Dupilumab Cuts COPD Exacerbations by 30% in Phase 3 Trial

A pivotal phase 3 trial of dupilumab (Dupixent) in adults with chronic obstructive pulmonary disease (COPD) showed that the biologic cut exacerbations by 30%, compared with placebo.

The topline results were announced in a release by Sanofi and Regeneron, which said more complete results will be presented in an upcoming scientific meeting.

All of the participants were current or former smokers; smoking accounts for 8 out of 10 COPD deaths in the United States, according to the CDC.

Besides meeting all key endpoints, the biologic also met all 12 secondary endpoints in the BOREAS trial, the first trial of 2 phase 3 studies to post results. In the randomized, double-blind, placebo-controlled, parallel-group, 52-week study, 939 adults aged 40 to 80 years received dupilumab (n = 468) or placebo (n = 471), added to standard-of-care inhaled therapy.

Results showed that patients on the biologic, which blocks the signaling of the interleukin (IL)-4 and IL-13 pathways, had improved patient-reported health-related quality of life as measured by St. George’s Respiratory Questionaire as well as reduction in the severity of respiratory symptoms of COPD.

Moderate or severe acute COPD exacerbations were slashed by 30% reduction over 52 weeks (P = .0005), the primary endpoint.

Lung function improved from baseline by 160 mL at 12 weeks compared with 77 mL for placebo (P < .0001), with the benefit versus placebo sustained through week 52 (P = .0003), both of which were key secondary endpoints.

Safety results were generally consistent with the known safety profile of dupilumab, which is already approved for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis and eosinophilic esophagitis.

Overall rates of adverse events were 77% for dupilumab and 76% for placebo.

Respiratory conditions like asthma and COPD are among the most costly health conditions in the United States, with spending of $35.5 billion and $34.3 billion, respectively, in 2016, according to a recent study. Worldwide, COPD is the third-leading cause of death.

The second, replicate phase 3 trial (NOTUS) is ongoing with data expected next year, said Sanofi and Regeneron.

“COPD is an urgent global health concern and a notoriously difficult-to-treat disease due to its heterogeneity, with no novel treatments approved in more than a decade,” said George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron. “These results also validate the role type 2 inflammation plays in driving COPD in these patients, advancing the scientific community’s understanding of the underlying biology of this disease.”

Reference

Dupixent demonstrates potential to become first biologic to treat COPD by showing significant reduction in exacerbations in pivotal trial. Paris and Tarrytown, New York. Sanofi. March 23, 2023. https://www.sanofi.com/en/media-room/press-releases/2023/2023-03-23-06-00-00-2632822. Accessed March 23, 2023