1. Oral Immunotherapy for Peanut Allergy in Children 1 to Less Than 4 Years of Age.
- Author
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Du Toit, George, Brown, Kari R., Vereda, Andrea, Irani, Anne-Marie, Tilles, Stephen, Ratnayake, Anoshie, Jones, Stacie M., and Vickery, Brian P.
- Subjects
ALLERGY desensitization ,ORAL drug administration ,TREATMENT effectiveness ,RANDOMIZED controlled trials ,PLACEBOS ,COMPARATIVE studies ,PEANUTS ,BLIND experiment ,DESCRIPTIVE statistics ,RESEARCH funding ,STATISTICAL sampling ,FOOD allergy ,ALLERGENS ,CHILDREN - 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.) [ABSTRACT FROM AUTHOR]
- Published
- 2023
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