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TEZSPIRE^® (tezepelumab) Efficacy Profile & Clinical Trials

The PATHWAY Study

Over 52 weeks 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‡§

Fictitious patients. May not be representative of general population.

TEZSPIRE® demonstrated statistically significant and clinically meaningful reductions in AAER requiring ER visits/hospitalization vs. placebo^1¶

Secondary endpoints for the PATHWAY trial^1,2

Change from baseline in:

Pre-dose pre-bronchodilator and post-bronchodilator FEV₁
ACQ-6
AQLQ(S)+12

In the PATHWAY trial, various factors such as treatment group, baseline blood eosinophil count (≥ or < 250 cells/uL), and baseline ICS dose level (medium or high) were included as covariates for the rate of asthma exacerbations.

* 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).

‡ The primary endpoint for PATHWAY 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. Rates are the total number of asthma exacerbations in each group/total person-year follow-up in each group with exact Poisson confidence intervals.

¶ 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. Rates are the total number of asthma exacerbations in each group/total person-year follow-up in each group with exact Poisson confidence intervals.
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; ER, emergency room; FEV₁, forced expiratory volume in one second; ICS, inhaled corticosteroids; OCS, oral corticosteroid; RR, rate ratio

References:

AstraZeneca Canada Inc. TEZSPIRE^® Product Monograph. 2024.
Corren J, et al. Tezepelumab in Adults with Uncontrolled Asthma. N Engl J Med. 2017;377(10):936-946.

Last reviewed: Sept 2024

Important safety information

TEZSPIRE® (tezepelumab) Efficacy Profile & Clinical Trials

The PATHWAY Study

TEZSPIRE^® (tezepelumab) Efficacy Profile & Clinical Trials