PEOPLE Study: Peanut Patch May Be Effective For Children

Learn essential information about the emerging peanut patch treatment for children with existing food allergies, including results from the PEOPLE trial’s 3-year results report.

Peanut allergy is one of the most common and lasting food allergies, and peanut allergy rates have tripled in recent years. Fortunately, though, a new treatment for peanut allergies is being tested---the peanut patch---and it shows promise.

Recent studies of the new peanut patch treatment, particularly the most recent Phase 3 extension trial named “PEOPLE”, show that the peanut patch can be an effective treatment for peanut allergies in children. Today, we’ll explain what parents need to know about the peanut patch, and break down the results from the PEOPLE trial’s 3-year results report.

What is the peanut patch?

The peanut patch is a patch applied on the skin that contains a small dose of peanut protein. It is designed to treat peanut allergies in children ages 4-11 years, using a daily skin treatment called epicutaneous immunotherapy (EPIT).

The EPIT treatment is meant to desensitize children to peanut by gradually releasing tiny amounts of peanut into their skin. If a child continues to receive the EPIT treatment daily for months, and the treatment is successful, their reaction threshold increases. This may help protect the child from an allergic reaction if they accidentally ingest peanut (as it will take more peanut to trigger an allergic reaction). So, if the peanut patch works as intended, it may help protect children with peanut allergies from life-threatening anaphylaxis.

The peanut patch is still undergoing clinical trials, and is only available to participants in these trials. It is not currently approved by the FDA. However, as the patch’s manufacturer reports, it “has obtained Fast Track and Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of peanut allergy in children.”

The PEOPLE Trial: The Peanut Patch May Be An Effective Treatment

Recent results of the PEOPLE (PEPITES Open Label Extension) study indicate that the peanut patch may be an effective peanut allergy treatment.

The PEOPLE study of the peanut patch was a follow-up to the earlier PEPITES study, so it’s important to understand how the PEPITES study laid the groundwork for this research.

The PEPITES Study: The Groundwork

In the earlier PEPITES study, peanut allergic children between the ages of 4 and 11 years either wore the peanut patch daily, or applied a placebo daily, for one year. The children then underwent an oral food challenge, where they were gradually exposed to peanut, to see how effective the patch treatment was in reducing their reaction threshold.

Although the PEPITES results were considered “disappointing,” the investigators still noticed that the patch showed greater success when used with younger children over longer periods. Because of this, the investigators decided to extend this study---and the study’s extension became known as the PEOPLE trial. The extension of treatment in the PEOPLE trial showed much more promising results.

The PEOPLE Study: The Continuation

What do parents need to know about the PEOPLE study and its 3-year results report? We’ve included a full breakdown for families below.

Questions Answers
What were the goals of the study?

To see if the peanut patch could increase peanut allergic children’s reaction threshold, so they would not react until they consumed 1,000 milligrams (mg) or more of peanut protein.

  • 1,000 mg = protein in 3 to 4 peanuts
  • Most peanut allergic children normally react to much smaller amounts. Some react to as little as 1mg peanut protein.
Who conducted the PEOPLE study?

David Fleischer, MD (director of the Allergy and Immunology Center at Children’s Hospital Colorado) and colleagues across the world, to investigate the Viaskin Peanut patch by DBV Technologies.

DBV Technologies funded the study, but did not influence the results.

Who participated in the PEOPLE study?
  • 198 children ages 4-11 who had peanut allergies.
  • All previously took part in PEPITES.
  • All received the actual peanut patch in PEPITES, not the placebo.
  • 141 of these children were included in final results.
How long did the children participate in the PEOPLE study?
  • They will participate for up to 5 years.
  • Currently, they’ve received 3 total years of peanut patch treatment.
How was the study conducted?
  • Children applied the peanut patch on their back daily
  • The dose was unblinded: Everyone knew they were receiving the patch treatment, not a placebo.
  • Epi-pens were available in case a child had an allergic reaction
How much peanut was in each daily patch? 250 micrograms (μg) of peanut protein.
Did participants have to avoid eating peanut? Yes, the children had to stick to a peanut-free diet.

This is because the peanut patch is only meant to protect against accidental, infrequent peanut consumption.
How did investigators determine if the children’s reaction threshold increased?

After 3 years of treatment, the children underwent a double-blind, placebo-controlled food challenge.

  • Children consumed gradually increasing doses of peanut to determine which was the smallest amount needed to cause an allergic reaction.
What did the results show?

After 3 years of treatment:

  • 51.8% of the children could consume 1,000 mg of peanut or more without having an allergic reaction
    • 13.4% could consume up to 5444 mg of peanut (14-18 peanuts) without an allergic reaction
  • 75.9% increased their reaction threshold compared to when they started the trial
What happened when some children discontinued the patch treatment for two months, to see if they could maintain desensitization?
  • Children who could safely consume 1,000 mg of peanut were given the option to stop patch treatment for two months.
    • 18 of the children who met the criteria chose to do so.
  • After the two months, the children then underwent another peanut challenge.
  • 14 of those 18 children (77.8%) maintained desensitization even after stopping the patch for two months.
    • They showed “sustained unresponsiveness.”
Were there any side effects of the peanut patch?
  • The most common was mild to moderate skin reactions at the site where the patch was applied.
  • There were no serious side effects of the peanut patch.
    • None of the children needed an Epi-pen during the treatment.

Results of the PEOPLE Study: Breaking Down the Findings

The results of the PEOPLE trial show that the peanut patch may be an effective treatment for children ages 4-11 with peanut allergies.

  • After 3 years of treatment, more than half (51.8%) of the children could consume 1,000 mg of peanut or more without having an allergic reaction, meeting the primary goal of the study.
  • 13.4% of the children could consume up to 5444 mg of peanut (14-18 peanuts) without an allergic reaction, the maximum amount of peanut offered in the food challenge.
  • 75.9% increased their reaction threshold compared to when they started the trial.
    • This means that it took more peanut to cause them to have an allergic reaction after the 3 years of treatment, compared to before they started treatment.

The peanut patch also appeared to be a safe peanut allergy treatment option.

Most reactions to the patch were mild to moderate skin reactions, and none of the children needed an Epi-pen during treatment.

As lead investigator Dr. David Fleischer reported to Allergic Living, “These new data provide further evidence that [the peanut patch] may reduce the risk of reaction from accidental exposure by increasing threshold reactivity through a treatment option that could be safe and convenient.”

The peanut patch may also be effective in creating sustained unresponsiveness, or desensitization that lasts even when a treatment is discontinued for a period of time.

  • 18 children who could safely consume 1,000 mg of peanut after 3 years on the patch stopped patch treatment for two months.
  • 14 of these children (77.8%) maintained desensitization (showed “sustained unresponsiveness”) after another food challenge.

Of course, we still don’t know how long the peanut patch can create sustained unresponsiveness for, or if it can consistently build this up in larger groups of children. Usually, some level of continued exposure is needed for sustained unresponsiveness.

Is the peanut patch a cure for food allergies?

Even though it’s designed to treat peanut allergies in children who already have them. Rather, it’s only meant to protect children with peanut allergies in case they accidentally eat peanut. Children who use the peanut patch must continue to eat a peanut-free diet.

The peanut patch is not a cure for peanut allergies

The desensitization that the peanut patch creates only allows the child to be protected from accidental consumption of peanut temporarily, during the treatment. It is still unknown if the peanut patch, and other desensitization treatments, can successfully achieve tolerance: the ability to permanently tolerate (not react to) ingesting the food without continued exposure to the allergen.

New Treatments Still Underline Need for Early Allergen Introduction

While the advancements in this area of research are exciting, and the peanut patch seems like a relatively safe option to treat peanut allergies, there is still no true cure for food allergies.

Because of this, Early and sustained allergen introduction in a child’s first year of life is still recommended, based on new landmark research and medical guidelines.

Introduce Allergens Safely and Easily with Ready. Set. Food!

All health-related content on this website is for informational purposes only and does not create a doctor-patient relationship. Always seek the advice of your own pediatrician in connection with any questions regarding your baby’s health.

These statements have not been evaluated by the Food and Drug Administration. Products are not intended to diagnose, treat, cure or prevent any disease.  If your infant has severe eczema, check with your infant’s healthcare provider before feeding foods containing ground peanuts.