Evidence map›Paper›PMID 40884290›Full record

Trial reportThe Laryngoscope2025

Effectiveness and Safety of Dupilumab Monotherapy in Japanese Patients With Chronic Rhinosinusitis With Nasal Polyps.

Shigeharu Fujieda, Tetsuji Takabayashi, Nobuo Ohta, Mamoru Yoshikawa, Yuki Kibe, Masato Ishida, Katsuhisa Suzuki, Yoshinori Takahashi, Nikhil Amin, Lakiea Wright and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IVMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Laryngoscope, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05049122 (A Single-arm, 52 Weeks, Phase 4 Study to Assess the Efficacy and Safety of Dupilumab in Patients With Chronic Rhinosinusitis With Nasal Polyposis), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 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.

NCT05049122 phase4completednot on this map

A Single-arm, 52 Weeks, Phase 4 Study to Assess the Efficacy and Safety of Dupilumab in Patients With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) Who Are Not Adequately Controlled With Existing Therapies

TypeinterventionalSponsorSanofiRan2021 to 2023Enrolled25ConditionsChronic Rhinosinusitis With Nasal PolypsArmsDupilumab SAR231893
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  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. Trial
  3. 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

12 authors.

Shigeharu FujiedaDepartment of Otorhinolaryngology-Head and Neck Surgery, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.
Tetsuji TakabayashiDepartment of Otorhinolaryngology-Head and Neck Surgery, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.ORCID 0000-0002-0012-149X
Nobuo OhtaDivision of Otolaryngology, Tohoku Medical and Pharmaceutical University, Sendai, Japan.ORCID 0000-0002-2821-6976
Mamoru YoshikawaDepartment of Otorhinolaryngology, Toho University Ohashi Medical Center, Tokyo, Japan.
Yuki KibeSanofi K.K, Tokyo, Japan.
Masato IshidaSanofi K.K, Tokyo, Japan.
Katsuhisa SuzukiSanofi K.K, Tokyo, Japan.
Yoshinori TakahashiSanofi K.K, Tokyo, Japan.
Nikhil AminClinical Sciences, Immunology and Inflammation, Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Lakiea WrightSanofi, Cambridge, Massachusetts, USA.
Lacey RobinsonSanofi, Cambridge, Massachusetts, USA.
Kenji YahataSanofi K.K, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe randomized, double-blind, placebo-controlled LIBERTY SINUS-24 and SINUS-52 studies demonstrated that dupilumab is effective for chronic rhinosinusitis with nasal polyps (CRSwNP) when used with an intranasal corticosteroid (INCS); however, INCSs are not approved for CRSwNP in Japan. The current study aimed to investigate the effectiveness and safety of dupilumab monotherapy in Japanese individuals with CRSwNP.

methodsThis phase 4, open-label, single-arm, multicenter study enrolled adult individuals with CRSwNP inadequately controlled with standard care therapies, including systemic corticosteroids and/or surgery. Subcutaneous dupilumab 300 mg was administered every 2 weeks; in participants with stable disease at week 24 (improvement of ≥ 2 points in the Nasal Polyp Score [NPS] from baseline at weeks 16 and 24), the dosing interval could be modified to every 4 weeks. The primary endpoint was the proportion of responders at week 24.

resultsThe study included 25 individuals with CRSwNP (mean ± standard deviation age of 53.4 ± 13.6 years; 60.0% male). At week 24, 23 participants (92.0%) were considered responders to dupilumab. Reductions from baseline to week 24 in bilateral endoscopic NPS (mean change -2.4), nasal congestion severity score (-1.58), and Lund-Mackay scores (-5.6) were observed with dupilumab. Dupilumab was well tolerated; over 52 weeks, 16 participants (69.6%) experienced a treatment-emergent adverse event (TEAE). Most TEAEs were mild in severity; moderate and severe TEAEs were reported in five (21.7%) and one (4.3%) participant, respectively.

conclusionDupilumab monotherapy was effective and well tolerated in Japanese individuals with symptomatic CRSwNP. LEVEL OF EVIDENCE: 3:

trial registrationClinicalTrials.gov identifier: NCT05049122.

Indexed as

Antibodies, Monoclonal, HumanizedNasal PolypsRhinitisSinusitisAdultAgedChronic DiseaseEast Asian PeopleFemaleHumansInjections, SubcutaneousJapanMaleMiddle AgedRhinosinusitisTreatment OutcomeAntibodies, Monoclonal, Humanizeddupilumabclinical trial, phase IVJapanmonoclonal antibodiesnasal polypsrhinosinusitis

Identifiers

PMID40884290
PMCPMC12706541

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.