TY - JOUR T1 - Effect of tezepelumab on the proportion of exacerbation-free patients with severe, uncontrolled asthma in NAVIGATOR JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.congress-2021.OA1198 VL - 58 IS - suppl 65 SP - OA1198 AU - Stephanie Korn AU - Arnaud Bourdin AU - Geoffrey Chupp AU - Gene Colice AU - Christopher S Ambrose AU - Kamil Kmita AU - Jean-Pierre Llanos-Ackert AU - Nestor Molfino AU - Bill Cook Y1 - 2021/09/05 UR - http://erj.ersjournals.com/content/58/suppl_65/OA1198.abstract N2 - Background: Tezepelumab is a human monoclonal antibody that blocks activity of thymic stromal lymphopoietin (TSLP). The phase 3 NAVIGATOR study (NCT03347279) investigated tezepelumab’s efficacy and safety in adults and adolescents with severe, uncontrolled asthma.Objective: This pre-specified exploratory analysis assessed the proportion of exacerbation-free patients during NAVIGATOR.Methods: This was a multicentre, randomized, double-blind, placebo-controlled study. Patients (12–80 years old) receiving medium- or high-dose inhaled corticosteroids and ≥1 additional controller medication with or without oral corticosteroids were randomized 1:1 to receive tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks. The proportion of exacerbation-free patients was assessed in the whole population and in patients grouped by the number of exacerbations experienced in the past year (2 or ≥3).Results: Of 1059 patients who received study treatment (tezepelumab 210 mg, n=528; placebo, n=531), 635 and 424 had 2 or ≥3 exacerbations in the past year, respectively. The proportion of exacerbation-free patients was higher in the tezepelumab group than the placebo group in the whole population (54.2% vs 38.6%; OR [95% CI]: 1.93 [1.51–2.47]), and among those who had 2 exacerbations (56.5% vs 44.6%; OR [95% CI]: 1.61 [1.17–2.21]) and ≥3 exacerbations (50.9% vs 29.1%; OR [95% CI]: 2.58 [1.72–3.86]) in the past year.Conclusion: Tezepelumab substantially increased the proportion of exacerbation-free patients versus placebo, even among those who had ≥3 exacerbations in the past year. These data demonstrate tezepelumab’s potential benefits in patients with severe, uncontrolled asthma.FootnotesCite this article as: European Respiratory Journal 2021; 58: Suppl. 65, OA1198.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). ER -