Effect of tezepelumab on exacerbation-related oral corticosteroid use in NAVIGATOR

Abstract

<b>Background:</b> Tezepelumab is a human monoclonal antibody that blocks activity of thymic stromal lymphopoietin. The phase 3 NAVIGATOR study (NCT03347279) investigated tezepelumab’s efficacy and safety in adults and adolescents with severe, uncontrolled asthma. <b>Objective:</b> This pre-specified exploratory analysis evaluated the effect of tezepelumab on exacerbation-related oral corticosteroid (OCS) use in patients from NAVIGATOR. <b>Methods:</b> NAVIGATOR was a multicentre, randomized, double-blind, placebo-controlled study. Patients (12–80 years old) receiving medium- or high-dose inhaled corticosteroids and ≥1 additional controller medication with or without OCS were randomized 1:1 to receive tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks. The total number of days of exacerbation-related OCS use was assessed in the tezepelumab and placebo groups, and per patient in each group. In patients receiving maintenance OCS treatment, days with increased use were counted. <b>Results:</b> Of 1061 randomized patients, 1059 received study treatment (tezepelumab 210 mg, n=528; placebo, n=531). Of these patients, 231 (44%) and 319 (60%) received OCS treatment for exacerbations during the treatment period in the tezepelumab and placebo groups, respectively. Over 52 weeks, the total number of days with exacerbation-related OCS use was 3706 and 8220 in the tezepelumab and placebo groups. The median (interquartile range) total number of days with exacerbation-related OCS use per patient was lower in the tezepelumab group (9 [5–16]) than the placebo group (14 [7–29]). <b>Conclusion:</b> Patients with severe, uncontrolled asthma treated with tezepelumab had fewer days of OCS use for exacerbations than those who received placebo.