Novel baseline predictors of adverse events during oral immunotherapy in children with peanut allergy - 19/04/17
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 |
A retrospective analysis was conducted, pooling data from 3 pediatric peanut OIT trials, comprising the largest analysis of peanut OIT safety to date.
Methods |
We pooled data from 104 children with peanut allergy from 3 peanut OIT studies. We catalogued AEs from parental reports, daily symptom diaries, and dose escalations. We included events that were considered 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 the overall group) due to persistent gastrointestinal symptoms. Baseline allergic rhinitis (AR) and peanut SPT wheal size were significant predictors of higher overall AE rates. SPT wheal size 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.
Conclusions |
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 wheal size, respectively. Further study is needed of predictive biomarkers and the overall risks and benefits of OIT.
Le texte complet de cet article est disponible en PDF.Key words : Peanut allergy, oral immunotherapy, safety, adverse events
Abbreviations used : AE, AR, ED, EoE, OIT
Plan
| ClinicalTrials.gov identifiers: NCT01891136, NCT00815035, and NCT00932828. |
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| Supported by the Food Allergy and Anaphylaxis Network, the Gerber Foundation, National Institutes of Health (NIH) (R01-AI068074, K23-AI-099083, and 5T32HL098099-03 [T32]); the Food Allergy Project; a Clinical and Translational Science Award (5M01-R000030-45); the National Peanut Board; an NIH National Center For Advancing Translational Sciences award (UL1TR001117); the Wallace Research Foundation; the Dorothy O. Robins and Family Endowment in Peanut Allergy; the Alex Orum Peanut Allergy Fund; Harvard Catalyst; and the Harvard Clinical and Translational Science Center (the National Center for Research Resources and the National Center for Advancing Translational Sciences, NIH award UL1 TR001102). |
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| Disclosures of potential conflicts of interest: The authors declare that they have no relevant conflicts of interest. |
Vol 139 - N° 3
P. 882 - mars 2017 Retour au numéro
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