The following is a summary of the “Participant characteristics and safety outcomes of peanut oral immunotherapy in the RAMSES and ARC011 trials,” published in the December 2022 issue of Allergy and Clinical Immunology by Ciaccio et al.

This study aims to characterize the safety and tolerability of PTAH in trial participants chosen based on clinical history and peanut sensitization parameters that did not undergo DBPCFCs and to compare these results with those of previous studies.

RAMSES (ARC007) was a randomized, double-blind, placebo-controlled experiment in children aged 4 to 17 with a physician-confirmed peanut allergy that lasted six months. The subsequent 6-month maintenance PTAH study was called ARC011. The primary endpoint for RAMSES and ARC011 was the frequency of treatment-emergent adverse events (AEs).

Participants in the phase 3 PALISADE and ARTEMIS trials of DBPCFCs were compared descriptively to those in the RAMSES and ARC011 studies regarding their baseline characteristics and safety results. 506 patients were randomly assigned to different therapy groups, and preliminary data suggested that the groups were comparable at the outset. In the first dose-increasing phase, 55.0% of PTAH patients and 33.9% of placebo patients experienced at least 1 adverse event, while 98.8% and 94.0% of patients experienced the same during the subsequent dose-increasing phases. 

The majority of those who experienced adverse events (AEs) only experienced mild to severe symptoms. Gastrointestinal adverse events were the most common. Baseline median peanut-specific immunoglobulin E and skin prick test results were greater in RAMSES individuals compared to the combined data from PALISADE and ARTEMIS. In addition, comparable trial-period safety results were seen. Results on the safety of PTAH in clinically selected children with peanut allergy do not appear to differ from data from phase 3 trials where DBPCFC is required for entry.

Source: sciencedirect.com/science/article/pii/S1081120622006573