Evidence map›Paper›PMID 37692126›Full record

ArticleJournal of asthma and allergy2023

Tezepelumab Efficacy in Patients with Severe, Uncontrolled Asthma with Comorbid Nasal Polyps in NAVIGATOR.

Tanya M Laidlaw, Andrew Menzies-Gow, Scott Caveney, Joseph K Han, Nicole Martin, Elliot Israel, Jason K Lee, Jean-Pierre Llanos, Neil Martin, Ayman Megally and 4 more

Erratum issued 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. An erratum has been issued. It is linked to trial NCT03347279 (A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents With Severe Uncontrolled Asthma), which is not on this map. Cited by 38 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 3 pooled it
13.5field-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.

NCT03347279 phase3completednot on this map

A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents With Severe Uncontrolled Asthma (NAVIGATOR)

TypeinterventionalSponsorAstraZenecaRan2017 to 2020Enrolled1,061ConditionsAsthmaArmsExperimental: Tezepelumab, Placebo
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 3 syntheses or guidelines pooled it, 56 citations in OpenAlex.

  1. Efficacy of tezepelumab in chronic rhinosinusitis with nasal polyps: a systematic review and meta-analysis.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 · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 9 institutions in 3 countries.

Tanya M Laidlaw *Jeff and Penny Vinik Center for Allergic Diseases Research, Division of Allergy and Clinical Immunology, Brigham and Women's Hospital, Boston, MA, USA.ORCID 0000-0001-6709-9795
Andrew Menzies-Gow *Royal Brompton and Harefield Hospitals, School of Immunology and Microbial Sciences, King's College London, London, UK.
Scott CaveneyGlobal Development, Inflammation, R&D, Amgen, Thousand Oaks, CA, USA.
Joseph K HanDepartment of Otolaryngology, Head and Neck Surgery, Eastern Virginia Medical School, Norfolk, VA, USA.
Nicole MartinBiometrics, Late-Stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Waltham, MA, USA.
Elliot IsraelDivisions of Pulmonary and Critical Care Medicine and Allergy and Clinical Immunology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.ORCID 0000-0002-2470-856X
Jason K LeeEvidence Based Medical Educator Inc., Toronto, ON, Canada.
Jean-Pierre LlanosGlobal Medical Affairs, Amgen, Thousand Oaks, CA, USA.
Neil MartinRespiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK.
Ayman MegallyLate-Stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Bhavini ParikhLate-Stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.ORCID 0009-0006-7374-1274
Sylvia VongTranslational Science and Experimental Medicine, Early Respiratory and Immunology, AstraZeneca, Gaithersburg, MD, USA.
Tobias WelteDepartment of Respiratory Medicine and German Center for Lung Research, Hannover Medical School, Hannover, Germany.ORCID 0000-0002-9947-7356
Jonathan CorrenDavid Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles, CA, USA.
AstraZeneca (United States) · USAstraZeneca (United Kingdom) · GBBrigham and Women's Hospital · USAmgen (United States) · USCenter for Global Development · USEastern Virginia Medical School · USKing's College London · GBMedizinische Hochschule Hannover · DEUniversity of California, Los Angeles · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Tezepelumab, a human monoclonal antibody, blocks thymic stromal lymphopoietin. In the phase 3 NAVIGATOR study (NCT03347279), tezepelumab reduced annualized asthma exacerbation rates (AAERs) versus placebo, irrespective of baseline disease characteristics, and improved lung function and symptom control versus placebo in adults and adolescents with severe, uncontrolled asthma. We assessed the efficacy of tezepelumab in patients with severe asthma with or without nasal polyps (NPs) in the 2 years before randomization in NAVIGATOR. Methods: Patients with severe asthma (N=1059) were randomized (1:1) and received tezepelumab 210 mg or placebo every 4 weeks subcutaneously for 52 weeks. Prespecified exploratory analyses included: AAER over 52 weeks and changes from baseline to week 52 in pre-bronchodilator forced expiratory volume in 1 second, Sino-Nasal Outcome Test (SNOT)-22 scores, and asthma control and health-related quality life (HRQoL) outcomes in NP subgroups. Changes from baseline in fractional exhaled nitric oxide (FeNO), blood eosinophil counts, total immunoglobulin E (IgE), eosinophil-derived neurotoxin (EDN), matrix metalloproteinase-10 (MMP-10), and serum interleukin (IL)-5, IL-6, IL-8 and IL-13 were assessed (post hoc). Results: Tezepelumab reduced the AAER over 52 weeks versus placebo by 85% (95% confidence interval [CI]: 72, 92; n=118) and 51% (95% CI: 40, 60; n=941) in patients with and without NPs, respectively. At week 52, tezepelumab improved lung function, asthma control and HRQoL versus placebo in patients with and without NPs. Tezepelumab reduced SNOT-22 total scores (least-squares mean difference versus placebo [95% CI]) in patients with NPs at 28 weeks (-12.57 points [-19.40, -5.73]) and 52 weeks (-10.58 points [-17.75, -3.41]). At week 52, tezepelumab reduced blood eosinophil counts and FeNO, IgE, IL-5, IL-13, EDN and MMP-10 levels versus placebo, irrespective of NP status. Conclusion: Tezepelumab resulted in clinically meaningful improvements in sino-nasal symptoms and asthma outcomes in patients with severe asthma with comorbid NPs.

Indexed as

chronic rhinosinusitisnasal polypsSNOT-22thymic stromal lymphopoietin

Identifiers

PMID37692126
PMCPMC10488831
OpenAlexW4386409297

What OpenQuestion holds

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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.