
The results of a sub-study related to a phase 3 trial released by Theravance Biopharma, Inc., show that Yupelri (revefenacin) provides consistent and durable improvements in lung function compared to a placebo over a 24-hour period.
The company said in a news release that the study, published in the International Journal of Chronic Obstructive Pulmonary Diseases, presented several key findings:
- Analysis of a retrospective, pooled sub-study from phase 3 studies 0126 and 0127 demonstrated that revefenacin improved bronchodilation versus placebo in patients with moderate to very severe COPD when assessed by forced expiratory volume in one second in area under the curve (FEV1 AUC) lung function effects.
- Rapid onset of bronchodilation was observed, with a mean FEV1 difference of 145 mL achieved at 15 minutes, exceeding the accepted Minimal Clinically Important Difference (MCID) of 100 mL with approximately 97.5% confidence.
- Day 84 bronchodilation improvements were sustained over 24 hours versus placebo, with mean differences of 282 mL, 220 mL, 205 mL and 212 mL for FEV1 AUC 0–2h, AUC 0–12h, AUC 12–24h and AUC 0–24h, respectively.
The company said trough FEV1 is an important endpoint often used in COPD trials and provides the magnitude of lung function benefit at the end of a given dosing interval. FEV1 AUC measurements provide additional information on the magnitude and consistency of bronchodilation throughout the dosing interval, including both daytime and nighttime effects.
Donald A. Mahler, MD, emeritus professor of medicine at Geisel School of Medicine at Dartmouth University in Hanover, New Hampshire, said in the news release these results provide additional clinical insight into the duration and consistency of revefanacin.
“Where previous data showed that revefanacin significantly improved peak and trough FEV1 at day 85 compared with placebo in patients with moderate to very severe COPD, this subset, post-hoc analysis depicts a more comprehensive view of 24-hour bronchodilation as assessed by examining AUC over multiple time periods,” he said.
“This drug also exhibits a substantial peak response as well as bronchodilation over the initial two-hour period,” added Blake LeMaster, MD, assistant professor of medicine in the Division of Allergy, Pulmonary and Critical Care Medicine at Vanderbilt University Medical Center. “Clinically meaningful bronchodilation was seen within the first 15 minutes of administration, persisting over the 24-hour duration during which patients underwent serial spirometry. These data demonstrate that revefenacin can provide rapid and prolonged bronchodilation with just a single dose.”