SAN FRANCISCO — Nearly half of all patients with severe, uncontrolled asthma who received a full course of the biologic agent tezepelumab (Tezspire) in the NAVIGATOR trial had a complete response to treatment at 1 year, results of a prespecified exploratory analysis indicated.
Among 471 patients assigned to tezepelumab who completed the on-treatment period of the phase 3 randomized trial, 46% had a complete response at 52 weeks, compared with 24% of patients assigned to placebo.
Complete response was defined as reduction in exacerbations of at least 50% over the previous year, improvement from baseline in Asthma Control Questionnaire 6 (ACQ-6) total score of at least 0.5 points, improvement in pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV1), and physician-assessed Clinical Global Impression measure of clinical change (CGI-C) score.
"These data further support the efficacy of tezepelumab in a broad population of patients with severe, uncontrolled asthma," said Njira Lugogo, MD, from the division of Pulmonary and Critical Care Medicine at the University of Michigan, Ann Arbor.
Lugogo presented results of the exploratory analysis at the American Thoracic Society International Conference 2022.
Exacerbations Reduced, Lung Function Improved
Primary results from NAVIGATOR, published in 2021 in The New England Journal of Medicineshowed that patients with severe, uncontrolled asthma randomly assigned to tezepelumab had fewer exacerbations and better lung function, asthma control, and health-related quality of life than patients assigned to placebo.
