Dupilumab reduces disease in COPD patients with type 2 inflammation: Second Phase 3 trial

Chronic obstructive pulmonary disease (COPD) patients who experience type 2 inflammation may soon benefit from a new medication called dupilumab. This promising drug has demonstrated rapid and sustained improvements in a pivotal Phase 3 clinical trial, as published in the New England Journal of Medicine. Dupilumab, a monoclonal antibody, is the first biologic shown to enhance clinical outcomes in COPD.

The efficacy of dupilumab will be evaluated by the United States Food and Drug Administration (FDA) in June, based on data from the clinical trial. The trial reported significant improvements in COPD patients, characterized by a notably lower annual rate of acute exacerbations and enhanced lung function compared to those who received a placebo. These improvements were noticeable 12 weeks after starting the treatment and persisted throughout the 52-week trial. The safety profile of dupilumab was comparable to the placebo, aligning with previously established safety data.

COPD is a lung disease that manifests through symptoms like chronic cough and difficulty breathing. Traditionally, COPD has been viewed as an inflammatory condition driven largely by neutrophilic inflammation. However, 20% to 40% of COPD patients exhibit a predominant type 2 inflammation, identifiable by elevated blood eosinophil counts, which increases their risk of exacerbations.

"Dupilumab markedly reduces the frequency of exacerbations and enhances lung function and symptom burden in COPD patients with type 2 inflammation and a high risk of exacerbations, who are already receiving maximum inhaled therapy," stated Surya Bhatt, M.D., a professor of medicine at the University of Alabama at Birmingham. Bhatt, along with Klaus Rabe, M.D., Ph.D., a pulmonary medicine expert at the LungenClinic Grosshansdorf in Germany, co-led this international study. The trial included 470 patients in the dupilumab group and 465 in the placebo group, with participants aged between 40 and 85 years.

This recent trial confirms the findings of an earlier Phase 3 trial, also led by Bhatt and Rabe, which underscored the benefits of dupilumab for COPD patients with elevated blood eosinophil counts and a high exacerbation risk, despite being on inhaled triple therapy. Rigorous clinical trials like these provide data that enable the FDA to assess whether the advantages of a new drug outweigh its risks for the intended patient population.

COPD patients frequently experience exacerbations, which can increase the likelihood of future exacerbations, accelerate the decline in lung function, and elevate the risk of death. According to Bhatt, enhancing lung function and reducing exacerbations are critical unmet needs for COPD patients.

"Globally, COPD is the third leading cause of death," Bhatt noted. "Exacerbations lead to a diminished quality of life, more hospitalizations, and a heightened risk of mortality." The introduction of dupilumab represents a potential breakthrough in addressing these significant challenges for COPD patients with type 2 inflammation.