COPD-related health care usage drops with ensifentrine in moderate to severe COPD
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Key takeaways:
- Unscheduled physician office visits, ED visits and unplanned hospitalizations made up the studied COPD-related health care resources.
- A lower moderate/severe exacerbation event rate was found with ensifentrine.
BOSTON — Fewer patients with moderate to severe COPD used health care resources related to the disease if they received ensifentrine for 48 weeks, according to a presentation at the CHEST Annual Meeting.
As Healio previously reported, adults with moderate to severe COPD who were symptomatic and smoked a minimum of 10 pack-years receiving 3 mg of twice-daily nebulized ensifentrine (Ohtuvayre, Verona Pharma) showed improved measures of lung function, quality of life and exacerbation rate over 12 or 24 weeks in the phase 3 ENHANCE-1 and ENHANCE-2 trials.
“These findings, along with the main findings of the ENHANCE-1 and ENHANCE-2 trials (which showed significant improvement in lung function at 24 weeks with ensifentrine 3 mg twice daily relative to placebo), support that ensifentrine appears to be a well-tolerated, inhaled medication with benefits in lung function and future exacerbations and health care utilization,” Emily Wan, MD, MPH, assistant professor of medicine at Harvard Medical School, told Healio.
Using data from the ENHANCE-1 trial, Wan and colleagues assessed 369 patients who met the criteria outlined above to determine how COPD-related health care resource utilization (unscheduled physician office visits, ED visits and unplanned hospitalizations) is impacted after 48-week ensifentrine treatment.
Notably, the FDA approved ensifentrine for treating adults with COPD this past June.
“As a clinician, I am very excited that ensifentrine, which is an inhaled [phosphodiesterase] 3 and 4 inhibitor, represents a new class of medication which is distinct from traditional beta agonists, anti-muscarinic agents and inhaled steroids,” Wan told Healio.
Within the study population, 280 patients (mean age, 65 years; 45% women) received ensifentrine, and the remaining 89 patients (mean age, 64 years; 42% women) received placebo.
Both those receiving ensifentrine and those receiving placebo had a comparable proportion of patients who experienced an exacerbation 15 months before screening (both 23%) and reported current smoking (56% vs. 58%). Further, mean percent predicted FEV1 at baseline was 52% predicted in the ensifentrine group and 51% predicted in the placebo group, according to the presentation.
Researchers found that 14.6% of the ensifentrine group utilized at least one COPD-related health care resource at the 48-week mark, and this was a smaller proportion than the 25.8% of the placebo group who utilized a COPD-related health care resource (20 vs. 34.8 COPD-related health care resource events per 100 patients).
This outcome, in which receipt of ensifentrine vs. placebo was more beneficial, held true when divided into the three outlined health care resources: unscheduled COPD-related physician office visit (11.8% vs. 22.5%), COPD-related ED attendance (0.4% vs. 1.1%) and unplanned COPD-related hospitalization (2.1% vs. 3.4%).
Between the two sets of patients, those treated with 48-week ensifentrine had a lower annualized moderate/severe exacerbation event rate (0.25 vs. 0.44; rate ratio = 0.56; 95% CI, 0.32-1; P = .05), according to the presentation.
“I think the most surprising thing was finding that, in a relatively small safety subset of the ENHANCE-1 trial, we were able to detect a signal with respect to reduced COPD-related health care utilization at 48 weeks in the ensifentrine arm,” Wan told Healio. “This correlates with the reduced rate of acute exacerbations observed at 48 weeks.”
“Future studies in larger cohorts with longer treatment times will be needed to confirm the findings we observed in this study,” Wan said. “These results were secondary analyses within a safety subset of the ENHANCE-1 trial.”
For more information:
Emily Wan, MD, MPH, can be reached at emily.wan@channing.harvard.edu.