Tezepelumab reduces asthma exacerbations requiring hospitalization or ED visit

Tezepelumab reduced asthma exacerbations requiring hospitalization or ED visits in adults and adolescents with severe, uncontrolled asthma, according to new data from the NAVIGATOR trial.

At the American Thoracic Society International Conference, Arnaud Bourdin, MD, PhD, professor of respiratory medicine in the department of pulmonology at the University of Montpellier, France, reported results from a secondary objective of the NAVIGATOR trial: assessment of the effect of tezepelumab (AstraZeneca, Amgen) on asthma exacerbations requiring hospitalization or an ED visit, and on the use of asthma-related unscheduled health care resources.

Results of the main NAVIGATOR trial, as previously reported by Healio, demonstrated that tezepelumab reduced exacerbations regardless of initial blood eosinophil count, improved lung function, provided asthma control and enhanced quality of life in patients with severe, uncontrolled asthma.

For the new analysis, Bourdin reported data from 1,059 patients aged 12 to 80 years with severe, uncontrolled asthma who had at least two exacerbations in the prior year. All patients were on background medications that included medium- to high-dose inhaled corticosteroids plus at least one additional controller medication with or without an oral corticosteroid. Patients were randomly assigned to receive subcutaneous tezepelumab 210 mg (n = 528) or placebo (n = 531) every 4 weeks for 52 weeks.

Over 52 weeks, tezepelumab significantly reduced the annualized asthma exacerbation rates requiring hospitalization longer than 24 hours or an ED visit of less than 24 hours by 79% (RR= 0.21; 95% CI, 63-88). The researchers also reported an 85% (RR = 0.15; 95% CI, 67-93) reduction in asthma-related hospital-only rates, with rates as low as 0.03 per patient per year. In addition, tezepelumab also reduced the time to first asthma exacerbation requiring hospitalization or an ED visit by 65% (HR = 0.35; 95% CI, 0.22-0.56).

In other results, patients assigned tezepelumab had fewer asthma-related hospitalizations (3.2% vs. 7%), ED visits (4.4% vs. 9.4%), unscheduled visits (35.4% vs. 43.5%), telephone calls with health care providers (19.1% vs. 25%) or ambulance transport (0.8% vs. 2.3%) compared with those assigned placebo.

No patient assigned tezepelumab required ICU admissions during the study.

According to a related press release, tezepelumab is the first and only asthma biologic in randomized trials to demonstrate consistently clinically meaningful asthma exacerbation reductions regardless of biomarkers, including blood eosinophil counts, allergic status and fractional exhaled nitric oxide levels.

“This analysis further supports the benefits of tezepelumab in patients with severe, uncontrolled asthma,” the researchers wrote in the abstract.

References:

• Bourdin A, et al. Am J Respir Crit Care Med. 2021;doi:10.1164/ajrccm-conference.2021.203.1.
• Press Release.