High degree of desensitization after one year of early-life peanut oral immunotherapy - SmaChO Randomized Controlled Trial.

BACKGROUND: The prevalence of peanut allergy is about 2% and mostly lifelong. Studies of oral immunotherapy (OIT) with peanut - daily oral intake of an initially low and then increasing dose of peanut - often show problematic side effects but there are indications of better safety and effect in younger children compared with older children and adults.

OBJECTIVE: To determine the safety and effectiveness of peanut OIT with a slow up-dosing strategy and low maintenance dose, in peanut allergic children 1-3 years of age, a 1-year interim analysis.

METHODS: In a randomized controlled trial (2:1 ratio) 75 children with median age 31 months (IQR 23 - 40) were assigned to receive peanut oral immunotherapy (OIT) (n=50) or peanut avoidance (n=25).

RESULTS: In the OIT group and the avoidance group, 43/50 and 20/25 children, respectively, performed the 1-year open oral peanut challenge. A cumulative dose of 750 mg peanut protein after one year was tolerated by 72% (36/50) in the OIT-group compared to 4% (1/25) in the avoidance-group, p<0.001. Median tolerated cumulative dose was 2750 mg (IQR 275 - 5000) peanut protein in the OIT-group compared to 2.8 mg (IQR 0.3 - 27.8) in the avoidance-group, p<0.001. Of the doses administered at home during the first year of OIT, 1.4% resulted in adverse events, 79% were mild, and three doses of epinephrine were given at home to two individuals.

CONCLUSION: In children 1-3 years of age, peanut OIT with the combination of slow up-dosing and low maintenance dose seems safe and effective after one year.

CLINICALTRIALS: GOV: NCT04511494.