Novel Baseline Predictors of Allergic Side Effects During Peanut Oral Immunotherapy

Abstract

Background

Though peanut oral immunotherapy (OIT) is a promising investigational therapy, its potential is limited by substantial adverse events (AEs), which are relatively understudied.

Objective

To conduct a retrospective analysis pooling three pediatric peanut OIT trials, comprising the largest analysis of peanut OIT safety to date.

Methods

We pooled 104 peanut-allergic children from three peanut OIT studies. We catalogued AEs from parental report, daily symptom diaries, and dose escalations. We included events that were likely related to OIT and identified potential baseline predictors of higher AE rates using generalized linear regression models.

Results

Eighty percent of subjects experienced likely-related AEs during OIT (72% during buildup and 47% during maintenance). Of these AEs, over 90% occurred while at home. Approximately 42% of subjects experienced systemic reactions, and 49% experienced gastrointestinal symptoms. Twenty percent of subjects dropped out, with half (10% of overall group) due to persistent gastrointestinal symptoms. Baseline allergic rhinitis (AR), asthma, and peanut skin prick test (SPT) were significant predictors of higher overall AE rates. SPT predicted increased gastrointestinal AEs, and AR predicted increased systemic reactions. Over the course of OIT, 61% of subjects received treatment for likely-related AEs, 59% with antihistamines and 12% with epinephrine.

Conclusion

Peanut OIT is associated with frequent AEs, with rates declining over time, and most graded mild. However, systemic reactions and intolerable gastrointestinal AEs do occur and are significantly associated with AR and peanut SPT, respectively. Further study is needed of predictive biomarkers and the overall risks and benefits of OIT.