NAVIGATOR Trial Outcomes for Tezepelumab Use in Severe, Uncontrolled Asthma

asthma attack in woman with inhaler
An analysis of NAVIGATOR trial data on tezepelumab use assessed patient-reported outcomes related to asthma control, symptoms, and HRQoL.

The following article is a part of conference coverage from CHEST 2021, being held virtually from October 17 to October 20, 2021. The team at Pulmonology Advisor will be reporting on the latest news and research conducted by leading experts in the field. Check back for more from CHEST 2021.


In a broad population of patients with severe asthma, researchers found that use of tezepelumab resulted in higher proportions of patients with clinically meaningful improvements in patient-reported outcome measures for asthma control, symptoms, and health-related quality of life (HRQoL). Findings of this research were presented at the CHEST Annual Meeting, held virtually October 17 to 20.

Tezepelumab, a human monoclonal antibody, blocks the activity of thymic stromal lymphopoietin, an epithelial cell-derived cytokine associated with asthma pathogenesis.

In the multicenter, randomized, double-blind, placebo-controlled, phase 3 NAVIGATOR study ( Identifier: NCT03347279), tezepelumab significantly reduced exacerbations and improved lung function in patients with severe, uncontrolled asthma, including those with baseline blood eosinophil counts of less than 300 cells/mL.

In NAVIGATOR, patients (ranging from 12 to 80 years of age) with severe, uncontrolled asthma were randomized to receive tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks. The current investigation reports findings derived from prespecified analyses of NAVIGATOR, evaluating patient-reported outcomes for asthma control, symptoms, and HRQoL.

After initiating treatment, patient-reported outcomes were assessed with the Asthma Control Questionnaire-6 (ACQ-6) monthly (starting at week 2), the standardized Asthma Quality of Life Questionnaire for patients aged 12 years and older (AQLQ[S]+12) every 3 months (starting at week 4), a weekly average of daily Asthma Symptom Diary (ASD) scores, and the St George’s Respiratory Questionnaire (SGRQ) every 6 months.

The investigators calculated the proportion of responders (defined by a score improvement from baseline of at least the minimum clinically important difference for each outcome measure).

A total of 1061 patients were randomized. Of those, 1059 patients received treatment (tezepelumab, n=528; placebo, n=531). For all patient-reported outcomes at week 52, the proportion of responders was higher in the tezepelumab group than in the placebo group. Results were as follows:

  • ACQ-6: 86.2% vs 76.5%; odds ratio (95% confidence interval), 1.99 (1.43–2.76);
  • AQLQ[S]+12; 77.5% vs 71.7%; 1.36 (1.02–1.82); ASD, 58.0% vs 50.1%, 1.68 (1.12–2.53);
  • SGRQ: 81.7% vs 72.6%, 1.66 (1.17–2.36);
  • ACQ-6 at week 2: 64.5% vs 56.4%, 1.48 (1.14–1.92);
  • AQLQ[S]+12 at week 4: 63.8% vs 60.5%; 1.14 (0.88–1.48);
  • ASD at week 1: 16.7% vs 11.0%; 1.82 (1.02–3.25); and
  • SGRQ at week 24: 81.5% vs 70.7%; 1.79 (1.27–2.52).

“These results, together with previously reported improvements in exacerbations and lung function, demonstrate the benefit of tezepelumab in a broad population of patients with severe, uncontrolled asthma,” concluded the investigators.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. 


Lugogo N, Ponnarambil S, Ambrose C, et al. Tezepelumab produces clinically meaningful responses on patient-reported outcome measures in patients with severe, uncontrolled asthma: results from the phase 3 NAVIGATOR study. Presented at: CHEST 2021; October 17-20, 2021; Orlando, FL/Virtual. Abstract 44A-47A.