September 06, 2017
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Tezepelumab lowers asthma exacerbations vs. placebo

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When compared with placebo, tezepelumab lowered clinically significant asthma exacerbations in adults with long-acting beta-agonists and medium-to-high doses of inhaled glucocorticoids, regardless of blood eosinophil counts at trial onset.

The results of the phase 2 trial were published recently in the New England Journal of Medicine.

“... In some patients, asthma remains uncontrolled despite the use of available recommended therapies,” Jonathan Corren, MD, of the allergy and immunology department at the David Geffen School of Medicine at the University of California, Los Angeles, and colleagues wrote.

Researchers randomly assigned 584 adults whose asthma was uncontrolled despite receiving long-acting beta-agonist therapy and medium-to-high doses of inhaled glucocorticoids into one of four groups: 70-mg tezepelumab every 4 weeks (low dose; n = 145); 210-mg tezepelumab every 4 weeks (medium dose; n = 145); 280-mg tezepelumab every 2 weeks (high dose; n = 146); and placebo every 2 weeks for the trial’s duration (n = 148). The primary endpoint was the yearly rate of asthma exacerbations at week 52.

Corren and colleagues found that annualized asthma exacerbation rates were 0.26 for the low-dose group (61% fewer exacerbations); 0.19 for the medium-dose group (71% fewer exacerbations); 0.22 for the high-dose group (66% fewer exacerbations); and 0.67 for the placebo group. Corren and colleagues also noted that these results mirrored each other, regardless of blood eosinophil counts at baseline.

In addition, researchers wrote that the prebronchodilator forced expiratory volume in 1 second at week 52 was higher in all tezepelumab groups vs. placebo; specifically, the difference was 0.12 liters with the low dose (P = 0.01), 0.11 liters with the medium dose (P = 0.02), and 0.15 liters with the high dose (P = 0.002).

The most common adverse events were, in order, asthma, nasopharyngitis, headache and bronchitis. Two patients in the medium-dose group, three patients in the high-dose group, and one patient in the placebo group had to stop their respective regimen because of adverse events.

“These findings highlight the potential advantages of targeting an upstream cytokine such as [thymic stromal lymphopoietin], which may affect disease activity more broadly than inhibition of a single downstream pathway,” Corren and colleagues wrote. “Future studies involving large, ethnically diverse populations of patients with uncontrolled asthma using the best available small-molecule therapies, including high-dose inhaled glucocorticoids plus [long-acting beta-agonist], will be important to demonstrate the clinical importance of our findings.” – by Janel Miller

Disclosure: Corren reports he receives grant support, lecture fees and honoraria from Genentech; lecture fees from and serves on an advisory board for Teva Pharmaceuticals; grant support from Sanofi; consulting fees from and serves on an advisory board for Vectura Group; and grant support and consulting fees from Regeneron. Please see the study for a full list of the other researchers’ relevant disclosures.