Evidence map›Paper›PMID 36828080›Full record

Trial reportThe Journal of allergy and clinical immunology2023

Open-label study of the efficacy, safety, and durability of peanut sublingual immunotherapy in peanut-allergic children.

Edwin H Kim, Corinne A Keet, Yamini V Virkud, Stacy Chin, Ping Ye, Anusha Penumarti, Johanna Smeekens, Rishu Guo, Xiaohong Yue, Quefeng Li and 3 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of allergy and clinical immunology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
16.0field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 66 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Article
  4. Implementing very-low-dose allergen exposure after suspected IgE-mediated reactions in infancy prior to allergist consultation.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2026
    Article
  5. Parent perspectives on guided self-care approaches to ensure timely access to therapy in infants with food allergy.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2026
    Article
  6. Article
  7. Efficacy and safety of Sublingual immunotherapy for allergic rhinitis: an overview of systematic reviews and meta analyses.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026
    Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Immunotherapy in Peanut Allergy: The Present and the Future.Allergy, asthma & immunology research · 2025
    Article
  15. Review
  16. Review
  17. Moving Beyond Desensitization to Tolerance in Food Allergy.The journal of allergy and clinical immunology. In practice · 2025
    Review
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 2 institutions in 1 country.

Edwin H KimDivision of Pediatric Allergy and Immunology, Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC. Electronic address: edwinkim@email.unc.edu.
Corinne A KeetDivision of Pediatric Allergy and Immunology, Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC.
Yamini V VirkudDivision of Pediatric Allergy and Immunology, Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC.
Stacy ChinCenter for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Md.
Ping YeDivision of Pediatric Allergy and Immunology, Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC.
Anusha PenumartiDivision of Pediatric Allergy and Immunology, Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC.
Johanna SmeekensDivision of Pediatric Allergy and Immunology, Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC.
Rishu GuoDivision of Pediatric Allergy and Immunology, Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC.
Xiaohong YueDivision of Pediatric Allergy and Immunology, Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC.
Quefeng LiDepartment of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Michael R KosorokDepartment of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Michael D KulisDivision of Pediatric Allergy and Immunology, Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC.
A Wesley BurksDivision of Pediatric Allergy and Immunology, Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC.
University of North Carolina at Chapel Hill · USUnited States Food and Drug Administration · US

Funding

Virology Research Program (Program 4)P30CA016086 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI David Darr · 1985 to 2026
$201.5M
Re-Entry Supplement: Investigation of Oral Microbial Enzymes for the Detection and Treatment of Periodontal DiseaseUL1TR002489 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, SHAHEEN, NICHOLAS J · 2018 to 2022
$48.6M
North Carolina Translational and Clinical Sciences Institute (NC TraCS)UM1TR004406 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI NICHOLAS J SHAHEEN · 2023 to 2026
$37.5M
RESEARCH TRAINING IN ALLERGY AND CLINICAL IMMUNOLOGYT32AI007062 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI David B. Peden, John W. Sleasman · 1985 to 2026
$6.1M
Sublingual Immunotherapy for Peanut AllergyR01AT004435 · NCCIH · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BURKS, A. WESLEY · 2008 to 2018
$3.6M
Endophenotypes of food allergy in response to oral immunotherapyK23AI130408 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI VIRKUD, YAMINI V · 2018 to 2022
$1.0M
NCATS NIH HHS UL1 TR002489NCATS NIH HHS UM1 TR004406NCCIH NIH HHS R01 AT004435NCI NIH HHS P30 CA016086NIAID NIH HHS K23 AI130408NIAID NIH HHS T32 AI007062
6 · The paper itself

Abstract

backgroundStudies on the efficacy of peanut sublingual immunotherapy (SLIT) are limited. The durability of desensitization after SLIT has not been well described.

objectiveWe sought to evaluate the efficacy and safety of 4-mg peanut SLIT and persistence of desensitization after SLIT discontinuation.

methodsChallenge-proven peanut-allergic 1- to 11-year-old children were treated with open-label 4-mg peanut SLIT for 48 months. Desensitization after peanut SLIT was assessed by a 5000-mg double-blind, placebo-controlled food challenge (DBPCFC). A novel randomly assigned avoidance period of 1 to 17 weeks was followed by the DBPCFC. Skin prick test results immunoglobulin levels, basophil activation test results, T

resultsFifty-four participants were enrolled and 47 (87%) completed peanut SLIT and the 48-month DBPCFC per protocol. The mean successfully consumed dose (SCD) during the DBPCFC increased from 48 to 2723 mg of peanut protein after SLIT (P < .0001), with 70% achieving clinically significant desensitization (SCD > 800 mg) and 36% achieving full desensitization (SCD = 5000 mg). Modeled median time to loss of clinically significant desensitization was 22 weeks. Peanut skin prick test; peanut-specific IgE, IgG4, and IgG4/IgE ratio; and peanut-stimulated basophil activation test, IL-4, IL-5, IL-13, IFN-γ, and IL-10 changed significantly compared with baseline, with changes seen as early as 6 months. Median rate of reaction per dose was 0.5%, with transient oropharyngeal itching being the most common, and there were no dosing symptoms requiring epinephrine.

conclusionsIn this open-label, prospective study, peanut SLIT was safe and induced clinically significant desensitization in most of the children, lasting more than 17 weeks after discontinuation of therapy.

Indexed as

Peanut HypersensitivitySublingual ImmunotherapyAdministration, OralAllergensArachisChildChild, PreschoolDesensitization, ImmunologicHumansImmunoglobulin EImmunoglobulin GInfantInterleukin-10Prospective StudiesAllergensImmunoglobulin EImmunoglobulin GInterleukin-10basophil activation testdesensitizationfood allergyIgEIgG4Peanut allergySLITsublingual immunotherapysustained unresponsiveness

Identifiers

PMID36828080
PMCPMC10257751
OpenAlexW4321483342

What OpenQuestion holds

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Registered trials

None linked

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.