Research success: help for children with peanut allergy

26-May-2023 - Germany

Patches containing peanut protein can reduce the risk of severe allergic reactions in children under four years of age in the long term. This is shown by a study with the participation of the University Hospital Frankfurt. The results have now been published in the renowned New England Journal of Medicine.

More and more young children in Western countries suffer from a peanut allergy, including in Germany. At the same time, peanuts or traces of them are present in numerous foods. The strict control of the diet and the constant fear of a so-called anaphylactic shock in case of accidental eating of peanut allergen stresses children and parents. A cure is not possible. Therapies for desensitization are available, but only for older children and adolescents.
A large-scale international study with the participation of the University Hospital Frankfurt has now taken care of the youngest sufferers. It tested immunotherapy with peanut allergen-coated patches for children between one and three years of age with peanut allergy. With success: the reaction threshold was raised by a median of 900 mg of peanut protein (equivalent to three peanuts) after twelve months of therapy, while in the placebo group, which had only received "sham therapy", no median increase in the reaction threshold was observed.

Hope for children and families

"The study offers hope for young children with peanut allergy and for their families. Patch treatment has been shown to be effective and safe. A further study is now being conducted to investigate the efficacy and safety profile of the patch in four- to seven-year-old peanut allergy sufferers," explains PD Dr. Katharina Blümchen from the Department of Pediatrics and Adolescent Medicine at Frankfurt University Hospital, who was involved in the study. The editor of the New England Journal of Medicine likewise called the results "good news for young children with peanut allergy."

Prof. Dr. Jan-Henning Klusmann, Director of the Department of Pediatrics and Adolescent Medicine at Frankfurt University Hospital, added: "The results represent real progress in the treatment of young children with peanut allergy. They are also a sign of the first-class patient care in our Department of Pneumology, Allergology, Infectiology and Gastroenterology. The opportunity to participate in internationally pioneering studies means that children cared for here can receive advanced therapies in some cases years before the drug is actually officially approved."

High everyday suitability, low risk

Studies have shown that early intake of peanut in complementary feeding reduces the risk of developing peanut allergy later in life. Thus, the immune system appears to be highly malleable at an early age. Immunotherapies, in which those affected take small doses of the allergen daily, for example, in order to bring about desensitization and raise the reaction threshold, have so far only been approved for children and adolescents with peanut allergy over the age of four. With this therapy, families must adhere to sometimes elaborate intake schedules, and side effects can occur.

The current study therefore uses patches containing the allergen, which are applied once a day between the shoulder blades. These do not have to be removed even for bathing or swimming, making them easier to use in everyday life. The dose that the patch contains (250µg peanut protein) is further below, for example, the maintenance dose of oral immunotherapy (300 mg peanut protein), i.e. the amount that must be taken at least regularly for the therapy to have a sustained effect.

Study at 51 sites

The study was conducted at 51 sites in eight countries from 2017 to 2022, with 307 infants fully completing the study. Frankfurt was one of three sites in Germany. All subjects received a patch once a day for a year. In a good third, the patch was a placebo. All children were allergic at baseline to a dose of 300 mg of peanut protein or less - the equivalent of a single peanut.

The goal of the study was to raise this trigger dose to 1,000 mg if the children were allergic to more than 10 mg at baseline or to raise the trigger dose to 300 mg if the children initially reacted to 10 mg or less. This goal was achieved by 67 percent of children in the intervention group that received patches containing the allergen and 33.5 percent in the placebo group.

That improvement was also seen in the children with placebos is not unexpected. Studies show that about 29 percent of affected children outgrow their allergy by age six. However, the other results of the current study support the effectiveness of desensitization.

Significant improvement, few side effects

In the group where the patches actually contained the peanut protein, the median change in trigger dose was 900 mg, compared with 0 mg in the placebo group. In addition, in the intervention group, just over 37 percent of the children were able to consume a total of 3,444 mg of peanut protein in the oral provocation at the end of the study until an allergic reaction occurred. In the placebo group, the figure was only 10 percent.

So-called adverse events occurred in almost all children during the study period - i.e. also in the placebo group. The most common adverse events were skin reactions around the patch, although these decreased over time. A total of 23 systemic allergic reactions occurred - 19 in the group receiving the patch with peanut allergen and four in the placebo group. According to the assessment of the respective study physician, four of these were due to treatment with the peanut patch. This represents 1.6 percent of all reported adverse reactions in the intervention group. All of these reactions were mild or moderate. The study was therefore also able to demonstrate the safety of the patch therapy.

Note: This article has been translated using a computer system without human intervention. LUMITOS offers these automatic translations to present a wider range of current news. Since this article has been translated with automatic translation, it is possible that it contains errors in vocabulary, syntax or grammar. The original article in German can be found here.