Daniel F. Soteres is on the clinical faculty of the University of Colorado Health Sciences Center in Denver, and has been in private practice at Asthma and Allergy Associates and Research Center in Colorado Springs and Pueblo since 2005. Dr. Soteres received his medical degree in 1998 from Tulane University School of Medicine in New Orleans. He simultaneously earned a master of public health degree, completed a four-year combined residency in internal medicine and pediatrics, served as chief resident in internal medicine, and completed his fellowship in allergy and immunology.
Dr. Soteres, there are many research studies currently trying to find a cure for food allergies. Which research studies do you feel are most likely to yield a cure?
There are a bunch of great studies going on right now and I believe that the next 10 years will reveal a lot more options for those with food allergies. Currently food-specific and non-specific therapies are being evaluated. The therapies that are most promising are a Chinese Herbal formulation, FAHF-2 and Oral Immunotherapy (OIT) protocols that may be given with anti-IgE antibody (aka. Xolair).
FAHF-2 is a mixture of 9 herbs that completely blocked anaphylaxis during a peanut challenge 5 months after therapy. This has been studied in Phase I clinical trials and was safe and effective.
There were 19 subjects with peanut and tree nut allergy. Two patients had some mild GI symptoms. Currently there is a Phase II clinical trial for safety and efficacy for patients 12-45 years old with peanut, tree nut, fish, sesame, or shellfish allergy.
Let’s define Tolerance versus Desensitization. Tolerance means that the food can be ingested safely despite long periods of avoidance. Desensitization means that protection is dependent on regular ingestion of a food allergen. If dosing is interrupted or discontinued, the protective effect might be lost or decreased.
Oral immunotherapy (OIT) is a desensitization process. Small amounts of a specific food are mixed in a safe food and ingested in gradually increasing doses. Dose escalation occurs at a hospital or clinic and then daily regular doses are continued at home. This desensitization protocol has been successful in patients with milk, egg, fish, peanut and other food allergies.
From the medical literature some patterns have emerged: 10-20% of patients fail the initial build-up phase due to reactions; 10-20% do not achieve the full maintenance dose. So, overall 50-75% achieve and tolerate the recommended maintenance dose. We do not know if those who use lower maintenance doses will become tolerant over time.
Humanized Monoclonal anti-IgE (Xolair) is currently approved as a treatment option for people with moderate to severe asthma. It has also been shown to increase tolerance to peanut exposure, but the study was stopped early.
********Despite all the research many questions remain: Using anti-IgE and OIT together has not been studied yet. Hypothetically, the anti-IgE should reduce the risk of reactions during the OIT procedure. For OIT more studies are needed to determine the optimal build-up schedule, the optimal maintenance dose, ideal duration, degree of protection, efficacy at different ages, severity and type of food allergies, and the need for patient protection in patients treated at home.
My 15 year old son, Morgan, is currently receiving allergy shots/immunotherapy for his environmental and pet allergies. Would that disqualify him from ever participating in a research study if he were continuing to receive this treatment? Many of the kids (and adults) who are allergic to foods are also allergic to environmental allergens. I do not think that allergy immunotherapy of environmental allergies will exclude Morgan or anyone from participating in food allergy research studies.
Would children in puberty not be good participants in a research study? Are there other criteria that would automatically disqualify a person? Clinical research trials are designed with specific inclusion and exclusion criteria. These studies will have to be done in adolescents as well as very young children. The only pitfall with the adolescent age group that I can think of is the issue of compliance. If an investigator (the physician in charge of the study at a site) determined that a patient did not have the maturity to take medicines, pursue regular follow up visits and responsibly keep a short daily diary then they may exclude that patient from participating. However, this is a rare occurrence and I don’t think it will prevent study of food allergy therapies in the adolescent population.
I have heard that 15 to 20% of participants in Wesley Burks’ research study of the ‘peanut flour’ have had to drop out of the research because of severe reactions. And that other children have had to drop out because of the onset of Eosinophilic Esophagitis. This seems frightening to me to subject a child to these possibilities. Yet there are those children who are now eating peanuts or drinking milk, who never thought that would be possible! How does a parent wisely choose whether their child should participate in a research study?
Each parent needs to collect information about the study and discuss it with their child. Next, they should discuss the study with their allergy doctor and the investigators performing the study. Specific questions should revolve around safety precautions taken during the study especially at times when you or your child may be asked to eat one of your food allergens. Desensitization protocols are not for everyone. However, the process of build-up and maintenance dosing to their food allergens can be quite liberating for individuals and families who live in fear of severe reactions.
The complication of Eosinophilic Esophagitis (EoE) has been reported but this has not been a common problem with OIT.
Does your office participate in any of the research? If so which one(s)? We are not currently involved in any of the current research on food allergy. These studies are limited to large academic centers. Our research center is ready to go when the academic centers begin preparing some of their treatments for FDA approval and mainstream care.
What is the peanut desensitization protocol that your office is doing?
The peanut desensitization protocol that I am using in my office is based on the current protocols that have been published in peer-reviewed journals like the JACI. I don’t call it “research-based” because we are not doing this in conjunction with any pharmaceutical companies or with the academic centers that have been doing research on this issue. To my knowledge there are about half a dozen private practice clinics around the US that are doing the same protocol as I am doing. Here, we have performed peanut desensitization on about 6 kids and one adult with fairly good success. One child had a systemic reaction during the build-up phase and they dropped out. The adult was doing very well, but had a systemic reaction shortly after going on maintenance. He also decided to stop the procedure. As I stated earlier, peanut desensitization is NOT for everyone. I’ve probably talked about a dozen families out of pursuing it. Recently I advised a family whose child has EoE not to do peanut desensitization due to the risk of worsening the condition.
Thank you Dr. Danny!