Evidence map›Paper›PMID 30488542›Full record

Trial reportAllergy2019

Dupilumab reduces local type 2 pro-inflammatory biomarkers in chronic rhinosinusitis with nasal polyposis.

Karin Jonstam, Brian N Swanson, Leda P Mannent, Lars-Olaf Cardell, Nian Tian, Ying Wang, Donghui Zhang, Chunpeng Fan, Gabriele Holtappels, Jennifer D Hamilton and 4 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Allergy, 2019. 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 86 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
86citing papers in PubMed, 8 pooled it
16.8field-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.

NCT01920893 phase2completednot on this map

A Randomized, Double-Blind, Phase 2, Placebo Controlled, 2 Arm Study To Evaluate Dupilumab In Patients With Bilateral Nasal Polyposis And Chronic Symptoms Of Sinusitis

TypeinterventionalSponsorSanofiRan2013 to 2014Enrolled60ConditionsNasal PolypsArmsPlacebo (for dupilumab), Dupilumab, Mometasone furoate nasal spray
NCT06188871 phase4withdrawnnot on this mapstarted 2024, after this paper: background citation

Early Changes in Type 2 Inflammatory Cytokines, Respiratory Oscillometry, and Sinonasal Microbiome With Dupilumab Treatment for Chronic Rhinosinusitis With Nasal Polyps

TypeinterventionalSponsorUniversity of RochesterRan2024 to 2027Enrolled0ConditionsChronic Rhinosinusitis With Nasal PolypsArmsDupilumab
3 · Its place in the literature

Who cites it

86 citing papers in PubMed, 8 syntheses or guidelines pooled it, 167 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  4. Efficacy of different biologics for treating chronic rhinosinusitis with nasal polyps: a network meta-analysis.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 · 2025
    Pooled it
  5. Biologics for chronic rhinosinusitis.The Cochrane database of systematic reviews · 2021
    Pooled it
  6. Guideline
  7. Biologics for chronic rhinosinusitis.The Cochrane database of systematic reviews · 2020
    Pooled it
  8. Guideline
  9. Trial
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  11. Trial
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  16. Review
  17. Article
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  20. Review

26 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 at 5 institutions in 5 countries.

Karin JonstamDivision of ENT Diseases, Department of Clinical Sciences, Intervention and Technology, Karolinska Institute, Stockholm, Sweden.ORCID 0000-0002-0545-8008
Brian N SwansonSanofi, Bridgewater, New Jersey.
Leda P MannentSanofi, Chilly-Mazarin, France.
Lars-Olaf CardellDivision of ENT Diseases, Department of Clinical Sciences, Intervention and Technology, Karolinska Institute, Stockholm, Sweden.ORCID 0000-0003-0538-9580
Nian TianSanofi, Bridgewater, New Jersey.
Ying WangSanofi, Bridgewater, New Jersey.
Donghui ZhangSanofi, Bridgewater, New Jersey.
Chunpeng FanSanofi, Bridgewater, New Jersey.
Gabriele HoltappelsUpper Airways Research Laboratory, Ghent University Hospital, Ghent, Belgium.
Jennifer D HamiltonRegeneron Pharmaceuticals, Inc., Tarrytown, New York.
Annette GrabherSanofi, Berlin, Germany.
Neil M H GrahamRegeneron Pharmaceuticals, Inc., Tarrytown, New York.
Gianluca PirozziSanofi, Bridgewater, New Jersey.
Claus BachertDivision of ENT Diseases, Department of Clinical Sciences, Intervention and Technology, Karolinska Institute, Stockholm, Sweden.ORCID 0000-0003-4742-1665
Sanofi (United States) · USKarolinska University Hospital · SERegeneron (United States) · USSanofi (France) · FRGhent University Hospital · BE

Funding

Regeneron Pharmaceuticals, Inc.Sanofi
6 · The paper itself

Abstract

backgroundChronic rhinosinusitis with nasal polyposis (CRSwNP) is a type 2-mediated inflammatory disease associated with significant clinical, social, and economic burdens and high unmet therapeutic need. Dupilumab, a fully human monoclonal antibody targeting the interleukin-4 receptor α (IL-4Rα) subunit, demonstrated efficacy and acceptable safety in CRSwNP and other type 2 diseases (eg, atopic dermatitis and asthma). We now report the local effects of dupilumab on type 2 inflammatory biomarkers in nasal secretions and nasal polyp tissues of patients with CRSwNP in a randomized, placebo-controlled, phase 2 trial (NCT01920893).

methodsCytokines, chemokines, and total immunoglobulin E (IgE) levels were measured using immunoassay techniques in nasal secretions and nasal polyp tissue homogenates of CRSwNP patients receiving dupilumab 300 mg or placebo weekly for 16 weeks.

resultsWith dupilumab, type 2 biomarker concentrations decreased in nasal secretions (least squares mean area under the curve from 0 to 16 weeks for the change from baseline) vs placebo for eotaxin-3 (-30.06 vs -0.86 pg/mL; P = 0.0008) and total IgE (-7.90 vs -1.86 IU/mL; P = 0.022). Dupilumab treatment also decreased type 2 biomarker levels in nasal polyp tissues at Week 16 vs baseline for eosinophilic cationic protein (P = 0.008), eotaxin-2 (P = 0.008), eotaxin-3 (P = 0.031), pulmonary and activation-regulated chemokine (P = 0.016), IgE (P = 0.023), and IL-13 (P = 0.031).

conclusionsDupilumab treatment reduced multiple biomarkers of type 2 inflammation in nasal secretions and polyp tissues of patients with CRSwNP, demonstrating that antagonism of IL-4Rα signaling suppresses IL-4-/IL-13-dependent processes, such as mucosal IgE formation, as well as the expression of chemokines attracting inflammatory cells to the nasal mucosa.

Indexed as

Nasal PolypsAdultAntibodies, Monoclonal, HumanizedBiomarkersChronic DiseaseCytokinesHumansImmunoglobulin EInflammationInterleukin-13Interleukin-4MaleMiddle AgedRhinitisSinusitisAntibodies, Monoclonal, HumanizedBiomarkersCytokinesdupilumabIL4 protein, humanImmunoglobulin EInterleukin-13Interleukin-4biomarkersdupilumabnasal polyposisnasal secretionstype 2 inflammation

Identifiers

PMID30488542
PMCPMC6590149
OpenAlexW2902877715

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.