ATS 2021 will feature presentations of original research from accepted abstracts. Mini Symposia and Thematic Poster Sessions are abstract based sessions.
Please use the form below to browse scientific abstracts and case reports accepted for ATS 2021. Abstracts presented at the ATS 2021 will be published in the Online Abstract Issue of the American Journal of Respiratory and Critical Care Medicine, Volume 203, May 3, 2021.
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Reductions in Asthma Exacerbation-Related Hospitalizations and Emergency Department Visits in Patients with Severe, Uncontrolled Asthma Treated with Tezepelumab: Results from the Phase 3 NAVIGATOR Study
Session Title
D7 - D007 ADVANCES IN ASTHMA THERAPIES
Abstract
A1203 - Reductions in Asthma Exacerbation-Related Hospitalizations and Emergency Department Visits in Patients with Severe, Uncontrolled Asthma Treated with Tezepelumab: Results from the Phase 3 NAVIGATOR Study
Author Block: A. Bourdin1, A. Menzies-Gow2, G. Chupp3, E. Israel4, Å. Hellqvist5, G. Hunter6, C. S. Ambrose7, J. Llanos Ackert8, G. Colice9, B. Cook7, J. Corren10; 1PhyMedExp, University of Montpellier, CNRS, INSERM, CHU Montpellier, Montpellier, France, 2Royal Brompton Hospital, London, United Kingdom, 3Yale School of Medicine, New Haven, CT, United States, 4Pulmonary and Critical Care Medicine, Allergy and Immunology, Brigham and Womens Hospital, Boston, MA, United States, 5Biometrics, Late-stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, 6Biometrics, Late-stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, 7Respiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, United States, 8Global Medical Affairs, Amgen, Thousand Oaks, CA, United States, 9Late-stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, United States, 10David Geffen School of Medicine, University of California Los Angeles (UCLA), Los Angeles, CA, United States.
RATIONALE
Patients with severe asthma may experience frequent exacerbations, which can require hospitalization and emergency department (ED) visits, placing a significant burden on patients and healthcare systems. Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin, an epithelial-derived cytokine implicated in asthma pathogenesis. The phase 3 NAVIGATOR study (NCT03347279) evaluated the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. A secondary objective of NAVIGATOR was to assess the effect of tezepelumab on exacerbations that required hospitalization or an ED visit, and on asthma-related, unscheduled healthcare resource use.
METHODS
NAVIGATOR was a multicenter, randomized, double-blind, placebo-controlled study. Patients (12-80 years old) with severe, uncontrolled asthma, who were receiving medium- or high-dose inhaled corticosteroids and at least one additional controller medication with or without oral corticosteroids, were randomized 1:1 to receive tezepelumab 210 mg subcutaneously or placebo every 4 weeks for 52 weeks. The annualized rate of asthma exacerbations that required hospitalization (>24 hours in hospital) or an ED visit (<24 hours in an ED) over 52 weeks was estimated in the tezepelumab and placebo groups using a negative binomial regression model. Time to first exacerbation that required hospitalization or an ED visit was assessed. In addition, the proportion of patients who required asthma-related healthcare resources over 52 weeks was evaluated.
RESULTS
Of 1061 randomized patients, 1059 received treatment (tezepelumab 210 mg, n=528; placebo, n=531). Tezepelumab reduced the annualized rate of exacerbations that required hospitalization or an ED visit by 79% (95% confidence interval: 63, 88) compared with placebo. Tezepelumab prolonged the time to first exacerbation that required hospitalization or an ED visit compared with placebo, with a risk reduction of 65% (hazard ratio [95% confidence interval]: 0.35 [0.22, 0.56]) (Figure). A lower proportion of patients in the tezepelumab group than in the placebo group required asthma-related hospitalizations (3.2% vs 7.0%), ED visits (4.4% vs 9.4%), unscheduled visits to a specialist (35.4% vs 43.5%), telephone calls with a healthcare provider (19.1% vs 25.0%) or ambulance transport (0.8% vs 2.3%).
CONCLUSIONS
Treatment with tezepelumab substantially reduced exacerbations that required hospitalization or an ED visit compared with placebo, consistent with results from the previous phase 2b PATHWAY study. In addition, patients treated with tezepelumab used less asthma-related healthcare resources than those who received placebo. This analysis further supports the benefits of tezepelumab in patients with severe, uncontrolled asthma.
Author Block: A. Bourdin1, A. Menzies-Gow2, G. Chupp3, E. Israel4, Å. Hellqvist5, G. Hunter6, C. S. Ambrose7, J. Llanos Ackert8, G. Colice9, B. Cook7, J. Corren10; 1PhyMedExp, University of Montpellier, CNRS, INSERM, CHU Montpellier, Montpellier, France, 2Royal Brompton Hospital, London, United Kingdom, 3Yale School of Medicine, New Haven, CT, United States, 4Pulmonary and Critical Care Medicine, Allergy and Immunology, Brigham and Womens Hospital, Boston, MA, United States, 5Biometrics, Late-stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, 6Biometrics, Late-stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, 7Respiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, United States, 8Global Medical Affairs, Amgen, Thousand Oaks, CA, United States, 9Late-stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, United States, 10David Geffen School of Medicine, University of California Los Angeles (UCLA), Los Angeles, CA, United States.
RATIONALE
Patients with severe asthma may experience frequent exacerbations, which can require hospitalization and emergency department (ED) visits, placing a significant burden on patients and healthcare systems. Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin, an epithelial-derived cytokine implicated in asthma pathogenesis. The phase 3 NAVIGATOR study (NCT03347279) evaluated the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. A secondary objective of NAVIGATOR was to assess the effect of tezepelumab on exacerbations that required hospitalization or an ED visit, and on asthma-related, unscheduled healthcare resource use.
METHODS
NAVIGATOR was a multicenter, randomized, double-blind, placebo-controlled study. Patients (12-80 years old) with severe, uncontrolled asthma, who were receiving medium- or high-dose inhaled corticosteroids and at least one additional controller medication with or without oral corticosteroids, were randomized 1:1 to receive tezepelumab 210 mg subcutaneously or placebo every 4 weeks for 52 weeks. The annualized rate of asthma exacerbations that required hospitalization (>24 hours in hospital) or an ED visit (<24 hours in an ED) over 52 weeks was estimated in the tezepelumab and placebo groups using a negative binomial regression model. Time to first exacerbation that required hospitalization or an ED visit was assessed. In addition, the proportion of patients who required asthma-related healthcare resources over 52 weeks was evaluated.
RESULTS
Of 1061 randomized patients, 1059 received treatment (tezepelumab 210 mg, n=528; placebo, n=531). Tezepelumab reduced the annualized rate of exacerbations that required hospitalization or an ED visit by 79% (95% confidence interval: 63, 88) compared with placebo. Tezepelumab prolonged the time to first exacerbation that required hospitalization or an ED visit compared with placebo, with a risk reduction of 65% (hazard ratio [95% confidence interval]: 0.35 [0.22, 0.56]) (Figure). A lower proportion of patients in the tezepelumab group than in the placebo group required asthma-related hospitalizations (3.2% vs 7.0%), ED visits (4.4% vs 9.4%), unscheduled visits to a specialist (35.4% vs 43.5%), telephone calls with a healthcare provider (19.1% vs 25.0%) or ambulance transport (0.8% vs 2.3%).
CONCLUSIONS
Treatment with tezepelumab substantially reduced exacerbations that required hospitalization or an ED visit compared with placebo, consistent with results from the previous phase 2b PATHWAY study. In addition, patients treated with tezepelumab used less asthma-related healthcare resources than those who received placebo. This analysis further supports the benefits of tezepelumab in patients with severe, uncontrolled asthma.
