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Young peanut allergic patients who have received the AR101 immunotherapy treatment have become peanut tolerant over time, protecting themselves from accidental ingestion, according to the findings of the Phase 3 trial. presented at the annual scientific meeting of the American College of Allergy, Asthma and Immunology.
The results were published simultaneously in The New England Medical Journal.
"Previous studies have suggested that oral immunotherapy is a potential strategy for the treatment of allergy by inducing desensitization, which is generally understood as a transient upward change in the threshold of reactivity to an allergen to following a controlled ongoing exposure to this same allergen ", Brian P. Vickery, MD, Associate professor of pediatrics at Emory University School of Medicine and member of the PALISADE group of clinical researchers.
"As the evidence from many preliminary clinical trials is limited by the small sample sizes and methods used, most current recommendations recommend that oral immunotherapy not be used in routine clinical settings," he said. they added.
The researchers randomized 551 patients aged 4 to 55 years (496 aged 4 to 17 years) with a peanut allergy in a 3: 1 ratio in order to receive a growing dose of AR101 (Aimmune Therapeutics) or D & # 39; 39, a placebo. Those who completed the regimen (300 mg daily for approximately 24 weeks) participated in a double-blind, placebo-controlled food trial at the end of the trial.
Vickery and colleagues found that during the challenge, 250 of 372 patients aged 4 to 17 years who received AR101 were able to ingest at least 600 mg of peanut protein without dose-limiting symptoms, compared to only five of 124 patients aged 4 to 17 years. who received a placebo. The maximum severity of symptoms was moderate in 25% of patients receiving RA101 (versus 59% of those receiving placebo) and severe in 5% of those receiving AR101 (versus 11% of those receiving placebo). The adverse events that occurred during the intervention – most of them moderate in those who received AR101 – occurred in more than 95% of participants aged 4 to 17 years. Efficacy has not been observed in patients over 18 years of age.
"We are excited about the opportunity to help peanut-allergic children and adolescents protect themselves from accidentally eating peanut-containing foods," Stephen Tilles, MD, The former president of ACAAI, the adviser to Aimmune Therapeutics and the co-author of the study said in a statement.
"When we started the study, we hoped that by treating patients with the equivalent of one peanut a day, many would tolerate up to two peanuts. We were pleased to note that two-thirds of the people participating in the study were able to tolerate the equivalent of two peanuts a day after 9 to 12 months of treatment, and that half of the patients tolerated Equivalent of four peanuts, "he added.
Jay Lieberman, MD, Vice Chair of the ACAAI's Food Allergy Committee and another co-author of the study, urged caution.
"It's not a miracle solution, and that does not mean people with peanut allergies can eat peanuts anytime. But it's definitely a breakthrough. The hope would be to have a treatment available in the second half of 2019. If this happens, people who receive and are able to tolerate this treatment should be protected from accidental exposures. "
In a related editorial, Michael R. Perkin, PhD, from the Population Health Research Institute at the University of London, described in more detail the adverse events associated with the much anticipated AR101.
"Desensitization has not been easy for patients. Adverse events were observed in 11.6% of participants in the active drug group and 2.4% in the control group during the intervention period leading to the withdrawal of the trial. It's not something to start at home, "he wrote.
"Epinephrine was used by 14% of participants in the active drug group as a result of treatment reactions. The long-term side effects of prolonged consumption of an allergen against which the body has produced IgE antibodies remain unknown. Current thinking focuses on eosinophilic diseases, such as eosinophilic esophagitis, but surveillance and monitoring will be crucial. " – by Janel Miller
Disclosures: Please refer to the study and the editorial for the relevant financial information of the authors.
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