GlaxoSmithKline and Innoviva, Inc. announced results from data presented at the American Thoracic Society (ATS) 2016 International Conference investigating the efficacy and safety of Anoro Ellipta (umeclidinium/vilanterol, ‘UMEC/VI’) in patients with moderate chronic obstructive pulmonary disease (COPD) who continued to have symptoms while on tiotropium monotherapy.
For patients in the study who were switched from tiotropium 18mcg to UMEC/VI 62.5/25mcg, a statistically significant improvement of 88ml (P<0.001; 95% CI 45, 131) was shown at week 12 for the primary efficacy endpoint of lung function (measured by trough FEV1), compared to patients who remained on tiotropium 18mcg for the duration of the study.
For the secondary efficacy endpoint of three hour post-dose FEV1, a statistically significant improvement in lung function of 73ml (P=0.004; 95% CI 24, 122) was also shown at week 12 for patients who were switched to UMEC/VI 62.5mcg, compared to patients who stayed on tiotropium 18mcg for the duration of the study.
Professor Neil Barnes, Global Respiratory Franchise Medical Head, GSK, said, “For COPD patients who remain symptomatic it is important that their lung function is optimised effectively. These efficacy data demonstrate the improvement in lung function that can be achieved in patients with moderate COPD when changing treatment from monotherapy with tiotropium 18mcg to dual bronchodilation with Anoro Ellipta.”
Furthermore, Dr. Ted Witek, chief scientific officer of Innoviva, Inc. said, “This adds to the growing evidence base that shows that use of two mechanistic pathways can help symptomatic patients with COPD to improve their lung function.”
The most commonly reported adverse events for both UMEC/VI 62.5/25mcg and tiotropium 18mcg were nasopharyngitis (7% UMEC/VI 62.5/25mcg; 7% tiotropium 18mcg) and headache (6% UMEC/VI 62.5/25mcg; 7% tiotropium 18mcg). The overall incidence of on-treatment adverse events was 30% in the UMEC/VI 62.5/25mcg group and 31% in the tiotropium 18mcg group. The incidence of any on-treatment non-fatal serious adverse event was 2% in the UMEC/VI 62.5/25mcg arm and 2% in the tiotropium 18mcg arm. There was one fatal serious adverse event in the UMEC/VI group which was not related to study medication.
The study (DB2116960) was a 12-week, multicentre, randomised, blinded study designed to compare UMEC/VI 62.5/25mcg once-daily with tiotropium 18mcg once-daily in patients with moderate COPD who continue to have symptoms on tiotropium.
Patients in the study were required to have been prescribed tiotropium 18mcg once-daily for at least 3 months prior to screening and have completed a 4-week run-in on open-label tiotropium prior to randomisation. Patients had to be ‘symptomatic’ (defined as 50–70% predicted post-bronchodilator forced expiratory volume in one second [FEV1] with a modified Medical Research Council [mMRC] score of ³1) at screening and at randomisation.
A total of 494 patients were randomised 1:1 to UMEC/VI 62.5/25mcg once-daily administered via the Ellipta inhaler or tiotropium 18mcg once-daily administered via a Handihaler inhaler and received at least one dose of study medication.
COPD is a disease of the lungs that includes chronic bronchitis, emphysema or both. COPD is characterised by obstruction to airflow that interferes with normal breathing. COPD is thought to affect 329 million people worldwide.
Long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD. Cigarette smoke, breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.
Anoro Ellipta is a combination long-acting muscarinic antagonist (LAMA) (also known as an anticholinergic)/long-acting beta2-adrenergic agonist (LABA).
In the US, Anoro Ellipta is indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Anoro Ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma. The FDA-approved strength is umeclidinium/vilanterol 62.5/25mcg.
In Europe, Anoro is indicated as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. The approved strength in Europe is UMEC/VI 55mcg/22mcg (delivered dose, equivalent to 62.5mcg/25mcg pre-dispensed dose).