Immunologic assessments from ARTEMIS: A European, phase 3, randomized, double-blind, placebo-controlled trial of AR101 in peanut-allergic subjects aged 4–17 years

Introduction In ARTEMIS, 58% of AR101-treated subjects vs. 2% of placebo-treated subjects tolerated 1000 mg peanut protein as a single dose at exit double-blind, placebo-controlled food challenge (DBPCFC; P  Methods All enrolled subjects had a clinical history of peanut allergy, demonstrated sensitization to peanut (skin prick test [SPT] mean wheal diameter ≥ 3 mm and/or peanut-specific immunoglobulin E [psIgE] ≥ 0.35 kUA/L), and reacted to ≤ 300 mg peanut protein at screening DBPCFC. SPT wheal diameter (mm), psIgE (kUA/L) and psIgG4 (mgA/L) assessments were performed at screening, end of dose escalation and study completion (following 3 months at 300 mg/day). Differences between treatment groups from screening to exit were analyzed using an ANCOVA model with terms fitted for group, country and screening value. Results A total of 175 ARTEMIS subjects (AR101 n = 132, placebo n = 43) were treated. SPT wheal diameter, psIgE levels, psIgG4 levels and psIgE/IgG4 ratio are summarized in Table 1 . From baseline to exit (AR101 vs. placebo), psIgG4 levels increased (P  Conclusion Exposure to AR101 was associated with immunologic changes consistent with immunomodulation: increased psIgG4, decreased peanut SPT wheal size and transient changes in psIgE levels, as reported in previous peanut oral immunotherapy trials.