Evidence map›Paper›PMID 37016622›Full record

ArticleJournal of asthma and allergy2023

Health-Related Quality of Life Impairment Among Patients with Severe Chronic Rhinosinusitis with Nasal Polyps in the SINUS-24 Trial.

Jorge F Maspero, Asif H Khan, Carl Philpott, Peter W Hellings, Claire Hopkins, Martin Wagenmann, Shahid Siddiqui, Jérôme Msihid, Scott Nash, Chien-Chia Chuang and 4 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal of asthma and allergy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02912468 (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), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
5.4field-weighted citation impact, top 4% 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.

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

11 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Review
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  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Canadian Real-World Study Long-Term Clinical Results Using Dupilumab for Chronic Rhinosinusitis With Polyps.Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale
    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 at 8 institutions in 5 countries.

Jorge F MasperoAllergy & Respiratory Research Unit, Fundación CIDEA, Buenos Aires, Argentina.ORCID 0000-0001-9750-2346
Asif H KhanGlobal Medical Affairs, Sanofi, Chilly-Mazarin, France.ORCID 0000-0001-9158-0116
Carl PhilpottRhinology and ENT Research Group, Norwich Medical School, University of East Anglia, Norwich, UK.ORCID 0000-0002-1125-3236
Peter W HellingsDepartment of Otorhinolaryngology - Head and Neck Surgery, University Hospitals Leuven, Leuven, Belgium.
Claire HopkinsDepartment of Otorhinolaryngology, King's College London, London, UK.
Martin WagenmannDepartment of Otorhinolaryngology, Düsseldorf University Hospital (UKD), Düsseldorf, Germany.ORCID 0000-0002-9734-0241
Shahid SiddiquiMedical Affairs, Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Jérôme MsihidHealth Economics and Value Assessment, Sanofi, Chilly-Mazarin, France.ORCID 0000-0003-4733-5855
Scott NashMedical Affairs, Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.ORCID 0000-0001-9208-5280
Chien-Chia ChuangHealth Economics and Value Assessment, Sanofi, Cambridge, MA, USA.ORCID 0000-0002-0895-4998
Siddhesh KamatMedical Affairs, Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.ORCID 0000-0001-5205-9184
Paul J RoweGlobal Medical Affairs, Sanofi, Bridgewater, NJ, USA.
Yamo DenizMedical Affairs, Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Juby A Jacob-NaraGlobal Medical Affairs, Sanofi, Bridgewater, NJ, USA.ORCID 0000-0002-5372-8762
Regeneron (United States) · USSanofi (France) · FRSanofi (United States) · USAVEO Oncology (United States) · USDüsseldorf University Hospital · DEKing's College London · GBKU Leuven · BEUniversity of East Anglia · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2 inflammatory disease with a high symptom burden. Data are lacking on the comparative health status of patients with CRSwNP. This analysis compared baseline physical and mental health-related quality of life (HRQoL) and overall health status of patients with severe CRSwNP enrolled in a Phase 3 clinical trial with general population norms and with other chronic diseases. Methods: In this post hoc cross-sectional analysis of baseline data from the SINUS-24 study (NCT02912468), HRQoL was measured using the 36-item Short Form (SF-36) questionnaire and general health status was measured using the EuroQol-5 Dimension visual analog scale (EQ-VAS). Analyses included the intention-to-treat (ITT) population and subgroups defined by prior sinonasal surgery, systemic corticosteroid use, and coexisting asthma or non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD). Scores were compared with published values for population norms (50 for SF-36 physical component summary (PCS) and mental component summary (MCS), 70.4-83.3 for EQ-VAS) and for rheumatoid arthritis, type 2 diabetes, and asthma. Results: In the ITT population (n=276), mean SF-36 physical component summary (PCS), SF-36 mental component summary (MCS), and EQ-VAS scores were below general population norms (46.4, 48.6, and 66.0, respectively). Mean SF-36 PCS and EQ-VAS scores were below population norms across all subgroups; mean SF-36 MCS scores were below the population norm in all subgroups except no prior surgery. SF-36 PCS and MCS scores from SINUS-24 were generally similar to other chronic diseases, except SF-36 PCS which was lower in rheumatoid arthritis. EQ-VAS scores in SINUS-24 were lower than in other chronic diseases. HRQoL scores weakly correlated with objective measures of disease severity. Conclusion: In patients with severe CRSwNP, including those with coexisting asthma/NSAID-ERD, HRQoL was worse than population norms and as burdensome as diseases such as type 2 diabetes, asthma, and rheumatoid arthritis.

Indexed as

chronic rhinosinusitis with nasal polypshealth-related quality of lifesymptom burden

Identifiers

PMID37016622
PMCPMC10066887
OpenAlexW4361214643

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.