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This website is intended for UK Healthcare professionals only. Other UK residents please visit astrazeneca.co.uk
In NAVIGATOR, a phase 3, 52-week, placebo-controlled trial (N=1059), TEZSPIRE (AAER 0.93) led to a relative risk reduction in exacerbations by 56% vs placebo (AAER 2.10), RR 0.44 CI:0.37-0.53; P<0.001; ARR=1.17. In patients with a bEOS <300, TEZSPIRE (AAER 1.02) led to a relative risk reduction in exacerbations by 41% vs placebo (AAER 1.73), RR 0.59 CI:0.46-0.75; P<0.001; ARR=0.71. In PATHWAY, a phase 2, 52-week, placebo-controlled trial (N=550; 137 patients were treated with the approved 210 mg dose), TEZSPIRE (AAER 0.20) led to a relative risk reduction in exacerbations by 71% vs placebo (AAER 0.72) (90% CI:54-82; P<0.001; ARR=0.52). All patients received SOC (MD or HD ICS + additional controller).1-4
Pooled post hoc sub-group analysis of two pivotal trials (PATHWAY, PHASE IIb AND NAVIGATOR, PHASE III): AAER reduction vs placebo5-7
Relative risk reductions (RRR) versus placebo shown as percentages on bar graph.
Individual subgroups by baseline phenotype and biomarkers, data within SmPC (image adapted from SmPC).
Exploratory analyses; pooled statistical analyses were not pre-specified
*No restrictions across eosinophilic and non-eosinophilic, allergic and non-allergic phenotypes, EOS, IgE and FeNO biomarkers.
†Figure adapted from: Corren J, et al. Am J Respir Crit Care Med. 2023
Additional secondary endpoint of NAVIGATOR (Phase III): AAER associated with hospitalisation or ED visit, or hospitalisation only vs placebo1,2†
Adapted from Menzies-Gow A, et al. NEJM. 2021. (Supplementary information)
Relative risk reductions (RRR) versus placebo shown as percentage on graph
• Number of exacerbations requiring hospitalisation or emergency department visit was 30 with TEZSPIRE vs 115 with placebo2
• Number of exacerbations requiring hospitalisation was 14 with TEZSPIRE vs 78 with placebo2
*No restrictions across eosinophilic and non-eosinophilic, allergic and non-allergic phenotypes, bEOS, IgE and FeNO biomarkers.
Pre-specified exploratory analysis of NAVIGATOR (Phase III): AAER over 52 weeks in severe uncontrolled asthma patients with comorbid nasal polyps8
Adapted from Menzies-Gow A, et al. Eur Respir J. 2021.(PA876)
Relative risk reductions (RRR) versus placebo shown as percentage on graph.
*Results are descriptive only as statistical testing not performed.
The number of nasal polyp patients in the overall study population was small (7.8%).2
Post hoc analysis of NAVIGATOR (Phase III): Exacerbation reductions in patients with comorbid CRSwNP, chronic sinusitis and rhinitis, vs placebo8,9
Adapted from Menzies-Gow A, et al. Eur Respir J. 2021 and Carr T, et al. JACI. 2022.
Relative risk reductions (RRR) versus placebo shown as percentage on graph
†Post hoc analysis of NAVIGATOR are descriptive only as statistical testing not performed.
Post hoc analysis of PATHWAY (Phase IIb): exacerbation data for TEZSPIRE vs placebo by season* (n=550; 137 patients treated with approved 210 mg dose)*
Adapted from Corren J, et al. J Asthma Allergy. 2021.
Relative risk reductions (RRR) versus placebo shown as percentage on graph
Post hoc analysis of PATHWAY is descriptive only as statistical testing not performed.
*All patients received SOC (MD or HD ICS + additional controller). Winter, spring, summer, and autumn were defined as January to March, April to June, July to September, and October to December, inclusive, respectively.3,4,11
Post hoc analysis of NAVIGATOR (Phase III): reduction of exacerbations vs placebo by age at asthma diagnosis2*
Adapted from Menzies-Gow A, et al. NEJM. 2021. Relative risk reductions (RRR) versus placebo shown as a percentage on graph. Post hoc analysis of NAVIGATOR is descriptive only as statistical testing not performed.
TEZSPIRE (tezepelumab) is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment5
AAER=annualised asthma exacerbation rate; bEOS=blood eosinophils; CI=confidence interval; CRSwNP=chronic rhinosinusitis with nasal polyps; FeNO=fractional exhaled nitric oxide; HD=high dose; ICS=inhaled corticosteroid; IgE=immunoglobulin E; MD=medium dose; PPB=parts per billion; RR=rate ratio; SOC=standard of care.
GB-56755 | November 2024
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