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TEZSPIRE® was assessed in two 52-week randomized, double-blind, parallel-group, placebo-controlled, clinical trials enrolling patients ≥ 18 years of age (PATHWAY) and ≥ 12 years of age (NAVIGATOR).1-3
In patients > 12 years old with severe asthma with both treatment arms as an add-on to background asthma therapy,*†
TEZSPIRE® demonstrated statistically significant and clinically meaningful reductions in the AAER vs. placebo in the overall population (primary endpoint)1‡§
In an exploratory subgroup analysis, TEZSPIRE® demonstrated significant reductions in AAER across different baseline biomarkers (NAVIGATOR)1,4
AAER RATIO ACROSS BASELINE BLOOD EOS LEVELS AND FeNO
Adapted from the Product Monograph.
Compared to placebo, TEZSPIRE®-treated patients experienced:
Similar findings were observed in PATHWAY.
TEZSPIRE® provided clinically meaningful improvements in the mean change from baseline in FEV1 vs. placebo1
Adapted from the Product Monograph.
More TEZSPIRE® treated patients demonstrated clinically meaningful (responder rates) improvements in ACQ-6 and AQLQ(S)+12 vs. placebo (NAVIGATOR, PATHWAY)1
Clinically meaningful improvements were defined as an improvement in a score of 0.5 at the end of the trial.
ACQ-6
AQLQ(S)+12
86% of patients on TEZSPIRE® vs. 77% with placebo
78% of patients on TEZSPIRE® vs. 72% with placebo
Similar findings were reported for PATHWAY.
The PATHWAY and NAVIGATOR trials enrolled a combined total of 1611 patients ≥ 12 years of age.
See below for additional inclusion criteria:
PATHWAY TRIAL
NAVIGATOR TRIAL
≥ 2 ASTHMA EXACERBATIONS:
≥ 2 ASTHMA EXACERBATIONS:
In both trials, patients were not required to have a minimum baseline level of blood eosinophils or other inflammatory biomarkers (e.g., FeNO or IgE).
Note, patients continued background asthma therapy during the trials.
The rate of clinically significant asthma exacerbations measured over 52 weeks.#
The rate of clinically significant asthma exacerbations measured over 52 weeks.#
Change from baseline in:
Change from baseline in:
Dig into the details of the pivotal NAVIGATOR and PATHWAY clinical trials.
* Background asthma therapy included regular treatment with medium- or high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller with or without OCS.
† Severe asthma was defined as a history of 2 or more asthma exacerbations requiring oral or systemic corticosteroid treatment or 1 asthma exacerbation resulting in hospitalization in the past 12 months (PATHWAY) or a history of 2 or more asthma exacerbations requiring oral or systemic corticosteroid treatment or resulting in hospitalization in the past 12 months (NAVIGATOR).
‡ The primary endpoint for PATHWAY and NAVIGATOR was the rate of clinically significant asthma exacerbations measured over 52 weeks. Clinically significant asthma exacerbations were defined as worsening of asthma requiring the use of or increase in oral or systemic corticosteroids for at least 3 days or a single depo-injection of corticosteroids, and/or emergency department visits requiring use of oral or systemic corticosteroids and/or hospitalization.
§ The annual asthma exacerbations and exacerbations requiring emergency room visit/hospitalization were analyzed through a negative binomial regression model, with the logarithm of time at risk included as an offset variable. In PATHWAY, treatment group, baseline blood eosinophil count (≥ or < 250 cells/uL), and baseline ICS dose level (medium or high) were included as covariates. Rates are the total number of asthma exacerbations in each group/total person-year follow-up in each group with exact Poisson confidence intervals. In NAVIGATOR, treatment, region, age group, and history of exacerbations were included as covariates and estimated marginal rates are presented from the model.
¶ Number of patients contributing to the full analysis with at least 1 change from the baseline value.
# Clinically significant asthma exacerbations were defined as worsening of asthma requiring the use of or increase in oral or systemic corticosteroids for at least 3 days or a single depo-injection of corticosteroids, and/or emergency department visits requiring use of oral or systemic corticosteroids and/or hospitalization.
AAER, annualized asthma exacerbations rate; ACQ-6, Asthma Control Questionnaire 6; AQLQ(S)+12; Standardised Asthma Quality of Life Questionnaire for ages 12 and older; CI, confidence interval; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in one second; ICS, inhaled corticosteroid; IgE, immunoglobulin E; LS, least-square; OCS, oral corticosteroid; RR, rate ratio
References:
Last reviewed: Sept 2024
TEZSPIRE® and the logo are trademarks of Amgen Inc. and the Amgen logo is a registered trademark of Amgen Inc., used under license by AstraZeneca Canada Inc.
© 2024 AstraZeneca Canada Inc. All rights reserved.
AstraZeneca and the AstraZeneca logo are registered trademarks of AstraZeneca AB, used under license by AstraZeneca Canada Inc.
TEZSPIRE® and the logo are trademarks of Amgen Inc. and the Amgen logo is a registered trademark of Amgen Inc., used under license by AstraZeneca Canada Inc.
© 2024 AstraZeneca Canada Inc. All rights reserved.
AstraZeneca and the AstraZeneca logo are registered trademarks of AstraZeneca AB, used under license by AstraZeneca Canada Inc.
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