The FINANCIAL — GlaxoSmithKline plc on October 20 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 62.5mcg once daily achieved a statistically significant improvement in lung function measured by trough forced expiratory volume in one second (FEV1) at 12 weeks (P<0.001), compared to tiotropium 18mcg administered once daily. The difference in treatment effect observed was 59ml (95% CI: 29, 88) for umeclidinium compared to tiotropium based on a per protocol analysis. For the intention to treat population, the difference observed was 53ml (95% CI: 25, 81), which was also statistically significant (P<0.001), according to GlaxoSmithKline.
Results from the randomised, open-label study 201315 showed thatumeclidinium 62.5mcg once daily was non-inferior to glycopyrronium 44mcg administered once daily, also measured by trough FEV1 at 12 weeks. The difference in treatment effect observed was 24ml (95% CI: -5, 54) for umeclidinium compared to glycopyrronium based on a per protocol analysis. For the intention to treat population, the difference observed was 33ml (95% CI: 5, 61).
In study 201316, 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. The incidence of any on-treatment serious adverse event in both treatment arms was 3%.
In study 201315, 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. The incidence of any on-treatment serious adverse event in both treatment arms was 3%.
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