24-week ensifentrine improves dyspnea in moderate to severe COPD
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Key takeaways:
- Across several subgroups, more patients receiving ensifentrine vs. placebo were classified as Transitional Dyspnea Index responders.
- Ensifentrine is currently under review by the FDA.
SAN DIEGO — Among patients with moderate to severe COPD, 24-week ensifentrine improved dyspnea, according to research presented at the American Thoracic Society International Conference.
“It is exciting that HCPs will hopefully have a new and novel therapy as add-on for patients experiencing persistent shortness of breath,” Donald A. Mahler, MD, emeritus professor of medicine at Dartmouth University and director of respiratory services at Valley Regional Hospital, told Healio.
As Healio previously reported, the global, multicenter, randomized, double blind, parallel-group, placebo-controlled phase 3 ENHANCE-1 and ENHANCE-2 trials found that adults with moderate to severe COPD who were symptomatic receiving ensifentrine (Verona Pharma) had improved measures of lung function, quality of life and exacerbation rate over 12 or 24 weeks.
In this pooled analysis of the ENHANCE-1 and -2 trials, Mahler and colleagues evaluated 975 patients receiving 3 mg of twice-daily nebulized ensifentrine and 574 patients receiving placebo to determine the impact ensifentrine treatment has on dyspnea at weeks 6, 12 and 24.
A similar proportion of patients from both groups were on long-acting muscarinic antagonist or long-acting beta agonist with or without an inhaled corticosteroid (ensifentrine group, 62%; placebo group, 61%), according to researchers.
Using the Transition Dyspnea Index (TDI), researchers found greater improvement in dyspnea/breathlessness between baseline and 24 weeks among those receiving ensifentrine vs. placebo (least-squares mean, 2; 95% CI, 1.5-2.4 vs. 0.9; 95% CI, 0.4-1.4; P < .05).
Researchers further classified patients with a minimum improvement of 1 TDI unit as responders. Responders made up 65% of the ensifentrine group at week 24, whereas they only made up 45% of the placebo group at this time (placebo-corrected OR = 1.9; 95% CI, 1.5-2.7; P < .05).
The ensifentrine group also had more TDI responders at week 6 and week 12 than the placebo group.
Across subgroups divided by gender, age, chronic bronchitis, smoking status and eosinophil levels at baseline, researchers continued to find that those receiving ensifentrine had a higher proportion of responders compared with those receiving placebo.
“The only unexpected finding was the magnitude of improvement in dyspnea given that about 60% of subjects were on concomitant inhaled therapies that have also been shown to improve dyspnea related to daily activities,” Mahler told Healio.
“If ensifentrine is approved by FDA, it will provide a novel mechanism of action to improve dyspnea — the most troublesome symptom of patients with COPD,” he added.