Evidence map›Paper›PMID 39300794›Full record

Trial reportAmerican journal of rhinology & allergy2025

Association Between Smell Loss, Disease Burden, and Dupilumab Efficacy in Chronic Rhinosinusitis with Nasal Polyps.

Zachary M Soler, Zara M Patel, Joaquim Mullol, Jose Mattos, Scott Nash, Changming Xia, Zhixiao Wang, Kinga Borsos, Mark Corbett, Juby A Jacob-Nara and 4 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of rhinology & allergy, 2025. 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 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

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

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

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Article
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.

Zachary M SolerDepartment of Otolaryngology, Head and Neck Surgery, Medical University of South Carolina, Charleston, SC, USA.ORCID 0000-0002-4304-595X
Zara M PatelDepartment of Otolaryngology, Head and Neck Surgery, Stanford University School of Medicine, Stanford, CA, USA.ORCID 0000-0003-2072-982X
Joaquim MullolRhinology Unit & Smell Clinic, ENT Department, Hospital Clínic, FRCB-IDIBAPS, Universitat de Barcelona, CIBERES, Barcelona, Catalonia, Spain.
Jose MattosDepartment of Otolaryngology, Head and Neck Surgery, University of Virginia Health System, Charlottesville, VA, USA.ORCID 0000-0001-8766-1626
Scott NashRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Changming XiaRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Zhixiao WangRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Kinga BorsosSanofi, Cambridge, MA, USA.
Mark CorbettSanofi, Bridgewater, NJ, USA.
Juby A Jacob-NaraSanofi, Bridgewater, NJ, USA.
Harry SacksRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Paul RoweSanofi, Bridgewater, NJ, USA.
Yamo DenizRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Andrew P LaneDepartment of Otolaryngology-Head and Neck Surgery, Johns Hopkins School of Medicine, Baltimore, MD, USA.ORCID 0000-0001-6369-5469

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the association between smell loss and other aspects of disease, and evaluate dupilumab efficacy in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) and moderate or severe smell loss.

methodsThis post-hoc analysis of the SINUS-24/52 studies (NCT02912468/NCT02898454) analyzed nasal polyp score (NPS, 0-8), nasal congestion/obstruction (NC, 0-3), Lund-Mackay CT-scan score (LMK-CT, 0-24), rhinosinusitis severity visual analog scale (RS-VAS, 0-10), and 22-item Sinonasal Outcome Test (SNOT-22, 0-110) according to baseline monthly average patient-reported loss of smell scores (LoS, 0-3) of >1 to 2 (moderate) or >2 to 3 (severe) in patients randomized to dupilumab 300 mg or placebo every 2 weeks.

resultsOf 724 patients randomized, baseline LoS was severe in 601 (83%) and moderate in 106 (15%). At baseline, severe versus moderate LoS was associated with 1-point greater severity of NC (odds ratio [OR] 6.01 [95% confidence interval, (CI) 3.95, 9.15]), 5-point greater severity of LMK-CT (OR 2.19 [1.69, 2.85]), and 8.9-point greater severity of SNOT-22 (OR 1.35 [1.20, 1.49]). At Week 24, least squares mean differences (95% CI) dupilumab versus placebo in change from baseline were: NPS -1.90 (-2.56, -1.25) and -1.95 (-2.20, -1.70) in the moderate and severe baseline LoS subgroups, respectively; NC -.35 (-.64, -.06) and -1.00 (-1.13, -.87); LMK-CT -6.30 (-7.88, -4.72) and -6.22 (-6.82, -5.63); RS-VAS -1.18 (-2.20, -.16) and -3.47 (-3.90, -3.03); and SNOT-22 -7.52 (-14.55, -.48) and -21.72 (-24.63, -18.82); all nominal

conclusionSignificant smell impairment in severe CRSwNP is associated with significant disease (NC, RS-VAS, LMK), health-related quality of life impairment (SNOT-22), asthma, and non-steroidal anti-inflammatory drug-exacerbated respiratory disease. Dupilumab significantly improved NPS, NC, LMK-CT, RS-VAS, and SNOT-22 in subjects with moderate and severe baseline smell loss.

Indexed as

Antibodies, Monoclonal, HumanizedNasal PolypsRhinitisSinusitisAdultChronic DiseaseCost of IllnessFemaleHumansMaleMiddle AgedRhinosinusitisSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizeddupilumabanosmiabiologicCRSwNPdupilumabHRQoLinterleukin-13interleukin-4interleukin-4 receptor alphaolfactionsmell loss

Identifiers

PMID39300794
PMCPMC11626849

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.