Evidence map›Paper›PMID 37026112›Full record

ArticleJournal of asthma and allergy2023

Clinical Efficacy among Patients with Chronic Rhinosinusitis with Nasal Polyps and Clinical Features of Obstructive Lung Disease: Post Hoc Analysis of the Phase III SINUS-24 and SINUS-52 Studies.

Jorge F Maspero, Claus Bachert, Fernando J Martinez, Nicola A Hanania, Benjamin Ortiz, Naimish Patel, Leda P Mannent, Amy Praestgaard, Nami Pandit-Abid, Shahid Siddiqui and 1 more

2 registry-linked trialsAbstract 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 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–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

5 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Article
  5. 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

11 authors.

Jorge F MasperoAllergy and Respiratory Research Unit, Fundación CIDEA, Buenos Aires, Argentina.
Claus BachertUpper Airway Research Laboratory, Department of Otorhinolaryngology, Ghent University Hospital, Ghent, Belgium.
Fernando J MartinezDivision of Pulmonary and Critical Care, Weill Cornell Medical College, New York, NY, USA.ORCID 0000-0002-2412-3182
Nicola A HananiaSection of Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston, TX, USA.
Benjamin OrtizImmunology and Allergy Medical Affairs, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Naimish PatelImmunology and Inflammation, Sanofi, Cambridge, MA, USA.
Leda P MannentGlobal Clinical Development, Sanofi, Chilly-Mazarin, France.
Amy PraestgaardImmunology and Inflammation, Sanofi, Cambridge, MA, USA.
Nami Pandit-AbidImmunology and Inflammation, Sanofi, Bridgewater, NJ, USA.
Shahid SiddiquiImmunology and Allergy Medical Affairs, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.ORCID 0000-0001-9726-9003
Megan HardinImmunology and Inflammation, Sanofi, Cambridge, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: To provide a descriptive summary of clinical efficacy and health-related quality of life (HRQoL) measures in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and clinical features of obstructive lung disease in the Phase III dupilumab studies SINUS-24 and SINUS-52 (NCT02912468, NCT02898454). Patients and Methods: Patients met a "broad" definition of having clinical features of obstructive lung disease with any of 3 criteria: (i) pre-bronchodilator forced expiratory volume in 1 second (FEV Results: Across both studies, 131 patients met the "broad" definition, of whom 90 also had asthma, and 115 patients met the "narrow" definition, of whom 74 had asthma. CRSwNP outcomes and HRQoL were improved with dupilumab vs placebo in both the broad and narrow subgroups. Among the 90 patients who met the broad definition and had asthma, dupilumab improved pre-bronchodilator FEV Conclusion: In a population of patients with CRSwNP and clinical features of obstructive lung disease, dupilumab improved CRSwNP and HRQoL outcomes, and, among those with a history of asthma, also improved lung function. These results support further analyses of dupilumab in patients with evidence of type 2 inflammation and obstructive lung disease such as COPD.

Indexed as

chronic obstructive pulmonary diseasedupilumabinterleukin-13interleukin-4obstructive lung diseasetype 2 inflammation

Identifiers

PMID37026112
PMCPMC10072142

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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.