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Efficacy

  • Improvements in lung function with Anoro vs tiotropium

    How is lung function measured?

    FEV1 is a key measurement of lung function. Using a spirometer, the amount of air that a patient is able to exhale from their lungs, as quickly as possible, in 1 second is measured. It is often used as a primary endpoint in clinical studies as it is a well-established means of measuring changes in lung function, which can be used as a marker of bronchodilator efficacy and duration of effect. Demonstration of changes in FEV1 is a standard requirement of the regulatory bodies involved in the assessment of COPD treatment. 1


    Anoro provided 2.4x greater trough FEV1 improvement at Day 169 2 3

    Adapted from Maleki-Yazdi et al. 2016 23

    Once-daily Anoro provided a 2.4x greater trough FEV1 improvement of 146mL from baseline vs. tiotropium (252mL vs. 107mL; p<0.001) at Day 169 in a treatment-naïve population.* 23

    FEV1, forced expiratory volume in 1 second
    *Not previously treated with a long-acting bronchodilator
    **Number of subjects with analysable data at Day 169

    Study design
    Pooled post hoc analysis of three Phase III, 24-week, multicentre, randomised, double-dummy, active-controlled, blinded trials comparing the efficacy and safety of Anoro and tiotropium once-daily in patients with COPD. The primary endpoint of all studies was trough FEV
    1 on Day 169..2 Details of the blinding process for all tiotropium comparator studies discussed can be found on page 474 in Decramer M et al. Lancet Respir Med 2014; 2:472–486.

    Anoro is a superior bronchodilator to umeclidinium, regardless of responder* status

    Patients shown to have previously responded to treatment with umeclidinium had an additional FEV1 increase from baseline of 114mL with Anoro on Day 14 compared to treatment with umeclidinium alone. Those who had previously not demonstrated responsiveness to umeclidinium and vilanterol** demonstrated an additional FEV1 increase from baseline of 70mL with Anoro on Day 14 when compared to treatment with umeclidinium. 4

    Responsiveness to Anoro in previous non-responders* to umeclidinium and vilanterol** 4

    0-6 weighted-mean FEV1 on Day 14 in UMEC responders* and non-responders based on a pooled post hoc analysis of two studies 4

    Adapted from Donohue et al. 2016 2

    *A responder is defined as having had an FEV1 increase from baseline of ≥12% and ≥200mL at any time 0–6h post-dose on Day 1
    **Vilanterol is not licensed as a monotherapy

    Study design
    Pooled, post hoc data from two randomised, double-blind, three-way, complete-block, crossover studies. For eligibility, all patients were required to have moderate to very severe COPD and were randomised to receive once-daily umeclidinium (62.5mcg), vilanterol (25mcg) or umeclidinium/vilanterol (62.5mcg/25mcg) over a 14-day period. The primary endpoint was 0–6h post-dose weighted mean FEV1 on Day 14 and the key secondary endpoint was trough FEV1 on Day 15. 4

    † Delivered doses: UMEC (55mcg) and VI (22mcg)

    Treatment with Anoro resulted in significantly greater improvements in lung function than treatment with its component monotherapies or placebo. At Day 169, trough FEV1 from baseline was compared for those treated with Anoro, its individual components: umeclidinium, vilanterol** and placebo (248mL, 175mL, 105mL and 0mL, respectively; all p≤0.002 vs. placebo). 5

  • Anoro Ellipta provided a clinically meaningful* improvement in health-related quality of life vs. placebo [5]

    Treatment with Anoro resulted in significantly greater improvements from baseline in St George’s Respiratory Questionnaire (SGRQ) total score at Day 168 compared with placebo (p<0.001).** 5

    Improvement from baseline in SGRQ score at Day 169 5

    Adapted from Donohue et al. 2013 5

    SGRQ, St George’s Respiratory Questionnaire

    *The SGRQ is a validated disease-specific health status assessment for use in asthma and COPD and a difference of 4 units or more is considered clinically meaningful 5 6

    **A step-down statistical procedure was used in this study and this outcome was below an endpoint that did not achieve statistical significance. Hence statistical significance on this comparison cannot be inferred

    Study design
    Data from a 24-week, double-blind, placebo-controlled, parallel-group study. Patients were randomised in a 3:3:3:2 ratio to receive one of three active treatments: Anoro (62.5/25mcg), umeclidinium (62.5mcg), vilanterol (25mcg) or placebo. The primary endpoint was trough FEV
    1 on Day 169 in the intent to treat (ITT) population. SGRQ score was an additional endpoint in this study. 5 6

  • Anoro provided a significant reduction in the use of rescue medication use vs. tiotropium [2]

    Patients treated with Anoro had a significant reduction from baseline in the use of rescue medication compared to treatment with tiotropium (-2 vs. -1.4 puffs per day, respectively; p<0.001). 2 7

        Change from baseline in rescue medication use over 24 weeks in ITT patients.2,7
     

    Adapted from Maleki-Yazdi et al. 2016 2 7

    Study design
    Data from a pooled post hoc analysis of three 24-week, multicentre, randomised, parallel group, blinded trials comparing Anoro and tiotropium. The primary endpoint for each study was trough FEV
    1 on Day 169. Daily use of rescue medication was an additional endpoint in each study. 2 Details of the blinding process for all tiotropium comparator studies discussed can be found on page 474 in Decramer M et al. Lancet Respir Med 2014; 2:472–486. 8

  • Anoro provided a clinically meaningful improvement in Transition Dyspnoea Index (TDI) score vs. placebo [5]

    Treatment with Anoro was shown to improve patient TDI score from baseline by an additional 1.2 units compared with placebo (2.4 units and 1.2 units improvement from baseline, respectively; p<0.001). 5

    Change from baseline in TDI score at Day 169 5

    Adapted from Donohue et al. 2013 5

    MCID, minimal clinically important difference

    Study design
    Data from a 24-week, double-blind, placebo-controlled, parallel-group study. Patients were randomised in a 3:3:3:2 ratio to receive one of three active treatments: Anoro (62.5/25mcg), umeclidinium (62.5mcg), vilanterol (25mcg) or placebo. The primary endpoint was trough FEV
    1 on Day 169 in the ITT population. TDI score was an additional endpoint in this study. A 1 unit change represents the minimal clinically important difference in TDI score. 5

  • Anoro is generally well tolerated [7]

    Anoro has an adverse event profile comparable to tiotropium in clinical studies. 7

    This information does not contain all safety information. For a complete description of adverse events, special warnings and precautions, please consult the full SmPC before prescribing this medicine, which you can access by clicking on product SmPC, request from GSK or you can access from the Website of the Pharmaceutical Services of the Ministry of Health

    http://www.phs.moh.gov.cy/web/guest/drug-search

References:

  1. Donohue JF. COPD 2005; 2:111–124.
  2. Maleki-Yazdi MR et al. Adv. in Ther 2016; 33(12):2188–2199.
  3. DOF RF/UCV/0112/15
  4. Donohue JF et al. Respir Med 2016; 112:65–74.
  5. Donohue JF et al. Respir Med 2013; 107:1538–1546.
  6. Jones PW. COPD 2005; 2:75-79.
  7. TDI Maleki-Yazdi MR et al. Am J Respir Crit Care Med. 2015; Poster P532 (A5765)
  8. Decramer M et al. Lancet Respir Med 2014; 2:472–486.

Before prescribing please consult the full SPC which you can request from GSK or access on the website of the Pharmaceutical Services of the Ministry of Health http://www.phs.moh.gov.cy/web/guest/drug-search

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