
Dupilumab Cuts COPD Exacerbations by 30% in Phase 3 Trial
Dupilumab is the first biologic to significantly improve lung function in chronic obstructive pulmonary disease (COPD), according to topline results released Thursday.
A pivotal phase 3 trial of dupilumab (Dupixent) in adults with
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,
Besides meeting all key endpoints, the biologic also met all 12 secondary endpoints in the
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
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,”
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.
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