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Peanut Oral Immunotherapy in Children with High-Threshold Peanut Allergy.

  • 2025-02-25
  • NEJM evidence 4(3)
    • Scott H Sicherer
    • Supinda Bunyavanich
    • M Cecilia Berin
    • Tracy Lo
    • Marion Groetch
    • Allison Schaible
    • Susan A Perry
    • Lisa M Wheatley
    • Patricia C Fulkerson
    • Helena L Chang
    • Mayte Suárez-Fariñas
    • Hugh A Sampson
    • Julie Wang

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 73
Population
73 participants aged 4 to 14 years reacting to a challenge of between 443 mg and 5043 mg of peanut protein
Methods
Randomized 1:1 to peanut oral immunotherapy using home-measured peanut butter versus peanut avoidance. Primary endpoint: difference in proportion tolerating a two-dose-level increase or 9043 mg peanut protein. Sustained unresponsiveness tested after 16 weeks of ad lib ingestion followed by 8 weeks of abstinence.
Funding
Independent

Background

Approved therapeutics for peanut allergy are not designed for the many patients with allergic reactions to more than one peanut.

Methods

We randomly assigned (1:1) participants 4 to 14 years of age reacting to a challenge of between 443 mg and 5043 mg of peanut protein to peanut oral immunotherapy (P-OIT) using home-measured peanut butter versus peanut avoidance. The primary end point was the difference between groups in the proportion tolerating a two-dose-level increase or 9043 mg of peanut protein. For ingestion participants tolerating 9043 mg, sustained unresponsiveness (tolerance off treatment) was tested after 16 weeks of ad lib ingestion followed by 8 weeks of abstinence.

Results

Of 73 participants, 38 were randomly assigned to P-OIT and 35 to avoidance. Thirty-two of 38 participants in the ingestion group (84.2%) and 30 of 35 in the avoidance group (85.7%) underwent the primary outcome food challenge. The primary analysis with prespecified multiple imputation for missing values showed 100% success for ingestion versus 21.0% for avoidance (between-group difference, 79.0 percentage points; 95% confidence interval [CI], 64.6 to 93.5; P<0.001). All 32 treated and 3 out of 30 avoiders (10%) tolerated 9043 mg. In the intention-to-treat analysis, sustained unresponsiveness occurred in 68.4% (26/38) on P-OIT versus 8.6% (3/35) tolerating 9043 mg among those avoiding (between-group difference, 59.9 percentage points; 95% CI, 42.4 to 77.3). No dosing reactions were greater than grade 1 severity, and no serious adverse events were reported.

Conclusions

In this trial of P-OIT using store-bought, home-measured peanut versus peanut avoidance in high-threshold peanut allergy, those treated achieved significantly higher rates of desensitization with a durable response off treatment. (Funded by the National Center for Advancing Translational Sciences [UL1TR004419] and the National Institute of Allergy and Infectious [U19AI136053]; ClinicalTrials.gov number, NCT03907397.).

Research Insights

  • peanut butter→Achieved Sustained Unresponsiveness

    sustained unresponsiveness occurred in 68.4% (26/38) on P-OIT versus 8.6% (3/35) tolerating 9043 mg among those avoiding (between-group difference, 59.9 percentage points; 95% CI, 42.4 to 77.3).

    Effect
    Beneficial
    Effect size
    Large
  • peanut butter→Improved Peanut Tolerance

    The primary analysis with prespecified multiple imputation for missing values showed 100% success for ingestion versus 21.0% for avoidance (between-group difference, 79.0 percentage points; 95% CI, 64.6 to 93.5; P<0.001).

    Effect
    Beneficial
    Effect size
    Large

Adverse Events Reported

  • peanut butter→Overall tolerability

    no serious adverse events were reported

    Finding
    Reported
  • peanut butter→dosing reactions

    No dosing reactions were greater than grade 1 severity

    Finding
    Reported
    Grade
    mild
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