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Journal of Asthma and Allergy Volume 16, 2023 - Issue
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ORIGINAL RESEARCH

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

Tanya M Laidlaw1 Jeff and Penny Vinik Center for Allergic Diseases Research, Division of Allergy and Clinical Immunology, Brigham and Women’s Hospital, Boston, MA, USA;2 Department of Medicine, Harvard Medical School, Boston, MA, USACorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0001-6709-9795View further author information
ORCID Icon,
Andrew Menzies-Gow3 Royal Brompton and Harefield Hospitals, School of Immunology and Microbial Sciences, King’s College London, London, UKView further author information
,
Scott Caveney4 Global Development, Inflammation, R&D, Amgen, Thousand Oaks, CA, USAView further author information
,
Joseph K Han5 Department of Otolaryngology, Head and Neck Surgery, Eastern Virginia Medical School, Norfolk, VA, USAView further author information
,
Nicole Martin6 Biometrics, Late-Stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Waltham, MA, USA;7 Cytel Inc, Waltham, MA, USAView further author information
,
Elliot Israel8 Divisions of Pulmonary and Critical Care Medicine and Allergy and Clinical Immunology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USAORCID Iconhttps://orcid.org/0000-0002-2470-856XView further author information
ORCID Icon,
Jason K Lee9 Evidence Based Medical Educator Inc., Toronto, ON, Canada;10 Toronto Allergy and Asthma Clinic, Toronto, ON, CanadaView further author information
,
Jean-Pierre Llanos11 Global Medical Affairs, Amgen, Thousand Oaks, CA, USAView further author information
,
Neil Martin12 Respiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK;13 University of Leicester, Leicester, UKView further author information
,
Ayman Megally14 Late-Stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USAView further author information
,
Bhavini Parikh14 Late-Stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USAORCID Iconhttps://orcid.org/0009-0006-7374-1274View further author information
ORCID Icon,
Sylvia Vong15 Translational Science and Experimental Medicine, Early Respiratory and Immunology, AstraZeneca, Gaithersburg, MD, USAView further author information
,
Tobias Welte16 Department of Respiratory Medicine and German Center for Lung Research, Hannover Medical School, Hannover, GermanyORCID Iconhttps://orcid.org/0000-0002-9947-7356View further author information
ORCID Icon &
Jonathan Corren17 David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles, CA, USAView further author information
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Pages 915-932 | Received 11 Apr 2023, Accepted 07 Aug 2023, Published online: 04 Sep 2023

Figures & data

Table 1 Baseline Demographics and Clinical Characteristics of Patients with and without Nasal Polyps in the 2 Years Before Randomization in the NAVIGATOR Study

Figure 1 AAER over 52 weeks in patients with or without nasal polyps in the 2 years before randomization in the NAVIGATOR study.

Note: n, number of patients contributing to the analysis.
Abbreviations: AAER, annualized asthma exacerbation rate; CI, confidence interval; NP, nasal polyp; Q4W, every 4 weeks.
Figure 1 AAER over 52 weeks in patients with or without nasal polyps in the 2 years before randomization in the NAVIGATOR study.

Table 2 Change from Baseline to Week 52 in Pre-Bronchodilator FEV1 and ACQ-6, AQLQ(S)+12 and ASD Scores in Patients with and without Nasal Polyps in the 2 Years Before Randomization in the NAVIGATOR Study

Figure 2 Change from baseline in SNOT-22 total score over 52 weeks in patients with nasal polyps in the 2 years before randomization in the NAVIGATOR study.

Notes: n, number of patients with at least one change from baseline value at any post-baseline visit. Data shown on bars are LS mean change (SE); difference versus placebo is expressed as LS mean (95% CI). SNOT-22 total score range: 0 (no problem) to 110 (problem as bad as can be); MCID, 8.9 points.Citation78,Citation79
Abbreviations: CI, confidence interval; LS, least-squares; MCID, minimum clinically important difference; Q4W, every 4 weeks; SE, standard error; SNOT, Sino-Nasal Outcome Test.
Figure 2 Change from baseline in SNOT-22 total score over 52 weeks in patients with nasal polyps in the 2 years before randomization in the NAVIGATOR study.

Figure 3 Change from baseline in SNOT-22 nasal (A), ear/facial (B), sleep (C), function (D) and emotion (E) domain scores over 52 weeks in patients with nasal polyps in the 2 years before randomization in the NAVIGATOR study.

Notes: n, number of patients with at least one change from baseline value at any post-baseline visit. Data shown on bars are LS mean change (SE); difference versus placebo is expressed as LS mean (95% CI). SNOT-22 comprises 22 items categorized into five domains: nasal (8 items), ear/facial (4 items), sleep (4 items), function (3 items) and emotion (3 items). SNOT-22 domain scores were calculated as the mean score of items in a given domain, ranging from 0 (no problem) to 5 (problem as bad as can be).Citation78,Citation79
Abbreviations: CI, confidence interval; LS, least-squares; Q4W, every 4 weeks; SE, standard error; SNOT, Sino-Nasal Outcome Test.
Figure 3 Change from baseline in SNOT-22 nasal (A), ear/facial (B), sleep (C), function (D) and emotion (E) domain scores over 52 weeks in patients with nasal polyps in the 2 years before randomization in the NAVIGATOR study.

Table 3 Baseline SNOT-22 Total and Domain Scores in Patients with Nasal Polyps in the 2 Years Before Randomization in the NAVIGATOR Study

Figure 4 Change from baseline in exploratory biomarkers over 52 weeks with tezepelumab compared with placebo in patients with or without NPs in the 2 years before randomization in the NAVIGATOR study.

Notes: n, number of patients contributing to the analysis at that time point. The dotted line represents no treatment difference.
Abbreviations: bEOS, blood eosinophil count; CI, confidence interval; EDN, eosinophil-derived neurotoxin; FeNO, fractional exhaled nitric oxide; IgE, immunoglobulin E; IL, interleukin; LS, least-squares; MMP, matrix metalloproteinase; NP, nasal polyp; Q4W, every 4 weeks.
Figure 4 Change from baseline in exploratory biomarkers over 52 weeks with tezepelumab compared with placebo in patients with or without NPs in the 2 years before randomization in the NAVIGATOR study.

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