Chronic obstructive pulmonary disease (COPD) patients with type 2 inflammation may soon have a new treatment option. Researchers report that dupilumab, a monoclonal antibody, has shown rapid and sustained improvements for patients in a pivotal Phase 3 clinical trial. This drug is the first biologic to demonstrate improvements in clinical outcomes for COPD patients. The findings were reported in the New England Journal of Medicine.This monoclonal antibody is the first biologic that has been shown to improve clinical outcomes in COPD. The United States Food and Drug Administration will be reviewing the data on the use of dupilumab in COPD in June.
The improvements in the disease, as measured by a significantly lower annualized rate of acute exacerbations and better lung function than adults with COPD who were treated with a placebo, were observed 12 weeks after the start of dupilumab and continued throughout the 52-week trial. In terms of safety, the number of adverse events was similar between the placebo and treatment groups and con rnrnconsistent with the established profile of dupilumab.
Individuals with COPD often experience coughing and difficulty breathing. It is typically seen as an inflammatory disease caused mainly by neutrophilic inflammation. However, 20-40% of COPD patients display a specific type of inflammation called type 2 inflammation, which is often identified by high levels of eosinophils in the blood. These patients are at a higher risk for exacerbations.
<p”Dupilumab has been shown to significantly reduce the frequency of exacerbations and improve lung function and symptoms in patients with COPD who have type 2 inflammation and are at high risk for exacerbations. This is in line with what has already been known about dupilumab’s effects.Dr. Surya Bhatt, a professor of medicine at the University of Alabama at Birmingham, emphasized the importance of maximal inhaled therapy for patients. He and Dr. Klaus Rabe of LungenClinic Grosshansdorf in Germany co-led a clinical study with 470 patients in the dupilumab group and 465 patients in the placebo group, all aged 40 to 85. The trial replicated a previous Phase 3 clinical study.The NEJM published a clinical trial of dupilumab by Bhatt and Rabe last year. This Phase 3 trial aimed to validate the findings of the initial trial for COPD patients with high blood eosinophil counts and a heightened risk of exacerbation, even with inhaled triple therapy. Well-designed clinical trials provide data that helps the FDA assess the benefits and risks of a new drug for its intended population. COPD patients frequently experience exacerbations that can increase their risk of future events.Exacerbations, a faster decline in lung function, and a higher chance of death are all associated with COPD. Dr. Bhatt emphasizes that improving lung function and reducing exacerbations are important areas for improvement in COPD patients.
“COPD is the third leading cause of death worldwide,” Dr. Bhatt stated. “Exacerbations of COPD result in reduced quality of life, more hospitalizations, and a greater risk of death.”
