/ Each half-peanut core contains about 150 mg of peanut protein.
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Peanut allergies are food allergies. Concentrated exposure to even a small number of peanut proteins can cause serious reactions. For children with these allergies, the killer can also be a cure – as long as it comes in smaller doses. The results of a clinical study published in the New England Journal of Medicine show excellent results for a careful desensitisation program. Treatment does not cure allergy and it has significant risks, but it can help the kids live their lives without fear of a peanut-fried trigger in everything they eat.
The principle of desensitisation or allergen immunotherapy (AIT) is to provide body exposure to allergen at small and gradually increasing doses, teaching it to react less when identifying something that it considers as an aggressor. In 2015, the Journal of Allergy and Clinical Immunology published in detail the "international consensus" treatment, which found that although the technique was unhealthy for hay fever, its uses were not adequate to treat food allergy.
The investigation of peanut allergies has been carried out by AIT, but it has not provided sufficiently high-quality evidence that it has been approved for treatment. So publishing the release of this phase 3 is a big news: the last stage of drug testing is complete before a company can apply for a pharmaceutical product for regulatory bodies such as the FDA. However, this does not mean that this science is done and everyone can go home – there are many unanswered questions and often several tests are needed before approval.
More than 66 sites in ten countries participated in this study and wrote 551 people in peanut allergy. Most of these patients – 496 of them – were 4 to 17 years old, which is part. All of these participants had participated in the food screening challenge that saw them either a oat protein or taste-disguised peanut protein for one day and then another day for another food. The idea was to make sure that the participant did not know if they had actually eaten peanuts – and the person who gave them food did not know what they were eating. The study involved only people who had reacted to hidden peanut protein.
Participants were then randomized – one-quarter of the placebo group set to receive a powder that was identical to the treatment but without the peanut protein and three quarters set to receive treatment. This treatment was initiated only as a 0.5 mg peanut protein in the initial stage and in 24 weeks gradually increased to 300 mg, approximately the same as one peanut. Then came the maintenance phase: 300 mg daily for a further 24 weeks.
When the treatment was over, the results were rough. In a second food challenge, researchers tested how high the participants' tolerance was obtained. This started with small peanut protein doses, and if a participant could take it, it increased the dose to the next round. Only 8% of children in the placebo group did it with a 300 mg dose compared to 77% of the treatment group.
In the next 600 mg rounds in the placebo group, four percent of the children did it, while 67 percent of the patients in the treatment group did. And 2.4% of the placebo group was able to tolerate 1000 mg of peanut protein compared to one half of the treatment group. Of the 55 adults tested, no response to the food challenge was statistically significant.
With permanent Epiphen
Exposing large children's groups to foods that are extremely allergic to it is to put it lightly, not without risk. The test tube had a high bounce rate of almost 12 percent in the active group due to side effects, and almost all patients received a reaction during the treatment period, two thirds of whom were moderate or severe. This is unlikely to be due to self-treatment itself, but is higher than the placebo group, less than half of whom experienced a moderate or serious incident.
During the final food challenge, five percent of the children in the treatment group had a severe reaction and 25% had a moderate reaction. This was much lower than in the placebo group by 11% and 59% respectively – but indicates that treatment and testing were significant risks. "This is not something to start at home," writes epidemiologist Michael Perkin.
The great weakness of the study is six months six of the maintenance period. Long-term treatment is ongoing but at this stage there is no evidence of how long the treatment is likely to be effective or even safe. If long-term care works, it would require constant discipline from the patients, probably throughout their lifetime, Perkin writes: "The biggest concern for immunotherapy is that the allergen tolerance that is induced is temporary and is lost if regular consumption ceases."
Despite these warnings, there is no doubt that this is an exciting and welcome news for kids with peanut allergies. "Most parents would see that their children rarely use peanuts as a very small liver to keep a potential systemic anaphylaxis", Perkin says.
New England Journal of Medicine, 2018. DOI: ().