Peanut allergy oral immunotherapy phase 3 trial shows promising results: rapid desensitisation to peanut protein, with a predictable safety profile that improved with treatment, and an associated improvement in self-reported and caregiver-reported food allergy-related quality of life.

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So this treatment may help people tolerate up to 1 peanut kernel? It doesn’t sound like much, but how many reactions could this eliminate from unintentionally contaminated foods? Considering all the warning labels “Processed in a facility that uses peanuts” and the like, I’m guessing quite a few?

Almighty_One

Summary Background Peanut allergy is the leading cause of food-related anaphylaxis. Current management options can negatively affect food allergy-related quality of life. We aimed to investigate the efficacy of an investigational oral biologic drug (AR101). Methods The AR101 Trial in Europe Measuring Oral Immunotherapy Success in peanut-allergic children (ARTEMIS) trial was a multicentre, double-blind, randomised, placebo-controlled phase 3 trial done at 18 hospitals in Ireland, France, Germany, Italy, Spain, Sweden, and the UK. Children and adolescents with peanut allergy, aged 4–17 years, who developed dose-limiting symptoms to 300 mg or less peanut protein (equivalent to approximately one peanut kernel) during a double-blind placebo-controlled food challenge test at study entry were enrolled. Participants were randomly assigned (3:1) to receive daily doses of either AR101 oral immunotherapy (AR101 group) or a taste-masked placebo (placebo group). All participants, investigators, and care providers were masked to treatment allocation until the study was completed. Doses were increased every 2 weeks over 6 months until a dose of 300 mg was reached and maintained for 3 months. The primary endpoint was the proportion of participants in the intention-to-treat or safety population (defined as those participants who had been randomly assigned and had received at least one dose of the assigned drug) who could consume a single dose of 1000 mg (cumulative dose 2043 mg) peanut protein without developing dose-limiting allergic symptoms at an exit double-blind placebo-controlled food challenge after 9 months of treatment. Additional endpoints included safety (ie, the frequency and severity of adverse events) and changes in food allergy-related quality of life, assessed by use of age-appropriate Food Allergy Quality of Life Questionnaires (FAQLQs) and the Food Allergy Independent Measure (FAIM). The study is registered with ClinicalTrials.gov, NCT03201003, and is completed. Findings Between June 12, 2017, and Feb 15, 2018, 227 patients were screened, of whom 175 were randomly assigned to the AR101 group (n=132) and the placebo group (n=43). All primary and secondary endpoints were met. 77 (58%) of 132 participants in the AR101 group tolerated 1000 mg peanut protein at the exit food challenge versus one (2%) of 43 participants in the placebo group (AR101–placebo treatment difference 56·0% [95% CI 44·1–65·2], p<0·0001). Adverse events were reported by almost all participants. The maximum severity of adverse events reported was mild or moderate for most participants who received AR101 (mild, 66 [50%] of 132 participants; moderate, 63 [48%]; and severe, one [1%]) or placebo (mild, 24 [56%] of 43 participants; moderate, 18 [42%]; severe, none). Participants aged 8–12 years in the AR101 group reported improvements that exceeded the minimum clinically important difference between the two groups across all FAQLQ domains. Additionally, participants in the AR101 group and their caregivers reported improvements that exceeded the minimum clinically important difference in FAIM domains related to the perceived likelihood and outcomes of a severe allergic reaction. Interpretation AR101 oral immunotherapy treatment led to rapid desensitisation to peanut protein, with a predictable safety profile that improved with treatment, and an associated improvement in self-reported and caregiver-reported food allergy-related quality of life. These patient-oriented outcomes provide invaluable data to help physicians, patients, and caregivers make informed, shared decisions on the management of peanut allergy. Funding Aimmune Therapeutics.

PHealthy

I know that nut allergies are a big deal, but growing up (I’m 29 and from a small rural town), I didn’t know of anyone with them. It seems like recently (the last 10 years?) They have become a much bigger deal. Are peanut allergies on the rise? Are peanuts being used more places? Did GenX just rub peanut butter on their babies and only keep the survivors? Is it just me using the internet more and therefore being more exposed to it?

xakeri

It’s also important to note this isn’t for everyone with a peanut allergy. Depending on the severity/IGE numbers you probably would never be able to do a OIT treatment. Which my son happens to be in the most severe category, I am happy however if this does alleviate some stress for families who can partake and it successfully impacts their life in a good way.

DragoonDerk

A friend’s kid is allergic to eggs so they did a 12 month slowly increasing addition of egg to a powder he mixed up and drank each day. It worked and he could tolerate eggs. After all of the trouble he went through, he decides that he hates eggs.

love2go