The following article is a part of conference coverage from CHEST 2021, being held virtually from October 17 to October 20, 2021. The team at Pulmonology Advisor will be reporting on the latest news and research conducted by leading experts in the field. Check back for more from CHEST 2021.
Maintenance treatment with nebulized revefenacin can improve the health of patients with moderate to very severe chronic obstructive pulmonary disease (COPD), an effect that may be more pronounced in women than men, according to a poster presentation for the CHEST 2021 Annual Meeting, held virtually October 17 to 20.
Revefenacin inhalation solution has demonstrated significant improvement in lung function and the health status of participants with COPD in phase 3 clinical trials.
Because women tend to have more severe symptoms and clinical outcomes from COPD, Ferguson and colleagues conducted subgroup analyses to evaluate improvements in the health status of women and men with moderate to very severe COPD treated with revefenacin.
Using the St George’s Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT), efficacy data were taken from 2 replicate, placebo-controlled, 12-week trials (ClinicalTrials.gov Identifiers: NCT02459080 and NCT02512510). Safety data was also pooled from the 12-week trials and a 52-week tiotropium-controlled safety trial (ClinicalTrials.gov Identifier: NCT02518139). The researchers found that revefenacin produced significant improvements from baseline in SGRQ scores with a placebo-adjusted least squares (LS) mean change of 5.2 (P <.0001) in women, but the difference was not significant for men, 1.7 (P =.16). Likewise, clinically relevant improvements in SGRQ occurred in 53% of women (P =.01) and 41% of men (P =.59) on revefenacin. The researchers also noted significant improvements in the CAT scores of women (P <.0001) and men (P =.04) treated with revefenacin, whereas clinically relevant improvements in CAT were reported in 51% of women (P =.01) and 47% of men (P =.08). Overall, the rate of adverse events was minimal and similar in women and men on revefenacin.
The investigators concluded, “Compared with placebo, nebulized revefenacin produced significant improvements in CAT scores in women and men with moderate to very severe COPD, and significant improvements in SGRQ scores in women alone.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Ferguson G, Feldman G, Pudi K, Lombardi D, Ohar J, Schneider R. Improvements in patient-reported outcomes with revefenacin for nebulization in women vs men with moderate to very severe COPD: subgroup analyses from phase 3 clinical trials. Presented at: CHEST 2021; October 17-20, 2021; Orlando, FL/Virtual. Abstract A1777-A1779.