Evidence map›Paper›PMID 33611847›Full record

Trial reportInternational forum of allergy & rhinology2021

Efficacy of dupilumab in patients with a history of prior sinus surgery for chronic rhinosinusitis with nasal polyps.

Claire Hopkins, Martin Wagenmann, Claus Bachert, Martin Desrosiers, Joseph K Han, Peter W Hellings, Stella E Lee, Jérôme Msihid, Amr Radwan, Paul Rowe and 5 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International forum of allergy & rhinology, 2021. 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 44 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 3 pooled it
11.7field-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
NCT02912468 phase3completednot on this map

A Randomized, 24-Week Treatment, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab 300 mg Every Other Week, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids

TypeinterventionalSponsorSanofiRan2016 to 2018Enrolled276ConditionsChronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)ArmsDupilumab SAR231893 (REGN668), Placebo, Mometasone furoate 50 micrograms
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 3 syntheses or guidelines pooled it, 82 citations in OpenAlex.

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  15. Stem Cell Niches for Olfactory Regeneration and Their Therapeutic Applications.Journal of rhinology : official journal of the Korean Rhinologic Society · 2025
    Review
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  19. Comparison between clinical and cytological findings in chronic rhinosinusitis with nasal polyps treated with Dupilumab.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 · 2024
    Article
  20. Efficacy and safety of dupilumab in the treatment of CRSwNP in the real-life setting: a review of the literature.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 · 2024
    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

15 authors at 10 institutions in 8 countries.

Claire HopkinsENT Department, Guy's and St Thomas' Hospitals, London, UK.ORCID 0000-0003-3993-1569
Martin WagenmannDepartment of Otorhinolaryngology, Düsseldorf University Hospital (UKD), Düsseldorf, Germany.ORCID 0000-0002-9734-0241
Claus BachertDepartment of Otorhinolaryngology, Ghent University, Ghent, Belgium.
Martin DesrosiersDepartment of Otorhinolaryngology, Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Montréal, QC, Canada.
Joseph K HanDivision of Allergy, Rhinology and Skull Base Surgery, Eastern Virginia Medical School, Norfolk, VA, USA.
Peter W HellingsDepartment of Otorhinolaryngology, University Hospitals Leuven, Leuven, Belgium.
Stella E LeeDepartment of Otorhinolaryngology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Jérôme MsihidSanofi, Chilly-Mazarin, France.
Amr RadwanRegeneron Pharmaceuticals, Inc., Uxbridge, London, UK.
Paul RoweSanofi, Bridgewater, NJ, USA.
Nikhil AminRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Yamo DenizRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Benjamin OrtizRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Leda P MannentSanofi, Chilly-Mazarin, France.
Rajesh RoutSanofi Genzyme, Reading, UK.
Regeneron (United States) · USSanofi (France) · FRCentre Hospitalier de l’Université de Montréal · CADüsseldorf University Hospital · DEEastern Virginia Medical School · USKU Leuven · BESanofi (United States) · USSt Thomas' Hospital · GBUniversity College Ghent · BEUniversity of Pittsburgh Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic rhinosinusitis with nasal polyps (CRSwNP) is a type 2 inflammatory disease treated with sinus surgery when refractory to medical intervention. However, recurrence postsurgery is common. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor for interleukin 4 (IL-4) and IL-13, key and central drivers of type 2 inflammation. We report the efficacy of dupilumab in patients with CRSwNP from the SINUS-24/SINUS-52 trials (NCT02912468/NCT02898454), by number of prior surgeries and time since last surgery.

methodsPatients were randomized to placebo or dupilumab 300 mg every 2 weeks. Post hoc subgroup analyses were performed for patients with 0, ≥1, 1/2, or ≥3 prior surgeries, and for patients who had surgery within <3, 3 to <5, 5 to <10, or ≥10 years. Efficacy outcomes at 24 weeks included co-primary endpoints nasal polyp score (NPS) and nasal congestion (NC), and Lund-Mackay (LMK), 22-item Sino-Nasal Outcome Test (SNOT-22), and smell scores.

resultsOf 724 patients randomized, 459 (63.4%) had ≥1 prior surgery. Baseline sinus disease (NPS, NC, LMK) and olfactory dysfunction (University of Pennsylvania Smell Identification Test [UPSIT] and loss of smell) scores were worse for patients with ≥3 prior surgeries vs no surgery. Baseline NPS and LMK were worse in patients with <3 years since last surgery than in patients with ≥5 years since last surgery. Dupilumab significantly improved all outcome measures vs placebo in all subgroups by number of surgeries and by time since last surgery. Improvements in NPS and LMK were greater in patients with <3 years since last surgery than patients with ≥5 years. Safety results were consistent with the known dupilumab safety profile.

conclusionDupilumab improved CRSwNP outcomes irrespective of surgery history, with greater improvements in endoscopic outcomes in patients with shorter duration since last surgery.

Indexed as

Nasal PolypsRhinitisAntibodies, Monoclonal, HumanizedChronic DiseaseHumansQuality of LifeTreatment OutcomeAntibodies, Monoclonal, Humanizeddupilumabchronic diseasechronic rhinosinusitissinus surgerysubcutaneous immunotherapytherapeutics

Identifiers

PMID33611847
PMCPMC8359289
OpenAlexW3132168886

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.