Novel baseline predictors of adverse events during oral immunotherapy in children with peanut allergy.
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.
Department of Pediatrics, Massachusetts General Hospital, Boston, Mass.
Yamini V
YV
Virkud
Department of Pediatrics, University of North Carolina, Chapel Hill, NC.
A Wesley
AW
Burks
Department of Pediatrics, University of North Carolina, Chapel Hill, NC.
Pamela H
PH
Steele
Department of Biostatistics, University of North Carolina, Chapel Hill, NC.
Lloyd J
LJ
Edwards
Duke Translational Medicine Institute, Duke University, Durham, NC.
Jelena P
JP
Berglund
Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, Ark.
Stacie M
SM
Jones
Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, Ark.
Amy M
AM
Scurlock
Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, Ark.
Tamara T
TT
Perry
Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, Ark.
Robert D
RD
Pesek
Department of Pediatrics, University of North Carolina, Chapel Hill, NC. Electronic address: bvickery@email.unc.edu.
Brian P
BP
Vickery
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003888:Desensitization, Immunologic / Q000009:adverse effects*; D004837:Epinephrine / Q000627:therapeutic use; D005260:Female; D006633:Histamine Antagonists / Q000627:therapeutic use; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D021183:Peanut Hypersensitivity / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic; D065631:Rhinitis, Allergic / Q000628:therapy
D006633:Histamine Antagonists; D004837:Epinephrine
Peanut allergy; adverse events; oral immunotherapy; safety