Dupilumab shows promising results in Phase 3 trial for COPD with type 2 inflammation

Patients with chronic obstructive pulmonary disease with type 2 inflammation may soon have access to a new drug – dupilumab -? that showed rapid and sustained improvements in patients in a pivotal Phase 3 clinical trial, researchers report in New England Journal of Medicine. This monoclonal antibody is the first biologic shown to improve clinical outcomes in COPD. Data supporting the use of dupilumab in COPD will be reviewed by the US Food and Drug Administration in June.

The improvements of the disease -? as measured by a significantly lower annual rate of acute exacerbations and significantly better lung function than placebo-treated adults with COPD—were observed 12 weeks after initiation of dupilumab and sustained throughout the 52-week trial period. Regarding safety, the number of adverse events was similar between the placebo and treatment groups and is consistent with the established profile of dupilumab.

The lung disease COPD is characterized by coughing and difficulty breathing. COPD has traditionally been considered an inflammatory disease caused primarily by neutrophilic inflammation. About 20 percent to 40 percent of COPD patients have type 2 inflammation-predominant COPD that is usually detected by an increased number of eosinophils in the blood. These patients have a high risk of exacerbations.

Dupilumab significantly reduces exacerbation frequency and improves lung function and symptom burden in COPD patients with type 2 inflammation and high risk of exacerbation already receiving maximal inhaled therapy.”

Surya Bhatt, MD, professor of medicine and endowed professor of airway disease at the University of Alabama at Birmingham Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine

Bhatt and Klaus Rabe, MD, Ph.D., professor of pulmonary medicine at LungenClinic Grosshansdorf, Grosshansdorf, Germany, co-led the international multicenter clinical study that had 470 patients in the dupilumab group and 465 patients in the placebo group. Patients ranged in age from 40 to 85 years.

The just-completed trial replicates an initial, nearly identical, Phase 3 clinical trial of dupilumab reported in the NEJM by Bhatt and Rabe last year. The current randomized, double-blind, placebo-controlled Phase 3 trial was needed to confirm the findings of this first trial for COPD patients with a blood eosinophil count of 300 cells per microliter or higher and an increased risk of exacerbation, despite that they undergo triple therapy by inhalation. Carefully designed clinical trials produce data that allow the FDA to determine whether the benefits of an investigational drug outweigh the known and potential risks to the intended population.

Patients with COPD often have exacerbations of the disease that can lead to an increased risk of subsequent exacerbations, accelerated decline in lung function, and increased risk of death. So, says Bhatt, improving lung function and reducing exacerbations are unmet needs in COPD patients.

“COPD is the third leading cause of death worldwide,” Bhatt said. “COPD exacerbations lead to poorer quality of life, increased hospitalizations and increased risk of death.”

Support came from Sanofi and Regeneron Pharmaceuticals Inc.

The results of the study were presented at the American Thoracic Society’s International Congress in May 2024 in San Diego, California, and were simultaneously published in the New England Journal of Medicine.