ASTHMA EXACERBATIONS BEFORE AND AFTER TEZEPELUMAB TREATMENT: A POOLED ANALYSIS OF PATHWAY AND NAVIGATOR STUDIES

Abstract

<h3>Introduction</h3> Tezepelumab, a human monoclonal antibody, blocks thymic stromal lymphopoietin. In the PATHWAY and NAVIGATOR studies, tezepelumab reduced asthma exacerbations versus placebo in patients with severe, uncontrolled asthma, irrespective of baseline blood eosinophil count (BEC), allergic status and maintenance oral corticosteroid (mOCS) use. This post hoc pooled analysis assessed the effect of tezepelumab on asthma exacerbations 12 months before and after treatment initiation. <h3>Methods</h3> PATHWAY (NCT02054130) and NAVIGATOR (NCT03347279) were multicenter, randomized, placebo-controlled studies with similar designs. Patients (12–80 years old) who received tezepelumab 210 mg or placebo subcutaneously every 4 weeks for up to 52 weeks were included. The mean number and rate of asthma exacerbations (accounting for time-at-risk) were summarized over 12 months before and after treatment initiation, respectively, for the overall pooled population and subgroups of baseline BEC, perennial allergic status and mOCS use. <h3>Results</h3> Overall, 1334 patients were included (tezepelumab, n=665; placebo, n=669). In the 12 months before treatment, the mean number of asthma exacerbations was similar between treatment groups in the overal population and across subgroups, except for those receiving mOCS (<b>Figure</b>). After up to 12 months of treatment, the rate of asthma exacerbations was lower with tezepelumab than the mean number of exacerbations before treatment and lower than the rate in the placebo group, overall and across subgroups (<b>Figure</b>). <h3>Conclusion</h3> Patients experienced fewer exacerbations after initiating tezepelumab treatment compared with the 12 months before treatment and compared with the placebo group. Similar reductions were observed irrespective of BEC, allergic status or mOCS use.