Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Apr;53(4):417-428.
doi: 10.1111/cea.14256. Epub 2022 Dec 12.

Efficacy of tezepelumab in patients with evidence of severe allergic asthma: Results from the phase 3 NAVIGATOR study

Jonathan Corren  1 , Christopher S Ambrose  2 , Janet M Griffiths  3 , Åsa Hellqvist  4 , Andrew W Lindsley  5 , Jean-Pierre Llanos  6 , Gene Colice  7 , Andrew Menzies-Gow  8
Affiliations
Randomized Controlled Trial

Efficacy of tezepelumab in patients with evidence of severe allergic asthma: Results from the phase 3 NAVIGATOR study

Jonathan Corren et al. Clin Exp Allergy. 2023 Apr.

Abstract

Background: Allergic asthma is the most common phenotype among patients with severe asthma. In the phase 3 NAVIGATOR study (NCT03347279), tezepelumab significantly reduced the annualized asthma exacerbation rate (AAER) versus placebo in patients with severe, uncontrolled asthma. This exploratory analysis evaluated the efficacy of tezepelumab in NAVIGATOR participants with evidence of severe allergic asthma.

Methods: Patients (12-80 years old) receiving medium- or high-dose inhaled corticosteroids and ≥ 1 additional controller medication, with or without oral corticosteroids, were randomized to tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks in NAVIGATOR. In this analysis, the AAER, forced expiratory volume in 1 second (FEV1 ), patient-reported outcomes (PROs), and type 2 biomarker levels were evaluated in patients grouped by sensitivity to perennial aeroallergens, confirmed symptomatic allergy, and eligibility for omalizumab treatment according to the United States (OMA-US) and the European Union (OMA-EU) prescribing information, including subgroups according to baseline blood eosinophil counts and fractional exhaled nitric oxide (FeNO) levels.

Results: Of 1059 patients who received treatment in NAVIGATOR, 680 (64%) had perennial aeroallergen sensitivity and 318 (30%) had confirmed symptomatic allergy; 379 (36%) and 359 (34%) patients were OMA-US- and OMA-EU-eligible, respectively. Tezepelumab reduced the AAER over 52 weeks versus placebo by 58% (95% confidence interval [CI]: 47-67) to 68% (95% CI: 55-77) across these subgroups. Among omalizumab-eligible patients, AAERs were reduced in patients across baseline blood eosinophil counts and FeNO levels. Tezepelumab improved FEV1 and PROs, and reduced type 2 biomarkers, versus placebo in patients with and without perennial allergy.

Conclusions: Tezepelumab was efficacious in patients with severe, uncontrolled asthma with evidence of allergic inflammation, defined by multiple clinically relevant definitions. These findings further support the benefits of tezepelumab in a broad population of patients with severe asthma, including those with severe allergic asthma.

Keywords: asthma; omalizumab; perennial aeroallergens; tezepelumab; thymic stromal lymphopoietin.

PubMed Disclaimer

References

REFERENCES

    1. Global Initative for Asthma. Global strategy for asthma management and prevention. 2021. Accessed July 8, 2021. https://ginasthma.org/wp-content/uploads/2021/05/GINA-Main-Report-2021-V....
    1. Genentech Inc. Xolair (omalizumab) prescribing information. 2003. Accessed July 14, 2021. https://www.gene.com/download/pdf/xolair_prescribing.pdf.
    1. AstraZeneca. Fasenra® (benralizumab) prescribing information. 2018. Accessed July 9, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761070s000lbl.pdf.
    1. Regeneron Pharmaceuticals Inc. Dupixent (dupilumab) prescribing information 2019. Accessed July 9, 2021. https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf.
    1. GlaxoSmithKline. Mepolizumab prescribing information. 2015. Accessed January 18, 2022. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Inform.... 2015;2022(18 January).

Publication types

MeSH terms