Evidence map›Paper›PMID 33993501›Full record

Trial reportAllergy2022

Dupilumab efficacy in chronic rhinosinusitis with nasal polyps from SINUS-52 is unaffected by eosinophilic status.

Shigeharu Fujieda, Shoji Matsune, Sachio Takeno, Nobuo Ohta, Mikiya Asako, Claus Bachert, Tomoyuki Inoue, Yoshinori Takahashi, Hiroyuki Fujita, Yamo Deniz and 4 more

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

Trial report in Allergy, 2022. 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 40 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 3 pooled it
13.3field-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.

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

40 citing papers in PubMed, 3 syntheses or guidelines pooled it, 93 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
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  19. Efficacy of Biologics in NSAID-ERD: United Airways From the Nose to the Bronchi.The journal of allergy and clinical immunology. In practice · 2024
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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 10 institutions in 5 countries.

Shigeharu FujiedaDepartment of Otorhinolaryngology-Head & Neck Surgery, Fukui, Japan.ORCID 0000-0002-9460-7377
Shoji MatsuneNippon Medical School, Musashi Kosugi Hospital, Kanagawa, Japan.
Sachio TakenoDepartment of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Nobuo OhtaDepartment of Otolaryngology, Tohoku Medical and Pharmaceutical University, Sendai, Japan.
Mikiya AsakoDepartment of Otolaryngology, Kansai Medical University, Osaka, Japan.
Claus BachertDepartment of Ear, Nose, and Throat Science, Ghent University, Ghent, Belgium.ORCID 0000-0003-4742-1665
Tomoyuki InoueSanofi K.K., Tokyo, Japan.
Yoshinori TakahashiSanofi K.K., Tokyo, Japan.
Hiroyuki FujitaSanofi K.K., Tokyo, Japan.
Yamo DenizRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Paul RoweSanofi, Bridgewater, NJ, USA.
Benjamin OrtizRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Yongtao LiSanofi, Bridgewater, NJ, USA.
Leda P MannentSanofi France, Chilly-Mazarin, Île-de-France, France.
Sanofi (Japan) · JPRegeneron (United States) · USSanofi (United States) · USHiroshima University · JPKansai Medical University · JPKarolinska Institutet · SENippon Medical School Musashi Kosugi Hospital · JPSanofi (France) · FRTohoku Medical and Pharmaceutical University · JPUniversity of Fukui · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe human monoclonal antibody dupilumab blocks interleukin (IL)-4 andIL-13, key and central drivers of type 2 inflammation. Dupilumab, on background mometasone furoate nasal spray (MFNS), improved outcomes in the phase III SINUS-52 study (NCT02898454) in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP). This posthoc analysis of SINUS-52 examined whether eosinophilic status of CRSwNP was a predictor of dupilumab efficacy.

methodsPatients were randomized 1:1:1 to dupilumab 300 mg every 2 weeks (q2w) until week 52; dupilumab 300 mg q2w until Week 24, then 300 mg every 4 weeks until week 52; or placebo (MFNS) until week 52. Coprimary endpoints were change from baseline in nasal polyps score (NPS), nasal congestion (NC), and Lund-Mackay score assessed by CT (LMK-CT) at week 24. Patients (n = 438) were stratified by eosinophilic chronic rhinosinusitis (ECRS) status according to the Japanese Epidemiological Survey of Refractory Eosinophilic Rhinosinusitis algorithm.

resultsDupilumab significantly improved NPS, NC, and LMK-CT scores versus placebo at week 24 in all ECRS subgroups (p < 0.001), with improvements maintained or increased at week 52 (p < 0.001). There was no significant interaction between ECRS subgroup (non-/mild or moderate/severe) and dupilumab treatment effect for all endpoints at weeks 24 and 52 (p > 0.05), except LMK-CT at week 24 (p = 0.0275). Similar results were seen for the secondary endpoints. Dupilumab was well tolerated across all ECRS subgroups.

conclusionDupilumab produced consistent improvement in symptoms of severe CRSwNP irrespective of ECRS status. Therefore, blood eosinophil level may not be a suitable biomarker for dupilumab efficacy in CRSwNP.

Indexed as

Nasal PolypsRhinitisAntibodies, Monoclonal, HumanizedChronic DiseaseHumansQuality of LifeTreatment OutcomeAntibodies, Monoclonal, HumanizeddupilumabbiologicsENT (rhinitiseosinophilsinflammationnasal polyps)sinusitis

Identifiers

PMID33993501
PMCPMC9290136
OpenAlexW3161025193

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.