The trial was conducted in several countries across Europe with a focus on children with peanut allergies aged 4 to 17 years.
For the trial, 227 children were randomly split into a daily dose of AR101 or a placebo group, and the dose was increased every two weeks over a six-month period. At the end of the six months, participants were receiving a dose of 300 mg peanut protein.
At the end of the trial, the researchers found that 58% of the individuals in the control group tolerated 1000mg of peanut protein versus 2% of the individuals in the placebo group. Although adverse events were reported by almost all of the individuals, the severity level for most participants in both groups was mild or moderate. In conclusion, AR101 oral immunotherapy treatment led to a desensitization to peanut protein and provided a predictable safety profile.
Hourihane, J. O. B., Beyer, K., Abbas, A., Fernández-Rivas, M., Turner, P. J., Blumchen, K., … & Sharma, V. (2020). 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. The Lancet Child & Adolescent Health.
For the trial, 227 children were randomly split into a daily dose of AR101 or a placebo group, and the dose was increased every two weeks over a six-month period. At the end of the six months, participants were receiving a dose of 300 mg peanut protein.
At the end of the trial, the researchers found that 58% of the individuals in the control group tolerated 1000mg of peanut protein versus 2% of the individuals in the placebo group. Although adverse events were reported by almost all of the individuals, the severity level for most participants in both groups was mild or moderate. In conclusion, AR101 oral immunotherapy treatment led to a desensitization to peanut protein and provided a predictable safety profile.
Hourihane, J. O. B., Beyer, K., Abbas, A., Fernández-Rivas, M., Turner, P. J., Blumchen, K., … & Sharma, V. (2020). 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. The Lancet Child & Adolescent Health.