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Only Anoro Ellipta has positive head-to-head data vs. another once-daily LAMA+LABA*1

* Anoro Ellipta showed statisical superiority on trough FEV1 at week 8 compared with tiotropium/ olodaterol.

Anoro Ellipta demonstrated an extra 41% improvement in lung function vs tiotropium/olodaterol (p<0.001) – 180ml vs. 128ml change from baseline in trough FEV1*1

2x the odds of achieving a clinically meaningful improvement† in lung function with Anoro Ellipta vs. tiotropium/olodaterol (OR= 2.05; 95% CI: 1.34; 3.14; p<0.001)1

Anoro Ellipta reduces rescue medication use by 38% vs. tiotropium/olodaterol (p<0.001) change from baseline - 0.94 vs 0.68 puffs/day1

First Anoro Ellipta showed statistical superiority vs. tiotropium3,4

Now Anoro Ellipta shows statistical superiority vs. tiotropium/olodaterol1

A head-to-head, in-class comparison study has been published that demonstrates Anoro Ellipta provides statistically superior improvement in lung function versus tiotropium/oladaterol as a secondary endpoint in the intention-to-treat population.1

The primary efficacy end point of the study was the change from baseline in trough FEV1 at week 8 in the per-protocol (PP) population.

DON’T HOLD BACK

  • Anoro Ellipta gives patients an extra 41% improvement in lung function vs. tiotropium/olodaterol (p<0.001) - 180ml vs. 128ml change from baseline in trough FEV1 1

    The primary endpoint of this study presents non-inferioroty of change in FEV1 at Week 8, with a non-inferiority margin set at -50mL, half the minimal clinically important difference.

    Previously, Anoro Ellipta has demonstrated a 2.4x greater improvement in lung function compared with tiotropium (p<0.001) in maintenance treatment-naïve population with COPD.2,3

  • 2x the odds of achieving a clinically meaningful improvement in lung function with Anoro Ellipta vs. tiotropium/olodaterol (OR= 2.05; 95% CI: 1.34; 3.14; p<0.001)1

    Patients using Anoro Ellipta have two times the odds of experiencing a ≥100 mL increase in trough FEV1 than patients using tiotropium/olodaterol (p<0.001).1

    Improvements in lung function ≥100mL are associated with decreased future exacerbation risk in some patients.2

    Patients achieving ≥100 mL increase in trough FEV1 at Week 81

    In this study, clinically meaningful improvement in lung function with Anoro Ellipta was observed from as early as 4 weeks.1

  • Hyperinflation, a common occurrence in COPD, impacts patients’ lives by limiting activity and preventing normal everyday activities.5,6Other lung function parameters were also assessed as additional study endpoints, these include forced final vital capacity (FVC) and inspiratory capacity (IC).1

    Anoro Ellipta demonstrated a statistically significant improvement in forced vital capacity (FVC) and inspiratory capacity (IC) vs.  tiotropium/olodaterol (P<0.001 and p<0.001 respectively)1

    Patients using Anoro Ellipta 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=0.001) at Week 8.1

  • This head-to-head study was an 8-week, randomised, open-label, two-period crossover study conducted in Germany, Spain, the UK, and the US.

    The study assessed the effect of Anoro Ellipta in comparison with  tiotropium/olodaterol in adult patients with moderate COPD (defined as FEV1 ≤70% to ≥50% predicted, mMRC ≥2).1This reflects the licensed indications of the two treatments.7

    Primary endpoint:1

    • Non-inferiority of change in 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
    • Trough FEV1 at Week 4
    • Measures of hyperinflation – change from baseline in trough FVC and IC at Week 8
    • Inhaler ease of use and errors
  • Anoro Ellipta reduces rescue medication use by 38% vs.  tiotropium/olodaterol (p<0.001) - 0.94 vs. 0.68 puffs/day1

    Footnotes:
    FEV1, forced expiratory volume in 1 second; ICF, informed consent form; mMRC, modified Medical Research Council scale.

    * superiority was a pre-specified secondary endpoint. Non-inferiority was the primary endpoint.1 (175 mL vs 122 mL; LS mean difference 53 mL (95% CI 26–80 mL); p\0.001)1

    +Greater than or equal to 100mL

    TIO: tiotropium. OLO: olodaterol

References:

  1. Feldman G.J et al. Adv Ther 2017; 34:doi 10.1007/s12325-017-0626-4.
  2. Maleki-Yazdi M et al. Adv Ther 2016; 33:2188–2199.
  3. GSK Data on file: RF/UCV/0112/15.
  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.
  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 55.22 mcg SmPC August 2018. Available at www.medicines.ie. Accessed November 2018.
  8. Spiolto Respimat SmPC. Available at www.medicines.ie, Accessed November 2018.

Adverse events should be reported directly to the HPRA; Freepost, Pharmacovigilance Section, Health Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Tel: +353 1 676 4971 medsafety@hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Anoro and Ellipta are registered trademarks of the GlaxoSmithKline group of companies.
Anoro Ellipta was developed in collaboration with Innovia.