Positive trial results for Incruse Ellipta (umeclidinium) in COPD- GlaxoSmithKline

GlaxoSmithKline has announced positive results from two head-to-head studies directly comparing the efficacy and safety of Incruse Ellipta (umeclidinium) to two available bronchodilator treatments, tiotropium (study 201316) or glycopyrronium (study 201315), when used by patients with COPD. Results from the randomised, blinded study 201316 showed that umeclidinium 62.5 µg once daily achieved a statistically significant improvement in lung function measured by trough forced expiratory volume in one second (FEV1) at 12 weeks, compared to tiotropium 18 µg administered once daily. The difference in treatment effect observed was 59 ml for umeclidinium compared to tiotropium based on a per protocol analysis. For the intention to treat population, the difference observed was 53 ml, which was also statistically significant. The most commonly reported on-treatment adverse events for both umeclidinium and tiotropium were headache (6% umeclidinium; 6% tiotropium) and nasopharyngitis (5% umeclidinium; 5% tiotropium). The overall incidence of on-treatment adverse events was 32% in the umeclidinium group and 30% in the tiotropium group.

Results from the randomised, open-label study 201315 showed that umeclidinium 62.5 µg once daily was non-inferior to glycopyrronium 44 µg administered once daily, also measured by trough FEV1 at 12 weeks. The difference in treatment effect observed was 24 ml for umeclidinium compared to glycopyrronium based on a per protocol analysis. For the intention to treat population, the difference observed was 33 ml. The most commonly reported on-treatment adverse events for both umeclidinium and glycopyrronium were headache (8% umeclidinium; 10% glycopyrronium) and nasopharyngitis (8% umeclidinium; 8% glycopyrronium). The overall incidence of on-treatment adverse events was 37% in the umeclidinium group and 36% in the glycopyrronium group. Data will be presented at a future scientific meeting.

Comment: Overall LABA/LAMA combinations are expected to become the best-selling inhaler class for COPD by 2021 as patients and doctors take advantage of easier dosing regimens and improved efficacy over the older ICS/LABA combinations, and even the newer once-daily ICS/LABA combinations such as GSK's Relvar Ellipta (fluticasone furoate/vilanterol).