Evidence map›Paper›PMID 34817082›Full record

Trial reportThe Laryngoscope2022

Dupilumab in CRSwNP: Responder Analysis Using Clinically Meaningful Efficacy Outcome Thresholds.

Chien-Chia Chuang, Isabelle Guillemin, Claus Bachert, Stella E Lee, Peter W Hellings, Wytske J Fokkens, Nicolas Duverger, Chunpeng Fan, Nadia Daizadeh, Nikhil Amin and 3 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Laryngoscope, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 5% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Platelet-to-lymphocyte ratio might predict the response to dupilumab treatment for patients with nasal polyposis.Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale · 2023
    Article
  11. Review
  12. Article
  13. Biological Therapy of Severe Asthma and Nasal Polyps.Journal of personalized medicine · 2022
    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

13 authors at 8 institutions in 7 countries.

Chien-Chia ChuangHealth Economics and Value Assessment, Sanofi, Cambridge, Massachusetts, U.S.A.ORCID 0000-0002-0895-4998
Isabelle GuilleminPatient Reported Outcomes, Sanofi, Lyon, France.
Claus BachertUpper Airways Research Laboratory and Department of Otorhinolaryngology, Ghent University, Ghent, Belgium.
Stella E LeeDivision of Otolaryngology-Head & Neck Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, U.S.A.
Peter W HellingsUpper Airways Research Laboratory and Department of Otorhinolaryngology, Ghent University, Ghent, Belgium.
Wytske J FokkensDepartment of Otorhinolaryngology, Amsterdam University Medical Centres, Location AMC, Amsterdam, The Netherlands.
Nicolas DuvergerDivision of Immuno-inflammation, Sanofi, Chilly-Mazarin, France.
Chunpeng FanDepartment of Biostatistics and Programming, Sanofi, Bridgewater, New Jersey, U.S.A.
Nadia DaizadehBiostatistics, Sanofi, Cambridge, Massachusetts, U.S.A.
Nikhil AminClinical Sciences Global Development, Regeneron Pharmaceuticals, Inc., Tarrytown, New York, U.S.A.
Leda P MannentGlobal Clinical Development, Sanofi, Chilly-Mazarin, France.
Asif H KhanGlobal Medical Affairs, Sanofi, Chilly-Mazarin, France.
Siddhesh KamatMedical Affairs, Regeneron Pharmaceuticals, Inc., Tarrytown, New York, U.S.A.
Sanofi (France) · FRRegeneron (United States) · USAmsterdam University Medical Centers · NLAVEO Oncology (United States) · USBrigham and Women's Hospital · USGhent University Hospital · BESanofi (United States) · USSun Yat-sen University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectives/hypothesisDupilumab, a fully human monoclonal antibody that blocks the shared interleukin (IL)-4/IL-13 receptor component, significantly improved outcomes for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) in the SINUS-24 and SINUS-52 studies. This post hoc analysis evaluated dupilumab's effect on patient-reported symptoms and objective outcome measures using thresholds of clinically meaningful within-patient change from baseline.

methodsPatients with CRSwNP receiving subcutaneous dupilumab or placebo every 2 weeks in SINUS-24/SINUS-52 were analyzed. Patients recorded severity of nasal congestion (NC), loss of smell (LoS), and anterior/posterior rhinorrhea (each within range 0-3) daily. Total Symptom Score (TSS) was calculated as a composite severity score (0-9) for these symptoms. Objective measures included University of Pennsylvania Smell Identification Test (UPSIT; 0-40), nasal polyps score (NPS; 0-8), and Lund-Mackay computed tomography score (LMK-CT; 0-24). Thresholds of within-patient change in scores from baseline at weeks 24 and 52 considered clinically meaningful were ≥1.0 (NC, LoS), ≥3.0 (TSS), ≥8.0 (UPSIT), ≥1.0 (NPS), and ≥5.0 (LMK-CT).

resultsA total of 724 and 303 patients were included in the week 24 and 52 analyses, respectively. Responder rates were significantly higher with dupilumab versus placebo at week 24 for NC (64% vs. 24%), LoS (63% vs. 14%), TSS (62% vs. 15%), UPSIT (54% vs. 6%), NPS (63% vs. 14%), and LMK-CT (59% vs. 3%); all P < .0001. Results were consistent at week 52.

conclusionSignificantly greater proportions of dupilumab-treated patients with CRSwNP compared with placebo demonstrated clinically meaningful improvements in patient-reported sinonasal symptoms and objective outcomes. LEVEL OF EVIDENCE: 2 Laryngoscope, 132:259-264, 2022.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedChronic DiseaseDouble-Blind MethodFemaleHumansMaleMiddle AgedNasal PolypsPatient Reported Outcome MeasuresRhinitisSinusitisTreatment OutcomeAntibodies, Monoclonal, HumanizeddupilumabAdult rhinologynose and paranasal sinusesquality of life

Identifiers

PMID34817082
PMCPMC9299704
OpenAlexW3215930918

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.