/ Each half peanuts contains about 150 mg & # 39; peanut protein.
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Peanut allergies are & # 39; allergies to food. Accidental exposure to tiny quantity & # 39; peanut protein can & # 39; provoke severe reactions. For children with & # 39; these allergies, the killer can & # 39; also be the cure – until enter a & # 39; even lower doses. The results of & # 39; clinical trial, published today in the New England Journal of Medicine, show excellent results for program & # 39; careful desensitization. The treatment does not cure the allergy, and to b & # 39; substantial risks, but can & # 39; helping kids to live their lives without fear & # 39; a & # 39; trigger with peanut flavor f & # 39; all eat everything.
The principle behind the desensitization, or immunotherapy of & # 39; allergens (AIT), is that the body is exposed to an allergen in & # 39; tiny doses and increasing b & # 39; gradual way and teaches to react at least recognize when something is considered as a person disappear. In 2015, the Journal of Allergy and Clinical Immunology published details about "international consensus" on the treatment, stating that while the technique is controversial for minduh, there was not enough knowledge on its use in the treatment of food allergy.
Research on the AIT to peanut allergy was, but did not provide sufficient evidence & # 39; quality to become an approved treatment. That is why the publication of & # 39; this trial & # 39; Phase 3 is news: what is the last stage of drug trials need to pass before the company can & # 39; applying for medicine to be licensed by regulatory bodies such as FDA. However, this does not mean that science is becoming about it and everyone can & # 39; go home – there are many more questions to be answered, and often more than one test is needed before approval.
The peanut challenge
This trial involved approximately 66 site in & # 39; 10 countries, and enrolled 551 patients with & # 39; peanut allergies. The most & # 39; patients – 496 of them – were between 4 and 17 years, are part of. All these participants took part in a challenge of food Screening watched given oat protein or protein peanut hidden tasty f & # 39; one day, and then the other food on the second day . The idea behind this was to be sure that the participants did not know whether they actually eat peanuts or not and the person giving food does not know X & # 39; they were eating, either. Only people who reacted to the hidden peanut proteins were included in the trial.
Then, participants were randomized quarter in the placebo group, set up to receive the same treatment but without powder peanut protein, and three-quarters down to receive treatment. What began as a treatment only 0.5 mg & # 39; peanut protein in the starting dose, and during the course of & # 39; 24 weeks, gradually increased to 300 mg, roughly the same as one peanut. Then came the phase & # 39; maintenance: 300 mg daily for 24 weeks.
When the treatment ended, the results were clear. F & # 39; & # 39 case; other food challenge, the researchers tested both had high tolerance participants. It started with & # 39; low doses & # 39; peanut protein and, if the player could & # 39; take it, increased the dose on the next round. Only eight percent of children in the placebo group made it through & # 39; round & # 39; 300 mg, compared to & # 39; 77 percent & # 39; those in the group & # 39; treatment.
In the next round & # 39; 600 mg, four & # 39; percent of children in the placebo group made, while 67 percent & # 39; those in group & # 39; treatment done. And 2.4 percent in the placebo group could tolerate 1,000 mg & # 39; peanut protein, compared to & # 39; half the group & # 39; treatment. Among the 55 adults tested, the differences in the responses to the food challenge were not statistically significant.
Standing by with & # 39; the EpiPen
Exposure & # 39; & # 39 large group; children to foods that are extremely allergic to it, to put mildly, is not without its risks. The trial had a high rate of & # 39; off & # 39; nearly 12 percent in the active group because of side effects, and almost all participants had achieved treatment response during the period & # 39; treatment, two thirds moderate or severe. This probably is not entirely attributable to the treatment itself, but it is higher than the rate in the placebo group, fewer than half had moderate or severe event during the trial.
During the final food challenge, five percent of the kids in the group & # 39; care had a severe reaction, and 25 percent had moderate response. This was much lower than the rate in the placebo group -11 percent and 59 percent, but rispettivament- shows that treatment and testing were important risks. "This is not something that begins at home," writes Michael Perkin epidemjologu f & # 39; s strength.
great weakness of the trial is the cessation of period & # 39; maintenance for six months. Ongoing trials & # 39; of & # 39 therapy; long-term maintenance, but in & # 39; this stage, m & # 39; there is no evidence to show the duration of the maintenance treatment x & # 39; is likely to be effective, or even safe. If maintenance on & # 39; long-term work, requiring continued discipline from patients, probably for the rest of & # 39; lives, Perkin writes: "The main concern is that immunotherapy tolerance & # 39; allergens to induce temporary and will be lost if regular consumption stops."
Despite these cautions, m & # 39; there is no doubt that this is an exciting and welcome news for children with & # 39; peanut allergies. "The majority of parents watching regular consumption & # 39; a few peanuts from children as a very small price to pay to keep the potential threat of & # 39; systemic anaphylaxis in the bay", says Perkin.
New England Journal of Medicine, 2018. DOI: ().