Evidence map›Paper›PMID 35034364›Full record

Trial reportAllergy2022

Dupilumab improves health related quality of life: Results from the phase 3 SINUS studies.

Stella E Lee, Claire Hopkins, Joaquim Mullol, Jérôme Msihid, Isabelle Guillemin, Nikhil Amin, Leda P Mannent, Yongtao Li, Shahid Siddiqui, Chien-Chia Chuang and 2 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized 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 2 registered trials, which are not on this map. Cited by 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed
11.5field-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

31 citing papers in PubMed, 57 citations in OpenAlex.

  1. Trial
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  8. Observational
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  13. The sinus surgery completeness score: a radiological assessment of the extent of endoscopic sinus surgery.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 · 2025
    Article
  14. Observational
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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
    Review
  20. 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

12 authors at 6 institutions in 4 countries.

Stella E LeeDivision of Otolaryngology-Head & Neck Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Claire HopkinsENT Department, Guy's and St Thomas' Hospitals, King's College London, London, UK.
Joaquim MullolHospital Clínic, IDIBAPS, Universitat de Barcelona, CIBERES, Barcelona, Spain.
Jérôme MsihidSanofi, Chilly-Mazarin, France.
Isabelle GuilleminSanofi, Lyon, France.
Nikhil AminRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Leda P MannentSanofi, Chilly-Mazarin, France.
Yongtao LiSanofi, Bridgewater, New Jersey, USA.
Shahid SiddiquiRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Chien-Chia ChuangSanofi, Cambridge, Massachusetts, USA.
Siddhesh KamatRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Asif H KhanSanofi, Chilly-Mazarin, France.
Sanofi (France) · FRRegeneron (United States) · USSanofi (United States) · USHarvard University · USHospital Clínic de Barcelona · ESKing's College London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2-mediated inflammatory disease with high symptom burden and reduced health-related quality of life (HRQoL). This report aimed to comprehensively understand the effects of dupilumab on domains of HRQoL, their individual elements, and health status in patients with severe CRSwNP from phase 3 SINUS-24 (NCT02912468) and SINUS-52 (NCT02898454) trials.

methodsPatients were randomized to dupilumab (n = 438) or placebo (n = 286) for 24 weeks (SINUS-24), or 52 weeks (SINUS-52). Disease-specific HRQoL using 22-item sino-nasal outcome test (SNOT-22), and health status using EuroQoL-visual analog scale (EQ-VAS) was evaluated in the pooled intention-to-treat (ITT) population (Week 24), SINUS-52 ITT (Week 52) and in the subgroups with/without asthma; non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD); and prior sinus surgery.

resultsAt baseline, patients had poor disease-specific HRQoL and general health status and identified "Decreased sense of smell/taste" and "Nasal blockage" as the most important symptoms. Dupilumab significantly improved SNOT-22 total, domain (Nasal, Sleep, Function, Emotion, and Ear/facial), and 22-item scores, and EQ-VAS, at Week 24 vs placebo (all p < .0001), with continued improvements to Week 52 in SINUS-52. Improvements occurred irrespective of comorbid asthma, NSAID-ERD, or prior surgery. A significantly greater proportion of dupilumab-treated patients exceeded clinically meaningful thresholds for SNOT-22 total score and EQ-VAS vs placebo (all subgroups p < .05 except patients without surgery at Week 24).

conclusionsDupilumab treatment led to significant clinically meaningful improvements across all aspects of disease-specific HRQoL, and general health status in patients with severe CRSwNP.

Indexed as

Antibodies, Monoclonal, HumanizedNasal PolypsQuality of LifeRhinitisSinusitisAnti-Inflammatory Agents, Non-SteroidalAsthmaChronic DiseaseHumansTreatment OutcomeAntibodies, Monoclonal, HumanizedAnti-Inflammatory Agents, Non-SteroidaldupilumabcomorbiditiesCRSwNPdupilumabHRQoLSNOT-22

Identifiers

PMID35034364
PMCPMC9305228
OpenAlexW4206412030

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.