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"The most recent results are exciting," said Dr. Jackie Garrett, who is certified in Allergy and Immunology about the potential of an experimental drug known as AR101 to make a very immune system sensitive more tolerant to peanut.
She was referring to the last phase, "Study of oral immunotherapy to peanut allergy AR101 for the desensitization of children and adults", from an international study whose results had just come out. to be published in the New England Journal of Medicine.
The most important randomized clinical trial on peanut allergy was to introduce increasing doses in children who were particularly sensitive to the oral experimental oral biologic drug, in the hope of 39, increase the tolerance of their immune system and reduce the risk of potentially life-threatening reaction called anaphylaxis when exposed to even a trace. quantities of peanuts.
Some 67.2% of participants aged 4 to 17 in the Phase III AR101 trial, whose active ingredient is defatted peanut meal, were able to ingest at least one dose 600 milligrams of peanut protein with no more than mild symptoms compared to 4% of the placebo group.
It is said that a peanut kernel contains about 250 to 300 milligrams of peanut protein.
"Peanut allergies affect about 2% of American children, which would mark a significant shift in the management of food allergy in these children," Garrett, based in Feeding Hills, Agawam, told Trinity Health of New England. Medical Group. treats patients with allergies, asthma and immunodeficiency.
"In particular, in children where less than a peanut causes symptoms of anaphylaxis, it would have a significant impact on the quality of life of these children and their families."
She added, "Current data suggests that only 20% of children have exceeded their peanut allergy."
Some 60 medical centers in Canada, Europe and the United States, including Massachusetts General Hospital, with more than 550 enrolled, participated in the Phase III trial.
The participants in the study were first tested for food and then asked to take the drug or a corresponding placebo in powdered form mixed with unheated food in graduated doses until to achieve a daily maintenance dose of 300 milligrams.
Some members of the active drug group had to use epinephrine during the test to counteract the adverse effects, which indicates that following such a diet to increase tolerance to a dose of maintenance n & # 39; Is not without risk.
Drug maker Aimmune Therapeutics, which is hoping to get FDA approval for its drug between ages 4 and 17, said patients in the first-in-class group in this age group would not tolerate more than 30 mg of protein peanut at the entrance, double-blind, placebo controlled food challenge; In addition, 72.2% had a medical history of anaphylaxis, 53.0% had a current or previous diagnosis of asthma and 65.5% had reported multiple food allergies.
"Previous therapeutic approaches included waiting for allergy resorption, repeated blood tests for skin and IgE every two years, oral challenges in an allergist office and training." caregivers on how to treat allergic reactions if they occurred, "said Garrett book on children with food allergies.
"Oral immunotherapy is a more aggressive treatment option.We do not expect the child to become less allergic.We use the immune system to help tolerate a greater amount of Peanut allergen before it reacts. "
She pointed out that the experimental drug is neither a cure nor a way for those allergic to eat peanuts, but that it is rather designed to lessen the allergic reaction that can occur in very sensitive people if they are accidentally exposed to small amounts.
"This product is definitely not a cure because they are still allergic.It just takes a larger amount of peanuts to make them have an allergic reaction while they take this product," he said. said Garrett.
"I think of the product plus a seatbelt that serves to reduce the risk of injury in a car accident.This product can protect from accidental exposure to peanuts when a larger amount food is needed to develop an allergy, it will be up to each family to decide if it's appropriate, but I'm excited about the opportunity to have this discussion with the families of my patients, it's an exciting time to food allergy.
She called oral immunotherapy "an important treatment option for all children with food allergies where a bite can cause anaphylaxis".
"We are fortunate that the PALISADE study is promising enough that this peanut powder oral immunotherapy may ultimately be considered by the FDA as a treatment for peanut allergies," said Garrett.
"This form of oral immunotherapy is ideal for patients for whom a very small amount of allergen can cause a serious allergic reaction. I have a handful of patients who would actually benefit from this therapy."
She added, "Their families have trouble attending receptions, restaurants and even schooling."
"They are afraid of having another reaction like that which has updated their child's allergy," Garrett said.
"This product, if approved, would do much to quell their fears – imagine that your child can eat two peanuts without having a serious allergic reaction."
While asserting that allergists "do not know the long-term consequences of oral immunotherapy in general" – the product currently requires a maintenance dose to maintain tolerance – and that the product presents "risks" potential "to be a" daily product at the service of the patient ". If approved, Peanut Powder Oral Immunotherapy would be a welcome addition to the Allergen Toolkit in the management of children with severe allergic reactions to peanut. "
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