by A recent Phase 3 clinical trial has shown that dupilumab, a monoclonal antibody, significantly reduces disease activity and improves lung function in chronic obstructive pulmonary disease (COPD) patients with type 2 inflammation. The findings, published in the New England Journal of Medicine, represent the first biologic to demonstrate clinical benefits in COPD. The data from this trial will be reviewed by the US Food and Drug Administration (FDA) in June.
The trial, which included 935 participants aged 40 to 85, revealed that patients receiving dupilumab experienced a lower annualized rate of acute exacerbations and improved lung function compared to placebo-treated adults with COPD. These improvements were observed after 12 weeks of treatment and were sustained throughout the 52-week trial period. The safety profile of dupilumab was consistent with previous studies, with a similar number of adverse events reported in both the placebo and treatment groups.
COPD is characterized by cough and labored breathing. Traditionally, it has been considered an inflammatory disease driven primarily by neutrophilic inflammation. Approximately 20-40% of COPD patients have a type 2 inflammatory phenotype, which is associated with a high risk of exacerbations and is often identified by elevated blood eosinophil counts.
Surya Bhatt, M.D., a professor of medicine and endowed professor of airways disease in the University of Alabama at Birmingham Department of Medicine Division of Pulmonary, Allergy and Critical Care Medicine, and Klaus Rabe, M.D., Ph.D., a professor of pulmonary medicine at the LungenClinic Grosshansdorf, Grosshansdorf, Germany, co-led the international multicenter study. The trial aimed to confirm the findings of an initial Phase 3 clinical trial of dupilumab published in the New England Journal of Medicine last year. This follow-up trial focused on COPD patients with blood eosinophil counts of 300 cells per microliter or higher and an elevated exacerbation risk, despite being on inhaled triple therapy.
Well-designed clinical trials generate data that enable regulatory agencies like the FDA to assess the potential benefits and risks of an investigational drug for its intended population.
