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ATS.2021: Tezepelumab Significantly Reduced Asthma Exacerbations Requiring Hospitalization in Phase 3 NAVIGATOR Trial


Results from the phase 3 NAVIGATOR clinical trial with tezepelumab demonstrate that the thymic stromal lymphopoietin (TSL) blocker significantly reduced asthma exacerbations requiring hospitalization and emergency department (ED) visits among adults and adolescents with severe, uncontrolled asthma, according to research presented American Thoracic Society's 2021 International Conference.

“Tezepelumab is the first and only asthma biologic to consistently demonstrate in randomized trials clinically meaningful exacerbation reductions irrespective of key biomarkers, including blood eosinophil counts, allergic status and FeNO (fractional exhaled nitric oxide),” wrote study authors.

Tezepelumab demonstrated significant and clinically meaningful reductions in AAER across all eosinophil level subgroups:
70% AAER reduction in EOS ≥300
41% AAER reduction in EOS <300 (p<.001)
39% AAER reduction in EOS <150

The multicenter, randomized, double-blind, placebo-controlled NAVIGATOR study randomized 1059 participants aged 12 to 80 years in a 1:1 fashion to receive treatment with tezepelumab (n=528) or placebo (n=531). Participants had severe, uncontrolled asthma, were receiving medium- or high-dose inhaled corticosteroids and at least one additional controller medication with or without oral corticosteroids. They received tezepelumab 210 mg subcutaneously or placebo every 4 weeks for 52 weeks.

The outcomes of interest in the current analysis were annualized asthma exacerbation rates (AAER) that required hospitalization (>24 hours in hospital) or an ED visit (<24 hours in an ED) over 52 weeks, time to first exacerbation that required hospitalization or an ED visit and the proportion of patients who required asthma-related healthcare resources over 52 weeks.

Tezepelumab reduced the rate of exacerbations that required hospitalization or an ED visit by 79% (95% confidence interval [CI]: 63, 88) vs placebo. The investigational therapy prolonged the time to first exacerbation that required hospitalization or an ED visit (vs placebo), with a risk reduction of 65% (HR [95% CI]: 0.35 [0.22, 0.56]).

A lower proportion of patients in the tezepelumab group vs 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 health care provider: 19.1% vs 25%
  • Ambulance transport: 0.8% vs 2.3%

There were also statistically significant improvements in key secondary endpoints among tezepelumab-treated patients vs those treated with placebo including lung function, asthma control and health-related quality of life. Investigators observed improvements in tezepelumab-treated patients as early as the second week of treatment or at the first time point assessment. These improvements were sustained throughout the treatment period.

“Patients with severe asthma are at an increased risk of mortality and, compared to patients with persistent asthma, have twice the risk of asthma-related hospitalizations,” stated the authors. “Reductions in hospitalizations are particularly important at this critical time.”

The investigators conclude: “These results show that tezepelumab has the potential not only to treat a broad population of severe asthma patients but also to reduce the burden severe asthma places on health care systems.”

Abstract https://conference.thoracic.org/program/abstract-search.php?sid=P5841

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

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