Effect of Tezepelumab on Lung Function in Patients With Severe, Uncontrolled Asthma in the Phase 3 NAVIGATOR Study

Abstract

Introduction: Severe asthma is associated with airway inflammation and airway obstruction. In the phase 3 NAVIGATOR study, tezepelumab treatment significantly improved pre-bronchodilator forced expiratory volume in 1 s (FEV 1 ) compared with placebo in patients with severe, uncontrolled asthma. This analysis assessed the effect of tezepelumab versus placebo on additional lung function parameters in patients from NAVIGATOR. Methods: NAVIGATOR was a multicenter, randomized, double-blind, placebo-controlled study. Patients (12-80 years old) receiving medium-or high-dose inhaled corticosteroids and at least one additional controller medication, with or without oral corticosteroids, were randomized 1:1 to tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks. Changes from baseline to week 52 in pre-bronchodilator FEV 1 , post-bronchodilator FEV 1 , forced vital capacity (FVC), pre-bronchodilator FEV 1 /FVC ratio, pre-bronchodilator forced expiratory flow between 25 and 75% of vital capacity (FEF 25-75 ), and morning and evening peak expiratory flow (PEF) were assessed. Results: Tezepelumab treatment improved all evaluated lung function parameters over 52 weeks compared with placebo [least-squares mean difference (95% confidence interval): pre-

The last step to achieve barrier damage control

“…Additional analysis showed that tezepelumab markedly reduced exacerbations precipitated by exposure to specific seasonal and perennial aeroallergens during periods of heightened exposure. This evidence demonstrated that the allergenic trigger could induce epithelial-driven exacerbations that tezepelumab is able to control (47). The phase 3 trial SOURCE showed a non-significant difference between treatment and placebo at 48-weeks on Oral Corticosteroids (OCS)-sparing effect (48).…”