Evidence map›Paper›PMID 39673367›Full record

Trial reportAllergy2025

Dupilumab as an Adjunct to Oral Immunotherapy in Pediatric Patients With Peanut Allergy.

R Sharon Chinthrajah, Sayantani B Sindher, Kari C Nadeau, Jeffrey G Leflein, Jonathan M Spergel, Daniel H Petroni, Stacie M Jones, Thomas B Casale, Julie Wang, Warner W Carr and 16 more

2 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Allergy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 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.

NCT03682770 phase2completednot on this map

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study in Pediatric Subjects With Peanut Allergy to Evaluate the Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2018 to 2021Enrolled148ConditionsPeanut AllergyArmsDupilumab, Placebo matching dupilumab, AR101
NCT03793608 phase2completednot on this map

A Study to Evaluate the Efficacy and Safety of Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2019 to 2021Enrolled25ConditionsPeanut AllergyArmsDupilumab
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Emerging Paediatric Uses of Dupilumab Beyond Approvals.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2026
    Review
  5. Review
  6. Update on biologic and small molecules treatments in pediatric allergic diseases.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2026
    Review
  7. Review
  8. Review
  9. Basophils in atopic dermatitis: Immunologic roles and clinical implications.Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2026
    Review
  10. Review
  11. Article
  12. Article
  13. Food allergy clinical course in children and adolescents treated with dupilumab for atopic dermatitis.Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2025
    Article
  14. Using Biologics in the Prevention of Anaphylaxis.Current allergy and asthma reports · 2025
    Review
  15. Article
  16. Review
  17. New insights into the mechanisms of childhood food allergies.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2025
    Review
  18. Review
  19. Review
  20. Article
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

26 authors.

R Sharon ChinthrajahSean N. Parker Center for Allergy and Asthma Research at Stanford University, Stanford, California, USA.ORCID https://orcid.org/0000-0003-2467-4256
Sayantani B SindherSean N. Parker Center for Allergy and Asthma Research at Stanford University, Stanford, California, USA.
Kari C NadeauHarvard T.H. Chan School of Public Health, Harvard University, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0002-2146-2955
Jeffrey G LefleinAllergy & Immunology Association of Michigan, Ypsilanti, Michigan, USA.
Jonathan M SpergelChildren's Hospital of Philadelphia, Perelman School of Medicine at University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Daniel H PetroniSeattle Allergy & Asthma Research Institute, Seattle, Washington, USA.
Stacie M JonesDepartment of Pediatrics, Division of Allergy and Immunology, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Arkansas, USA.
Thomas B CasaleDivision of Allergy & Immunology, University of South Florida, Tampa, Florida, USA.
Julie WangDepartment of Pediatrics, Division of Allergy & Immunology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Warner W CarrAllergy & Asthma Associates of Southern California, Food Allergy Center of Southern California, Southern California Research, Mission Viejo, California, USA.
Wayne G ShrefflerFood Allergy Center and Department of Pediatrics, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Robert A WoodDivision of Pediatric Allergy & Immunology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Erik WambreBenaroya Research Institute, Seattle, Washington, USA.ORCID https://orcid.org/0000-0002-3628-0011
Jinzhong LiuRegeneron Pharmaceuticals Inc., Tarrytown, New York, USA.
Bolanle AkinladeRegeneron Pharmaceuticals Inc., Tarrytown, New York, USA.
Amanda AtanasioRegeneron Pharmaceuticals Inc., Tarrytown, New York, USA.
Jamie M OrengoRegeneron Pharmaceuticals Inc., Tarrytown, New York, USA.ORCID https://orcid.org/0000-0002-2695-6508
Jennifer D HamiltonRegeneron Pharmaceuticals Inc., Tarrytown, New York, USA.ORCID https://orcid.org/0000-0003-1236-5245
Mohamed A KamalRegeneron Pharmaceuticals Inc., Tarrytown, New York, USA.
Andrea T HooperRegeneron Pharmaceuticals Inc., Tarrytown, New York, USA.
Kiran PatelFormer Employee, Sanofi, Cambridge, Massachusetts, USA.
Elizabeth LawsSanofi, Bridgewater, New Jersey, USA.
Leda P MannentSanofi, Chilly-Mazarin, France.
Daniel C AdelmanDepartment of Medicine, Allergy/Immunology, University of California, San Francisco, California, USA.
Anoshie RatnayakeAimmune Therapeutics, Brisbane, California, USA.
Allen R RadinRegeneron Pharmaceuticals Inc., Tarrytown, New York, USA.

Funding

Sanofi and Regeneron Pharmaceuticals Inc.
6 · The paper itself

Abstract

backgroundPeanut allergy is a common, life-threatening food allergy in children. We evaluated whether dupilumab, which blocks the activity of interleukin (IL)-4/IL-13, enhances the efficacy of oral immunotherapy (OIT) AR101 in pediatric patients with peanut allergy.

methodsA Phase II, multicenter, randomized, double-blind study was conducted in the USA (NCT03682770) in pediatric patients (6-≤ 17 years old) with confirmed peanut allergy. Patients were randomized 2:1 to receive dupilumab + OIT or placebo + OIT during a 28-40-week up-dosing period. Patients in the dupilumab + OIT group were re-randomized 1:1 and received dupilumab + OIT or placebo + OIT during 24-week OIT maintenance, undergoing a 2044 mg (cumulative) of peanut protein double-blind, placebo-controlled food challenge (DBPCFC) following up-dosing, maintenance, and at 12-week post-treatment follow-up.

resultsThe study enrolled 148 patients, 123 of whom were included in the modified full analysis set, with a mean age of 11.1 years. Dupilumab + OIT treatment (n = 84) led to a 20.2% increase (p < 0.05) in the number of patients who passed a DBPCFC to 2044 mg (cumulative) of peanut protein following the up-dosing period versus placebo (OIT alone, n = 39). Following the OIT maintenance period, continuous dupilumab treatment improved the number of patients who passed a DBPCFC to 2044 mg (cumulative) of peanut protein versus patients continuously on OIT alone (16.6% difference [95% CI -9.7, 42.8], p = 0.2123). Safety was consistent with known dupilumab safety profile.

conclusionsDupilumab provided a modest increase efficacy of OIT in children and adolescents with peanut allergy, though it did not provide protection against OIT-related anaphylaxis.

trial registrationClinicalTrials.gov identifier: NCT03793608.

Indexed as

Antibodies, Monoclonal, HumanizedDesensitization, ImmunologicPeanut HypersensitivityAdministration, OralAdolescentAllergensChildDouble-Blind MethodFemaleHumansImmunoglobulin EMaleTreatment OutcomeAllergensAntibodies, Monoclonal, HumanizeddupilumabImmunoglobulin EchildrendupilumabOITpeanut allergy

Identifiers

PMID39673367
PMCPMC11891407

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.