Only Anoro has positive head-to-head data vs. Spiolto
Cardiovascular events, such as cardiac arrhythmias, may be seen after the administration of muscarinic receptor antagonists and sympathomimetic agents, including umeclidinium/vilanterol. Therefore, Anoro Ellipta should be used with caution in patients with severe cardiovascular disease. 7
Non-inferiority was met for the primary endpoint at Week 8 in the per protocol population (n=227) (175mL for Anoro and 122mL for Spiolto, 95% CI: 26, 80; p<0.001)
Previously, Anoro has demonstrated a 2.4x greater improvement in lung function compared with Spiriva (p<0.001) in maintenance treatment-naïve population with COPD, based on a pooled post hoc subgroup analysis of 3 studies. 34
2x the odds of achieving a clinically meaningful improvement in lung function with Anoro vs. Spiolto 1 (95% CI 1.34, 3.14; OR = 2.05, p<0.001)
Patients using Anoro have two fold increased odds of experiencing a ≥100 mL increase from baseline in trough FEV1 than patients using Spiolto (p<0.001). 1
Patients achieving ≥100 mL increase in trough FEV1 at Week 8 1
Other lung function parameters were also assessed as additional study endpoints, these include forced final vital capacity (FVC) and inspiratory capacity (IC). 1
Anoro demonstrated a statistically significant improvement in forced vital capacity (FVC) and inspiratory capacity (IC) vs. Spiolto (P<0.001 and P<0.01 respectively) 1
Patients using Anoro experienced a significant improvement from baseline in the hyperinflation measures of FVC (LS mean change 202 mL vs. 135 mL; p<0.001) and IC (169 mL vs. 122 mL; p<0.01) at Week 8. 1
This was an 8-week, multicentre, randomised, open-label, two-period crossover, complete-block design study to compare Anoro Ellipta (UMEC/VI) with Spiolto Respimat (TIO/OLO) once-daily in symptomatic patients with moderate COPD (post-bronchodilator FEV1 ≤70%–≥50% of predicted value and mMRC≥2) and not receiving ICS-containing therapy at inclusion. Patients were randomised to receive Anoro Ellipta 55/22mcg (one inhalation, once-daily) followed by Spiolto Respimat 5/5mcg (two puffs of 2.5/2.5mcg, once-daily), each for 8 weeks, with an interim 3-week washout, or vice-versa.
The primary endpoint was change from baseline in trough FEV1 at Week 8 with a non-inferiority margin of -50mL in the per-protocol (PP) population. 7-9
Primary endpoint: 1
- Change from baseline in trough FEV1 at Week 8, with a non-inferiority margin set at −50 mL, half the minimal clinically important difference
Secondary endpoints: 1
- Proportion of FEV1 responders at Weeks 4 and 8, with responders defined as patients with a ≥100 mL increase in trough FEV1 from baseline at Weeks 4 and 8
- Change from baseline, trough FEV1 at Week 4
- Measures of hyperinflation – change from baseline in trough FVC and IC at Week 8
- Inhaler ease of use
More patients preferred Ellipta vs. Respimat for ease of use (p<0.001) in patients declaring a preference. 1
FEV1, forced expiratory volume in 1 second; ICF, informed consent form; mMRC, modified Medical Research Council scale.
*At Week 8 in a randomised, open-label, two-period crossover study in adults with moderate COPD (defined as FEV1 ≤70% to ≥50% predicted, mMRC ≥2). 1
**Spiolto is a trade mark of Boehringer Ingelheim
***Spiriva is a trade mark of Boehringer Ingelheim
****Respimat is a trade mark of Boehringer Ingelheim
†Defined as ≥100 mL increase from baseline in trough FEV1 at Week 8 (p<0.001) vs. Spiolto. 1
††Delivered doses for Anoro Ellipta (55/22mcg)
†††2.5/2.5mcg x 2 inhalations once daily via the Respimat inhaler
††††Number of subjects with analysable data at Day 169
- Feldman G.J et al. Adv Ther 2017; 34:doi 10.1007/s12325-017-0626-4
- Calverley PM et al. Early response to inhaled bronchodilators and corticosteroids as a predictor of 12-month treatment responder status and COPD exacerbations. Int J COPD 2016; 11 :381–390.
- Maleki-Yazdi M et al. Adv Ther 2016; 33:2188–2199.
- GSK Data on file: RF/UCV/0112/15.
- Thomas M et al. No room to breathe: the importance of lung hyperinflation in COPD. Prim Care Respir J 2013; 22 :101–111.
- O’Donnell DE, Laveneziana P. Physiology and consequences of lung hyperinflation in COPD. Eur Respir Rev 2006; 15: 61–67.
- Anoro Ellipta Summary of Product Characteristics. GlaxoSmithKline.
- Spiolto Respimat Summary of Product Characteristics. Boehringer Ingelheim 2017.
- Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017. Available from: http://goldcopd.org. [Accessed August 2017]
- GSK Data on file: RF/UCV/0073/17
- Spiriva SmPC, 2015