On-treatment clinical remission with tezepelumab among patients with severe, uncontrolled asthma in the phase 3 NAVIGATOR study
Mario Castro, Christopher S. Ambrose, Gene Colice, Stephanie L. Roseti, K. Kmita, B. Cook, Nicole Martin, Jean-Pierre Llanos-Ackert, Andrew Menzies‐Gow
Abstract
<b>Background:</b> Tezepelumab, a human monoclonal antibody, blocks the activity of thymic stromal lymphopoietin (TSLP). <b>Objective:</b> This exploratory analysis assessed the proportion of patients receiving tezepelumab who achieved a predefined definition of on-treatment clinical remission in the phase 3 NAVIGATOR study (NCT03347279). <b>Methods:</b> NAVIGATOR was a multicenter, randomized, double-blind, placebo-controlled study. Patients (12–80 years old) were randomized 1:1 to receive tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks. The proportion of patients who achieved on-treatment clinical remission (see <b>Table</b> for components) at week 52 was assessed among those who completed the on-treatment period and had no relevant data missing at week 52. <b>Results:</b> Overall, 528 and 531 patients received tezepelumab and placebo, respectively. Of patients who completed the on-treatment period (481 and 459, respectively), the proportion who achieved on-treatment clinical remission, and across each component, was higher with tezepelumab than placebo (<b>Table</b>). The odds of a patient achieving clinical remission were more than threefold higher with tezepelumab than placebo. <b>Conclusions:</b> A greater proportion of patients achieved on-treatment clinical remission with tezepelumab than placebo, further supporting the efficacy of tezepelumab in patients with severe, uncontrolled asthma.