“Food allergies affect 5% to 10% of the population in developed nations, including an estimated 32 million Americans,” Dr. Casale says. “Despite the large number of patients suffering from food allergies, up until the end of January 2020, no treatment for food allergies had been approved by the FDA. The only options were avoidance of food allergen triggers and acute management of allergic reactions.” Oral immunotherapy (OIT) is an emerging option for the treatment of persistent immunoglobulin E (IgE)-mediated food allergy, explains Thomas B. Casale, MD. However, although efficacious in inducing desensitization, OIT is not curative and is not without potential harms and burdens. Dr. Casale and colleagues addressed critical issues regarding OIT at the Oral Immunology for Food Allery Summit, organized and hosted by Food Allergy Research & Education (FARE) and resulting in a consensus report (Table).

The Need to Recognize the Risk-Benefit Ratio for OIT

“An increasing number of clinicians, especially allergists, are using OIT to treat patients with food allergy,” says Dr. Casale. “Successful reports of this therapeutic intervention have been published, and the recent FDA approval of arachis hypogaea for peanut allergy will likely attract patients to ask about this therapy. However, OIT is associated with adverse events, including acute allergic reactions with administration. It is important to recognize the potential risk–benefit ratio for this therapy and to discuss, as a physician, whether it is appropriate to offer and, as a patient, whether it is the best therapeutic option.”

The summit focused on four key perspectives, Dr. Casale notes, in order to provide information for clinicians and their patients considering OIT:

  1. Practicing physician perspective. OIT is an emerging option for the treatment of food allergy, but it is not appropriate for all patients with a history of allergic reactions to food. Careful consideration must be given before offering OIT.
  2. Patient perspective. Patients must be aware of the benefits, potential harms, and burdens of OIT, as well as alternatives. A shared decision-making process is critical. The decision of whether to pursue OIT should reside between the patient, their families, and all legal guardians of a pediatric patient if applicable, following a thorough discussion to the treating physician’s best ability.
  3. Institute for Clinical and Economic Research perspective. More information is needed to determine whether the risk from accidental exposures is greater than that occurring with OIT.
  4. Regulatory perspective. Given the large amount of resources needed for the approval of one product, discussion is needed on how a regulatory agency can help facilitate approval of multiple food OIT. Also, clinicians should explore how a registry can be used to best study outcomes of OIT in private practice.

Use of OIT Should Be a Shared Decision

Dr. Casale stresses that the decision to use of OIT must go beyond the risk, harms, and potential benefits and include the associated time commitment and costs. Choosing the appropriate product for an OIT regimen that is not FDA-approved must be addressed.

Physicians offering OIT, he notes, should be able to provide emergency care for an acute allergic reaction due to the therapy. “Moreover, they should inform patients about potential adverse events secondary to the therapy when given at home,” he says.

Dr. Casale would like to see more research into the effectiveness and safety of OIT when given in private practice using products that are not FDA approved. “We need to have more information on whether the therapy improves quality of life compared with simply avoiding the potential offending allergen,” he says. We also need good data on the use of multiple food OIT. We must also study whether patients of different racial and ethnic backgrounds respond similarly to patients primarily enrolled in the arachis hypogaea studies.” He also recommends that clinicians, particularly allergists and immunologists, use this report to help determine whether a particular patient is an appropriate candidate for OIT. “Physicians should refer to the report to help guide them in the best practice of OIT, especially if they are offering OIT with non-FDA-approved products,” he says.


Consensus report from the Food Allergy Research & Education (FARE) 2019 Oral Immunotherapy for Food Allergy Summit