PMID- 27609653
OWN - NLM
STAT- MEDLINE
DCOM- 20170721
LR  - 20240213
IS  - 1097-6825 (Electronic)
IS  - 0091-6749 (Print)
IS  - 0091-6749 (Linking)
VI  - 139
IP  - 3
DP  - 2017 Mar
TI  - Novel baseline predictors of adverse events during oral immunotherapy in children 
      with peanut allergy.
PG  - 882-888.e5
LID - S0091-6749(16)30894-6 [pii]
LID - 10.1016/j.jaci.2016.07.030 [doi]
AB  - 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.
CI  - Copyright (c) 2016 American Academy of Allergy, Asthma & Immunology. Published by 
      Elsevier Inc. All rights reserved.
FAU - Virkud, Yamini V
AU  - Virkud YV
AD  - Department of Pediatrics, Massachusetts General Hospital, Boston, Mass.
FAU - Burks, A Wesley
AU  - Burks AW
AD  - Department of Pediatrics, University of North Carolina, Chapel Hill, NC.
FAU - Steele, Pamela H
AU  - Steele PH
AD  - Department of Pediatrics, University of North Carolina, Chapel Hill, NC.
FAU - Edwards, Lloyd J
AU  - Edwards LJ
AD  - Department of Biostatistics, University of North Carolina, Chapel Hill, NC.
FAU - Berglund, Jelena P
AU  - Berglund JP
AD  - Duke Translational Medicine Institute, Duke University, Durham, NC.
FAU - Jones, Stacie M
AU  - Jones SM
AD  - Department of Pediatrics, University of Arkansas for Medical Sciences, Little 
      Rock, Ark.
FAU - Scurlock, Amy M
AU  - Scurlock AM
AD  - Department of Pediatrics, University of Arkansas for Medical Sciences, Little 
      Rock, Ark.
FAU - Perry, Tamara T
AU  - Perry TT
AD  - Department of Pediatrics, University of Arkansas for Medical Sciences, Little 
      Rock, Ark.
FAU - Pesek, Robert D
AU  - Pesek RD
AD  - Department of Pediatrics, University of Arkansas for Medical Sciences, Little 
      Rock, Ark.
FAU - Vickery, Brian P
AU  - Vickery BP
AD  - Department of Pediatrics, University of North Carolina, Chapel Hill, NC. 
      Electronic address: bvickery@email.unc.edu.
LA  - eng
GR  - R01 AI068074/AI/NIAID NIH HHS/United States
GR  - T32 HL098099/HL/NHLBI NIH HHS/United States
GR  - UL1 TR001102/TR/NCATS NIH HHS/United States
GR  - UL1 TR001117/TR/NCATS NIH HHS/United States
GR  - K23 AI099083/AI/NIAID NIH HHS/United States
PT  - Journal Article
DEP - 20160905
PL  - United States
TA  - J Allergy Clin Immunol
JT  - The Journal of allergy and clinical immunology
JID - 1275002
RN  - 0 (Histamine Antagonists)
RN  - YKH834O4BH (Epinephrine)
SB  - IM
CIN - Ann Allergy Asthma Immunol. 2018 Mar;120(3):241-244. PMID: 29409852
MH  - Adolescent
MH  - Child
MH  - Child, Preschool
MH  - Desensitization, Immunologic/*adverse effects
MH  - Epinephrine/therapeutic use
MH  - Female
MH  - Histamine Antagonists/therapeutic use
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Male
MH  - Peanut Hypersensitivity/*therapy
MH  - Randomized Controlled Trials as Topic
MH  - Rhinitis, Allergic/therapy
PMC - PMC5337444
MID - NIHMS828879
OTO - NOTNLM
OT  - Peanut allergy
OT  - adverse events
OT  - oral immunotherapy
OT  - safety
EDAT- 2016/09/10 06:00
MHDA- 2017/07/22 06:00
PMCR- 2018/03/01
CRDT- 2016/09/10 06:00
PHST- 2015/09/17 00:00 [received]
PHST- 2016/06/02 00:00 [revised]
PHST- 2016/07/01 00:00 [accepted]
PHST- 2016/09/10 06:00 [pubmed]
PHST- 2017/07/22 06:00 [medline]
PHST- 2016/09/10 06:00 [entrez]
PHST- 2018/03/01 00:00 [pmc-release]
AID - S0091-6749(16)30894-6 [pii]
AID - 10.1016/j.jaci.2016.07.030 [doi]
PST - ppublish
SO  - J Allergy Clin Immunol. 2017 Mar;139(3):882-888.e5. doi: 
      10.1016/j.jaci.2016.07.030. Epub 2016 Sep 5.