RT Journal Article
SR Electronic
T1 Tezepelumab efficacy in patients with severe, uncontrolled asthma and comorbid nasal polyps in NAVIGATOR
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP PA876
DO 10.1183/13993003.congress-2021.PA876
VO 58
IS suppl 65
A1 Andrew Menzies-Gow
A1 Jonathan Corren
A1 Elliot Israel
A1 Tobias Welte
A1 Christopher S Ambrose
A1 Bill Cook
A1 Gillian Hunter
A1 Jean-Pierre Llanos-Ackert
A1 Gene Colice
YR 2021
UL http://erj.ersjournals.com/content/58/suppl_65/PA876.abstract
AB Background: 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 patients with severe, uncontrolled asthma.Objective: This pre-specified exploratory analysis evaluated the effect of tezepelumab in NAVIGATOR patients with or without reported nasal polyps (NP+ or NP−) in the past 2 years.Methods: NAVIGATOR was a multicentre, 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 annualized asthma exacerbation rate (AAER) over 52 weeks and the least-squares (LS) mean changes from baseline to week 52 in pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV1) and Sino-Nasal Outcomes Test (SNOT)-22 score were assessed in NP subgroups.Results: Of 1059 patients (tezepelumab, n=528; placebo, n=531), 83 had NP in the past 2 years and 976 did not. Mean (SD) baseline pre-BD FEV1 (tezepelumab, placebo) was 2.01 (0.75) L and 1.89 (0.66) L for NP+ patients and 1.82 (0.71) L and 1.85 (0.71) L for NP− patients. Tezepelumab reduced AAER by 86% (95% CI: 70–93) and 52% (95% CI: 42–61), and improved pre-BD FEV1 by 0.20 L (95% CI: 0.02–0.37) and 0.13 L (95% CI: 0.08–0.18) versus placebo in NP+ and NP− patients, respectively. Tezepelumab reduced SNOT-22 score in NP+ patients by 9.6 points (95% CI: 0.9–18.2) versus placebo (baseline mean scores: tezepelumab, 49.4; placebo, 47.8).Conclusion: Tezepelumab reduced exacerbations and improved lung function and nasal symptoms in patients with severe, uncontrolled asthma and comorbid NP.FootnotesCite this article as: European Respiratory Journal 2021; 58: Suppl. 65, PA876.This abstract was presented at the 2021 ERS International Congress, in session “Prediction of exacerbations in patients with COPD”.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).