Improvements in health status with revefenacin, a once-daily, nebulized, long-acting muscarinic antagonist for chronic obstructive pulmonary disease.

Autor: Donohue JF; Division of Pulmonary Diseases and Critical Care, Department of Medicine, University of North Carolina School of Medicine, 130 Mason Farm Rd, Chapel Hill, NC, 27514, USA. Electronic address: james_donohue@med.unc.edu., Ferguson GT; Pulmonary Research Institute of Southeast Michigan, 29255 W 10 Mile Rd A, Farmington Hills, MI, 48336, USA. Electronic address: garytferguson@msn.com., Ohar JA; Department of Internal Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Medicine at Wake Forest University School of Medicine, Medical Center Blvd 7th Floor, Winston-Salem, NC, 27157, USA. Electronic address: johar@wakehealth.edu., Lombardi DA; Theravance Biopharma US, Inc., 901 Gateway Blvd, South San Francisco, CA, 94080, USA. Electronic address: davidlombardi3@gmail.com., Schneider RF; Theravance Biopharma US, Inc., 901 Gateway Blvd, South San Francisco, CA, 94080, USA. Electronic address: rozdoc100@gmail.com., Johnson K; Theravance Biopharma US, Inc., 901 Gateway Blvd, South San Francisco, CA, 94080, USA. Electronic address: kjohnson@theravance.com.
Jazyk: angličtina
Zdroj: Respiratory medicine [Respir Med] 2023 Mar; Vol. 208, pp. 107123. Date of Electronic Publication: 2023 Jan 18.
DOI: 10.1016/j.rmed.2023.107123
Abstrakt: Background: Replicate, 12-week, phase 3 trials (0126 and 0127) of once-daily nebulized revefenacin 175 μg vs placebo demonstrated significant bronchodilation and improvements in health status in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). This post hoc analysis evaluated improvement in patient-reported outcomes (PROs), including the St. George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Clinical COPD Questionnaire (CCQ) in both women and men.
Methods: Participants were pooled from the two 12-week studies (411 [51%] women and 401 [49%] men). Changes in PROs were assessed overall and separately in men and women.
Results: Revefenacin improved SGRQ and CAT total scores from baseline in both studies; improvement in CCQ total score reached significance only in 0126. In pooled data, a greater proportion of patients achieved clinically meaningful response in SGRQ score (≥4-unit decrease from baseline) with revefenacin vs placebo (odds ratio, 1.5; 95% confidence interval, 1.1-2.1; P = 0.012). Clinically meaningful responses were also seen in CAT (≥2-unit decrease from baseline) and CCQ (≥0.4-unit decrease from baseline) scores with revefenacin vs placebo. When stratified by sex, improvements from baseline in SGRQ, CAT, and CCQ scores following revefenacin vs placebo reached statistical significance only in women.
Conclusions: Maintenance treatment with revefenacin improved health status in patients with moderate to very severe COPD; however, the effect was more pronounced for women than men.
Clinicaltrials: GOV: NCT02459080; NCT02512510.
Competing Interests: Declaration of competing interest JFD is a consultant and advisory committee member for Theravance Biopharma US, Inc.; Sunovion Pharmaceuticals; and Mylan, a Viatris company. GTF is a consultant and speaker for and received financial support from Theravance Biopharma US, Inc., and Mylan, a Viatris company. JAO served on advisory boards for AstraZeneca, Boehringer Ingelheim, GSK, Mylan Inc., Reckitt Benckiser, Sunovion Pharmaceuticals, and Theravance Biopharma US, Inc.DAL was a contract employee of Theravance Biopharma US, Inc., at the time of this study. RFS is an employee of BioMarin Pharmaceuticals, Inc.; received consulting fees from GSK, Merck, and BreathResearch; and received salary from Pfizer and from Theravance Biopharma US, Inc., where she was employed when these analyses were done. KJ is an employee of Theravance Biopharma US, Inc.
(Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
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