EFFECT OF AGE ON EFFICACY AND SAFETY OF ONCE-DAILY UMECLIDINIUM IN PATIENTS WITH COPD

Abstract

SESSION TITLE: Medications and the Treatment of Obstructive Lung Disease SESSION TYPE: Original Investigations PRESENTED ON: 10/10/2018 08:45 AM - 09:45 AM PURPOSE: Chronic Obstructive Pulmonary Disease (COPD) is commonly seen in elderly patients, who may be perceived to have increased difficulty in using or obtaining full benefit from fundamentally important inhaled medications. We therefore investigated the effect of age on the lung function benefit observed with the inhaled long-acting muscarinic antagonist (LAMA) umeclidinium (UMEC) 62.5 mcg relative to placebo in subjects with COPD. METHODS: A post-hoc analysis of the intent-to-treat (ITT) population from a multicenter, double-blind trial (DB2113373) evaluated lung function by age: <65 or ≥65 years. Subjects were randomized to treatment with UMEC 62.5mcg, UMEC/vilanterol (VI, a long-acting β2-agonist) 62.5/25mcg, VI 25mcg, or placebo once-daily in the morning via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. The primary endpoint was change from baseline in trough forced expiratory volume in 1 second (FEV1) at the study end (Day 169). Spirometry was performed at each study visit. An evaluation of safety by age was conducted using summaries of adverse events reported during the trial. Results are presented for UMEC and placebo; findings for UMEC/VI were previously reported (Asmus M, et al. ATS 2018). RESULTS: The total ITT population included 867 subjects (UMEC, N = 217; placebo, N = 174) in the <65 age group and 665 subjects (UMEC, N = 201; placebo, N = 106) in the ≥65 age group. Significant improvements from baseline in least squares mean trough FEV1 at Day 169 were observed with UMEC compared with placebo for both the <65 (difference=110mL; 95% confidence interval [CI] 55, 165mL; p<0.001) and ≥65 (difference=123mL; 95% CI 67, 179mL; p<0.001) groups. Consistent and statistically significant improvements from baseline in trough FEV1 with UMEC compared with placebo were also seen for both age groups at all timepoints measured (p<0.001 for all comparisons; data not shown). In addition, more subjects who received UMEC experienced a clinically meaningful improvement in lung function (increase in trough FEV1 of ≥100 mL from baseline) at Day 169 with UMEC compared to placebo, respectively, for both the <65 (39% vs 20%; odds ratio [OR]=2.7; 95% CI 1.7, 4.4; p<0.001) and ≥65 (46% vs 18%; OR=3.9; 95% CI 2.2, 6.9; p<0.001) age groups. The overall safety profile for UMEC, including cardiac and vascular events, was similar between age groups. CONCLUSIONS: UMEC provided consistently significant and clinically meaningful improvements in lung function compared with placebo throughout the study in patients with COPD who were <65 and ≥65 years old and was well tolerated. CLINICAL IMPLICATIONS: These data provide evidence of consistent and clinically meaningful lung function response in patients treated with UMEC delivered via the ELLIPTA DPI regardless of age. DISCLOSURES: Employee relationship with GlaxoSmithKline Please note: >$100000 Added 03/01/2018 by Isabelle BOUCOT, source=Web Response, value=Salary Employee relationship with GlaxoSmithKline Please note: >$100000 Added 03/01/2018 by Isabelle BOUCOT, source=Web Response, value=shareholder Employee relationship with GlaxoSmithKline Please note: >$100000 Added 02/27/2018 by Scott Caveney, source=Web Response, value=Shareholder Employee relationship with GlaxoSmithKline Please note: >$100000 Added 02/27/2018 by Scott Caveney, source=Web Response, value=Salary Employee relationship with GSK Pharmaceuticals UK Please note: >$100000 Added 03/08/2018 by Ian Naya, source=Web Response, value=Stocks Employee relationship with GlaxoSmithKline Please note: >$100000 Added 02/27/2018 by Tedi Soule, source=Web Response, value=Salary Employee relationship with GlaxoSmithKline Please note: $5001 - $20000 Added 02/27/2018 by Tedi Soule, source=Web Response, value=stock holder My spouse/partner as a stock holder relationship with gl Please note: $5001 - $20000 Added 02/27/2018 by Tedi Soule, source=Web Response, value=stockRemoved 02/27/2018 by Tedi Soule, source=Web Response My spouse/partner as a stockholder relationship with GlaxoSmithKline Please note: $5001 - $20000 Added 02/27/2018 by Tedi Soule, source=Web Response, value=stock No relevant relationships by Lee Tombs, source=Web Response