The following article is a part of conference coverage from CHEST 2021, being held virtually from October 17 to October 20, 2021. The team at Pulmonology Advisor will be reporting on the latest news and research conducted by leading experts in the field. Check back for more from CHEST 2021.
The human monoclonal antibody tezepelumab led to rapid improvements in morning and evening peak expiratory flow (PEF) compared with placebo in patients with severe and uncontrolled asthma, according to a poster presentation for the 2021 CHEST Annual Meeting, held virtually October 17 to 20.
The reported research findings were from the multicenter, placebo-controlled, phase 3 NAVIGATOR trial (ClinicalTrials.gov Identifier: NCT03347279). The analysis of this trial included 1059 patients with asthma who were receiving medium- or high-dose inhaled corticosteroids as well as 1 or more additional controller medication, with or without oral corticosteroids.
Patients were randomly assigned to receive either 210 mg tezepelumab (n=528) or placebo (n=531) subcutaneously every 4 weeks for a total of 52 weeks. Researchers used a repeated measures model to estimate least-squares (LS) mean changes in the weekly mean morning and evening PEF and the differences in PEF between treatment arms.
The weekly mean morning PEF at baseline was 261.7 L/min in the tezepelumab group vs 262.5 (105.8) L/min in the placebo group. Additionally, the weekly mean evening PEF was 276.9 L/min in the tezepelumab group vs 278.2 (106.9) L/min in the placebo group.
Over the 52-week treatment period, the investigators observed greater improvements in weekly mean morning and evening PEF with tezepelumab vs placebo. In terms of the weekly mean morning PEF, the LS mean difference between tezepelumab and placebo was 7.4 L/min (95% CI, 3.4–11.4) at week 1; 13.9 L/min (95% CI, 9.2–18.7) at week 2; 16.6 L/min (95% CI, 8.9–24.3) week 26; and 16.6 L/min (95% CI, 8.1–25.1) at week 52.
With regard to the weekly mean evening PEF, the LS mean difference between tezepelumab and placebo was 5.4 L/min (95% CI, 1.7–9.2) at week 1; 12.5 L/min (95% CI, 7.7–17.2) at week 2; 16.4 L/min (95% CI, 8.7–24.2) at week 26; and 14.9 L/min (95% CI, 6.3–23.4) at week 52.
The researchers concluded that their “analysis demonstrates that tezepelumab rapidly and sustainedly improves lung function in a broad range of patients with severe, uncontrolled asthma.”
Disclosure: Multiple authors declared affiliations with the pharmaceutical industry. Please refer to the original article for a full list of disclosures.
Israel E, Ambrose C, Hunter G, et al. Rapid improvement in morning and evening peak expiratory flow in patients with severe, uncontrolled asthma treated with tezepelumab. Presented at: CHEST 2021; October 17-20, 2021; Orlando, FL/Virtual. Abstract A34-A36.