ORLANDO – compared with those receiving placebo, according to research results.
Stacie M. Jones, MD, of the University of Arkansas and Arkansas Children’s Hospital, Little Rock, presented the late-breaking results from the pivotal PALISADE trial at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization, in which Dr. Jones and her colleagues sought to examine the safety and efficacy of the novel oral immunotherapy AR101 for patients with peanut allergy.
They enrolled 551 patients aged 4-49 years (average age, 11.3 years) who reacted to 100 mg or less of peanut protein at the time of screening in double-blind, placebo-controlled food challenges. Patients who were randomly assigned to receive AR101 received initial escalation phases and up-dosing phases before they eventually received a maintenance dose of 300 mg/day for approximately 6 months.At 12 months, 67% of patients who received AR101 tolerated 600 mg or more of peanut protein, compared with 4% of control patients (P less than .00001). The tolerance benefit for AR101 appeared to continue when the researchers evaluated 1,000 mg of peanut protein. A dose of 1,000 mg or more was tolerated by 50% of patients in the AR101 group, compared with 2.4% of patients in the control group (P less than .00001).