Do we need more pharma or more farms to treat food allergies?
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Key takeaways:
- Oral and sublingual immunotherapy can mitigate allergic reactions.
- Interest in how the gut microbiome impacts food allergy is growing.
- Quality commercial food can create change at the cellular level.
Editor’s Note: In Healio Allergy/Asthma’s column, “Food Allergy: Fact vs. Fiction,” Douglas H. Jones, MD, breaks down what’s true and what’s myth for a variety of topics related to food allergies. If you have a question that you would like answered in this column, email Jones at rmaaimd@gmail.com or Richard Gawel at rgawel@healio.com.
The field of food allergy treatment has been evolving rapidly, with several promising developments in recent years. Typically, much of what makes headlines, though, surrounds who pays for the headlines.
Today, I want to break down some of the basics of the treatments available that allergists utilize and also introduce some in the pipeline. More importantly, I want to pose the question of whether more pharma or farms are needed as we embark on this food allergy treatment journey.
So, what is currently in clinical practice for treatment of food allergies?
Oral immunotherapy
OIT has been the most widely used treatment and has been in clinical practice for well over a decade. It involves gradually introducing small amounts of the allergen into the patient’s diet, with the goal of increasing tolerance over time.
Recent research has focused on refining OIT protocols to improve safety and efficacy. Studies have shown that OIT can be effective for most allergens, including peanuts, milk, eggs, wheat, soy, tree nuts, seeds, shellfish, fish and spices. This process takes anywhere from 6 to 12 months, on average. Length of time may vary depending on the patient and the protocol.
With this treatment, patients often have the choice upon completion to free-eat the food or be taken to a level of protection where they still avoid the foods but do have a measure of protection against reactions if they are accidentally exposed. The goals of the treatment are discussed and jointly decided by the patient and the treating allergist.
The vast majority of patients who do OIT are treated successfully with commercially available foods. There is one FDA-approved product, Palforzia (Stallergenes Greer), that is used for peanut allergy only.
The Journal of Allergy and Clinical Immunology: In Practice recently published a letter that I coauthored with Richard L. Wasserman, MD, PhD, and Hugh H. Windom, MD, about a survey conducted by the Food Allergy Support Team (FAST), a group of allergists dedicated to enhancing food OIT.
The survey polled members of OITAdvisors, a Google group comprising 550 board-certified allergists and immunologists and their staffs, during the spring of 2023. Representatives of 129 private allergy practices responded, and 97.5% had treated one patient or more with OIT. Collectively, more than 26,000 patients had been treated.
“Specific foods treated include peanut (100%), tree nuts (86%), cow milk (80%), egg (79%), seeds (69%), wheat (56%) and legumes (39%) with fewer than 10% treating fish or shellfish allergy,” we wrote.
Also, most of the respondents used retail food for peanut OIT, and 4.5% used the FDA-approved product in less than 5% of patients.
Sublingual immunotherapy
SLIT is rapidly expanding and involves placing a small dose of the allergen under the tongue. It has been more commonly used for environmental allergens but is now being used for food allergies as well. Recent studies have looked at optimizing dosing and frequency to enhance efficacy and reduce side effects.
In this method, there are two major ways of introducing the allergen: with the use of real food, and with the use of commercially available allergen extract. Both are carefully prepared for proper dosing, and both are effective.
Overall, there are fewer restrictions surrounding the dosing with SLIT as opposed to OIT and fewer adverse reactions. However, in most cases, the patient will need to continue to avoid the allergenic foods but may gain some protection against accidental ingestion, similar to lower-dosed versions of OIT.
Biologic therapies
In February 2024, omalizumab (Xolair; Genentech, Novartis) was approved for IgE-mediated food allergies. Its official food allergy indication is for the reduction of allergic reactions (Type 1), including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy. With this, patients also avoid the foods to which they are allergic. There are various studies investigating its use in conjunction with OIT as well.
Of the treatments available, OIT is the one that provides the most opportunity for someone to free-eat the food they were once allergic to, whereas the other treatments are used in conjunction with food allergen avoidance.
All these treatments are to be done under the direction of someone specializing in food allergies and their implementation and utilization. Great caution, monitoring and individualization should be done to ensure the safety and efficacy for the patient.
More biologics are on the way. Drugs such as monoclonal antibodies are being investigated for their potential to modify the immune response. For instance, dupilumab (Dupixent; Sanofi, Regeneron), a drug initially developed for asthma and eczema, is being explored for its effects on food allergies. These therapies work by targeting specific pathways in the immune system involved in allergic reactions.
Peanut toothpaste
Intrommune Therapeutics’ INT301 peanut toothpaste is a specialized product designed for OIT for peanut allergies. The concept behind peanut toothpaste is to introduce tiny, controlled amounts of peanut protein into the patient’s system through daily brushing, which helps to build tolerance over time.
The toothpaste includes a measured amount of peanut protein, which is gradually increased over time as part of a structured treatment plan. The dosage is carefully monitored and adjusted to help the patient develop tolerance without causing severe allergic reactions.
Patients use the toothpaste as part of their daily oral hygiene routine. The idea is that consistent, small exposures to the allergen can help desensitize the immune system over a longer period.
INT301 is currently being studied in clinical trials to assess its safety and effectiveness. Early research suggests that it could be a promising approach to peanut allergy treatment, but more data are needed to confirm its benefits and long-term outcomes.
The use of peanut toothpaste is part of a broader trend toward innovative methods for allergy desensitization, aiming to make treatment more accessible and less invasive compared with traditional oral immunotherapy methods. However, if FDA-approved, it will initially be limited to peanut.
Also in the pipeline
Epicutaneous immunotherapy, or EPIT, uses a patch that includes the allergen and is worn on the skin. The allergen is absorbed through the skin, gradually desensitizing the immune system.
DBV Technologies’ VP250 patch has shown promise in clinical trials for treating peanut allergies, with ongoing research exploring its effectiveness and long-term benefits. Once again, this is something that, if FDA-approved, will only be available for peanut allergy, initially.
Research is also being done on creating vaccines that could provide long-term protection against food allergies. These vaccines aim to induce an immune response that would prevent allergic reactions.
Advances in understanding the genetic and immunological underpinnings of food allergies also are paving the way for more targeted therapies. For instance, identifying specific genetic markers associated with food allergies can help tailor treatment approaches to individual patients.
Additionally, there is growing interest in how the gut microbiome influences food allergies. Some studies suggest that manipulating the microbiome could potentially play a role in preventing or treating food allergies, though this area is still in the early stages of research.
These advances represent a significant shift toward more personalized and effective treatments for food allergies. Clinical trials and ongoing research are crucial for validating these new approaches and bringing them into mainstream practice.
FAST, a nonprofit dedicated to the education and best practices of food allergy diagnostics and treatment, is also an important collaboration of allergists to answer the critical practical questions that could never be answered in the setting of a clinical trial.
Pharma or farms?
With these advances, I want to get back to my initial question. Do we need more pharma or farms? Let me start with some powerful lessons that I have learned from doing OIT over 10 years.
First, food is power. When used correctly, we can utilize quality commercial food to create change at the cellular level to a degree that it influences the immune system to go from a potentially life-threatening response to one of tolerance and nonreactivity. Pharmaceuticals are not needed for that even though they have been manufactured. As described above, more than 95% of patients have been treated with food, not pharma, for OIT.
Second, the microbiome is power. The emergence of the importance of the balance of the gut force has been enlightening. Its impact is far reaching. We see how the maturation of the gut flora early in life can prevent food allergies. We are at a tipping point in discovery with the microbiome. I think it has more power than any pharmaceutical.
Third, integration is power. Food allergy does not exist in isolation. It exists in the context of a complex human with integrated bidirectional communication systems comprising the immune system, nervous system, and endocrine system.
Various internal and external inputs and stressors sway this dynamic. This plays a role in how our bodies communicate with food, both the receiving and interpretation of those signals, and that dictates the response or nonresponse.
As we focus on these three lessons, we speak more to the root cause of the issues and not just the effects.
Many, not all, of the pharmaceutical products focus on peanuts. We call this “peanut privilege.” However, most people are not allergic to peanuts. They are allergic to something else. So, what about them? Also, many products are geared toward effects, not causes.
I am not suggesting that these products do not have a place. Each may fill a void and have a niche. However, they can be expensive, and access is limited.
The biologics can be an exception, as they can enhance safety for patients, and when used in conjunction with immunotherapy, they can have a profound impact in accessibility for patients. They can make treatment possible for some for whom it would not be possible.
In my opinion, among the pharmaceuticals, the biologics can play the most significant role. However, when looking at food-specific pharmaceutical products, when compared with what we can do with correct usage of food, we need more farms, I think. But I leave that to you to decide.
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Douglas H. Jones, MD, FAAAAI, FACAAI, is cofounder of Global Food Therapy, Food Allergy Support Team and OITConnect, the director at Rocky Mountain Allergy at Tanner Clinic, and a Healio Allergy/Asthma Peer Perspective Board Member. He can be reached at rmaaimd@gmail.com or on Instagram @drdouglasjones.