Cecilia Brown

DocwireNews

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&rsquo;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, &minus;0.14-0.22). The ACQ-6 score least-squares mean change from baseline to week 52 was &minus;1.12 in patients treated with tezepelumab and &minus;0.97 in patients who received placebo (least-squares mean difference, &minus;0.15; 95% CI, &minus;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&rsquo;s investigators.&ldquo;Tezepelumab was well tolerated in NAVIGATOR patients recruited in Japan, and no new safety findings were identified,&rdquo; Dr. Ishizuka and colleagues concluded. &ldquo;Taken together, these findings further support the potential benefits of tezepelumab in patients with severe, uncontrolled asthma.&rdquo;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

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Tezepelumab Halves Exacerbation Rates in Severe, Uncontrolled Asthma

Asthma

Tezepelumab, a monoclonal antibody that inhibits thymic stromal lymphopoietin, reduced asthma exacerbation rates by 51% over placebo in patients with severe, uncontrolled ...

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