At-home Dosing Adherence During Characterized Oral Desensitization Immunotherapy (CODIT) for Peanut Allergy

Abstract

RATIONALE: AR101, a pharmaceutical-grade peanut protein formulation, was well tolerated and demonstrated robust activity in a Phase 2, double-blind, placebo-controlled trial in 4-21 year olds. We now report results on at-home dosing adherence. METHODS: Subjects took their daily dose at home by mixing the capsules' content in non-allergenic food, and consuming the entire serving. Subjects documented doses taken at home using diary logs and returned unused capsules to the clinic at every visit. At-home adherence, defined as full, partial (at least 1/2 dose was taken), and missed home doses, was expressed as a percentage of planned at-home doses. RESULTS: 55 subjects (AR101, n=29; Placebo, n=26) received at least 1 dose of randomized study treatment. The number of days of planned athome doses was 139.8 days (SD: 38.63) for the overall group. The mean number of days (% [SD]) with any at-home dose (either a full or partial dose) was similar for AR101 and Placebo groups (94.7 [6.80] vs 96.9 [3.37], respectively), as was the percentage of days with full doses (93.6 [6.86] for AR101 and 96.7 [3.41] for Placebo, 95.1 [5.68] overall). The mean number of days (% [SD]) with partial doses was higher for AR101 than Placebo (1.1 [1.94] vs 0.2 [0.50], respectively) as was the mean number of days (% [SD]) with missed doses (4.7 [6.84] for AR101; 2.4 [2.84] for Placebo). CONCLUSIONS: At-home dosing adherence during ARC001 was very high, both for AR101 and matching placebo, as the full dose was taken more than 95% of the days.