Evidence map›Paper›PMID 34459002›Full record

ArticleAllergy2022

Efficacy and safety of dupilumab in patients with uncontrolled severe chronic rhinosinusitis with nasal polyps and a clinical diagnosis of NSAID-ERD: Results from two randomized placebo-controlled phase 3 trials.

Joaquim Mullol, Tanya M Laidlaw, Claus Bachert, Leda P Mannent, G Walter Canonica, Joseph K Han, Jorge F Maspero, Cesar Picado, Nadia Daizadeh, Benjamin Ortiz and 4 more

Open access · hybridAbstract read
In one paragraph

Article in Allergy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 3 pooled it
12.9field-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.

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

51 citing papers in PubMed, 3 syntheses or guidelines pooled it, 91 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Heterogeneity in the definition of chronic rhinosinusitis disease control: a systematic review of the scientific 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 · 2023
    Pooled it
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  18. [Progress and prospects of anti-IL-4/IL-13 monoclonal antibody treatment in chronic rhinosinusitis with nasal polyps].Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery · 2025
    Review
  19. Article
  20. Asthma Phenotypes and Biomarkers.Respiratory care · 2025
    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

14 authors at 10 institutions in 7 countries.

Joaquim MullolRhinology Unit & Smell Clinic, ENT Department, Hospital Clínic, IDIBAPS, Universitat de Barcelona, CIBERES, Barcelona, Catalonia, Spain.ORCID 0000-0003-3463-5007
Tanya M LaidlawDivision of Allergy and Clinical Immunology, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0001-6709-9795
Claus BachertUpper Airways Research Laboratory and Department of Otorhinolaryngology, Ghent University, Ghent, Belgium.ORCID 0000-0003-4742-1665
Leda P MannentGlobal Clinical Development, Sanofi, Chilly-Mazarin, France.
G Walter CanonicaDepartment of Biomedical Sciences, Humanitas University, Personalized Medicine Asthma & Allergy Unit-IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.ORCID 0000-0001-8467-2557
Joseph K HanDepartment of Otolaryngology & Head and Neck Surgery, Eastern Virginia Medical School, Norfolk, Virginia, USA.
Jorge F MasperoAllergy and Respiratory Medicine, Fundación CIDEA, Buenos Aires, Argentina.ORCID 0000-0001-9750-2346
Cesar PicadoClinical & Experimental Respiratory Immunoallergy, IDIBAPS, Universitat de Barcelona, CIBERES, Barcelona, Catalonia, Spain.ORCID 0000-0001-7400-4993
Nadia DaizadehBiostatistics, Sanofi, Cambridge, Massachusetts, USA.ORCID 0000-0002-4136-4068
Benjamin OrtizImmunology and Allergy Medical Affairs, Regeneron Pharmaceuticals, Inc., New York, USA.
Yongtao LiGlobal Medical Affairs Respiratory, Sanofi, Bridgewater, New Jersey, USA.
Marcella RuddyClinical Sciences Global Development, Regeneron Pharmaceuticals, Inc., Tarrytown, New Jersey, USA.
Elizabeth LawsImmunology and Inflammation, Sanofi, Bridgewater, New Jersey, USA.
Nikhil AminClinical Sciences Global Development, Regeneron Pharmaceuticals, Inc., Tarrytown, New Jersey, USA.ORCID 0000-0002-1865-9861
Regeneron (United States) · USSanofi (United States) · USAVEO Oncology (United States) · USBrigham and Women's Hospital · USConsorci Institut D'Investigacions Biomediques August Pi I Sunyer · ESEastern Virginia Medical School · USHospital Clínic de Barcelona · ESHumanitas University · ITSanofi (France) · FRSun Yat-sen University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAbout one-tenth of patients with difficult-to-treat chronic rhinosinusitis with nasal polyps (CRSwNP) have comorbid non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD). Dupilumab, a fully human monoclonal antibody that blocks the shared interleukin (IL)-4/IL-13 receptor component, is an approved add-on treatment in severe CRSwNP. This post hoc analysis evaluated dupilumab efficacy and safety in patients with CRSwNP with/without NSAID-ERD.

methodsData were pooled from the phase 3 SINUS-24 and SINUS-52 studies in adults with uncontrolled severe CRSwNP who received dupilumab 300 mg or placebo every 2 weeks. CRSwNP, nasal airflow, lung function, and asthma control outcomes at Week 24 were evaluated, and treatment-subgroup interactions were assessed for patients with and without NSAID-ERD.

resultsOf 724 patients, 204 (28.2%) had a diagnosis of NSAID-ERD. At Week 24, least squares mean treatment differences demonstrated significant improvements in nasal polyp score, nasal congestion (NC), Lund-Mackay computed tomography, 22-item Sinonasal Outcome Test (SNOT-22), Total Symptom Score (TSS), rhinosinusitis severity visual analog scale, peak nasal inspiratory flow (PNIF), six-item Asthma Control Questionnaire score, and improvement in smell with dupilumab versus placebo (all p < .0001) in patients with NSAID-ERD. Treatment comparisons demonstrated significantly greater improvements with dupilumab in patients with versus without NSAID-ERD for NC (p = .0044), SNOT-22 (p = .0313), TSS (p = .0425), and PNIF (p = .0123).

conclusionsIn patients with uncontrolled severe CRSwNP, dupilumab significantly improved objective measures and patient-reported symptoms to a greater extent in the presence of comorbid NSAID-ERD than without. Dupilumab was well tolerated in patients with/without NSAID-ERD.

Indexed as

Antibodies, Monoclonal, HumanizedNasal PolypsRespiration DisordersSinusitisAdultAnti-Inflammatory Agents, Non-SteroidalAsthmaChronic DiseaseClinical Trials, Phase III as TopicHumansRandomized Controlled Trials as TopicTreatment OutcomeAntibodies, Monoclonal, HumanizedAnti-Inflammatory Agents, Non-Steroidaldupilumabchronic rhinosinusitis with nasal polypsdupilumabIL-13IL-4non-steroidal anti-inflammatory drug-exacerbated respiratory disease

Identifiers

PMID34459002
PMCPMC9292324
OpenAlexW3196930238

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.