Treatment with the investigational oral biologic drug AR101 led to rapid desensitisation to peanut protein in children with peanut allergy, according to an article reporting ARTEMIS trial results published in Lancet Child & Adolescent Health.
The analysis included 175 patients, of whom 132 were randomly assigned to the AR101 group and 43 to the placebo group. The interventions were delivered in three phases, with increasing doses every 2 weeks over 6 months until a dose of 300 mg was reached and maintained for 3 months.
The primary clinical efficacy endpoint was the proportion of participants who tolerated 1000 mg peanut protein as a single dose with no dose-limiting symptoms after 9 months of treatment. Additional endpoints included safety (frequency and severity of adverse events) and changes in food allergy-related quality of life.
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 oral immunotherapy treatment showed efficacy in desensitisation to peanut protein, with a predictable safety profile, and an improvement in food allergy-related quality of life.