FARE Statement on Oral Immunotherapy for Food Allergies

FARE Statement

FARE has invested approximately $80 million over the last two decades toward food allergy research, funding a wide range of clinical, basic and epidemiological studies. Of the many areas in which we have invested, oral immunotherapy (OIT) is one that has received the most extensive funding. Therefore, FARE has been a strong supporter of the development of OIT.

The aim of OIT is to administer a food allergen slowly, in small but steadily increasing doses, until the patient stops reacting to the food (termed becoming desensitized to the food). OIT studies have shown promising results, though adverse reactions are frequent and may cause significant side effects like abdominal pain, wheezing and/or diarrhea. Published data from placebo-controlled trials have shown that only 50 to 70 percent of patients attempting OIT complete desensitization, with the failures primarily due to side effects. Also, there currently are no standardized protocols or foods used in OIT and no FDA approved approach that could allow insurance to reimburse for this therapy. Thus, there are challenges with the current practice of OIT.

The National Institute of Allergy and Infectious Diseases (NIAID) Guidelines for the Diagnosis and Management of Food Allergy in the United States does not recommend allergen immunotherapy to treat IgE-mediated food allergy. The expert panel that authored this document believes that additional safety and efficacy studies are needed. Because of this, FARE helped launch Allergen Research Corporation (now Aimmune Therapeutics) to perform the large-scale studies required for FDA approval. In addition, multiple, small studies continue to show efficacy for new approaches to OIT, which is why FARE continues to support innovative OIT development in academic centers.

In the meantime, there is an ongoing debate on whether food allergy OIT is ready for use in private practice. This topic has been addressed in multiple academic and private allergist forums and in articles published in peer-reviewed medical journals, including this piece in The Journal of Allergy and Clinical Immunology: In Practice, which considers the state of the evidence as well as the issues for allergists and their patients. An allergist doing OIT for patients in a private practice develops his/her own individualized protocols and uses his/her unique food preparation. While many report success, the exact outcomes and complications cannot be fully assessed given the differences in the feeding protocol and in the food used in treatment. Therefore, while FARE supports those patients who might consider private practice OIT, we are not able to evaluate or compare any particular practice or physician.

Ultimately, the decision to enter private practice OIT is an individual one that should be reached after extensive consultation between a patient and his/her allergist including an assessment of the involved risk. We believe the discussions around starting OIT should occur in a manner akin to the informed consent procedures in a clinical trial setting.

Formal Phase III clinical trials are underway in peanut OIT. These are randomized, double-blinded, placebo-controlled trials, where all the significant variables in the therapy are held constant to explore more rigorously what happens with the introduction of a stringently controlled investigational agent. FARE hopes these studies will allow FDA approval for OIT so that all doctors can provide this treatment to patients in a uniform manner under insurance coverage.

FARE’s commitment to supporting the 15 million Americans living with food allergies is unwavering. While the pace of research may be frustratingly slow, FARE is working every day to advance food allergy research through innovative approaches such as our new FARE Clinical Network. The studies performed in our network include evaluations of product safety, efficacy and of underlying immunology that should inform future research endeavors, including the development of the next generation of food allergy diagnostics and treatments. We believe this research will improve the lives of individuals with food allergies.

Media Contact
Nancy Gregory
Senior Director of Communications
Direct: 703-563-3066

For general inquiries, please call 800-929-4040.

About FARE

Food Allergy Research & Education (FARE) works on behalf of the 15 million Americans with food allergies, including all those at risk for life-threatening anaphylaxis. This potentially deadly disease affects 1 in every 13 children in the U.S. – or roughly two in every classroom. FARE’s mission is to improve the quality of life and the health of individuals with food allergies, and to provide them hope through the promise of new treatments. Our work is organized around three core tenets: LIFE – support the ability of individuals with food allergies to live safe, productive lives with the respect of others through our education and advocacy initiatives; HEALTH – enhance the healthcare access of individuals with food allergies to state-of-the-art diagnosis and treatment; and HOPE – encourage and fund research in both industry and academia that promises new therapies to improve the allergic condition. For more information, please visit www.foodallergy.org and find us on Twitter@FoodAllergyFacebookYouTube and Pinterest.