This site requires JavaScript to be enabled to work properly. Please modify your settings or use a different browser to continue

       

You are now leaving GSK’s website

This link will take you to a non-GSK website. GSK does not recommend, endorse or accept liability for sites controlled by third-parties.

Continue

Go back

Request a contact

Stay informed

Request a Rep

Efficacy

Step-up to Anoro Ellipta for COPD patients who are symptomatic despite maintenance monotherapy 1

In a direct comparator study:

Anoro Ellipta significantly improved lung function* vs Spiriva Handihaler(tiotropium) in moderate-to-very severe COPD patients 2

*Trough FEV1 at day 169 (p<0.01)

Anoro Ellipta Efficacy image1

Anoro Ellipta improved health-related QoL* vs Spiriva Handihaler in moderate-to-very severe COPD patients 2

*Change in SGRQ score from baseline at day 168

Anoro Ellipta Efficacy image2

  • Study Design

    • A 24-week, phase III, multicenter, randomized, blinded, double-dummy, parallel-group study in patients aged ≥40 years with moderate-to-very severe COPD and an established clinical history of COPD.2
    • Patients were randomized 1:1 to Anoro Ellipta 62.5/25mcg (n=454) or Spiriva 18 mcg via HandiHaler (n=451).2
    • Primary endpoint was tough FEV1 at day 169. Primary analyses were performed on the intent-to-treat (ITT) population, defined as all randomised patients who had received at least one dose of study drug during the treatment period.2
    • Safety analyses include incidence of adverse events (AEs) and AEs of special interest(cardiovascular events, pneumonia, lower respiratory tract infection).2

  • Safety Adverse events for Anoro Ellipta were similar to Tiotropium via Handihaler 2

    Due to anti muscarinic activity (a LAMA class effect), Anoro Ellipta should be used with caution in patients with urinary retention or with narrow angle glaucoma.

    Anoro Ellipta Efficacy image3

Footnotes:
FEV1: forced Expiratory Volume in 1 second; COPD: chronic obstructive pulmonary disorder; QoL: Quality of life; LAMA, long-acting muscarinic antagonist; SGRQ, St. George's Respiratory Questionnaire; LRTI, lower respiratory tract infection.

References:

  1. Yang IA, Dabscheck EJ, George J, Jenkins SC, McDonald CF, McDonald VM, Smith BJ, Zwar NA. COPD-X Concise Guide for Primary Care. Brisbane. Lung Foundation Australia. 2017
  2. Maleki-Yazdi MR;Respiratory medicine;2014;108;1752-1760
  3. Anoro Ellipta approved Product Information

Aim:

To compare the efficacy and safety of once-daily LAMA/LABA combinations Anoro Ellipta (umeclidinium/vilanterol) and Spiolto Respimat (tiotropium/olodaterol)

Results:

Anoro Ellipta provided an additional 52mL improvement in lung function compared to Spiolto Respimat* 2

*Trough FEV1 change from baseline at week 8 in the ITT population (180mL vs 128mL; 95% CI (28, 77), p<0.001).

Anoro Ellipta Efficacy image4
  • Anoro Ellipta met the non-inferiority endpoint of the study (non-inferiority margin of -50mL) in the PP population (175mL vs 122mL; n=227; p<0.001).

More patients achieved a clinically meaningful improvement in lung function* with Anoro Ellipta than with Spiolto Respimat 2

*Improvement of ≥100mL in trough FEV1 from baseline at week 8 (66% vs 48% response; odds ratio (OR) 2.05 (95% CI: 1.34, 3.14), p<0.001).

Anoro Ellipta Efficacy image5
  • 66% of patients using Anoro achieved a clinically meaningful improvement of ≥100mL in trough FEV1 from baseline, compared to 48% of patients using Spiolto;
  • Patients receiving Anoro had twofold increased odds of experiencing a clinically meaningful increase (100mL or more) from baseline in trough FEV1 at week 8 compared with patients receiving Spiolto (odds ratio 2.05; 95% CI (1.34-3.14), p<0.001).

  • The head-to-head study design

    Anoro Ellipta Efficacy image6

    This was an 8-week, multicentre, randomised, open-label, two-period crossover, complete-block design study to compare Anoro Ellipta with Spiolto Respimat 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. 236 patients were randomised to receive Anoro Ellipta 62.5/25mcg (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.

    Primary endpoint: 2

    • Change from baseline in trough FEV1 at Week 8, in the per-protocol population (n=227) with a non-inferiority margin of -50mL.

    Other endpoints: 2

    • Proportion of FEV1 responders at week 8 (defined as a change from baseline of ≥100 mL)
    • Trough FEV1 at week 4
    • Trough FVC at weeks 4 and 8
    • Reliever salbutamol medication use (puffs/day and % reliever-free days)
    • CAT score and % CAT responders at weeks 4 and 8
    • Daily respiratory symptoms assessed with the Evaluating Respiratory Symptoms—COPD (E-RSCOPD) scale and % E-RSCOPD responders; and
    • Ease of inhaler use assessments

  • Anoro Ellipta had a simillar safety profile to Spiolto Respimat 2

    Both Anoro and Spiolto demonstrated comparable tolerability profiles with an overall incidence of on-treatment adverse events of 25% in the Anoro group and 31% in the Spiolto group.

    The most frequently reported adverse events for Anoro Ellipta and Spiolto Respirmat included:

    • Viral upper respiratory tract infections (Anoro 5%; Spiolto 6%)
    • Upper respiratory tract infections (Anoro 3%; Spiolto 3%)
    • Cough (Anoro 1%; Spiolto 1%)
    • Diarrhoea (Anoro 1%; Spiolto 1%)
    Anoro Ellipta Efficacy image7

  • Anoro Ellipta Safety

    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.1

    Due to antimuscarinic activity (i.e. a LAMA class effect), Anoro Ellipta should be used with caution in patients with urinary retention or narrow angle glaucoma. 1

    Refer to the Anoro Product Information for a full listing of precautions.

  • Anoro Ellipta reduced the use of reliever medication vs Spiolto Respimat (puffs-day) 2

    Anoro Ellipta provided a 38% greater reduction in reliever medication use vs Spiolto Repsimat (p<0.001)2

    Anoro Ellipta Efficacy image8

  • Inhaler - Ease of Use Assessments 1 2 3

    • In the inhaler-naive population (n=75), significantly more patients rated Ellipta higher than Respimat on overall ease of use (40% vs 11%; p=0.001).
    • All declared preferences were higher for Ellipta than for Respimat (p≤0.001).
    Anoro Ellipta Efficacy image9

Footnotes:
FEV1, forced expiratory volume in 1 second; mMRC, modified Medical Research Council scale; CAT, COPD Assessment Test; FVC, Forced Vital Capacity; IC, Inspiratory Capacity; ITT, Intent to Treat;COPD, Chronic Obstructive Pulmonary Disease; LAMA, long-acting muscarinic antagonist; PP, Per Protocol.

References:

  1. Anoro Ellipta Product Information
  2. Feldman GJ et al. Adv Ther 2017; Supplement DOI 10.1007/s12325-017-0626-4
  3. Feldman G.J et al. Adv Ther 2017; 34:doi 10.1007/s12325-017-0626-4

The Ellipta Inhaler: Design, Functionality and Performance

The success of an inhaled therapy depends on a successful combination of drug, inhaler and patient effort. This video focuses on the inhaler element of achieving treatment benefit for patients. Learn about:

  • What are the inhaler types available
  • Different types of dry powder inhalers (DPIs)
  • Design and features of the Ellipta inhaler
Video player requires JavaScript enabled. You can download this video here: https://videos.gskstatic.com/pharma/GSKpro/SaudiArabia/MP4/Respiratory/how_to_use_video_ellipta.mp4https://videos.gskstatic.com/pharma/GSKpro/SaudiArabia/WEBM/Respiratory/how_to_use_video_ellipta.webmhttps://videos.gskstatic.com/pharma/GSKpro/SaudiArabia/OGV/Respiratory/how_to_use_video_ellipta.ogv

Fewer patients made a critical error with Ellipta vs other commonly used inhalers* (p<0.001 for all comparisons)1

*Percentage of patients who performed at lease one critical error (an error likely to result in no or minimal medication being inhaled) after reading the patient information leaflet1

*Critical errors were defined as errors that are likely to result in no or minimal medication being inhaled.

Anoro Ellipta Efficacy image10

  • Study Design

    The critical errors study was a randomised, open-label, placebo, crossover, multicentre study involving 567 adult patients (ITT) with COPD who were naïve to the Ellipta inhaler and one of the other inhaler devices. 1

    Each sub-study compared Ellipta with one of five other inhaler devices: Accuhaler, MDI, Turbuhaler, HandiHaler and Breezhaler. At one single visit, patients received inactive placebo inhalers in a crossover study design, after reading the patient information leaflet.1

    Anoro Ellipta Efficacy image 11
    • All participants were receiving treatment for COPD and were naive to using the Ellipta inhaler and at least one of the other inhaler devices
    • Participants received inactive treatment (placebo) via the Ellipta inhaler and one of the three other inhaler devices depending on the study to which they were allocated
    • Patients were randomised to determine the sequence in which they demonstrated inhaler use
    • At the study visit, participants were asked to demonstrate use of the inhaler after reading the patient information leaflet; any errors made were recorded by a study nurse using a specific checklist for each inhaler
    • The primary endpoint was the percentage of participants making at least one critical error after reading the patient information leaflet

  • Inhaler Critical Errors

    Anoro Ellipta Efficacy image 12
    inhaler_critical_errors_table_2

Footnotes:
PIL: patient information leaflet, MDI: metered dose inhaler, ITT: intention-to-treat, COPD: chronic obstructive pulmonary disorder

References:

  1. Van Der Palen J, et al. NPJ Prim Care Respir Med 2016; 26:16079.

All mentioned products are registered medicine or vaccine for GSK Saudi. This website contains promotional content. For adverse event reporting to one of GSK medicines / vaccines, please contact our representative,or fill the form on this website or contact GSK Head office on the address below: ©2020 GlaxoSmithKline, All rights reserved. GlaxoSmithKline Saudi Arabia, P.O. Box 55850, Jeddah 21544, Saudi Arabia. Tel: (012) 6536666 Fax: (012) 6536660.