Patch to treat peanut allergies seems safe to wear for years
A three-year trial testing a patch for the treatment of severe peanut allergies in children has find treatment should be generally safe and well tolerated, with the rates of side effects decreasing over time.
Designed to test the peanut allergy patch under real-world conditions similar to how researchers think it will be used, the study was presented at the American College of Allergy, Asthma and Immunology Annual Meeting. in New Orleans.
Peanut allergy problems: About 2% of the western world suffers from peanut allergies, newspaper review says Allergy.
Peanut allergy is a particularly nasty, the researchers note; compared to other food allergies, people with allergies to peanuts are more likely to suffer from serious and life-threatening reactions episodes of anaphylaxis, where their immune system releases a flood of chemicals within seconds of exposure that can collapse the body and be fatal if left untreated. (If you’ve seen someone stick an epipen in a person’s leg, you know how fast, brutal, and terrifying anaphylaxis can be.)
Unfortunately, these delicious legumes are allor.
âAbout 7% to 14% of patients with [peanut allergy] experience accidental exposure to peanuts each year, and one-third to one-half may experience anaphylaxis, although deaths are rare, âthe researchers wrote.
In children in particular, a peanut allergy can also lead to bullying and exclusion, adding a social cost to the medical.
Treating peanut allergies: The high burden of peanut allergies – and the potential for them to increase – makes it urgent to find ways to treat the disease.
The peanut allergy patch, developed by French biopharmaceutical company DBV Technologies, is based on a relatively new technique that involves safely exposing people to their allergens through the skin, called epicutaneous immunotherapy (EPIT).
DBV’s platform is called Viaskin. The patch, which is currently under investigation and has not been cleared for use, contains dried allergens – in this case, a tiny amount of peanut protein, which MedPage today described as being the equivalent of about a thousandth of a peanut.
The rate of moderate and severe side effects was decreasing each year.
When applied to the skin, condensation forms between the allergen and the skin. This condensation makes the allergen soluble and it is absorbed by the intact top layer of the skin, the epidermis. Once in the dermis, it triggers a milder immune response that can hopefully train your body to avoid an allergy attack.
Safety test: Double REALIZE, the DBV trial was designed to test the safety profile of the peanut allergy patch when worn in the same way a patient would wear it if approved.
REALIZE enrolled 393 children with peanut allergies, including 14 with a history of severe anaphylaxis. These subjects were randomly assigned to two groups for the first six months, one receiving the peanut allergy patch and the other receiving the placebo.
After these six months, all subjects received the Viaskin patch for peanut allergies, in a study known as the âopenâ study. Then the safety and tolerability information was collected for three years.
Almost all of the subjects had at least one side effect, the effects being most common during the first year and worsening over time. While 91% of participants had treatment-related adverse reactions in the first year, MedPage reported, the proportion of moderate and severe effects dropped sharply in the second year, to 34.5% and 4 , 9%, respectively, and 23.9% and 0.9% in the third year. .
The side effects considered to be mild, however, remained quite frequent, affecting a shadow of more than 70% until the third year.
The patch: According to MedPage, most of the side effects were at the site of the patch, said Terri Brown-Whitehorn of Children’s Hospital of Philadelphia, a consultant to DBV, during the presentation.
The patch is worn on the patient’s back and then moved periodically. Redness of the skin and itching at the application site accounted for the lion’s share of the side effects and were considered mild to moderate.
The were more serious reactions, however, since 16 patients had 17 anaphylactic events considered to be caused by the peanut allergy patch over the three years. None of these reactions were considered serious and, interestingly, the researchers did not find a difference in the reports of side effects in subjects with a history of severe anaphylaxis and those without.
âOver 36 months, Viaskin Peanut was generally well tolerated, with a decrease in the frequency and intensity of local and systemic treatment-related adverse reactions over time,â the researchers wrote.
âNo safety concerns have arisen in subjects with a history of severe peanut anaphylaxis. “
A rocky path: Originally gaining Fast Track and Breakthrough Status from the FDA, the DBV patch underwent a setback last summer, when the FDA rejected his request.
The peanut allergy patch is still undergoing several Phase 3 trials to test its effectiveness.
While the agency did not raise any safety concerns with the therapy, per se, they had issues with the design and manufacture of the patch and its adhesive. Since, layoffs have been announced, as the company scaled back its efforts to focus on revising the peanut allergy patch.
Although the results of the safety trial are encouraging, the patch is still in several phase 3 trials to test its effectiveness in reducing allergic reactions. The company has submitted to the EU a new submission of the
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