[ad_1]
Each half-core of peanut contains about 150 mg of peanut protein.
Share this story
Peanut allergies are food allergies. Accidental exposure to a minute amount of peanut protein can cause severe reactions. For children suffering from these allergies, the murderer could also be the remedy, provided the doses are even smaller. The results of a clinical trial, published today in the New England Journal of Medicine, show excellent results for a thorough desensitization program. The treatment does not cure allergy and carries substantial risks, but it could help children live their lives without fear of a peanut-trigger in everything they eat.
The principle of desensitization, or allergen immunotherapy (AIT), involves exposing the body to the allergen in tiny and increasing doses, teaching it to react less when it recognizes something that it considers like an invader. In 2015, the Journal of Allergy and Clinical Immunology published a document detailing the "international consensus" on treatment, claiming that while this technique is not controversial for hay fever, it was not sufficiently understood as for its use in the treatment of food allergy.
The AIT research for peanut allergies has been, but has not provided enough high quality evidence to become an approved treatment. That's why the release of this phase 3 trial is great news: it's the last step in getting drug trials to go through before the company can ask for the drug to be licensed by regulators like the FDA. However, that does not mean that science about it is over and everyone can go home. There are still many issues to be resolved and it often takes more than one try before being approved.
The challenge of peanut
This trial was conducted at 66 sites in 10 countries and included 551 peanut allergic patients. Most of these patients – 496 of them – were between 4 and 17 years old, which is part of the. All of these participants had taken part in a food selection trial that was administered to them one day, either oat protein or peanut protein disguised as flavoring, and then the other on the second day. The underlying idea was to make sure that the participant did not know if he was actually eating peanuts – and the person who gave them the food did not know what he was eating either. Only people who reacted to the hidden peanut protein were included in the test.
The participants were then randomized: a quarter of the placebo group, configured to receive a powder identical to the treatment, but without peanut protein, and three quarters defined to receive the treatment. This treatment started with 0.5 mg of peanut protein in the initial dose and, in the last 24 weeks, gradually increased to 300 mg, about the same as a peanut. Then comes the maintenance phase: 300 mg daily for an additional 24 weeks.
At the end of treatment, the results were striking. In another food challenge, the researchers tested how tolerant the participants were. This started with low doses of peanut protein and, if the participant could take it, increased the dose in the next round. Only eight percent of children in the placebo group managed to pass the 300 mg cycle, compared to 77% of those in the treatment group.
In the next 600 mg cycle, 4% of children in the placebo group were successful, while 67% of those in the treatment group were successful. And 2.4% of the placebo group could tolerate 1,000 mg of peanut protein, compared to half of the treated group. Of the 55 adults tested, differences in food challenge responses were not statistically significant.
Standing with the epipen
Exposing a large group of children to the food they are extremely allergic to is, to put it lightly, not without risk. The trial resulted in a high dropout rate of nearly 12% in the active group due to side effects and almost all participants undergoing treatment had a reaction during the treatment period , two-thirds of them being moderate or severe. This is probably not entirely attributable to the treatment itself, but is higher than the rate observed in the placebo group, less than half of whom experienced a moderate or severe event during the trial.
During the last food challenge, 5% of the children in the treatment group had a severe reaction and 25% had a mild reaction. This rate was well below the rate observed in the placebo group – 11% and 59% respectively – but shows that the treatment and the tests involved significant risks. "It's not something to start at home," writes epidemiologist Michael Perkin in one.
One of the major weaknesses of the test is the cutting of the maintenance period to six months. Long-term maintenance treatment trials are underway, but at this stage there is no evidence of how long the maintenance of the treatment will be effective or safe. If long-term maintenance works, it will require constant discipline on the part of patients, probably for the rest of their lives, writes: "The main concern regarding immunotherapy is that allergen tolerance-induced temporary and lost if regular consumption ceases. "
Despite these warnings, there is no doubt that this is great news for children with peanut allergies. "Most parents consider that the regular consumption of some peanuts by their child is a very small price to pay to avoid the potential threat of systemic anaphylaxis," says Perkin.
New England Journal of Medicine, 2018. DOI: ().
Source link
