Safety Data on Dupilumab, Ensifentrine for COPD, with MeiLan Han, MD

In a recent interview with the HCPLive editorial team, MeiLan Han, MD, professor of internal medicine for the Division of Pulmonary and Critical Care Medicine at the University of Michigan Health System, spoke on recent updates that were added in the 2025 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Report.¹

These new revisions included 3 additional sections as well as a set of revisions made to existing topics in the chronic obstructive pulmonary disease (COPD) space. Han primarily touched on the new information included on dupilumab as well as ensifentrine in her previous segment, with this portion of her interview touching on safety data for the 2 drugs.

“For all medications, there are certain things that you need to watch out for,” Han said. “Obviously, anybody can have an allergic reaction, but I would think, generally speaking, that the side effect profile for both of these medications appears to be fairly low. Ensifentrine is an inhaled medication. Now, there is already an approved PDE4-inhibitor on the market, which is roflumilast. One of the biggest challenges with roflumilast is that patients have a lot of GI side effects like nausea and diarrhea, to the point that many patients that I've tried to start on those medications don't tolerate it.”

Han added that a positive element of ensifentrine, given that it is a nebulized product, is that there are not the same level of GI side effects.

“For dupilumab, we have a lot of experience with this drug, because it's already approved for many, many other conditions including asthma,” she explained. “So yes, patients can always have rare reactions to injections. But generally speaking, dupilumab is also incredibly well tolerated and does not, for instance, have 1 of the challenges that we have with with patients with type 2 inflammation where they end up getting a lot of steroids that could be inhaled steroids or oral steroids, and those clearly have a lot of side effects.”

Later, Han was asked to highlight any additional details she felt it was important to cover regarding dupilumab and ensifentrine for patients with COPD.

“I think it's important to know that as we start, as you start prescribing any new medication, it can be kind of a little bit challenging to navigate the approval pathways,” Han said. “So for ensifentrine in particular, there is a specialty kind of pathway and some very specific forms that have to be filled out. Sometimes I've already run into problems with pharmacies in getting it. It's Medicare Part B and not Medicare Part D. This happens all the time with inhaled medications. For dupilumab with it being an injection, I think the good news is that most physicians at this point should are more familiar with the process of prescribing biologics, some of the approvals that are required there, and how to initiate patients on biologics.”

The quotes used in this summary of Han’s interview are edited for 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.}