Evidence map›Paper›PMID 23265698›Full record

Trial reportThe Journal of allergy and clinical immunology2013

Sublingual immunotherapy for peanut allergy: a randomized, double-blind, placebo-controlled multicenter trial.

David M Fleischer, A Wesley Burks, Brian P Vickery, Amy M Scurlock, Robert A Wood, Stacie M Jones, Scott H Sicherer, Andrew H Liu, Donald Stablein, Alice K Henning and 5 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of allergy and clinical immunology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00580606 (Sublingual Immunotherapy for Peanut Allergy), which is not on this map. Cited by 103 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
103citing papers in PubMed, 2 pooled it
17.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00580606 phase1 / phase2completednot on this map

Sublingual Immunotherapy for Peanut Allergy: A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Pilot Study With a Whole Peanut Extract

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2007 to 2014Enrolled40ConditionsFood Hypersensitivity, Hypersensitivity, Immediate Hypersensitivity, Peanut HypersensitivityArmsGlycerinated peanut allergenic extract, Placebo for peanut extract (glycerin)
3 · Its place in the literature

Who cites it

103 citing papers in PubMed, 2 syntheses or guidelines pooled it, 306 citations in OpenAlex.

  1. Pooled it
  2. Immunotherapy (oral and sublingual) for food allergy to fruits.The Cochrane database of systematic reviews · 2015
    Pooled it
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  12. Utility of component analyses in subjects undergoing sublingual immunotherapy for peanut allergy.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2016
    Trial
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43 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 7 institutions in 1 country.

David M FleischerDepartment of Pediatrics, National Jewish Health, Denver, CO 80206, USA. Fleischerd@njhealth.org
A Wesley Burks
Brian P Vickery
Amy M Scurlock
Robert A Wood
Stacie M Jones
Scott H Sicherer
Andrew H Liu
Donald Stablein
Alice K Henning
Lloyd Mayer
Robert Lindblad
Marshall Plaut
Hugh A Sampson
Consortium of Food Allergy Research (CoFAR)
Emmes (United States) · USIcahn School of Medicine at Mount Sinai · USArkansas Children's Hospital · USNational Jewish Health · USUniversity of North Carolina at Chapel Hill · USJohns Hopkins University · USNational Institutes of Health · US

Funding

Institute for Clinical and Translational Research (UL1)UL1RR025005 · NCRR · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2007 to 2011
$75.8M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025780 · NCRR · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2008 to 2011
$61.3M
Mechanistic CoreU19AI066738 · NIAID · MOUNT SINAI SCHOOL OF MEDICINE OF NYU · PI SICHERER, SCOTT H · 2005 to 2016
$43.6M
Colorado Clinical and Translational Science Institute (UL1)UL1TR000154 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2012 to 2013
$20.4M
Mount Sinai Institutes for Clinical and Translational SciencesUL1TR000067 · NCATS · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI SAMPSON, HUGH A · 2012 to 2014
$16.5M
Food Allergy Research Consortium and Statistical CenterU01AI066560 · NIAID · THE EMMES COMPANY, LLC · PI DAWSON, PETER RUSSELL, LINDBLAD, ROBERT · 2005 to 2016
$12.8M
Arkansas Center for Clinical and Translational ResearchUL1TR000039 · NCATS · UNIV OF ARKANSAS FOR MED SCIS · PI BECK, CORNELIA MARIE, JAMES, LAURA P · 2012 to 2014
$10.0M
NCATS NIH HHS UL1 TR000039NCATS NIH HHS UL1 TR000067NCATS NIH HHS UL1 TR000154NCRR NIH HHS UL1 RR 025005NCRR NIH HHS UL1 RR025005NCRR NIH HHS UL1 RR025780NIAID NIH HHS U01 AI066560NIAID NIH HHS U01AI066560NIAID NIH HHS U19 AI066738NIAID NIH HHS U19AI066738
6 · The paper itself

Abstract

backgroundThere are presently no available therapeutic options for patients with peanut allergy.

objectiveWe sought to investigate the safety, efficacy, and immunologic effects of peanut sublingual immunotherapy (SLIT).

methodsAfter a baseline oral food challenge (OFC) of up to 2 g of peanut powder (approximately 50% protein; median successfully consumed dose [SCD], 46 mg), 40 subjects, aged 12 to 37 years (median, 15 years), were randomized 1:1 across 5 sites to daily peanut or placebo SLIT. A 5-g OFC was performed after 44 weeks, followed by unblinding; placebo-treated subjects then crossed over to higher dose peanut SLIT, followed by a subsequent crossover Week 44 5-g OFC. Week 44 OFCs from both groups were compared with baseline OFCs; subjects successfully consuming 5 g or at least 10-fold more peanut powder than the baseline OFC threshold were considered responders.

resultsAfter 44 weeks of SLIT, 14 (70%) of 20 subjects receiving peanut SLIT were responders compared with 3 (15%) of 20 subjects receiving placebo (P < .001). In peanut SLIT responders, median SCD increased from 3.5 to 496 mg. After 68 weeks of SLIT, median SCD significantly increased to 996 mg (compared with Week 44, P = .05). The median SCD at the Week 44 Crossover OFC was significantly higher than baseline (603 vs 71 mg, P = .02). Seven (44%) of 16 crossover subjects were responders; median SCD increased from 21 to 496 mg among responders. Of 10,855 peanut doses through the Week 44 OFCs, 63.1% were symptom free; excluding oral-pharyngeal symptoms, 95.2% were symptom free.

conclusionsPeanut SLIT safely induced a modest level of desensitization in a majority of subjects compared with placebo. Longer duration of therapy showed statistically significant increases in the SCD.

Indexed as

Desensitization, ImmunologicAdministration, SublingualAdolescentAdultAllergensArachisBasophilsChildFemaleHumansImmunoglobulin EMalePeanut HypersensitivityTreatment OutcomeYoung AdultAllergensImmunoglobulin E

Identifiers

PMID23265698
PMCPMC3550002
OpenAlexW2097001981

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.