Evidence map›Paper›PMID 25656999›Full record

Trial reportThe Journal of allergy and clinical immunology2015

Sublingual immunotherapy for peanut allergy: Long-term follow-up of a randomized multicenter trial.

A Wesley Burks, Robert A Wood, Stacie M Jones, Scott H Sicherer, David M Fleischer, Amy M Scurlock, Brian P Vickery, Andrew H Liu, Alice K Henning, Robert Lindblad and 4 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of allergy and clinical immunology, 2015. 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 64 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

64 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Review
  9. Article
  10. Sublingual immunotherapy for allergy to shrimp: the nine-year clinical experience of a Midwest Allergy-Immunology practice.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2024
    Article
  11. Review
  12. WALKING BACKWARDS: REFLECTING ON THE VALUE OF MENTORS.Transactions of the American Clinical and Climatological Association · 2024
    Article
  13. Article
  14. Review
  15. Review
  16. Treatment Approaches to Food Allergy.Handbook of experimental pharmacology · 2022
    Review
  17. Oral Immunotherapy for Children with Cow's Milk Allergy.Pathogens (Basel, Switzerland) · 2021
    Review
  18. Basophil activation test in food allergy: is it ready for real-time?Current opinion in allergy and clinical immunology · 2021
    Review
  19. Review
  20. Review

4 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

14 authors.

A Wesley BurksDepartment of Pediatrics, University of North Carolina, Chapel Hill, NC. Electronic address: wburks@email.unc.edu.
Robert A WoodDepartment of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Md.
Stacie M JonesDepartment of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
Scott H SichererDepartment of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.
David M FleischerDepartment of Pediatrics, University of Colorado Denver School of Medicine and Children's Hospital Colorado, Denver, Colo.
Amy M ScurlockDepartment of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
Brian P VickeryDepartment of Pediatrics, University of North Carolina, Chapel Hill, NC.
Andrew H LiuDepartment of Pediatrics, National Jewish Health, Denver, Colo.
Alice K HenningEMMES Corporation, Rockville, Md.
Robert LindbladEMMES Corporation, Rockville, Md.
Peter DawsonEMMES Corporation, Rockville, Md.
Marshall PlautNational Institutes of Health (National Institutes of Allergy and Infectious Diseases), Bethesda, Md.
Hugh A SampsonDepartment of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.
Consortium of Food Allergy Research

Funding

Immune Tolerance Network UM1 2023 SupplementUM1AI109565 · NIAID · BENAROYA RESEARCH INST AT VIRGINIA MASON · PI Mark S Anderson, Jane Hoyt Buckner · 2014 to 2026
$451.6M
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
Pilot Project for the DTMI CRA ProgramUL1RR024128 · NCRR · DUKE UNIVERSITY · PI CALIFF, ROBERT M · 2006 to 2010
$48.1M
Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
Mechanistic CoreU19AI066738 · NIAID · MOUNT SINAI SCHOOL OF MEDICINE OF NYU · PI WOOD, ROBERT A · 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
Understanding the Mechanism of Mucosal ImmunotherapyR01AI068074 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BURKS, A. WESLEY · 2007 to 2016
$3.8M
Immunoregulatory Networks in Chlamydia Genital Tract InfectionK08AI077932 · NIAID · ARKANSAS CHILDREN'S HOSPITAL RES INST · PI SCURLOCK, AMY M. · 2009 to 2013
$662k
NCATS NIH HHS UL1 TR000039NCATS NIH HHS UL1 TR000067NCATS NIH HHS UL1 TR000154NCATS NIH HHS UL1TR000154NCATS NIH HHS UL1 TR001082NCRR NIH HHS UL 1 RR024128NCRR NIH HHS UL1 RR 025005NCRR NIH HHS UL1 RR025005NCRR NIH HHS UL1 RR025780NIAID NIH HHS 1K08 AI 077932NIAID NIH HHS 2U19 AI 066738NIAID NIH HHS 5U01 AI 066560NIAID NIH HHS AI 066738NIAID NIH HHS AI 44236NIAID NIH HHS R01 AI 068074NIAID NIH HHS U01 AI066560NIAID NIH HHS U01AI066560NIAID NIH HHS U19 AI 066738NIAID NIH HHS U19 AI066738NIAID NIH HHS U19AI066738NIAID NIH HHS UMI AI 109565
6 · The paper itself

Abstract

backgroundWe previously reported the initial results of the first multicenter, randomized, double-blind, placebo-controlled clinical trial of peanut sublingual immunotherapy (SLIT), observing a favorable safety profile associated with modest clinical and immunologic effects in the first year.

objectiveWe sought to provide long-term (3-year) clinical and immunologic outcomes for our peanut SLIT trial. Key end points were (1) percentage of responders at 2 years (ie, could consume 5 g of peanut powder or a 10-fold increase from baseline), (2) percentage reaching desensitization at 3 years, (3) percentage attaining sustained unresponsiveness after 3 years, (4) immunologic end points, and (5) assessment of safety parameters.

methodsResponse to treatment was evaluated in 40 subjects aged 12 to 40 years by performing a 10-g peanut powder oral food challenge after 2 and 3 years of daily peanut SLIT therapy. At 3 years, SLIT was discontinued for 8 weeks, followed by another 10-g oral food challenge and an open feeding of peanut butter to assess sustained unresponsiveness.

resultsApproximately 98% of the 18,165 doses were tolerated without adverse reactions beyond the oropharynx, with no severe symptoms or uses of epinephrine. A high rate (>50%) discontinued therapy. By study's end, 4 (10.8%) of 37 SLIT-treated participants were fully desensitized to 10 g of peanut powder, and all 4 achieved sustained unresponsiveness. Responders at 2 years showed a significant decrease in peanut-specific basophil activation and skin prick test titration compared with nonresponders.

conclusionsPeanut SLIT induced a modest level of desensitization, decreased immunologic activity over 3 years in responders, and had an excellent long-term safety profile. However, most patients discontinued therapy by the end of year 3, and only 10.8% of subjects achieved sustained unresponsiveness.

Indexed as

Sublingual ImmunotherapyAdolescentAllergensArachisBasophilsComorbidityFemaleFollow-Up StudiesHumansImmunoglobulin EMalePeanut HypersensitivityPlant Proteins, DietaryTreatment OutcomeAllergensImmunoglobulin EPlant Proteins, Dietarydesensitizationfollow-upfood allergyPeanut allergysublingual immunotherapy

Identifiers

PMID25656999
PMCPMC4527157

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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.