2025-02-10 マウントサイナイ医療システム (MSHS)
<関連情報>
- https://www.mountsinai.org/about/newsroom/2025/eating-gradually-increasing-doses-of-store-bought-peanut-butter-enables-children-with-high-threshold-allergy-to-safely-consume-peanuts
- https://evidence.nejm.org/doi/full/10.1056/EVIDoa2400306
高閾値ピーナッツアレルギーの小児におけるピーナッツ経口免疫療法 Peanut Oral Immunotherapy in Children with High-Threshold Peanut Allergy
Scott H. Sicherer, M.D., Supinda Bunyavanich, M.D., M.P.H., M.Phil., M. Cecilia Berin, Ph.D., Tracy Lo, R.N., Marion Groetch, M.S., R.D.N., Allison Schaible, M.S., R.D.N., Susan A. Perry, R.N., +5, and Julie Wang, M.D.
NEJM Evidence Published February 10, 2025
DOI:10.1056/EVIDoa2400306
Abstract
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.)
