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High Degree of Desensitization After 1 Year of Early-Life Peanut Oral Immunotherapy: Small Children Oral Immunotherapy (SmaChO) Randomized Controlled Trial.

  • 2024-05
  • The journal of allergy and clinical immunology. In practice 12(5)
    • Carina Uhl
    • Susanna Klevebro
    • Eva Sverremark-Ekström
    • Sandra G Tedner
    • Josef Brandström
    • Chrystalleni Papageorgiou
    • Erik Melén
    • Jon R Konradsen
    • Caroline Nilsson
    • Anna Asarnoj

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 75
Population
75 children, median age 31 months (interquartile range [IQR], 23-40 months) who were allergic to peanut
Methods
Randomized controlled trial (2:1 ratio), peanut OIT with slow up-dosing strategy and low maintenance dose vs peanut avoidance
Blinding
Open-label
Duration
1 year
Funding
Unclear

Background

The prevalence of peanut allergy is about 2% and mostly lifelong. Studies of oral immunotherapy (OIT) with peanut (the 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 children aged 1 to 3 years who were allergic to peanut, through a 1-year interim analysis.

Method

In a randomized controlled trial (2:1 ratio), 75 children, median age 31 months (interquartile range [IQR], 23-40 months) were assigned to receive peanut OIT (n = 50) or peanut avoidance (n = 25).

Results

In the OIT and avoidance groups, 43 of 50 and 20 of 25 children, respectively, performed the 1-year open oral peanut challenge. A cumulative dose of 750 mg peanut protein after 1 year was tolerated by 72% (36 of 50 children) in the OIT group compared with 4% (1 of 25) in the avoidance group (P < .001). Median tolerated cumulative dose was 2,750 mg (IQR, 275-5,000 mg) peanut protein in the OIT group compared with 2.8 mg (IQR, 0.3-27.8 mg) in the avoidance group (P < .001). Of the doses administered at home during the first year of OIT, 1.4% resulted in adverse events and 79% were mild, and three doses of epinephrine were given at home to two individuals.

Conclusion

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

Research Insights

  • Peanut Protein→Increased Tolerated Peanut Protein Dose

    Median tolerated cumulative dose was 2,750 mg (IQR, 275-5,000 mg) peanut protein in the OIT group compared with 2.8 mg (IQR, 0.3-27.8 mg) in the avoidance group (P < .001).

    Effect
    Beneficial
    Effect size
    Large
    Dose
    low maintenance dose

Adverse Events Reported

  • Peanut Protein→Overall tolerability

    Of the doses administered at home during the first year of OIT, 1.4% resulted in adverse events and 79% were mild

    Finding
    Reported
    Grade
    mild
  • Peanut Protein→adverse events

    Of the doses administered at home during the first year of OIT, 1.4% resulted in adverse events and 79% were mild

    Finding
    Reported
    Magnitude
    1.4% of doses resulted in adverse events
  • Peanut Protein→epinephrine administration

    three doses of epinephrine were given at home to two individuals

    Finding
    Reported
    Magnitude
    three doses of epinephrine were given at home to two individuals
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