Annual asthma exacerbation rates may be independently decreased with the use of tezepelumab therapy in patients with uncontrolled asthma, according to a study published in the New England Journal of Medicine.
Researchers identified 584 patients with asthma currently using long-acting beta-agonists (LABA) and medium to high doses of inhaled glucocorticoids. Participants in the Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma (ClinicalTrials.gov Identifier NCT02054130) were randomly assigned to receive a low (70 mg every 4 weeks), medium (210 mg every 4 weeks), high (280 mg every 2 weeks) dose of tezepelumab, a human monoclonal antibody specific for the epithelial-cell-derived cytokine thymic stromal lymphopoietin, or placebo (every 2 weeks). Patients must have had a history of 2 asthma exacerbations leading to systemic glucocorticoid treatment or an exacerbation that led to hospitalization within 12 months of trial entry. Efficacy of treatment was determined by the annualized rate of asthma exacerbations at week 52 of treatment.
Study results showed that treatment with tezepelumab was independently associated with lower asthma exacerbation rates when compared with the placebo group. Annual rates of exacerbation in individuals receiving low, medium, or high doses of tezepulmab were 0.26, 0.19, and 0.22, respectively, compared with 0.67 in patients receiving placebo (P <.001 for all comparisons). Overall, exacerbation rates in the treatment group compared with the placebo group were 61% lower (90% CI, 39-75; P <.001), 71% (90% CI, 53-82; P <.001), and 66% (90% CI, 47-79; P <.001), respectively.
In addition, the prebronchodilator forced expiratory volume in 1 second (FEV1) was higher in all tezepulemab treatment groups (difference, 0.12 liters with the low dose [P =.01], 0.11 liters with the medium dose [P =.02], and 0.15 liters with the high dose[P =.002]).
The investigators concluded that treatment with tezepelumab resulted in significantly lower annualized asthma exacerbation rates in patients with uncontrolled asthma, despite LABA and medium to high dose inhaled glucocorticoid treatment, compared with patients that received placebo.
Corren J, Parnes JR, Wang L, et al. Tezepelumab in adults with uncontrolled asthma. N Engl J Med. 2017;377:936-946.