Q&A: What Does Omalizumab Mean for Oral Immunotherapy Treatment for Multiple Food Allergies?

 

We recently posted a press release from the National Institute of Allergy and Infectious Diseases about a clinical trial that shows the medicine omalizumab can make oral immunotherapy more effective. Members of our Medical Scientific Council answer questions on this news and what it means for the future of food allergy treatment.


Oral immunotherapy (OIT) is a proposed method to treat food allergy. It is currently in late-stage clinical trials (peanut specifically). It is expected to be approved by the U.S. Food and Drug Administration (FDA) soon. There have been many clinical trials for specific food OIT alone and with medicines, such as omalizumab, as reported in this study. 

Q: What is OIT?

A: OIT is a method of giving immunotherapy by mouth. Immunotherapy is a way of very carefully treating a person with allergic disease by giving them a very small amount of the allergen. OIT involves giving a patient the food by mouth in tiny amounts that increase over time. The amount is carefully increased on a regular basis over months to years.

This process can desensitize a person to the allergen. This means while on the treatment, they have a lower chance of reacting to the allergen. The hopes are that a person could have a larger amount of the allergen in the future and not react when off the treatment. This is called tolerance.

Q: What is omalizumab, or anti-IgE medicine?

A: Omalizumab (example brand name Xolair) is an antibody specific medicine. It targets the Immunoglobulin E (IgE) antibody in a person’s body. IgE is also known as the allergy antibody. It is a special protein that recognizes something a person is allergic to and starts an allergic response.

The medicine lowers the amount of free IgE in the body, which could reduce allergy symptoms. It is FDA approved for use in severe asthma and chronic urticaria (hives).

Q: How is omalizumab given?

A: Omalizumab is often given as a shot under the skin once every 2-4 weeks.

Q: What did this study try to determine?

A: Many studies have looked at OIT for single foods, such as peanut. But this pilot study looked at OIT for multiple foods alone and with omalizumab. The goal was to see if omalizumab improved the effects of OIT. Children age 4-15 years old with multiple food allergies were chosen at random to be in one of two groups. The first had OIT by itself. This was the placebo group. The second had OIT with 16 weeks of omalizumab. There were 12 placebo group patients and 36 treatment group patients who received omalizumab.

Q: What were the main results?

A: More patients in the treatment group – 30 out of 36 or 83 percent – passed food challenges up to 2 grams of food protein at the end of the study (36 weeks). This was more than the placebo group – 4 out of 12 or 33 percent. This suggests that omalizumab may help improve how OIT works for those with multiple food allergies.

Q: What were some of the drawbacks of the study?

A: There were a few drawbacks of the study. They were:

  • As a pilot study, the sample size included only a small number of patients (36 received omalizumab, 12 received placebo).
  • The treatment failed for six patients in the omalizumab group. Eight treatment failures were in the placebo group. Treatment failures were patients who could not tolerate the OIT without having a reaction. Of the other patients who made it to the final food challenge in both parts of the study, all 30 passed in the omalizumab-treated group. All four of the four challenges passed in the placebo group.
  • The main outcome for the oral food challenge was only to 2 grams. Most food challenges in clinical practice aim for a dose of at least 4 to 8 grams. A secondary outcome was 4 grams, which these same patients (who passed the 2-gram challenges) passed to at least two foods.
  • Omalizumab is currently not FDA approved for treatment of food allergies.
  • This study was only done at one location and not in multiple centers.
     

Q: What does this recent study mean for parents managing multiple food allergies?

A: In the future, the use of omalizumab could improve how well OIT works for multiple food allergies. This offers hope for parents of children with multiple food allergies that a plan is in the future to treat several foods together.

Q: Were there side effects reported in the study?

A: During weeks 8-16, all patients had at least one adverse event. The most common in both groups were gastrointestinal and some respiratory side effects. In both groups, more than 91 percent had hives (urticaria).

Q: How long will it be before this treatment may become available to patients?

A: As a pilot study, this is an early use of this medicine in a small group of patients being given OIT for multiple food allergies. It is likely that this method may take a few more years of study before it is routinely available.

Medical Review December 2017.

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Omalizumab is manufactured using Chinese hamster ovary (CHO) cells and is therefore contaminated with numerous CHO proteins. It is well documented that patients start developing anti-drug antibodies (ADA) against monoclonal antibody treatments such as omalizumab. This can result in drug ineffectiveness. More worrisome is antibodies created against CHO. It is well known from cancer research that immunization with homologous xenogeneic proteins (injection of animal proteins like CHO, that resemble human proteins) can result in autoimmunity. In other words, antibodies created against CHO can cross-react and begin attacking your own body's tissues.

IgE is involved in helminth defense (worm infection) and defense against diseases such as dengue. Attacking all IgE with Omalizumab, makes the body more vulnerable to worm infections and and diseases such as dengue.

Immune response to a differentiation antigen induced by altered antigen: A study of tumor rejection and autoimmunity

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC26218/

Elevated levels of total and dengue virus-specific immunoglobulin E in patients with varying disease severity.

https://www.ncbi.nlm.nih.gov/pubmed/12629649

 

It must be clarified that OIT is not a cure. It is changing the disease state. IgE is naturally involved in helminth defense (worm infections). A "low intensity" worm infection is IgE dominated. This is equivalent to food allergy. A "high intensity" worm infection is IgG4 dominated (high IgG4/IgE) ratio. This is equivalent to a person with food allergy who has received OIT. In food allergy, your immune system has been programmed to recognize food items as worms. So continued food allergen consumption following OIT is an ongoing "infection" which can lead to conditions such as eosinophilic esophagitis (EoE) because the immune system is still fighting the food exposure as a worm infection. 

So OIT is about moving away from anaphylaxis towards a chronic disease state with risks of eosinophilic diseases.

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