MeiLan Han, MD: Discussing Updates on Dupilumab, Ensifentrine in 2025 GOLD Report

Following the latest additions to the 2025 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Report, including 3 new sections and several additions made to existing sections, MeiLan K. Han, MD, spoke in an interview with HCPLive about the updates and their significance for chronic obstructive pulmonary disease (COPD).^1,2

Han, known for her work as professor of internal medicine for the Division of Pulmonary and Critical Care Medicine at the University of Michigan Health System, spoke with the editorial team specifically about 2 recent revisions to the GOLD 2025 Report regarding dupilumab and ensifentrine.

“I think some of the updates in the 2025 GOLD document that people were most interested in related to the placement of 2 new medications that were approved for COPD within the last year,” Han said. “So that includes ensifentrine, which is a nebulized PDE3 and PDE4 inhibitor, as well as dupilumab, that targets the IL-4 and IL-13 which are two of the key and central drivers of type 2 inflammation.”

Han explained that diagnosis, staging, and categorization have not changed in the report, adding that there are still A, B, and E categories for low risk symptoms. She then pointed to the new suggestion to consider ensifentrine additionally when those on long-acting β2 agonists (LABAs) plus long-acting muscarinic antagonists (LAMAs) still maintain significant symptoms.

“For Group E in particular, the initial recommendation now is LABA plus LAMA, which is a little bit of a change from before,” Han explained. “I think it was confusing to a lot of practitioners that LABA ICS is nowhere in the initial treatment. So we actually now, in the updated document, have some specific discussions about what to do with patients that are already on ICS LABA.”

Next, Han pointed to updates on the follow-up treatment algorithm. She added that many appear to forget the difference between follow-up and initial treatment, with a shift in algorithms.

“Ensifentrine was placed on the left hand side of the follow up treatment pathway, which is the
‘dyspnea side,’ and you have to remember that ensifentrine studies showed that there were significant improvements in lung function and symptoms,” Han said. “They actually happened to also see improvement in exacerbations, but those patients were on a wide variety of background therapies, and not many patients were on triple inhaled therapy.”

GOLD, consequently, did not place ensifentrine on the ‘exacerbation’ half of the report, Han noted. Next, Han commented on dupilumab’s placement in the document.

“We see that dupilumab was placed parallel with 3 other potential add-ons, once you've maximized triple inhaled therapy for some patients,” she explained. “So the previous add-ons could have included azithromycin or roflumilast. Now, dupilumab is a new potential add-on for patients who have 300 eosinophils or greater.”

The dupilumab studies were described by Han as having been conducted much more rigorously in patients already on triple therapy.

“Based on the findings from the BOREAS and NOTUS studies, there is quite good data to suggest that dupilumab added onto triple therapy can help to reduce exacerbations in patients with high eosinophils, so that's where dupilumab comes in,” Han said.

For additional information on this topic, view the latest updates to the 2025 GOLD Report here. To find out more from Han, view her full interview segment posted above.

The quotes contained in this interview summary are edited for the purposes of clarity.

Han has reported receiving grants from GSK, Nuvaira, Gala Therapeutics, the COPD Foundation, the American Lung Association, and Biodesix; and consulting fees from Sanofi, AstraZeneca, Boehringer Ingelheim, Novartis, Pulmonx, Teva, Verona, Merck, Mylan, DevPro, Aerogen, Polarian, Regeneron, Altesa, Amgen, Roche, RS BioTherapeutics, Apreo Health, and Genentech.

References

1. ^{Global initiative for chronic obstructive lung disease 2025 report. https://goldcopd.org/wp-content/uploads/2024/11/GOLD-2025-Report-v1.0-12Nov2024_WMV-Draft.pdf. Date accessed: November 18, 2024.}
2. ^{GOLD report 2025 key changes summary. https://goldcopd.org/wp-content/uploads/2024/11/KEY-CHANGES-GOLD-2025-11Nov2024.pdf. Date accessed: November 18, 2024.}