ATS 2021: In a subgroup of oral corticosteroid-dependent patients with severe asthma from the newly released NAVIGATOR study, tezepelumab reduced exacerbations and improved lung function.
In a new analysis to be presented at the upcoming American Thoracic Society International Conference, being held virtually May 14-19, 2021, tezepelumab treatment was found to be beneficial in patients with severe, uncontrolled asthma requiring maintenance oral corticosteroids (mOCS).
“In adults and adolescents with severe, uncontrolled asthma requiring mOCS, additional treatment with tezepelumab resulted in a numerically lower rate of exacerbations, and clinically meaningful improvements in lung function, quality of life and asthma symptoms versus placebo,” authors stated in the abstract.
Researchers aimed to assess the efficacy of tezepelumab—a potential first-in-class human monoclonal antibody that blocks thymic stromal lymphopoietin—in a subgroup of patients from the pivotal phase 3 NAVIGATOR study who were receiving mOCS.
NAVIGATOR was a multicenter, randomized, double-blind, placebo-controlled study of 1061 patients aged 12-80 years with severe, uncontrolled asthma receiving medium- or high-dose inhaled corticosteroids with ≥1 additional controller medication with or without mOCS. Participants were randomized 1:1 to receive tezepelumab 210 mg subcutaneously or placebo every 4 weeks for 52 weeks.
In the current analysis, researchers examined 100 participants who were receiving mOCS (tezepelumab, n=49; placebo, n=51) at baseline and throughout the study period. The primary endpoint was annualized asthma exacerbation rate (AAER) over 52 weeks.
The secondary endpoints included pre-bronchodilator forced expiratory volume in 1 second (FEV1) and Asthma Control Questionnaire-6 (ACQ-6), Asthma Quality of Life Questionnaire (AQLQ), and Asthma Symptom Diary (ASD) scores.
The results showed that patients who received tezepelumab had a numerically lower AAER than those who received placebo (2.12 vs 2.94, 28% reduction). Compared with placebo, tezepelumab improved pre-bronchodilator FEV1 as well as ACQ-6, AQLQ, and ASD scores.
“These findings support the benefits of tezepelumab in patients with severe, OCS-dependent asthma,” authors concluded.
The abstract, Effect of tezepelumab in oral corticosteroid-dependent patients with severe asthma: Results from the phase 3 NAVIGATOR study, also appears in the Online Abstracts issue of the American Journal of Respiratory and Critical Care Medicine.