Tezepelumab increases proportion of patients free from exacerbations

Tezepelumab increased the proportion of exacerbation-free patients with severe, uncontrolled asthma compared with placebo, even among those with three or more exacerbations within the previous year.

Results from the prespecified exploratory analysis of the NAVIGATOR trial were presented at the virtual European Respiratory Society International Congress.

“Tezepelumab increased the proportion of exacerbation-free patients vs. placebo among those with two exacerbations in the prior year, but also in patients with even more exacerbations,” Stephanie Korn, MD, senior physician in pneumology and respiratory medicine at IKF Pneumologie Mainz and Thoraxklinik Ambulanz and Heidelberg, Germany, said during a presentation. ... “These data provide further evidence of the potential benefits of tezepelumab in patients with severe, uncontrolled asthma.”

Healio previously reported results from the NAVIGATOR study, a phase 3, multicenter, randomized, double-blind, placebo-controlled study, in which tezepelumab (Amgen/AstraZeneca) demonstrated a reduction in asthma exacerbations among patients with severe asthma and a broad range of inflammatory profiles.

The new prespecified exploratory analysis included 1,059 patients aged 12 to 80 years (mean age, 49.5 years; 36.5% men) with severe, uncontrolled asthma. All patients received either medium- or high-dose inhaled corticosteroids and one or more additional controller medication with or without oral corticosteroids. Patients were randomly assigned to receive subcutaneous tezepelumab 210 mg (n = 528) or placebo (n = 531) every 4 weeks for 52 weeks.

Researchers assessed the proportion of exacerbation-free patients in the overall population and the proportion of exacerbation-free patients when categorized by asthma exacerbations experienced within the past year (two, n = 635; three, n = 424).

The proportion of exacerbation-free patients was higher among those assigned tezepelumab compared with placebo in the overall population (54.2% vs. 38.6%; OR = 1.93; 95% CI, 1.51-2.47), according to Korn.

In addition, higher proportions of exacerbation-free patients were observed with tezepelumab vs. placebo among those with two asthma exacerbations in the previous year (56.5% vs. 44.6%; OR = 1.61; 95% CI, 1.17-2.21) and in those with three or more asthma exacerbations (50.9% vs. 29.1%; OR = 2.58; 95% CI, 1.72-3.86) in the previous year, Korn said.

Researchers also observed an improvement in prebronchodilator FEV₁ at 52 weeks among exacerbation-free patients assigned tezepelumab compared with placebo irrespective of the number of prior exacerbations (two prior exacerbations: change, 0.26 vs. 0.14; 95% CI, 0.03-0.22; three prior exacerbations: change, 0.3 vs. 0.09; 95% CI, 0.08-0.35).