Evidence map›Paper›PMID 33226139›Full record

Trial reportThe Laryngoscope2021

The Effect of Dupilumab on Intractable Chronic Rhinosinusitis with Nasal Polyps in Japan.

Shigeharu Fujieda, Shoji Matsune, Sachio Takeno, Mikiya Asako, Makiko Takeuchi, Hiroyuki Fujita, Yoshinori Takahashi, Nikhil Amin, Yamo Deniz, Paul Rowe and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Laryngoscope, 2021. 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 28 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 7 pooled it
5.5field-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

28 citing papers in PubMed, 7 syntheses or guidelines pooled it, 55 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. Pooled it
  4. Pooled it
  5. Pooled it
  6. 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
  7. Geographic Disparities in Evidence Investigating the Use of Biologics in Chronic Rhinosinusitis.Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale
    Pooled it
  8. Trial
  9. Observational
  10. Review
  11. Observational
  12. Article
  13. Article
  14. Correlation of sino-nasal outcome test and nasal polyp score in dupilumab-treated chronic rhinosinusitis with nasal polyps.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
    Article
  15. Review
  16. Biologic Therapies across Nasal Polyp Subtypes.Journal of personalized medicine · 2024
    Review
  17. Article
  18. Article
  19. Article
  20. Review
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

11 authors at 8 institutions in 3 countries.

Shigeharu FujiedaUniversity of Fukui, Fukui, Japan.ORCID 0000-0002-9460-7377
Shoji MatsuneNippon Medical School, Musashi Kosugi Hospital, Kanagawa, Japan.
Sachio TakenoGraduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.ORCID 0000-0002-9853-2501
Mikiya AsakoKansai Medical University, Osaka, Japan.
Makiko TakeuchiSanofi K.K, Tokyo, Japan.
Hiroyuki FujitaSanofi K.K, Tokyo, Japan.
Yoshinori TakahashiSanofi K.K, Tokyo, Japan.
Nikhil AminRegeneron Pharmaceuticals, Inc, Tarrytown, New York, U.S.A.
Yamo DenizRegeneron Pharmaceuticals, Inc, Tarrytown, New York, U.S.A.
Paul RoweSanofi, Bridgewater, New Jersey, U.S.A.
Leda MannentSanofi, Chilly-Mazarin, France.
Sanofi (Japan) · JPRegeneron (United States) · USHiroshima University · JPKansai Medical University · JPNippon Medical School Musashi Kosugi Hospital · JPSanofi (France) · FRSanofi (United States) · USUniversity of Fukui · JP

Funding

Regeneron Pharmaceuticals, Inc.Sanofi and Regeneron Pharmaceuticals, IncSanofi Genzyme
6 · The paper itself

Abstract

objectives/hypothesisDupilumab, which blocks the shared receptor component for interleukin-4 and interleukin-13, reduced polyp size, sinus opacification, and symptom severity, and was well tolerated in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) in the SINUS-52 study (NCT02898454). We assessed dupilumab in patients enrolled at Japanese centers.

methodsPatients on a background of mometasone furoate nasal spray, received dupilumab 300 mg every 2 weeks (q2w) for 52 weeks (Arm A); dupilumab 300 mg q2w for 24 weeks, followed by every 4 weeks (q4w) for 28 weeks (Arm B); or placebo (Arm C). Co-primary endpoints were week 24 nasal polyp score (NPS), nasal congestion (NC) score, and sinus Lund-Mackay CT (LMK-CT) scores. Symptoms, sense of smell, health-related quality of life, and safety were assessed during the 52-week treatment period.

resultsOf 49 patients enrolled in Japan, 45 completed the study. Week 24 least squares (LS) mean improvement versus placebo were as follows: NPS (Arm A: -3.1, P < .0001; Arm B: -2.1, P = .0011); NC score (Arm A: -1.2, P < .0001; Arm B: -0.9, P < .0001); and LMK-CT (Arm A: -5.1, P = .0005; Arm B: -2.8, P = .0425). The most common treatment-emergent adverse event in dupilumab and placebo-treated patients was nasopharyngitis.

conclusionDupilumab provided rapid, significant, and clinically meaningful improvements for patients with CRSwNP in Japan. Dupilumab was well tolerated, and safety and efficacy were consistent with the overall study population. LEVEL OF EVIDENCE: 2 Laryngoscope, 131:E1770-E1777, 2021.

Indexed as

AdultAntibodies, Monoclonal, HumanizedChronic DiseaseDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansJapanMaleMiddle AgedMometasone FuroateNasal PolypsNasal SpraysRhinitisSeverity of Illness IndexAntibodies, Monoclonal, HumanizeddupilumabMometasone FuroateNasal SpraysChronic rhinosinusitisefficacyimmunotherapyJapanesenasal polyps

Identifiers

PMID33226139
PMCPMC8247406
OpenAlexW3107155720

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.