Effect of nebulized revefenacin on health status may be more pronounced in women with COPD
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Maintenance treatment with nebulized revefenacin improves the health status of patients with moderate to very severe COPD, especially in women, according to a subgroup analysis of two phase 3 studies.
“Compared with men, women tend to have more severe symptoms, earlier onset of disease and greater susceptibility to COPD with less tobacco exposure. Women with severe disease have higher risk of hospitalization and death from COPD,” Gary T. Ferguson, MD, FCCP, pulmonologist at the Pulmonary Research Institute of Southeast Michigan in Farmington Hills, said during a presentation at the CHEST Annual Meeting. “Revefenacin inhalation solution has been demonstrated to significantly improve lung function and health status of participants with COPD enrolled in phase 3 clinical trials.”
Ferguson reported results of a subgroup analysis that evaluated improvements in health status among women and men with moderate to very severe COPD who were assigned revefenacin (Yupelri; Theravance Biopharma, Mylan). The analysis focused on efficacy data from two 12-week, replicate, placebo-controlled phase 3 trials of 109 patients each, and safety data from the two phase 3 trials as well as a 52-week tiotropium-controlled safety trial of 335 patients. In the 12-week trials, patients received revefenacin 175 µg administered via a jet nebulizer or placebo; in the 52-week study, patients received revefenacin or tiotropium (Spiriva Respimat, Boehringer Ingelheim).
Patient-reported outcomes were measured using the St. George’s Respiratory Questionnaire (SGRQ) and the COPD assessment test. Minimally clinically important differences included a decrease of 4 U or more in score from baseline for the SGRQ and a decrease of 2 U for the COPD assessment test.
In total, 300 women received revefenacin, 211 women received placebo, 195 men received revefenacin and 206 men received placebo.
Revefenacin improved the SGRQ scores among women with COPD (P < .001) compared with men (P = .158). In the responder analysis, 36.2% of women in the placebo group and 52.7% in the revefenacin group met the criteria for clinically meaningful improvement in SGRQ (OR = 2.12; 95% CI, 1.17-3.84; P = .014). SGRQ improvement in men was 36.3% in the placebo group and 40.8% in the revefenacin group, but this was not significant (OR = 1.18; 95% CI, 0.64-2.17; P = .586), according to the researchers.
Revefenacin also improved COPD assessment test scores in both women (P < .0001) and men (P = .041). In the responder analysis, 33.3% of women in the placebo group and 51.4% in the revefenacin group met criteria for clinically meaningful improvement in the COPD assessment test (OR = 2.3; 95% CI, 1.27-4.16; P = .006) compared with 37.8% of men in the placebo group and 46.9% in the revefenacin group (OR = 1.7; 95% CI, 0.93-3.07; P = .084).
Treatment-emergent adverse events were similar among women and men in all groups. The incidence of serious treatment-emergent adverse events was slightly higher among women who received revefenacin compared with men (9.1% vs. 6.9%), according to the results.
“Maintenance treatment with revefenacin can improve the health status of patients with moderate to very severe COPD,” Ferguson said. “However, the effect appears to be more pronounced in women than in men.”