IMPROVEMENTS IN HEALTH STATUS WITH REVEFENACIN: A POST HOC ANALYSIS OF ST GEORGE’S RESPIRATORY QUESTIONNAIRE IN PATIENT SUBGROUPS FROM REPLICATE PHASE 3 TRIALS

Abstract

SESSION TITLE: Obstructive Lung Disease Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: October 18-21, 2020 PURPOSE: Revefenacin (REV), a long-acting muscarinic antagonist, is approved for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Previous phase 3 trials showed significant bronchodilation in patients with COPD in response to once-daily REV and significant improvements in St George’s Respiratory Questionnaire (SGRQ). This post hoc analysis assessed SGRQ in prespecified subgroups of patients with moderate to very severe COPD defined by certain demographic and clinical characteristics. METHODS: Changes in health status were analyzed, pooled from replicate 12-week phase 3 studies (0126 [NCT02459080]/0127 [NCT02512510]), REV 175 μg vs placebo [PBO]) using SGRQ patient-reported outcomes administered at day 85. RESULTS: Statistically significant (P<0.05) improvements in SGRQ total scores were found with REV vs PBO by age group: <65 years (least square mean difference [95% confidence interval] vs PBO −4.23 [−6.25, −2.21]), ≥65 years (−3.15 [−5.25, −1.04]); inhaled corticosteroid use: yes (−3.73 [−6.00, −1.48]), no (−3.47 [−5.39, −1.55]); baseline post-bronchodilator percent predicted forced expiratory volume in 1 second (FEV1): <50% (−5.65 [−8.12, −3.18]), ≥50% (−2.74 [−4.55, −0.94]); symptom improvement by modified Medical Research Council Dyspnea Scale (mMRC): <2 (−2.97 [−5.00, −0.95]), ≥2 (−4.35 [−6.43, −2.26]); smoking status: current smoker (−5.22 [−7.35, −3.10]), former smoker (−2.26 [−4.26, −0.26]). Statistical significance of REV over PBO was also reached in the subgroup of patients not concurrently using a long-acting β-agonist (LABA)-containing product (−3.73 [−5.20, −2.27]). However, statistically significant improvements in SGRQ total scores were not observed in patients taking concomitant LABA (3.35 [−10.69, 17.39]; P=0.64). CONCLUSIONS: Improvements in health status based on SGRQ occurred in REV-treated patients regardless of demographics (age <65 or ≥65 years, current or former smoker) and clinical characteristics, including patients with severe markers of disease (FEV1 <50%, mMRC ≥2). These findings further support the use of revefenacin as a once-daily bronchodilator for the maintenance treatment of patients with COPD. CLINICAL IMPLICATIONS: Maintenance treatment with REV may improve the health status of patients with COPD. DISCLOSURES: Employee relationship with Theravance Biopharma Please note: >$100000 Added 04/30/2020 by Glenn Crater, source=Web Response, value=Salary Own Stock relationship with Theravance Biopharma Please note: >$100000 Added 04/30/2020 by Glenn Crater, source=Web Response, value=Ownership No relevant relationships by James Donohue, source=Web Response Consultant relationship with Theravance BioPharma, Inc Please note: >$100000 by David Lombardi, source=Web Response, value=Consulting Consultant relationship with Forest, Please note: $1-$1000 Added 04/07/2020 by Thomas Siler, source=Web Response, value=Grant/Research Support Removed 04/07/2020 by Thomas Siler, source=Web Response Grant/Research Support relationship with GlaxoSmithKline Please note: >$100000 Added 04/15/2020 by Thomas Siler, source=Web Response, value=Grant/Research Support Grant/Research Support relationship with Pearl Please note: >$100000 Added 04/15/2020 by Thomas Siler, source=Web Response, value=Grant/Research Support Grant/Research Support relationship with Theravance Biopharma US, Inc. Please note: >$100000 Added 04/15/2020 by Thomas Siler, source=Web Response, value=Grant/Research Support Grant/Research Support relationship with Novartis Please note: $20001 - $100000 Added 04/15/2020 by Thomas Siler, source=Web Response, value=Grant/Research Support Grant/Research Support relationship with Chiesi USA Please note: $20001 - $100000 Added 04/15/2020 by Thomas Siler, source=Web Response, value=Grant/Research Support Grant/Research Support relationship with West-Ward Please note: >$100000 Added 04/15/2020 by Thomas Siler, source=Web Response, value=Grant/Research Support Grant/Research Support relationship with Seer, Inc. Please note: $20001 - $100000 Added 04/15/2020 by Thomas Siler, source=Web Response, value=Grant/Research Support Grant/Research Support relationship with CompleWare Please note: $20001 - $100000 Added 04/15/2020 by Thomas Siler, source=Web Response, value=Grant/Research Support Grant/Research Support relationship with Sanofi Please note: $20001 - $100000 Added 04/15/2020 by Thomas Siler, source=Web Response, value=Grant/Research Support Grant/Research Support relationship with Evidera Please note: >$100000 Added 04/15/2020 by Thomas Siler, source=Web Response, value=Grant/Research Support Grant/Research Support relationship with Novum Please note: $20001 - $100000 Added 04/15/2020 by Thomas Siler, source=Web Response, value=Grant/Research Support Grant/Research Support relationship with Cipla Please note: $20001 - $100000 Added 04/15/2020 by Thomas Siler, source=Web Response, value=Grant/Research Support Grant/Research Support relationship with ResTORbio Please note: $20001 - $100000 Added 04/15/2020 by Thomas Siler, source=Web Response, value=Grant/Research Support Grant/Research Support relationship with Sunovion Pharmaceuticals, Inc. Please note: $5001 - $20000 Added 04/15/2020 by Thomas Siler, source=Web Response, value=Grant/Research Support Speaker/Speaker's Bureau relationship with GlaxoSmithKline Please note: $5001 - $20000 Added 04/15/2020 by Thomas Siler, source=Web Response, value=Honoraria Speaker/Speaker's relationship with Sunovion Pharmaceuticals, Inc. Please note: $20001 - $100000 Added 04/15/2020 by Thomas Siler, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Mylan Inc./Theravance Biopharma US, Inc. Please note: $20001 - $100000 Added 04/15/2020 by Thomas Siler, source=Web Response, value=Honoraria Consultant relationship with GlaxoSmithKline Please note: $5001 - $20000 Added 04/15/2020 by Thomas Siler, source=Web Response, value=Consulting fee Consultant relationship with AstraZeneca Please note: $1-$1000 Added 04/15/2020 by Thomas Siler, source=Web Response, value=Consulting fee