Efficacy of tezepelumab in patients with severe, uncontrolled asthma and low blood eosinophil counts not receiving maintenance oral corticosteroids

Abstract

<b>Background:</b> Tezepelumab, a human monoclonal antibody that blocks thymic stromal lymphopoietin activity, reduced exacerbations in patients with severe, uncontrolled asthma, including those with low blood eosinophil counts (BEC), in the phase 2b PATHWAY (NCT02054130) and phase 3 NAVIGATOR (NCT03347279) studies. Some patients were receiving maintenance oral corticosteroids (mOCS), which can reduce BEC. <b>Objective:</b> This <i>post hoc</i> analysis assessed the efficacy of tezepelumab in patients with severe, uncontrolled asthma and low BEC not receiving mOCS (to exclude patients whose BEC was influenced by mOCS), using pooled PATHWAY and NAVIGATOR data. <b>Methods:</b> PATHWAY and NAVIGATOR were multicentre, randomized, placebo-controlled studies with similar designs. Patients (12–80 years old) included in this analysis received tezepelumab 210 mg or placebo subcutaneously every 4 weeks for up to 52 weeks. The annualized asthma exacerbation rate (AAER) was assessed in patients not receiving mOCS at baseline or during the study, grouped by baseline BEC: &lt;300, 150–&lt;300, and &lt;150 cells/µL. <b>Results:</b> Tezepelumab reduced the AAER versus placebo by 49–50% in patients not receiving mOCS with baseline BEC &lt;300, 150–&lt;300 or &lt;150 cells/µL (<b>Figure</b>). <b>Conclusion:</b> These data further support the efficacy of tezepelumab in patients with severe, uncontrolled asthma and low BEC, including those not receiving mOCS.