Evidence map›Paper›PMID 38802635›Full record

Trial reportAdvances in therapy2024

Efficacy of Tezepelumab in Patients with Severe, Uncontrolled Asthma Across Multiple Clinically Relevant Subgroups in the NAVIGATOR Study.

Tara F Carr, Wendy C Moore, Monica Kraft, Guy Brusselle, Mario Castro, Geoffrey L Chupp, Michael E Wechsler, Gillian Hunter, Andrew W Lindsley, Jean-Pierre Llanos and 3 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Advances in therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing 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.

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

19 citing papers in PubMed.

  1. Review
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  11. Asthma biologic effectiveness by age and sex in the US CHRONICLE study.The journal of allergy and clinical immunology. Global · 2026
    Article
  12. Review
  13. Review
  14. Tezepelumab for asthma with current or previous smoking habit: Case series.The journal of allergy and clinical immunology. Global · 2025
    Article
  15. Review
  16. Review
  17. 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
  18. Review
  19. 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

13 authors.

Tara F CarrAsthma and Airway Disease Research Center, University of Arizona, Tucson, AZ, USA.
Wendy C MooreDepartment of Internal Medicine, Section on Pulmonary, Critical Care, Allergy and Immunologic Diseases, Wake Forest School of Medicine, Winston-Salem, NC, USA.
Monica KraftDepartment of Medicine, Icahn School of Medicine, Mount Sinai Health System, New York, NY, USA.
Guy BrusselleDepartment of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.
Mario CastroDivision of Pulmonary, Critical Care and Sleep Medicine, University of Kansas School of Medicine, Kansas City, KS, USA.
Geoffrey L ChuppYale Center for Asthma and Airway Disease, Yale School of Medicine, Yale University, New Haven, CT, USA.
Michael E WechslerNational Jewish Health, Denver, CO, USA.
Gillian HunterBiometrics, Late-Stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.
Andrew W LindsleyUS Medical Affairs, Amgen, Thousand Oaks, CA, USA.ORCID 0000-0003-2670-704X
Jean-Pierre LlanosGlobal Medical Affairs, Amgen, Thousand Oaks, CA, USA.ORCID 0000-0002-7785-6881
Luke K BurkeRespiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.
Shradha ChandaranaRespiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, 1 MedImmune Way, Gaithersburg, MD, 20878, USA.
Christopher S AmbroseRespiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, 1 MedImmune Way, Gaithersburg, MD, 20878, USA. chris.ambrose@astrazeneca.com.ORCID 0000-0003-4175-7336

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

introductionMany patients with severe asthma continue to experience symptoms and exacerbations despite treatment with standard-of-care therapy. In the phase 3 NAVIGATOR study, tezepelumab significantly reduced exacerbations over 52 weeks compared with placebo in patients with severe, uncontrolled asthma. This analysis assessed the efficacy of tezepelumab in reducing asthma exacerbations in various clinically relevant subgroups of patients in NAVIGATOR.

methodsNAVIGATOR was a phase 3, multicentre, randomized, double-blind, placebo-controlled study. Participants (12-80 years old) with severe, uncontrolled asthma were randomized 1:1 to receive tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks. Pre-specified and post hoc analyses were performed to evaluate the annualized asthma exacerbation rate (AAER) over 52 weeks in clinically relevant subgroups of patients defined by baseline patient characteristics, medical history, exacerbation triggers, medication eligibility and medication use before and during the study.

resultsTezepelumab reduced the AAER over 52 weeks compared with placebo across a wide range of patient subgroups assessed. Reductions in exacerbations were similar across subgroups defined by baseline patient characteristics, ranging from 48% (95% confidence interval [CI]: 21, 65) to 60% (95% CI: 44, 71) in subgroups analysed by sex, smoking history and body mass index. Among the asthma-related comorbidity subgroups investigated, patients with aspirin or NSAID sensitivity had the greatest reductions in AAER with tezepelumab compared with placebo (83%; 95% CI: 66, 91). In patients eligible to receive dupilumab, tezepelumab reduced exacerbations compared with placebo by 64% (95% CI: 54, 71). Reductions in the AAER with tezepelumab compared with placebo were also observed irrespective of exacerbation trigger category and the number of asthma controller medications patients were receiving at baseline.

conclusionThese findings further support the benefits of tezepelumab in patients with severe, uncontrolled asthma and can help to inform healthcare providers' treatment decisions. CLINICAL

trial registrationNAVIGATOR (NCT03347279).

Indexed as

Anti-Asthmatic AgentsAntibodies, Monoclonal, HumanizedAsthmaAdolescentAdultAgedAged, 80 and overChildDouble-Blind MethodFemaleHumansMaleMiddle AgedSeverity of Illness IndexTreatment OutcomeYoung AdultAnti-Asthmatic AgentsAntibodies, Monoclonal, HumanizedtezepelumabAsthmaBiologicsComorbiditiesExacerbationSevere asthmaTezepelumab

Identifiers

PMID38802635
PMCPMC11213736

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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.