Peanut Patch Treatment for Toddlers: Your Questions Answered

A new study involving researchers from Children’s Hospital of Philadelphia (CHOP) found daily use of a “peanut patch” for one year was effective in desensitizing two-thirds of peanut-allergic toddlers and lessening the likelihood of an allergic reaction upon accidental exposure. The findings were published this week in the New England Journal of Medicine.

“The exciting part of this study is that we found that the “peanut patch” did help to desensitize some patients – but not all – to peanut,” said Terri F. Brown-Whitehorn, MD, one of the study authors. “They tolerated higher amounts of peanut than they did the year prior, and the patch itself did not show any increase in safety concerns in a younger age group.

Dr. Brown-Whitehorn, an attending physician in CHOP’s Division of Allergy and Immunology and site Principal Investigator, recently sat down to discuss the research. She and others at CHOP have been investigating skin patches and oral immunotherapy as ways to desensitize children to their food allergens for more than a decade.

Question: Can my child get the “peanut patch”? If not, when will they be able to?

Answer: The “peanut patch” is not yet approved by the U.S. Food and Drug Administration (FDA). Currently, it is only available through research trials like the one reported recently in the New England Journal of Medicine, of which CHOP was part. While we are hopeful the FDA will approve the patch for more broad-based use, we do not know the timeline for when that may happen.

Q: Is the clinical trial still underway at CHOP? Can I enroll my child?

A: The research trial that was reviewed in the New England Journal of Medicine is no longer enrolling new patients. There are some patients – who were part of the original study – who remain on an extended version of the study.

Q: Why did this clinical trial not include older children?

A: There have been studies in older children with peanut allergies (see Resources below), but authors of this study wanted to focus on younger age groups and assess responses to the “peanut patch” from a safety and efficacy standpoint. What that means is that we wanted to test if the patch was safe for younger patients to use and whether it produced the desired result of making children tolerate more peanut during a food challenge and less likely to react if they were accidentally exposed to a peanut. For patients with peanut allergy, there is currently no FDA-approved product to help desensitize children younger than 4 years of age to peanut or peanut protein.

Q: How is the peanut patch different than oral immunotherapy (OIT)?

A: Patients who are in the “peanut patch” study are trying to change their immune system through the skin, known as epicutaneous immunotherapy. Patients’ patches are applied in a specific way on the back, worn for 24 hours, and replaced every 24 hours. Dosing (the amount of peanut protein on the patch) is constant throughout the study (1/1000th of a peanut).

With oral immunotherapy, patients ingest specific doses (amounts) of peanut protein – that are gradually increased over time. It’s important to work very closely with a healthcare provider experiences in oral immunotherapy. We do NOT recommend families doing this on their own. There are different rules and recommendations to enhance safety for patients on oral immunotherapy that are not needed for those receiving epicutaneous immunotherapy.

Q: Which option – oral immunotherapy or the skin patch – is better for my child?

A: Families will need to discuss this with their healthcare provider. There are pros and cons of each method, and currently the so-called “peanut patch” is not available except through research studies.

Q: Does the peanut patch have any side effects? If so, what are they?

A: The most common side effects of the “peanut patch” are redness, itchiness and irritation at the site of the patch, which seems to go away over time.

“We are often able to help patients tolerate the patch with creams or oral medications,” adds Courtney Rooney, BSN, RN, clinical research coordinator with the Food Allergy Center at CHOP and study coordinator of the most recent clinical trial.

In addition, there was a small risk of an allergic reaction to the patch, as seen in prior studies; however, this was not increased in the toddler age group. During the study, patients continued to avoid intentional peanut ingestion and always had an epinephrine auto-injector available.

Q: Is the patch a cure for peanut allergies? Will my child be able to eat peanuts and peanut butter after receiving this treatment?

A: The patch is NOT a cure for peanut allergies. Unfortunately, we do not have a cure for peanut allergies. Patients wearing the patch cannot freely eat peanuts. They must continue to avoid peanuts, read labels and carry epinephrine auto-injectors.

The goal of the peanut patch and this type of therapy is to increase the amount (also known as the threshold dose) that may trigger an allergic reaction. Because children underwent food challenges before and after wearing the peanut patch for a year, we were able to compare specific amounts of peanut that led to a reaction. Two-thirds of the patients tolerated significantly more peanut than they did prior to wearing the patch. In addition, while they may have had an allergic reaction, they needed to ingest more peanut to have the reaction.

Of course, we would have loved to have many patients tolerate all dosing of peanut during the challenge (there were some), but this remains a step in the right direction.

It is important to note that the patients and families in these studies are heroes. We know that the children are allergic to peanut, and they must undergo food challenges to assess the amount that causes a reaction and undergo treatment including wearing a patch (some of the children had placebo patch and some had real patch), and then a year later undergo food challenges to assess their response to the patch.

In addition, patients and families had to closely watch and describe any issues related to the patch or other illnesses that occurred during the year. There was also an open-labelled extension study, so all patients – no matter if they were originally in the peanut patch or placebo patch group – could receive the peanut patch and continue yearly food challenges to assess their progress. The extension study is still in progress, and we are eager to learn the results.

Q: If my child begins the peanut patch, how long will they have to wear the patch? If they stop wearing it, will the results/benefits fade?

A: This was a one-year study. The extension study will tell us more about this age group and whether wearing the patch longer is beneficial. I personally think it helps to wear it longer, but the research will be available in the future. I foresee the peanut patch as a multi-year treatment, that perhaps transitions to ingesting a small amount of peanut like in oral immunotherapy. Again, we are learning more and more based on this study and other studies we have already participated in. The New England Journal of Medicine study did not examine whether results and benefits fade in children after they stop wearing the patch.

Q: Is this the same patch that was reviewed by the FDA a few years ago? Why wasn’t that patch FDA-approved?

A: Yes, this is the same patch the FDA considered a few years ago and recommended improving the adhesive properties of the patch. The company has worked on this issue and a new version will be studied soon (with the same amount of peanut in the patch) in patients aged 4 to 7 to assess safety and efficacy.

To learn more about food allergy research trials at CHOP, please email foodallergyresearch@chop.edu.

Q: Are researchers – at CHOP and elsewhere – looking to develop patches like this for other food allergies? If so, which ones and how soon might my child be able to use it?

A: Researchers (including at CHOP) have looked at using a milk patch for patients with immediate severe allergic reactions to milk. More studies are needed.

Q: What’s next on the horizon for food allergy research?

A: As allergists and researchers, we are excited to one day be able to offer patients and their families with food allergy options for therapy over time. We are also hopeful that one day we may have some sort of marker that may tell us which option may work best for each patient.

Resources

Sampson HA, Shreffler WG, Yang WH, Sussman GL, Brown-Whitehorn TF, Nadeau KC, Cheema AS, Leonard SA, Pongracic JA, Sauvage-Delebarre C, Assa'ad AH, de Blay F, Bird JA, Tilles SA, Boralevi F, Bourrier T, Hébert J, Green TD, Gerth van Wijk R, Knulst AC, Kanny G, Schneider LC, Kowalski ML, Dupont C.: Effect of Varying Doses of Epicutaneous Immunotherapy vs. Placebo on Reaction to Peanut Protein Exposure Among Patients With Peanut Sensitivity: A Randomized Clinical Trial. JAMA, 318(18): 1798-1809, Nov. 2017.

Fleischer DM, Greenhawt M, Sussman G, Begin P, et al. Effect of epicutaneous Immunotherapy vs. Placebo on Reaction to Peanut Protein Ingestion Among Children With Peanut Allergy. The PEPITES randomized clinical trial. JAMA, 2019;321(10); 946-955.

Fleischer DM, Shreffler WG, Campbell DE, Green TD, Anvari S, Assa'ad A, Bégin P, Beyer K, Bird JA, Brown-Whitehorn T, Byrne A, Chan ES, Cheema A, Chinthrajah S, Chong HJ, Davis CM, Ford LS, Gagnon R, Greenhawt M, Hourihane JO, Jones SM, Kim EH, Lange L, Lanser BJ, Leonard S, Mahler V, Maronna A, Nowak-Wegrzyn A, Oriel RC, O'Sullivan M, Petroni D, Pongracic JA, Prescott SL, Schneider LC, Smith P, Staab D, Sussman G, Wood R, Yang WH, Lambert R, Peillon A, Bois T, Sampson HA.: Long-term, Open-label Extension Study of the Efficacy and Safety of Epicutaneous Immunotherapy for Peanut Allergy in Children: PEOPLE 3-year results. J Allergy Clinical Immunology, Oct. 2020.

Fleischer DM, Spergel JM, Kim EH, Campbell DE, Green TD, et al. Evaluation of Daily Patch Application During Epicutaneous Immunotherapy for Peanut Allergy. Allergy Asthma Proc, 2020 Jul 1;41(4); 278-284.

Pongracic JA, Gagnon R, Sussman G, Siri D, Oriel RC, Brown-Whitehorn TF, et al. Safety of Epicutaneous Immunotherapy in Peanut-allergic Children: REALISE Randomized Clinical Trial Results. J Allergy Clinical Immunology Practice, 2021; Nov 27; S2213-2198.