Q&A: Omalizumab a ‘paradigm shift’ in treating food allergy

Key takeaways:

• The prevalence of food allergy in adults and children is growing.
• Omalizumab is not a cure, and patients must continue avoidance.
• Omalizumab may decrease the risks of oral immunotherapy.

Patients with food allergy who used omalizumab experienced increased thresholds for reacting to peanut and other foods to which they were allergic, according to a study published in The New England Journal of Medicine.

These results resonated beyond allergy specialists and other medical professionals, with extensive media coverage driving interest in the drug among patients and families with food allergy.

Healio spoke with Ari Y. Zelig, MD, an allergist with Charleston ENT & Allergy, to find out more about how this new indication will impact treatment.

Healio: How does omalizumab (Xolair; Genentech/Novartis) build upon current treatments for food allergy?

Zelig: According to Food Allergy Research & Education (FARE), 33 million Americans suffer from food allergy, and this number continues to rise. Food allergy is associated with morbidity and mortality as well as psychosocial implications. A staggering 51% of adults and 42% of children with food allergies have experienced a severe reaction, FARE also reports. The prevalence of food allergy among children has increased by 50% from 1997 to 2011. From 1997 to 2008, the incidence of peanut and tree nut allergy has more than tripled among U.S. children. The diagnosis of anaphylactic food reactions has increased by 377% from 2007 to 2016. Every 10 seconds, food allergy sends a patient to the emergency room, accounting for 3.4 million emergency room visits annually in the U.S. Childhood hospitalizations have tripled for food allergy. These startling statistics reveal an unmet need for a condition with limited treatment options.

Prior to omalizumab’s FDA approval for food allergy, options for management of IgE-mediated food allergy included strict avoidance, treatment of reactions should they occur and oral immunotherapy. To date, there is only one FDA-approved OIT treatment for peanut allergy called Palforzia (Aimmune Therapeutics). This product desensitizes patients to 300 mg of peanut protein, or roughly one peanut. Patients still need to avoid peanuts, but in the event of accidental exposure, the risk of a severe allergic reaction is reduced. Food OIT for other food allergens may be offered by some allergists, but it is off label and therefore not well covered by insurance.

Despite avoidance, many patients still experience allergic reactions due to accidental exposure and cross contamination. Patients and their caregivers experience daily bouts of anxiety over the possibility of an allergic reaction, which could be fatal. Out-of-pocket costs and time required to undergo an OIT regimen have been prohibitive for many patients. The risks, including anaphylaxis, associated with food OIT have limited its widespread adoption among allergists.

Omalizumab is an absolute game changer and represents a paradigm shift in the treatment of food allergy. By blocking IgE, the risk of an allergic reaction, especially a severe, life-threatening one, is decreased significantly. Omalizumab can be used as monotherapy to provide a level of security to those patients most at risk, or it can be used in addition to a food OIT program to boost its efficacy while reducing associated risks.

Healio: Have you had any inquiries about omalizumab from your food allergy patients?

Zelig: Given the fact that it was so recently approved by the FDA, I have not had specific patient requests yet. However, I often have patients and their caregivers ask if there are any new breakthrough treatment options for food allergy on the horizon. Many patients with food allergy are frustrated by their lack of options and are afraid to go out to eat at restaurants or consume anything that is made outside of their own kitchen. I expect in the coming weeks to months, there will be many inquiries from patients and their caregivers asking if omalizumab is right for them or their child.

Healio: What do physicians and the public need to know about this treatment?

Zelig: Physicians and the public need to be made aware of this breakthrough treatment option, which is now available for patients with IgE-mediated food allergy. The morbidity, mortality and psychosocial implications of food allergy cannot be underestimated. I strongly recommend that all patients with food allergy be referred to an allergist for evaluation and to discuss options for management. While omalizumab is a groundbreaking therapy for food allergy, it is important to note that it is not a cure. Patients must be counseled to continue avoidance measures.

Healio: Do you expect to incorporate omalizumab into your treatment?

Zelig: I have been eagerly awaiting the approval of omalizumab for food allergy. In my opinion, the patients who most desperately need this therapy are those who have had severe, potentially fatal reactions from accidental exposure to trace amounts of their food allergens. Omalizumab has clearly proven to be effective at reducing the risk of allergic reactions, especially anaphylaxis, for those who are most sensitized. This breakthrough therapy provides a level of protection and relieves anxiety for patients and their caregivers. The improvement in quality of life this will provide such patients is immeasurable.

Additionally, omalizumab increases the threshold dose patients can tolerate when undergoing food OIT. I expect food OIT to become more widely accepted by allergists as omalizumab decreases the risks associated with it. Of course, shared decision-making lies at the heart of everything that we do, and after discussing risks and benefits with patients we will continue to tailor individualized therapy for patients with food allergy.

Healio: What do you think the next step should be in this research?

Zelig: There are several next steps in this research. In regard to its use in conjunction with food OIT programs, we need to clarify how long patients will require omalizumab in order to maintain tolerance. Can it be discontinued once reaching a threshold dose of a food allergen, or do patients require it indefinitely in order to maintain tolerance?

The issue that I am most interested in is the long-term implication of starting omalizumab early in life. By blocking IgE as early as age 1 year, can we halt the progression of the atopic march, or the typical progression of commonly associated allergic conditions? Do patients who begin omalizumab at age 1 year or in early childhood have lower rates of asthma, allergic rhinitis, new onset food allergies and atopic dermatitis? If omalizumab can act as a preventative medication to stop the atopic march in its tracks, it could justify the high cost of such a biologic long-term.

As mentioned previously, this new approval represents a paradigm shift in the management of food allergy. Further research will demonstrate if it is also a milestone in personalized medicine for patients who are at highest risk to suffer from severe atopic, lifelong conditions.

Reference:

• Wood RA, et al. N Engl J Med. 2024;doi:10.1056/NEJMoa2312382.

For more information:

Ari Y. Zelig, MD, can be reached at ari.zelig@gmail.com.