Peanut allergies affect about a million children in the U.S., and most never outgrow them. Luckily, some promising remedies are in the works.
Ever since he was a baby, Sharon Wong’s son Brandon suffered from rashes, prolonged respiratory issues and vomiting. In 2006, as a young child, he was diagnosed with a severe peanut allergy.
"My son had a history of reacting to traces of peanuts in the air or in food,” says Wong, a food allergy advocate who runs a blog focusing on nut free recipes, cooking techniques and food allergy awareness. “Any participation in school activities, social events, or travel with his peanut allergy required a lot of preparation.”
Peanut allergies affect around a million children in the U.S. Most never outgrow the condition. The problem occurs when the immune system mistakenly views the proteins in peanuts as a threat and releases chemicals to counteract it. This can lead to digestive problems, hives and shortness of breath. For some, like Wong’s son, even exposure to trace amounts of peanuts could be life threatening. They go into anaphylactic shock and need to take a shot of adrenaline as soon as possible.
Typically, people with peanut allergies try to completely avoid them and carry an adrenaline autoinjector like an EpiPen in case of emergencies. This constant vigilance is very stressful, particularly for parents with young children.
“The search for a peanut allergy ‘cure’ has been a vigorous one,” says Claudia Gray, a pediatrician and allergist at Vincent Pallotti Hospital in Cape Town, South Africa. The closest thing to a solution so far, she says, is the process of desensitization, which exposes the patient to gradually increasing doses of peanut allergen to build up a tolerance. The most common type of desensitization is oral immunotherapy, where patients ingest small quantities of peanut powder. It has been effective but there is a risk of anaphylaxis since it involves swallowing the allergen.
"By the end of the trial, my son tolerated approximately 1.5 peanuts," Sharon Wong says.
DBV Technologies, a company based in Montrouge, France has created a skin patch to address this problem. The Viaskin Patch contains a much lower amount of peanut allergen than oral immunotherapy and delivers it through the skin to slowly increase tolerance. This decreases the risk of anaphylaxis.
Wong heard about the peanut patch and wanted her son to take part in an early phase 2 trial for 4-to-11-year-olds.
“We felt that participating in DBV’s peanut patch trial would give him the best chance at desensitization or at least increase his tolerance from a speck of peanut to a peanut,” Wong says. “The daily routine was quite simple, remove the old patch and then apply a new one. By the end of the trial, he tolerated approximately 1.5 peanuts.”
How it works
For DBV Technologies, it all began when pediatric gastroenterologist Pierre-Henri Benhamou teamed up with fellow professor of gastroenterology Christopher Dupont and his brother, engineer Bertrand Dupont. Together they created a more effective skin patch to detect when babies have allergies to cow's milk. Then they realized that the patch could actually be used to treat allergies by promoting tolerance. They decided to focus on peanut allergies first as the more dangerous.
The Viaskin patch utilizes the fact that the skin can promote tolerance to external stimuli. The skin is the body’s first defense. Controlling the extent of the immune response is crucial for the skin. So it has defense mechanisms against external stimuli and can promote tolerance.
The patch consists of an adhesive foam ring with a plastic film on top. A small amount of peanut protein is placed in the center. The adhesive ring is attached to the back of the patient's body. The peanut protein sits above the skin but does not directly touch it. As the patient sweats, water droplets on the inside of the film dissolve the peanut protein, which is then absorbed into the skin.
The peanut protein is then captured by skin cells called Langerhans cells. They play an important role in getting the immune system to tolerate certain external stimuli. Langerhans cells take the peanut protein to lymph nodes which activate T regulatory cells. T regulatory cells suppress the allergic response.
A different patch is applied to the skin every day to increase tolerance. It’s both easy to use and convenient.
“The DBV approach uses much smaller amounts than oral immunotherapy and works through the skin significantly reducing the risk of allergic reactions,” says Edwin H. Kim, the division chief of Pediatric Allergy and Immunology at the University of North Carolina, U.S., and one of the principal investigators of Viaskin’s clinical trials. “By not going through the mouth, the patch also avoids the taste and texture issues. Finally, the ability to apply a patch and immediately go about your day may be very attractive to very busy patients and families.”
Brandon Wong displaying origami figures he folded at an Origami Convention in 2022
Sharon Wong
Clinical trials
Results from DBV's phase 3 trial in children ages 1 to 3 show its potential. For a positive result, patients who could not tolerate 10 milligrams or less of peanut protein had to be able to manage 300 mg or more after 12 months. Toddlers who could already tolerate more than 10 mg needed to be able to manage 1000 mg or more. In the end, 67 percent of subjects using the Viaskin patch met the target as compared to 33 percent of patients taking the placebo dose.
“The Viaskin peanut patch has been studied in several clinical trials to date with promising results,” says Suzanne M. Barshow, assistant professor of medicine in allergy and asthma research at Stanford University School of Medicine in the U.S. “The data shows that it is safe and well-tolerated. Compared to oral immunotherapy, treatment with the patch results in fewer side effects but appears to be less effective in achieving desensitization.”
The primary reason the patch is less potent is that oral immunotherapy uses a larger amount of the allergen. Additionally, absorption of the peanut protein into the skin could be erratic.
Gray also highlights that there is some tradeoff between risk and efficacy.
“The peanut patch is an exciting advance but not as effective as the oral route,” Gray says. “For those patients who are very sensitive to orally ingested peanut in oral immunotherapy or have an aversion to oral peanut, it has a use. So, essentially, the form of immunotherapy will have to be tailored to each patient.” Having different forms such as the Viaskin patch which is applied to the skin or pills that patients can swallow or dissolve under the tongue is helpful.
The hope is that the patch’s efficacy will increase over time. The team is currently running a follow-up trial, where the same patients continue using the patch.
“It is a very important study to show whether the benefit achieved after 12 months on the patch stays stable or hopefully continues to grow with longer duration,” says Kim, who is an investigator in this follow-up trial.
"My son now attends university in Massachusetts, lives on-campus, and eats dorm food. He has so much more freedom," Wong says.
The team is further ahead in the phase 3 follow-up trial for 4-to-11-year-olds. The initial phase 3 trial was not as successful as the trial for kids between one and three. The patch enabled patients to tolerate more peanuts but there was not a significant enough difference compared to the placebo group to be definitive. The follow-up trial showed greater potency. It suggests that the longer patients are on the patch, the stronger its effects.
They’re also testing if making the patch bigger, changing the shape and extending the minimum time it’s worn can improve its benefits in a trial for a new group of 4-to-11 year-olds.
The future
DBV Technologies is using the skin patch to treat cow’s milk allergies in children ages 1 to 17. They’re currently in phase 2 trials.
As for the peanut allergy trials in toddlers, the hope is to see more efficacy soon.
For Wong’s son who took part in the earlier phase 2 trial for 4-to-11-year-olds, the patch has transformed his life.
“My son continues to maintain his peanut tolerance and is not affected by peanut dust in the air or cross-contact,” Wong says. ”He attends university in Massachusetts, lives on-campus, and eats dorm food. He still carries an EpiPen but has so much more freedom than before his clinical trial. We will always be grateful.”
Virtual-first care, or V1C, could increase the quality of healthcare and make it more patient-centric by letting patients combine in-person visits with virtual options such as video for seeing their care providers.
That’s the idea behind virtual-first care (V1C), a new care model centered on convenient, customized, high-quality care that integrates a full suite of services tailored directly to patients’ clinical needs and preferences. This package includes asynchronous communication such as texting; video and other live virtual modes; and in-person options.
V1C goes beyond what you might think of as standard “telehealth” by using evidence-based protocols and tools that include traditional and digital therapeutics and testing, personalized care plans, dynamic patient monitoring, and team-based approaches to care. This could include spit kits mailed for laboratory tests and complementing clinical care with health coaching. V1C also replaces some in-person exams with ongoing monitoring, using sensors for more ‘whole person’ care.
Amidst all this momentum, we have the opportunity to rethink the goals of healthcare innovation, but that means bringing together key stakeholders to demonstrate that sustainable V1C can redefine healthcare.
Established V1C healthcare providers such as Omada, Headspace, and Heartbeat Health, as well as emerging market entrants like Oshi, Visana, and Wellinks, work with a variety of patients who have complicated long-term conditions such as diabetes, heart failure, gastrointestinal illness, endometriosis, and COPD. V1C is comprehensive in ways that are lacking in digital health and its other predecessors: it has the potential to integrate multiple data streams, incorporate more frequent touches and check-ins over time, and manage a much wider range of chronic health conditions, improving lives and reducing disease burden now and in the future.
Recognizing the pandemic-driven interest in virtual care, significant energy and resources are already flowing fast toward V1C. Some of the world’s largest innovators jumped into V1C early on: Verily, Alphabet’s Life Sciences Company, launched Onduo in 2016 to disrupt the diabetes healthcare market, and is now well positioned to scale its solutions. Major insurers like Aetna and United now offer virtual-first plans to members, responding as organizations expand virtual options for employees. Amidst all this momentum, we have the opportunity to rethink the goals of healthcare innovation, but that means bringing together key stakeholders to demonstrate that sustainable V1C can redefine healthcare.
That was the immediate impetus for IMPACT, a consortium of V1C companies, investors, payers and patients founded last year to ensure access to high-quality, evidence-based V1C. Developed by our team at the Digital Medicine Society (DiMe) in collaboration with the American Telemedicine Association (ATA), IMPACT has begun to explore key issues that include giving patients more integrated experiences when accessing both virtual and brick-and-mortar care.
Digital Medicine Society
V1C is not, nor should it be, virtual-only care. In this new era of hybrid healthcare, success will be defined by how well providers help patients navigate the transitions. How do we smoothly hand a patient off from an onsite primary care physician to, say, a virtual cardiologist? How do we get information from a brick-and-mortar to a digital portal? How do you manage dataflow while still staying HIPAA compliant? There are many complex regulatory implications for these new models, as well as an evolving landscape in terms of privacy, security and interoperability. It will be no small task for groups like IMPACT to determine the best path forward.
None of these factors matter unless the industry can recruit and retain clinicians. Our field is facing an unprecedented workforce crisis. Traditional healthcare is making clinicians miserable, and COVID has only accelerated the trend of overworked, disenchanted healthcare workers leaving in droves. Clinicians want more interactions with patients, and fewer with computer screens – call it “More face time, less FaceTime.” No new model will succeed unless the industry can more efficiently deploy its talent – arguably its most scarce and precious resource. V1C can help with alleviating the increasing burden and frustration borne by individual physicians in today’s status quo.
In healthcare, new technological approaches inevitably provoke no shortage of skepticism. Past lessons from Silicon Valley-driven fixes have led to understandable cynicism. But V1C is a different breed of animal. By building healthcare around the patient, not the clinic, V1C can make healthcare work better for patients, payers and providers. We’re at a fork in the road: we can revert back to a broken sick-care system, or dig in and do the hard work of figuring out how this future-forward healthcare system gets financed, organized and executed. As a field, we must find the courage and summon the energy to embrace this moment, and make it a moment of change.