Oral immunotherapy for peanut allergy in children 1 to less than 4 years of age

Toit, George Du, Brown, Kari R., Vereda, Andrea, Irani, Anne-Marie, Tilles, Stephen, Ratnayake, Anoshie, Jones, Stacie M., Vickery, Brian P. and Erlewyn-Lajeunesse, Michel , POSEIDON Study Group (2023) Oral immunotherapy for peanut allergy in children 1 to less than 4 years of age. NEJM Evidence, 2 (11). (doi:10.1056/evidoa2300145).

Abstract

Background: peanut allergy is a common childhood allergy, and the only approved treatment for children 4 to 17 years of age is peanut allergen powder-dnfp (PTAH) oral immunotherapy.

Methods: for this phase 3, randomized, double-blind, placebo-controlled trial, we enrolled peanut-allergic children 1 to <4 years of age who experienced dose-limiting symptoms from ≤300 mg peanut protein during a screening double-blind, placebo-controlled food challenge (DBPCFC). Participants received PTAH or placebo, randomized in a 2:1 ratio, for approximately 12 months. At the trial conclusion, all participants underwent an exit BDPCFC. The primary end point was desensitization (i.e., tolerating a ≥600-mg single dose of peanut protein with only mild allergy symptoms).

Results: in the PTAH-treated group (n=98), 73.5% of participants tolerated a single dose of ≥600 mg peanut protein at exit DBPCFC compared with 6.3% in the placebo group (n=48). Most participants experienced an adverse event (98.0% of PTAH-treated and 97.9% of placebo-treated participants), which was mild or moderate in grade for 93.2% of participants (92.9% in PTAH-treated and 93.8% in placebo-treated participants). Treatment-related adverse events, which were mild to moderate, were experienced by 75.5% of PTAH-treated and 58.3% of placebo-treated participants. Three treatment-related systemic allergic reactions, none of which were severe or serious in grade, were noted in two PTAH-treated participants (2%).

Conclusions: in peanut-allergic children 1 to <4 years of age treated with PTAH for approximately 12 months, the majority tolerated all peanut protein dose levels assessed. PTAH-treated patients had more treatment-related adverse events, which were mild to moderate severity. (Funded by Aimmune Therapeutics; ClinicalTrials.gov number, NCT03736447.)

This record has no associated files available for download.

Contributors

Author: Michel Erlewyn-Lajeunesse

Download statistics