More IMPACT trial results shows Trelegy Ellipta has benefits for both reversible and nonreversible COPD patients in exacerbations and lung function versus dual therapy.
Singe-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI; Trelegy Ellipta) continues to boast positive findings from the Informing the Pathway of COPD Treatment (IMPACT) study.
In new data to be presented at the 2018 CHEST Annual Meeting in San Antonio, TX, GlaxoSmithKline (GSK) has reported their first-of-its-kind triple therapy inhaler significantly reduced the annual rate of moderate-to-severe and severe exacerbations, improved lung function, and boosted overall quality of life in patients with chronic obstructive pulmonary disease (COPD)—regardless of baseline reversibility.
The IMPACT trial—a 52-week, randomized, double-blind, parallel-group, global analysis involving 10,355 symptomatic patients with COPD who have a history of moderate-to-severe exacerbations—compared Trelegy Ellipta to combination therapies inhaled corticoid steroid/long-acting beta agonist (ICS/LABA) and long-acting muscarinic agonist/long-acting beta agonist (LAMA/LABA).
Trelegy Ellipta, the first triple therapy approved by the US Food and Drug Administration (FDA) for the treatment of patients with COPD on fixed-dose treatment in September 2017, is itself a ICS/LAMA/LABA combination therapy. The original intent of the IMPACT trial was to understand the benefits and risks of the triple combination therapy in treating COPD, in addition to improving the understand of what particular patients need ICS therapy or maximal bronchodilation.
In this newest analyses, led by Robert Wise, MD, of the Johns Hopkins University School of Medicine, patients who were reversible were defined through different between pre- and post-albuterol assessments of forced expiratory volume in 1 second (FEV1) of at least 12% and 200 mL.
Investigators also assessed for the effect of baseline reversibility on treatment response across the 3 treatment arms. Lung function and quality of life were measured by patient responders on the St George Respiratory Questionnaire (SGRQ).
Investigators reported that 18% of patients demonstrated reversibility, with a significant reduction in the rate of moderate and severe exacerbation in both reversible and nonreversible patients administered FF/UMEC/VI versus those administered UMEC/VI. Severe exacerbation reduction rates were 44% (95% CI: 14 — 63) in reversible patients, and 31% (95% CI: 17-44) in nonreversible patients.
Lung function, as measured by change from baseline in trough FEV1 at week 52, was markedly better in all patients administered FF/UMEC/VI (76 ml) than in those administered UMEC/VI (49 ml). In quality of life measures, independent of reversibility status at screening, patients on the triple therapy fared better than double therapy patients (all P < .05).
The analyses concluded with near-sweeping results: statistically significant improvements of FF/UMEC/VI versus UMEC/VI was observed on all endpoints in nonreversible patients, as well as on the moderate-to-severe exacerbation rate and lung function endpoints for reversible patients. The triple therapy did fail to reduce the rate of severe exacerbations over the dual therapy in reversible patients, however.
“Regardless of baseline reversibility, FF/UMEC/VI showed statistically significant and clinically relevant improvements on a range of important outcomes compared with UMEC/VI,” investigators concluded.
The study, “Treatment Effects of FF/UMEC/VI vs FF/VI and UMEC/VI in Reversible and Nonreversible COPD Patients: Analyses of the IMPACT Study,” will be presented at CHEST 2018.