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Only Anoro has positive head-to-head data vs. Spiolto

1.4x superior improvement in lung function vs Spiolto (180ml vs. 128ml change from baseline in trough FEV1 at week 8; 95% CI, 28, 77; p<0.001) 1

2x the odds of achieving a clinically meaningful improvement in lung function with Anoro vs. Spiolto (95% CI 1.34, 3.14; OR - 2.05, p<0.001) 1

More patients prefer Ellipta vs. Respimat for ease of use (p<0.001) in patients declaring a preference 1

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

Due to antimuscarinic activity (i.e. a LAMA class effect), Anoro Ellipta and Spiriva should be used with caution in patients with urinary retention or narrow angle glaucoma. 7 11

At first ANORO showed superiority vs. Spiriva*** 34

Now ANORO shows superiority vs. Spiolto 1

A new head-to-head, in-class comparison study across multiple endpoints has been published that demonstrates superiority of ANORO over Spiolto on lung function. 1

DON’T HOLD BACK

  • Prescribe ANORO for superior improvement in lung function vs Spiolto

    1.4x superior lung function improvement vs. Spiolto (180mL vs 128mL change from baseline in trough FEV1 at week 8; 95% CI 28, 77; p<0.001 1

    Patients treated with Anoro experienced a 1.4x improvement in lung function from baseline compared with Spiolto. 1

    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

  • Prescribe ANORO for significantly more clinical responders vs Spiolto

    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

  • ANORO demonstrated statistically significant improvement in other lung volume parameters vs Spiolto

    Hyperinflation, a common occurrence in COPD, impacts patients’ lives by limiting activity and preventing normal everyday activities. 56

    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

  • The head-to-head study design

    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
  • Inhaler: ease of use

    More patients preferred Ellipta vs. Respimat for ease of use (p<0.001) in patients declaring a preference. 1

    There is a significant relationship between poor inhaler use and symptom control in patients with COPD. 9

    96% of patients find the Ellipta inhaler ‘very easy’ or ‘easy’ to use compared with 83% of patients using the Respimat inhaler. 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

References:

  1. Feldman G.J et al. Adv Ther 2017; 34:doi 10.1007/s12325-017-0626-4
  2. 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.
  3. Maleki-Yazdi M et al. Adv Ther 2016; 33:2188–2199.
  4. GSK Data on file: RF/UCV/0112/15.
  5. Thomas M et al. No room to breathe: the importance of lung hyperinflation in COPD. Prim Care Respir J 2013; 22 :101–111.
  6. O’Donnell DE, Laveneziana P. Physiology and consequences of lung hyperinflation in COPD. Eur Respir Rev 2006; 15: 61–67.
  7. Anoro Ellipta Summary of Product Characteristics. GlaxoSmithKline.
  8. Spiolto Respimat Summary of Product Characteristics. Boehringer Ingelheim 2017.
  9. 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]
  10. GSK Data on file: RF/UCV/0073/17
  11. Spiriva SmPC, 2015

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