Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.
This week, we reported on findings from a study presented at the 2024 American Thoracic Society International Conference, May 17-22, 2024, in San Diego, CA.
The study
In the COURSE phase 2a clinical trial, patients aged 40 to 80 years with moderate-to-very severe chronic obstructive pulmonary disease (COPD) were randomly assigned to receive tezepelumab 420 mg or placebo subcutaneously every 4 weeks for up to 52 weeks. The 337 participants received triple inhaled maintenance therapy, and had had 2 or more documented COPD exacerbations in the 12 months leading to the first study visit. The cohort was stratified by global region and by prior number of COPD exacerbations (2 vs 3 or more) and randomly assigned to receive either tezepelumab 460 mg, or placebo, by subcutaneous injection every 4 weeks during trial site visits over the 52-week treatment period. They were followed for a 12-week post-treatment period. The primary endpoint was the annualized rate of moderate or severe COPD exacerbations; this was also assessed in subgroups including baseline BEC and smoking history.
The findings
Compared to placebo, tezepelumab led to a 17% numerical reduction in the annual rate of moderate or severe disease exacerbations compared to placebo at 52 weeks.
When COURSE trial investigators looked at response to tezepelumab by participant BEC levels, there were important differences from the overall group, with a significant reduction of exacerbations classified as moderate or severe of 37% compared to placebo among participants with BEC levels of 150 cells/µL or greater. Further, among participants with BEC levels of 300 cells/µL or more, investigators reported a reduction in the rate of exacerbations of 46%.
Authors' comment
"The tezepelumab COURSE results are particularly important as they show activity in COPD across a broad patient population including those with baseline blood eosinophil counts greater than 150 cells/μL.”