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Novel Drug Shows Promise for Treating Poorly Controlled Asthma

Tezepelumab was associated with lower asthma exacerbation rates among patients with poorly controlled asthma who were receiving long-acting beta-agonists and medium-to-high doses of inhaled glucocorticoids, according to a recent study.

The phase 2 randomized, double-blind, placebo-controlled trial included patients with moderate-to-severe asthma, which was poorly controlled despite treatment with long-acting beta-agonists and medium-to-high doses of inhaled glucocorticoids. Participants were randomly assigned to receive 1 of 3 dose levels of subcutaneous tezepelumab or placebo (n=148) over a 52-week treatment period. Tezepelumab was administered at a dosages of 70 mg every 4 weeks to 145 patients (low dose), at 210 mg every 4 weeks to 145 patients (medium dose), and at 280 mg every 2 weeks to 146 patients (high dose). The annualized rate of asthma exacerbations after 52 weeks of treatment was assessed as the primary endpoint.
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At week 52, the annualized asthma exacerbation rates were 0.26, 0.19, and 0.22 for patients in the low dose, medium dose, and high dose groups, respectively, compared with 0.67 for patients in the placebo group. Compared with placebo, tezepelumab lowered the rate of asthma exacerbations by 61% in the low dose group, 71% in the medium dose group, and 66% in the high dose group. These results were similar in all patients, regardless of blood eosinophil counts at baseline.

Additionally, the prebronchodilator forced expiratory volume in 1 second was higher for all patients who received tezepelumab at 52 weeks compared with patients who received placebo.

One patient in the placebo-group, 2 patients in the medium-dose group, and 3 patients in the high-dose group discontinued the study due to adverse events.

“Among patients treated with long-acting beta-agonists and medium-to-high doses of inhaled glucocorticoids, those who received tezepelumab had lower rates of clinically significant asthma exacerbations than those who received placebo, independent of baseline blood eosinophil counts,” the researchers concluded.

—Melissa Weiss

Reference:

Corren J, Parnes JR, Wang L, et al. Tezepelumab in adults with uncontrolled asthma [published online September 7, 2017]. N Engl J Med. doi:10.1056/NEJMoa1704064.