Patients with severe uncontrolled asthma receiving tezepelumab experienced fewer exacerbations, better lung function, and quality of life improvements compared with placebo, according to the results of a recent study published in the New England Journal of Medicine.

Researchers conducted a phase 3, multicenter, randomized placebo-controlled trial to examine pulmonary outcomes in patients aged 12 to 80 years receiving either tezepelumab or placebo subcutaneously every 4 weeks for 1 year (NAVIGATOR; Identifier: NCT03347279). The primary outcome was the annualized rate of asthma exacerbations over a period of 52 weeks. Secondary outcomes included forced expiratory volume in 1 second (FEV1) and scores on the Asthma Control Questionnaire (ACQ-6) and Asthma Quality of Life Questionnaire (AQLQ). 

Among the 1061 patients who met both the study inclusion and exclusion criteria and underwent randomization, 529 were assigned to the tezepelumab group and 532 were assigned to the placebo group. In the primary study outcome, the annualized rate of asthma exacerbations was 0.93 (95% CI, 0.80-1.07) with tezepelumab and 2.10 (95% CI, 1.84-2.39) with placebo. Improvements were greater with tezepelumab than with placebo with respect to FEV1 (difference, 0.13 liters; 95% CI, 0.08-0.18; P <.001) and scores on the ACQ-6 (difference, -0.33; 95% CI, -0.46 to -0.20; P <.001) and AQLQ (difference, 0.34; 95% CI, 0.20-0.47; P <.0001).

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“Patients with severe, uncontrolled asthma who received tezepelumab had fewer exacerbations and better lung function, asthma control, and health-related quality of life than those who received placebo,” concluded the study authors.

Disclosure: This research was supported by AstraZeneca and Amgen. Please see the original reference for a full list of authors’ disclosures.


Menzies-Gow A, Corren J, Bourdin A, et al. Tezepelumab in adults and adolescents with severe, uncontrolled asthma. N Engl J Med. 2021;384(19):1800-1809. doi:10.1056/NEJMoa2034975