PMID- 30423449
OWN - NLM
STAT- MEDLINE
DCOM- 20200713
LR  - 20200713
IS  - 2213-2201 (Electronic)
VI  - 7
IP  - 2
DP  - 2019 Feb
TI  - Efficacy, Safety, and Quality of Life in a Multicenter, Randomized, 
      Placebo-Controlled Trial of Low-Dose Peanut Oral Immunotherapy in Children with 
      Peanut Allergy.
PG  - 479-491.e10
LID - S2213-2198(18)30720-7 [pii]
LID - 10.1016/j.jaip.2018.10.048 [doi]
AB  - BACKGROUND: Only 2 small placebo-controlled trials on peanut oral immunotherapy 
      (OIT) have been published. OBJECTIVE: We examined the efficacy, safety, 
      immunologic parameters, quality of life (QOL), and burden of treatment (BOT) of 
      low-dose peanut OIT in a multicenter, double-blind, randomized placebo-controlled 
      trial. METHODS: A total of 62 children aged 3 to 17 years with IgE-mediated, 
      challenge-proven peanut allergy were randomized (1:1) to receive peanut OIT with 
      a maintenance dose of 125 to 250 mg peanut protein or placebo. The primary 
      outcome was the proportion of children tolerating 300 mg or more peanut protein 
      at oral food challenge (OFC) after 16 months of OIT. We measured the occurrence 
      of adverse events (AEs), immunologic changes, and QOL before and after OIT and 
      BOT during OIT. RESULTS: Twenty-three of 31 (74.2%) children of the active group 
      tolerated at least 300 mg peanut protein at final OFC compared with 5 of 31 
      (16.1%) in the placebo group (P < .001). Thirteen of 31 (41.9%) children of the 
      active versus 1 of 31 (3.2%) of the placebo group tolerated the highest dose of 
      4.5 g peanut protein at final OFC (P < .001). There was no significant difference 
      between the groups in the occurrence of AE-related dropouts or in the number, 
      severity, and treatment of objective AEs. In the peanut-OIT group, we noted a 
      significant reduction in peanut-specific IL-4, IL-5, IL-10, and IL-2 production 
      by PBMCs compared with the placebo group, as well as a significant increase in 
      peanut-specific IgG(4) levels and a significant improvement in QOL; 86% of 
      children evaluated the BOT positively. DISCUSSION: Low-dose OIT is a promising, 
      effective, and safe treatment option for peanut-allergic children, leading to 
      improvement in QOL, a low BOT, and immunologic changes showing tolerance 
      development.
CI  - Copyright (c) 2018 American Academy of Allergy, Asthma & Immunology. Published by 
      Elsevier Inc. All rights reserved.
FAU - Blumchen, Katharina
AU  - Blumchen K
AD  - Department of Children and Adolescent Medicine, Division of Pneumology, 
      Allergology and Cystic fibrosis, University Hospital Frankfurt, Frankfurt am 
      Main, Germany; Department of Pediatric Pneumology, Immunology and Intensive Care 
      Medicine, Charite Universitatsmedizin Berlin, Berlin, Germany. Electronic 
      address: katharina.bluemchen@kgu.de.
FAU - Trendelenburg, Valerie
AU  - Trendelenburg V
AD  - Department of Pediatric Pneumology, Immunology and Intensive Care Medicine, 
      Charite Universitatsmedizin Berlin, Berlin, Germany.
FAU - Ahrens, Frank
AU  - Ahrens F
AD  - Children's Hospital "Altona", Hamburg, Germany.
FAU - Gruebl, Armin
AU  - Gruebl A
AD  - Department of Pediatrics, Technical University Munich, Munich, Germany.
FAU - Hamelmann, Eckard
AU  - Hamelmann E
AD  - Department of Pediatrics, Allergy Center, Ruhr-University Bochum, Bochum, 
      Germany; Children's Center Bethel, EvKB, Bielefeld, Germany.
FAU - Hansen, Gesine
AU  - Hansen G
AD  - Department of Pediatric Pneumology, Allergology and Neonatology, Hannover Medical 
      School, Hannover, Germany.
FAU - Heinzmann, Andrea
AU  - Heinzmann A
AD  - Department of Pediatrics and Adolescent Medicine, University Medical Center, 
      Medical Faculty, University of Freiburg, Freiburg, Germany.
FAU - Nemat, Katja
AU  - Nemat K
AD  - Department of Pediatrics, University Hospital Carl Gustav Carus, Technical 
      University of Dresden, Dresden, Germany.
FAU - Holzhauser, Thomas
AU  - Holzhauser T
AD  - Paul-Ehrlich-Institut, Division of Allergology, Langen, Germany.
FAU - Roeder, Martin
AU  - Roeder M
AD  - Paul-Ehrlich-Institut, Division of Allergology, Langen, Germany; Institute for 
      Product Quality (IFP), Berlin, Germany.
FAU - Rosenfeld, Leonard
AU  - Rosenfeld L
AD  - Department of Pediatric Pneumology, Immunology and Intensive Care Medicine, 
      Charite Universitatsmedizin Berlin, Berlin, Germany.
FAU - Hartmann, Oliver
AU  - Hartmann O
AD  - Sphingotec, Hennigsdorf, Germany.
FAU - Niggemann, Bodo
AU  - Niggemann B
AD  - Department of Pediatric Pneumology, Immunology and Intensive Care Medicine, 
      Charite Universitatsmedizin Berlin, Berlin, Germany.
FAU - Beyer, Kirsten
AU  - Beyer K
AD  - Department of Pediatric Pneumology, Immunology and Intensive Care Medicine, 
      Charite Universitatsmedizin Berlin, Berlin, Germany.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20181110
PL  - United States
TA  - J Allergy Clin Immunol Pract
JT  - The journal of allergy and clinical immunology. In practice
JID - 101597220
RN  - 0 (Allergens)
SB  - IM
MH  - Administration, Oral
MH  - Adolescent
MH  - Allergens/*administration & dosage
MH  - Child
MH  - Child, Preschool
MH  - Desensitization, Immunologic/adverse effects/*methods
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Peanut Hypersensitivity/*therapy
MH  - *Quality of Life
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Children
OT  - Desensitization
OT  - Induction
OT  - Oral immunotherapy
OT  - Peanut allergy
OT  - Tolerance
EDAT- 2018/11/14 06:00
MHDA- 2020/07/14 06:00
CRDT- 2018/11/14 06:00
PHST- 2018/09/29 00:00 [received]
PHST- 2018/10/23 00:00 [accepted]
PHST- 2018/11/14 06:00 [pubmed]
PHST- 2020/07/14 06:00 [medline]
PHST- 2018/11/14 06:00 [entrez]
AID - S2213-2198(18)30720-7 [pii]
AID - 10.1016/j.jaip.2018.10.048 [doi]
PST - ppublish
SO  - J Allergy Clin Immunol Pract. 2019 Feb;7(2):479-491.e10. doi: 
      10.1016/j.jaip.2018.10.048. Epub 2018 Nov 10.