Results from a large phase 3 trial of tezepelumab showed the monoclonal antibody performed better than placebo at improving lung function and asthma scores in patients with severe asthma, according to recent research published in the New England Journal of Medicine.
“Managing severe asthma is challenging, with multiple inflammatory pathways often contributing to the complexity of a patient's disease. These latest results underscore the potential of tezepelumab to transform treatment for a broad population of severe asthma patients, regardless of their type of inflammation,” Andrew Menzies-Gow, MD, of Royal Brompton Hospital in London, said in a press release.
In the phase 3 NAVIGATOR trial, 1,061 adolescent and adult patients received either subcutaneous tezepelumab (210 mg) or placebo for up to 52 weeks, and investigators tracked the number of exacerbations over the course of the trial. The investigators also examined exacerbation rates in patients with blood eosinophil counts < 300 cells per μL at baseline. As secondary endpoints, they examined forced expiratory volume in 1 second (FEV1), Asthma Control Questionnaire–6 (ACQ-6), Asthma Quality of Life Questionnaire (AQLQ), and Asthma Symptom Diary (ASD) scores.
The results showed a significantly lower annualized rate of exacerbations for patients who received tezepelumab (0.93; 95% confidence interval, 0.80-1.07) compared with the placebo (2.10; 95% CI, 1.84-2.39) group (rate ratio, 0.44; 95% CI, 0.37-0.53; P < .001). Among patients with blood eosinophil counts < 300 cells per μL at baseline, those in the tezepelumab group (1.02; 95% CI, 0.84-1.23) had a significantly lower number of annual exacerbations than the placebo (1.73; 95% CI, 1.46-2.05) group (rate ratio, 0.59; 95% CI, 0.46-0.75; P < .001).
Regarding secondary outcomes, the investigators found improved significantly outcomes in the tezepelumab group for prebronchodilator FEV1 (0.23 vs. 0.09 L; difference, 0.13 liters; 95% CI, 0.08-0.18; P < .001), ACQ-6 scores (−1.55 vs. −1.22; difference, −0.33; 95% CI, −0.46 to −0.20; P < .001), AQLQ scores (1.49 vs. 1.15; difference, 0.34; 95% CI, 0.20-0.47; P < .001) and ASD scores (−0.71 vs. −0.59; difference, −0.12; 95% CI, −0.19 to −0.04; P = .002) compared with the placebo group. Investigators noted no significant differences in the frequency and types of adverse events in either group.
“The reduction in hospitalizations seen in NAVIGATOR is important because patients with severe asthma have twice the risk of asthma-related hospitalizations. These results show tezepelumab has the potential to treat a broad population of severe asthma patients and to reduce the burden that this disease places on healthcare systems,” Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, said in a press release.