WHERE WE STAND TODAY
FARE’s vision – to make the world safe for people with food allergies – guides our research strategy. Our primary goals are to develop new treatments that will protect individuals with food allergies against life-threatening anaphylaxis, and ultimately, to find a cure. FARE researchers have contributed to major advances in the field, greatly increasing our understanding of food allergy. Although we still have much to learn, the pace of food allergy research is accelerating every day, and new therapies are on the horizon.
This overview explains where we stand today, and how FARE-funded researchers are making a difference.
Revealing the Impact of Food Allergies
Today, it is widely acknowledged that food allergies are a significant and growing health problem in the U.S. and other developed countries. This understanding of the disease is due, in large part, to the work of epidemiologists — researchers who focus on the causes and distribution of diseases in human populations. Epidemiological studies provide vital clues that help scientists and public health officials to prevent and control disease. (For example, epidemiologists discovered the link between smoking and cancer.)
Over the past 10-15 years, research has provided compelling evidence of the impact of food allergies in the United States. We have learned that up to 15 million Americans, including 1 in 13 children, have a food allergy, and that nearly 40 percent of these children have already experienced a severe or life-threatening reaction. Other studies have revealed the economic burden of food allergies and their damaging effect on families’ quality of life.
The work of FARE-funded investigators continues to provide important data about who gets food allergies and the possible role of such factors as diet, hygiene, geography, ethnicity, and much more. Epidemiologists’ findings provide new avenues for other researchers – such as immunologists and geneticists – to explore. Finally, because these studies provide powerful evidence of the growth and impact of food allergies, they also help advocates make a strong case for laws and policies that create safer environments for people with food allergies, and for federal funding for research.
Evidence-Based Guidelines for Managing Food Allergies
In 2010, the National Institute of Allergy and Infectious Diseases (NIAID) released Guidelines for the Diagnosis and Management of Food Allergy in the United States. This landmark document – the first of its kind – draws on the expertise of 34 professional associations, federal agencies, and advocacy groups, including FARE. These guidelines are “evidence-based” – meaning that they set forth the best practices for diagnosing and treating food allergies, based on the highest quality scientific studies available and the consensus of experts in the field. By providing standardized clinical guidelines to generalists and specialists nationwide, this document helps ensure better care for individuals with food allergies.
Further, the Guidelines helped establish the direction of research by identifying gaps in our current scientific knowledge of food allergies. Federal agencies, such as the National Institutes of Health (NIH), and FARE use this crucial information as a foundation for planning and funding future research initiatives, including clinical trials of new treatments.
Developing New Therapies
Unfortunately, strict avoidance of problem foods is still the only way to prevent a reaction. But there is good news: Clinical trials of promising new treatments are underway. Among other important data, researchers are trying to determine if these therapies will result in desensitization or tolerance.
Desensitization means that a person can consume a significant amount of a problem food without experiencing a reaction. However, desensitization is not permanent. In order to stay safe, people would have to continue this therapy for the rest of their lives. Still, a treatment that would desensitize large numbers of people with food allergies – protecting them against potentially fatal reactions – would be life-changing.
The ideal treatment would lead to tolerance – long-lasting immunological changes that would allow people with food allergies to safely eat problem foods, even after the treatment is discontinued.
Clinical trials of the treatments described below are being conducted at major medical centers nationwide, with funding from FARE, the NIH, and other sources.
During OIT, the food allergen (a commercially manufactured powder mixed with a harmless food) is administered slowly, in small but steadily increasing doses, until the patient is desensitized to it. Early clinical trials have demonstrated that OIT is safe and that it is effective in 70-80 percent of patients, provided that it is properly administered in a controlled setting. However, researchers still must determine the most effective dosage and time frame for treatment. Further, they must learn whether or not OIT can desensitize large numbers of patients, and finally, if it can lead to tolerance.
Some studies combine OIT with omalizumab (Xolair®), an asthma medication. If successful, these trials will show that omalizumab minimizes the frequency of reactions to OIT. This regimen would allow physicians to safely escalate patients’ intake of food allergens, resulting in more rapid desensitization than OIT alone.
Currently, FARE-funded studies are evaluating OIT for peanut, walnut, and multiple food allergens, which are administered simultaneously. Our ultimate goal is to support advanced clinical trials that will lead to the development of standardized, FDA-approved OIT products for the eight major food allergens: peanut, tree nuts, milk, egg, fish, shellfish, wheat and soy.
- Sublingual Immunotherapy (SLIT)
The concept behind SLIT is very similar to OIT, except that the food allergen is dissolved in a solution that is placed under the tongue. To date, SLIT generally has not been as effective as OIT, but it is less likely to cause serious allergic reactions. FARE is currently funding a study that evaluates both OIT and SLIT in people with peanut allergy.
- Food Allergy Herbal Formula 2 (FAHF-2)
This Chinese herbal therapy may prevent anaphylactic reactions to multiple food allergens. Currently, a Phase 2 study, co-funded by the NIH and FARE, is evaluating this treatment in patients who are allergic to peanut, tree nuts, fish, shellfish, and sesame.
In addition to supporting clinical trials, FARE has invested in the development of important therapeutic approaches that are not yet ready for testing in humans. Of particular note, we recently funded a preclinical study that led to the development of antigen-specific tolerance therapy. Using this approach, researchers at Northwestern University Feinberg School of Medicine successfully “turned off” life-threatening reactions in peanut-allergic mice. In time, this method could become the basis for a promising new therapy.
Pathways to a Cure
FARE seeks to identify and answer the crucial questions that will enable us to solve the puzzle of food allergy. To this end, we fund both basic and clinical research. At our biennial Research Retreat, which was held in Washington, DC in April 2013, FARE brought together prominent researchers, senior government and industry representatives, and food allergy advocates. We are finalizing a comprehensive strategic plan for food allergy research that is based on their deliberations.
The key to our success is our partnership with our stakeholders – including friends like you. We urge you to explore our current research grants and to learn more about food allergy clinical trials.