Maintenance treatment with revefenacin may be beneficial for patients with moderate to very severe chronic obstructive pulmonary disease (COPD), with a potentially greater effect in women than in men, according to study findings published in Respiratory Medicine.
Investigators sought to determine whether revefenacin improved patient-reported outcomes (PROs) in patients with COPD compared with placebo in a post hoc subgroup analysis of 2 replicate, randomized, double-blind, 12-week phase 3 trials, Study 0126 (ClinicalTrials.gov Identifier: NCT02459080) and Study 0127 (ClinicalTrials.gov: NCT02512510). The 2 trials had assessed improvements in health status among patients with moderate to severe COPD who received once-daily nebulized revefenacin 175 µg from a standard jet nebulizer or placebo.
The post hoc study investigators assessed improvement in PROs by measuring the change over time in participant scores on the St. George’s Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Clinical COPD Questionnaire (CCQ). Clinically meaningful improvements were defined as decreases of at least 4 units in SGRQ, at least 2 units in CAT, and at least 0.4 units in CCQ scores from baseline.
The patient cohort included 411 (51%) women (mean [SD] age, 63 [9] years) and 401 (49%) men (mean age, 64 [9] years).
Revefenacin was associated with improved SGRQ and CAT total scores in both studies and in CCQ total score in Study 0126. In Study 0127, improvement in CCQ score was not statistically significant, as the placebo response was greater than expected. Notably:
(1) for SGRQ scores, pooled data showed that a statistically significantly greater percentage of patients had clinically meaningful improvements in SGRQ score with revefenacin compared with placebo based on thresholds of 4 points (46.9% vs 36.2%; P =.012), 8 points (35.1% vs 22.5%; P =.001), and 12 points (26.0% vs 11.6%; P =.0001).
(2) With respect to CAT scores, revefenacin was associated with a clinically meaningful increase in CAT score compared with placebo in Study 0126 (50.4% vs 33.8%, respectively; P =.010), although the difference was not statistically significant in Study 0127 (48.4% vs 39.2%, respectively).
(3) With respect to CCQ scores, the percentage of patients who had clinically meaningful total scores improvements was statistically significantly greater in those who received revefenacin vs placebo, according to pooled data (43.3% vs 31.9%, respectively; P =.003).
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Further research is needed to ascertain the reasons underlying the different levels of improvement between women and men with revefenacin, although this could be related to sex-based differences in symptom burden often observed among patients with COPD.
Revefenacin was associated with statistically significant improvements in CAT scores vs placebo in men and women. However, improvements in SGRQ and CCQ scores with revefenacin vs placebo had statistical significance only in women. The percentage of participants experiencing clinically meaningful improvement with revefenacin treatment vs placebo was: (1) based on SGRQ scores: 52.7% vs 36.2% of women, respectively (P =.014) and 40.8% vs 36.3% of men, respectively (not statistically significant); (2) based on CAT scores: 51.4% vs 33.3% of women, respectively (P =.006) and 46.9% vs 37.8% of men, respectively (not statistically significant); (3) and based on CCQ scores, 49.3% vs 31.9% of women, respectively (P =.002) and 37.1% vs 31.9% of men, respectively (not statistically significant).
The researchers noted that their findings are limited by the 3-month treatment period.
“Further research is needed to ascertain the reasons underlying the different levels of improvement between women and men with revefenacin, although this could be related to sex-based differences in symptom burden often observed among patients with COPD,” stated the researchers.
Disclosure:This work was supported by Theravance Biopharma Ireland Limited. Medical writing support was funded by Mylan Inc, now merged with Upjohn to be Viatris, and by Theravance Biopharma US, Inc. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
