The findings provide data to help physicians, patients, and caregivers make informed, shared decisions on the management of peanut allergy.
Jonathan O'B Hourihane, MD
Oral immunotherapy treatment with AR101 leads to rapid desensitization to peanut protein, according to recent study findings.
The findings provided data to help physicians, patients, and caregivers make informed, shared decisions on the management of peanut allergy.
Jonathan O’B Hourihane, MD, and colleagues aimed to investigate the efficacy of AR101 as current management options for peanut allergy can negatively affect food allergy-related quality of life. The team found the investigational oral biologic drug had a predictable safety profile that improved with treatment and an associated improvement in self-reported and caregiver-reported food allergy-related quality of life.
The investigators conducted the multicenter, double-blind, randomized, placebo-controlled phase 3 trial at 18 hospitals across Europe. Included in the study were children and adolescents aged 4-17 years old who had peanut allergy and developed dose-limiting symptoms to 300 mg or less peanut protein during a double-blind placebo-controlled food challenge test.
Hourihane and the team randomized participants 3:1 to receive daily doses of AR101 or a taste-masked placebo. The doses increased every 2 weeks over 6 months until a dose of 300 mg was reached and maintained for 3 months.
The study’s primary endpoint was the proportion of patients in the intention to treat or safety population (those who received at least 1 dose of the assigned drug) who could consume a single dose of 1000 mg peanut protein without developing dose-limiting allergic symptoms at a double-blind placebo-controlled food challenge after treatment for 9 months. Other endpoints were safety and changes in food allergy-related quality of life, measured by Food Allergy Quality of Life Questionnaires (FAQLQ) and the Food Allergy Independent Measure (FAIM).
The team screened 227 patients and 175 were randomly assigned to the AR101 group (n=132) and the placebo group (n=43). The investigators reported all primary and secondary endpoints were met. More than half (58%) of the 132 patients in the AR101 group tolerated 1000 mg of peanut protein at the exit food challenge compared to 1 (2%) of 43 patients in the placebo group (AR101 placebo treatment difference, 56; 95% CI, 441.-65.2; P <.0001).
Almost all participants reported adverse events. Among those who received AR101, the highest level of severity of such adverse events were mild or moderate (mild, 50% of 132 participants; moderate, 48%; severe, 1%). For those who received placebo, the severity was similar (mild, 56% of 43 participants; moderate, 42%; severe, none).
In the AR101 group, a subset of participants aged 8-12 years old reported improvements that exceeded the minimally clinically important difference between the 2 groups across all FAQLQ domains, Those in the AR101 group, along with their caregivers, reported clinically important differences in FAIM domains related to the perceived likelihood and outcomes of a severe allergic reaction.
Approved by the US Food and Drug Administration as the first immunotherapy indicated for a food allergy, AR101 has shown positive results in several trials as they relate to the safety and efficacy of the drug.
The latest findings may lead to better management of peanut allergy, Hourihane and the team concluded.
The study, “Efficacy and safety of oral immunotherapy with AR101 in European children with a peanut allergy (ARTEMIS): a multicentre, double-blind, randomised, placebo-controlled phase 3 trial,” was published online in The Lancet Child & Adolescent Health.