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

doi:10.1016/j.jaci.2020.05.027

Journal of Allergy and Clinical Immunology

Volume 146, Issue 2, August 2020, Pages 244-249

https://doi.org/10.1016/j.jaci.2020.05.027 Get rights and content

Food allergy is a major health problem affecting 5% to 10% of the population in developed nations, including an estimated 32 million Americans. 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 US Food and Drug Administration. The only options were avoidance of food allergen triggers and acute management of allergic reactions. A considerable body of data exists supporting oral immunotherapy (OIT) as a promising, novel treatment option, including that for the now Food and Drug Administration–approved peanut OIT product Palforzia (Aimmune Therapeutics, Brisbane, Calif). However, data for long-term quality-of-life improvement with OIT varies, depending on the measures used for analysis. Like many therapies, OIT is not without potential harms, and burdens, and the evaluation of patient-specific risk-benefit ratio of food OIT produces challenges for clinicians and patients alike, with many unanswered questions. Food Allergy Research & Education organized the Oral Immunotherapy for Food Allergy Summit on November 6, 2019, modeled after the PRACTALL sessions between the European Academy of Allergy and Clinical Immunology and the American Academy of Allergy, Asthma & Immunology to address these critical issues. Health care providers, patient representatives, researchers, regulators, and food allergy advocates came together to discuss OIT and identify areas of common ground as well as gaps in existing research and areas of uncertainty and disagreement. The purpose of this article was to summarize that discussion and facilitate collaboration among clinicians and patients to help them make better-informed decisions about offering and accepting OIT, respectively, as a therapeutic option.

Section snippets

Candidate selection

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. European food allergy guidelines published in 2018 have recommended the use of OIT in “highly specialized clinical centers with expertise and facilities to safely deliver this therapy” for milk, egg, or peanut, whereas the older US practice guidelines recommend against its use and need to be updated, especially with the approval of Palforzia.⁴

Physician/facility considerations

Centers or clinical practices that offer OIT should be competent in the diagnosis and treatment of food allergy, the administration of oral food challenges, and the management of systemic allergic reactions, including anaphylaxis. The FDA approval of Palforzia stipulated a Risk Evaluation and Mitigation Strategy. Because of the risks of acute allergic reactions during OIT, this therapy should be performed under the supervision of a board-certified or board-eligible allergist/immunologist. All

OIT product considerations

Any product used for OIT should have clearly labeled protein content and information about the manufacturing facility’s risk for cross-contamination. This is especially important if the product is not pharmaceutical grade. The amounts of major allergens may also vary if these are not included in the label contents, especially between products.²³ FDA-approved products such as Palforzia will be dosed on measurements of protein content and of representative allergens that, to minimize lot-to-lot

Regulatory considerations

The legal definition of a drug is “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”²⁵ According to this definition, food administered to a patient for OIT can be considered a drug. Therefore, any prospective studies examining OIT for food allergy treatment would likely require an investigational new drug application through the FDA. The FDA framework facilitates a systematic approach to address key questions that remain regarding OIT. However,

Unmet needs

There were several deficiencies in knowledge surrounding OIT identified and discussed at the summit (Table I). The acceptance of a standard definition of desensitization or the adoption of a better term that more accurately reflects the changes in clinical and immunologic status that result after OIT would be beneficial. Clinical trials and studies of OIT should examine effectiveness across patients of differing socioeconomic status, race, and ethnicity. Most published OIT studies examine a

Summary

OIT is an emerging option for the treatment of persistent IgE-mediated food allergy. Key points about OIT are listed in Table II. It is efficacious in inducing desensitization but is not without potential harms and burdens, and it is not curative. OIT is an option for motivated families with appropriate social support to maintain strict adherence to the office visits and restrictions surrounding dosing. Physicians and patients should use a shared decision-making process to determine whether OIT

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: Food Allergy Research & Education hosted the meeting that produced this document and provided support for writing the manuscript.

: Disclosure of potential conflict of interest: A. N. Pepper and T. B. Casale are investigators on Aimmune-sponsored studies. B. P. Vickery reports grants and personal fees from Aimmune Therapeutics, personal fees from AllerGenis, grants and personal fees from Food Allergy Research & Education (FARE), grants from Genentech, grants from DBV Technologies, grants from NIH-NIAID, and grants from Regeneron, outside the submitted work. W. Shreffler has received payment from FARE, Aimmune Therapeutics, Buhlmann Laboratories AG, and Sanofi Pasteur. The rest of the authors declare that they have no relevant conflicts of interest.

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Reviews and feature articleConsensus report from the Food Allergy Research & Education (FARE) 2019 Oral Immunotherapy for Food Allergy Summit

Section snippets

Candidate selection

Physician/facility considerations

OIT product considerations

Regulatory considerations

Unmet needs

Summary

J Allergy Clin Immunol Pract

J Allergy Clin Immunol Pract

Lancet

Ann Allergy Asthma Immunol

Ann Allergy Asthma Immunol

J Allergy Clin Immunol Pract

J Allergy Clin Immunol

Lancet

J Allergy Clin Immunol

J Allergy Clin Immunol Pract

J Allergy Clin Immunol

J Allergy Clin Immunol Pract

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