Efficacy of Tezepelumab in Patients with Moderate-to-Severe Uncontrolled Asthma: A Pooled Analysis of the Phase 2b PATHWAY and Phase 3 NAVIGATOR Studies

Rationale Tezepelumab, a human monoclonal antibody, blocks thymic stromal lymphopoietin (TSLP). This post hoc analysis was designed to evaluate the efficacy of tezepelumab with increased precision in subgroups of patients with moderate-to-severe, uncontrolled asthma using pooled data from the phase 2b PATHWAY and phase 3 NAVIGATOR studies. Methods PATHWAY (NCT02054130) and NAVIGATOR (NCT03347279) were multicenter, randomized, double-blind, placebo-controlled studies with similar designs. Patients with moderate-to-severe, uncontrolled asthma who received tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks were included in this pooled analysis. The primary endpoint was the annualized asthma exacerbation rate (AAER) over 52 weeks. Results Overall, 1334 patients were included (tezepelumab, n=665; placebo, n=669). Tezepelumab reduced the AAER versus placebo by 60% (95% CI, 52-66) overall; by 48% (95% CI, 26-64) and 63% (95% CI, 54-70) in patients with baseline blood eosinophil counts <150 cells/µL and ≥150 cells/µL (assessed centrally), respectively; by 40% (95% CI, 21-54) and 70% (95% CI, 62-76) in patients with baseline FeNO levels <25 ppb and ≥25 ppb, respectively; and by 62% (95% CI, 53-70) and 54% (95% CI, 38-66) in those who were positive or negative for allergy to perennial aeroallergens, respectively. Among all included patients, tezepelumab reduced the annualized rate of exacerbations that required hospitalization or an emergency department visit by 79% versus placebo (95% CI: 65-87). Safety findings were similar between treatment groups. Conclusions Tezepelumab reduced exacerbations in a broad population of patients with moderate-to-severe, uncontrolled asthma, and substantially reduced exacerbations that required hospitalization or an emergency department visit versus placebo. Acknowledgments Medical writing support was provided by Madeleine Wynn, MRes, of PharmaGenesis London, London, UK, with funding provided by AstraZeneca and Amgen Inc. Publication History Article published online: 11 May 2022 © 2022. Thieme. All rights reserved. Georg Thieme Verlag Rüdigerstraße 14, 70469 Stuttgart, Germany

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