where we give patients the injection, watch them for a period of time, and then discharge them home. It is going to be a challenge to see if we’re going to be able to get people to do this in the clinic or if people will have any comfort level in doing it at home. Also, think about children getting an injection every 2 to 4 weeks. I don’t think parents are going to want to necessarily do that. So, there will be an issue with potentially having specialized nursing care to give these injections on a regular basis. It’s not necessarily straightforward for everybody.

Healio: Is there anything else that the public and patients need to know about this treatment?

Rubin: A lot of people may think that with this treatment, they may be able to freely eat the food that they’re allergic to. But they can’t do that. A lot of people who have other types of adverse reactions to food such as celiac disease or eosinophilic esophagitis may think they’re eligible for treatment. There is often a little bit of confusion when you say “food allergy,” which may encompass a lot of different issues. But this is specifically for what we call IgE-mediated disease, for people who have to carry an EpiPen with them, for that type of food allergy.

Healio: Beyond omalizumab, what is next in the evolution of food allergy treatment?

Rubin: We need more access to epinephrine. We need people to be able to hold onto it and feel comfortable with it. An epinephrine nasal spray known as neffy (ARS Pharma) was supposed to be approved last summer, but the FDA wanted an additional study. That’s going to eventually come out. There also is a sublingual strip of epinephrine that is probably going to be out in the next 1 to 2 years. So, we’ll have needle-free alternatives that will help reduce the chances of having severe allergic reactions turn into shock and potentially death.

For more information:

Zachary E. Rubin, MD, can be reached at zrubin@gmail.com.