Tezepelumab, a monoclonal antibody that inhibits thymic stromal lymphopoietin, reduced asthma exacerbation rates by 51% over placebo in patients with severe, uncontrolled asthma, according to results of a recent phase 3 trial.
Tamotsu Ishizuka, MD, PhD, of the University of Fukui, and colleagues conducted the trial and published its results in Allergology International.
The multicenter, randomized, double-blind, placebo-controlled NAVIGATOR study included 97 patients 12 to 80 years old who were recruited in Japan. Researchers randomized patients to receive tezepelumab 210 mg (n=58) or placebo (n=39) subcutaneously every 4 weeks for 1 year. The study’s primary end point was the annualized asthma exacerbation rate. Secondary end points included the change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) and Asthma Control Questionnaire (ACQ)-6 score.
The annualized asthma exacerbation rate was around twice as high in patients who received placebo (3.12; 95% CI, 1.82-5.35) than in patients treated with tezepelumab (1.54; 95% CI, 0.90-2.64). The annualized asthma exacerbation rate was reduced by 51% in patients treated with tezepelumab compared with those who received placebo (rate ratio, 0.49; 95% CI, 0.25-0.99).
The pre-bronchodilator FEV1 least-squares mean change from baseline to week 52 was 0.23 liter for patients treated with tezepelumab and 0.19 liter for patients who received placebo (least-squares mean difference, 0.04; 95% CI, −0.14-0.22). The ACQ-6 score least-squares mean change from baseline to week 52 was −1.12 in patients treated with tezepelumab and −0.97 in patients who received placebo (least-squares mean difference, −0.15; 95% CI, −0.63-0.32).
Researchers reported adverse events in 86.2% of patients treated with tezepelumab and 87.2% of patients who received placebo.
The rate of responses and adverse events in this study was similar to the overall NAVIGATOR cohort, according to the study’s investigators.
“Tezepelumab was well tolerated in NAVIGATOR patients recruited in Japan, and no new safety findings were identified,” Dr. Ishizuka and colleagues concluded. “Taken together, these findings further support the potential benefits of tezepelumab in patients with severe, uncontrolled asthma.”
Ishizuka T, Menzies-Gow A, Okada H, et al. Efficacy and safety of tezepelumab in patients recruited in Japan who participated in the phase 3 NAVIGATOR study. Allergol Int. 2022. doi:10.1016/j.alit.2022.07.004