The following is a summary of “Improvements in health status with revefenacin, a once-daily, nebulized, long-acting muscarinic antagonist for chronic obstructive pulmonary disease,” published in the MARCH 2023 issue of Pulmonology by Donohue, et al.
Patients with moderate to very severe chronic obstructive pulmonary disease (COPD) showed significantly greater bronchodilation and improvements in health status in replicate, 12-week phase 3 trials (0126 and 0127) of once-daily, nebulized revefenacin 175 μg vs placebo. Using the St. George’s Respiratory Questionnaire (SGRQ), the COPD Assessment Test (CAT), and the Clinical COPD Questionnaire (CCQ), researchers for a post hoc analysis, assessed change in patient-reported outcomes (PROs) in both women and men.
About 411 [51%] women and 401 [49%] men were merged from the two 12-week studies as participants. Overall and separately for men and women, changes in PROs were evaluated.
Revefenacin raised SGRQ and CAT total scores from baseline in both studies; however, only study 0126 saw a significant improvement in CCQ total score. In pooled data, revefenacin outperformed the placebo in terms of the percentage of patients who saw clinically significant improvement in SGRQ score (≥4-unit decrease from baseline) (odds ratio, 1.5; 95% CI, 1.1-2.1; P = 0.012). With revefenacin vs. placebo, clinically significant responses were also observed in CAT (≥2-unit drop from baseline) and CCQ (≥0.4-unit decrease from baseline) scores. Improvements in SGRQ, CAT, and CCQ scores compared to baseline after revefenacin vs. placebo only reached statistical significance in women when results were stratified by sex.
Patients with moderate to very severe COPD who were receiving revefenacin maintenance medication reported an improvement in their health status; however, the effect was more significant in women than in males.
Reference: resmedjournal.com/article/S0954-6111(23)00011-2/fulltext