/ Each half of the peanut core contains about 150 mg of peanut protein.
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Peanut allergies are from food allergies. An accidental exposure to even a small amount of peanut protein can cause severe reactions. For children with these allergies, the killer can also be light as long as he comes in even smaller doses. The results of a clinical study published today in the New England Journal of Medicine show excellent results for a careful desensitization program. Treatment does not cure allergy and comes with significant risks, but it can help children to live their lives without fear of peanut flavor triggering in everything they eat.
The principle of desensitization or allergen immunotherapy (AIT) is to give the body exposure to the allergen in small and gradually increasing doses, teaching it to react less when it recognizes something it thinks as an invader. In 2015, the Allergy and Clinical Immunology newspaper published in detail the "international consensus" on the treatment, stating that while technique was indisputable for hay fever, there was not enough understanding of its use in the treatment of food allergy.
AIT peanut allergy studies have been, but have not provided, enough high-quality evidence to turn them into approved treatments. That is why the publication of this Phase 3 trial is great news: this is the final stage in which drug trials must pass before the company can apply for drug licensing by regulatory bodies such as the FDA. However, this does not mean that science is done and everyone can go home – there are many more questions to be answered and often more than one experience before approval.
This study covers 66 sites in 10 countries and they have registered 551 patients with peanut allergies. Most of these patients – 496 of them – are between 4 and 17 years of age. All of these participants participated in a food study that gave them oatmeal or flavored peanuts a day, and then another meal on the second day. The idea behind this was to make sure that the participant did not know whether or not she actually ate peanut – and the man who gave them the food did not know what they were eating. Only people who responded to the hidden peanut protein were included in the study.
The participants were then randomized – one quarter of the placebo group, adjusted to receive a powder identical to the treatment but without peanut protein, and three-quarters to be treated. This treatment starts with only 0.5 mg of peanut protein at the initial dose and gradually increases to 300 mg for 24 weeks – roughly the same as a peanut. Then the maintenance phase came: 300 mg every other day for another 24 weeks.
When the treatment was over, the results were bright. With another food challenge, researchers are testing how well the participants have tolerated. This starts with low doses of peanut protein and if the participant can take it, raise the dose to the next round. Only eight percent of children in the placebo group have gone through a 300 mg round, compared with 77% of patients in the treatment group.
In the next round of 600 mg, four percent of the children in the placebo group managed to do so, while 67% of the patients in the treatment group did. And 2.4% in the placebo group could tolerate 1,000 mg of peanut protein compared to half of the treated group. Among the 55 adults surveyed, differences in responses to the nutritional challenge were not statistically significant.
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Exposure of a large group of children to food for which they are extremely allergic is mild, not without the risks. The study had a high dropout rate of nearly 12% in the active group due to side effects and almost all treatment responders had a response during treatment, with two-thirds moderate or severe. This is probably not entirely due to therapy itself but is higher than in the placebo group, fewer than half of whom had a moderate or severe event during the trial.
During the last food challenge, five percent of the children in the treatment group had a severe reaction and 25 percent had a moderate response. This is much lower than the frequency in the placebo group – 11% and 59%, respectively, but shows that treatment and testing pose significant risks. "This is not something to start at home," wrote epidemiologist Michael Perkin in one.
A major weakness in the study is the discontinuation of the six-month maintenance period. Long-term maintenance therapy studies are in progress, but there is no evidence at this stage of how long it may be effective or even safe to maintain treatment. If the duration of maintenance is such, it will require a lengthy discipline from patients, probably for the rest of their lives, "Perkin says," The main concern with immunotherapy is that the allergenic tolerance that is triggered will be temporary and lost if it stops regular consumption. "
Despite these warnings, there is no doubt that this is exciting and welcome news for children with peanut allergies. "Most parents will see the regular consumption of several peanuts by their child as a very low price to pay to contain the potential danger of systemic anaphylaxis," says Perkin.
New England Journal of Medicine, 2018. DOI: ().