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Randomized Controlled Trial
. 2021 Aug;38(8):4321-4332.
doi: 10.1007/s12325-021-01843-2. Epub 2021 Jul 8.

The Risk Reduction of Accidental Exposure-Related Systemic Allergic Reactions Extrapolated Based on Food Challenge Data After 1 Year of Peanut Oral Immunotherapy

Shengsheng Yu  1 , Alex Smith  2 , Steve Hass  3 , Eric Wu  4 , Xinglei Chai  4 , Jenny Zhou  5 , Rajeev Ayyagari  4 , Jun S Liu  6 , Dan Robison  2 , Sarah M Donelson  2 , Stephen Tilles  2
Affiliations
Randomized Controlled Trial

The Risk Reduction of Accidental Exposure-Related Systemic Allergic Reactions Extrapolated Based on Food Challenge Data After 1 Year of Peanut Oral Immunotherapy

Shengsheng Yu et al. Adv Ther. 2021 Aug.

Abstract

Introduction: The phase 3 trial PALISADE, comparing peanut (Arachis hypogaea) allergen powder-dnfp (PTAH) oral immunotherapy versus placebo in peanut-allergic children, reported that a significantly higher percentage of PTAH-treated participants tolerated higher doses of peanut protein after 1 year of treatment. This study used PALISADE data to estimate the reduction in the risk of systemic allergic reaction (SAR) after accidental exposure following 1 year of PTAH treatment.

Methods: Participants (aged 4-17 years) enrolled in PALISADE were included. Parametric interval-censoring survival analysis with the maximum likelihood estimation was used to construct a real-world distribution of peanut protein exposure using lifetime SAR history and highest tolerated dose (HTD) from a double-blind, placebo-controlled food challenge conducted at baseline. The SAR risk reduction was extrapolated using the exposure distribution and the HTD were collected at baseline and trial exit for PTAH- and placebo-treated participants.

Results: Assuming a maximum peanut protein intake of 1500 mg, participants were estimated to have < 1% probability of ingesting > 0.01 mg during daily life. The mean annual SAR risk at trial entry was 9.25-9.98%. At trial exit, the relative SAR risk reduction following accidental exposure was 94.9% for PTAH versus 6.4% for placebo. For PTAH-treated participants with exit HTD of 600 or 1000 mg without dose-limiting symptoms, the SAR risk reduction increased to 97.2%. The result was consistent in the sensitivity analysis across different parametric distributions.

Conclusion: Oral immunotherapy with PTAH is expected to result in a substantially greater reduction in risk of SAR following accidental exposure compared to placebo among children with peanut allergy.

Keywords: Accidental exposure; Immunotherapy; Peanut allergy; Systemic allergic reaction risk reduction; peanut (Arachis hypogaea) allergen powder-dnfp.

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Figures

Fig. 1
Fig. 1
Estimated probability density function of daily peanut protein exposure with a maximum intake of 1500 mg; AIC Akaike information criterion, BIC Bayesian information criterion, lnorm log-normal
See this image and copyright information in PMC

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