Evidence map›Paper›PMID 37322842›Full record

Trial reportThe Annals of otology, rhinology, and laryngology2023

Effect of Dupilumab on Type 2 Biomarkers in Chronic Rhinosinusitis With Nasal Polyps: SINUS-52 Study Results.

Claus Bachert, Tanya M Laidlaw, Seong H Cho, Joaquim Mullol, Brian N Swanson, Souad Naimi, Marion Classe, Sivan Harel, Alexandre Jagerschmidt, Elizabeth Laws and 4 more

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

Trial report in The Annals of otology, rhinology, and laryngology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02898454 (A Randomized, Double-blind, 52-week, Placebo Controlled Efficacy and Safety Study of Dupilumab, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
8.1field-weighted citation impact, top 2% 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.

NCT02898454 phase3completednot on this map

A Randomized, Double-blind, 52-week, Placebo Controlled Efficacy and Safety Study of Dupilumab, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids

TypeinterventionalSponsorSanofiRan2016 to 2018Enrolled448ConditionsChronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)ArmsDupilumab SAR231893 (REGN668), Placebo, Mometasone furoate nasal spray
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Dupilumab Extended Interval Dosing in Chronic Rhinosinusitis With Nasal Polyps: A Systematic Review and Meta-analysis.Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2026
    Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Dupilumab Dampens Mucosal Type 2 Response During Acetylsalicylic Acid Challenge in N-ERD Patients.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2026
    Article
  7. Review
  8. [Progress and prospects of anti-IL-4/IL-13 monoclonal antibody treatment in chronic rhinosinusitis with nasal polyps].Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery · 2025
    Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Efficacy of Biologics in NSAID-ERD: United Airways From the Nose to the Bronchi.The journal of allergy and clinical immunology. In practice · 2024
    Review
  15. Article
  16. Review
  17. Clinical, laboratory, and histopathological factors associated with revision surgery in chronic rhinosinusitis with nasal polyps.Romanian journal of morphology and embryology = Revue roumaine de morphologie et embryologie
    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

14 authors at 9 institutions in 6 countries.

Claus BachertDepartment of Otorhinolaryngology - Head and Neck Surgery, University Hospital of Münster, Münster, Germany.ORCID 0000-0003-4742-1665
Tanya M LaidlawDivision of Allergy and Clinical Immunology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Seong H ChoDivision of Allergy-Immunology, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.ORCID 0000-0003-0933-953X
Joaquim MullolRhinology Unit & Smell Clinic, ENT Department, Hospital Clínic, IDIBAPS, Universitat de Barcelona, CIBERES, Barcelona, Catalonia, Spain.
Brian N SwansonCollege of Life Sciences, Thomas Jefferson University, Philadelphia, PA, USA.
Souad NaimiMolecular and Digital Histopathology, Sanofi, Vitry-sur-Seine, France.
Marion ClassePathology Department, Institut Gustave Roussy, Villejuif, France.
Sivan HarelClinical Sciences Global Development, Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Alexandre JagerschmidtGlobal Clinical Development, Sanofi, Chilly-Mazarin, France.
Elizabeth LawsImmunology and Inflammation Global Development, Sanofi, Bridgewater, NJ, USA.
Marcella RuddyClinical Sciences Global Development, Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Amy PraestgaardDepartment of Biostatistics, Sanofi, Cambridge, MA, USA.
Nikhil AminClinical Sciences Global Development, Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Leda P MannentGlobal Clinical Development, Sanofi, Chilly-Mazarin, France.
Regeneron (United States) · USSanofi (France) · FRSanofi (United States) · USBrigham and Women's Hospital · USHospital Clínic de Barcelona · ESInstitut Gustave Roussy · FRSun Yat-sen University · CNThomas Jefferson University · USUniversity of South Florida · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesChronic rhinosinusitis with nasal polyps (CRSwNP), asthma, and non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD) are frequent coexisting conditions and share type 2 inflammatory pathophysiology, with interleukin (IL)-4 and IL-13 as key cytokines. Dupilumab is a monoclonal antibody that blocks the shared receptor for IL-4 and IL-13. The objective of this analysis was to evaluate dupilumab's effect on type 2 inflammation biomarkers in patients with CRSwNP with/without coexisting asthma or NSAID-ERD from the SINUS-52 (NCT02898454) study.

methodsPatients received treatment with dupilumab or placebo for 52 weeks. Blood and urinary biomarkers were evaluated through 52 weeks, and nasal secretions and mucosa brushings through 24 weeks.

resultsOf 447 patients, 60% had coexisting asthma and 27% had coexisting NSAID-ERD. At baseline, blood eotaxin-3, eosinophils, and periostin, nasal secretion eotaxin-3, and urinary leukotriene E

conclusionDupilumab reduced local and systemic type 2 inflammatory biomarkers in patients with CRSwNP, including mast cells in nasal mucosa and cysteinyl leukotrienes in urine. These findings provide insight into the processes driving CRSwNP and the mechanisms of dupilumab's therapeutic effects. CLINICAL TRIAL REGISTRY NAME: SINUS-52 https://www.clinicaltrials.gov/ct2/show/NCT02898454. CLINICALTRIALS.GOV IDENTIFIER: NCT02898454.

Indexed as

Antibodies, Monoclonal, HumanizedAsthmaNasal PolypsRhinitisSinusitisAdultAnti-Inflammatory Agents, Non-SteroidalBiomarkersCell Adhesion MoleculesChemokine CCL26Chronic DiseaseDouble-Blind MethodEosinophilsFemaleHumansLeukotriene E4Antibodies, Monoclonal, HumanizedAnti-Inflammatory Agents, Non-SteroidalBiomarkersCCL26 protein, humanCell Adhesion MoleculesChemokine CCL26dupilumabLeukotriene E4POSTN protein, humanasthmabiomarkerscomorbiditiesCRSwNPdupilumabNSAID-ERDtype 2 inflammation

Identifiers

PMID37322842
PMCPMC10571440
OpenAlexW4380869559

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.