Prescribing information can be found at the bottom of the page.

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Trelegy▼ Ellipta (Fluticasone furoate/Umeclidinium/Vilanterol) Prescribing information | Patient information leaflet | SmPC

Not all COPD triple therapies are the same

With many options to choose from when prescribing ICS/LAMA/LABA therapy for appropriate patients, what differences set them apart? What can these differences mean for your patients?

Sylvia
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Respiratory specialists are facing a new and challenging environment; keeping your patients with COPD healthy and well controlled could be more important now than ever due to the increased risk of illness from COVID-19.2

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Making sure your patients are correctly optimised on the right triple therapy could help your patients who are not adequately treated on ICS/LABA (or an ICS/LABA containing treatment). With many choices for triple therapy available, including multiple inhaler and single inhaler options, it is important to choose one that has demonstrated outcomes that align to your priorities for patients.

Trelegy Ellipta is a once-daily, single inhaler COPD triple therapy for patients with moderate to severe COPD on treatment with an ICS/LABA (or an ICS/LABA containing treatment) who are symptomatic and at risk of an exacerbation1, defined as:

  • Has worsening of symptoms or
  • Has experienced an exacerbation treated with antibiotics or oral corticosteroids in the past 12 months
Learn more about identifying patients who may benefit from Trelegy Ellipta
Trilegy pack

With over 40 choices for multiple inhaler triple therapy and the recent introduction of single inhaler triple therapy options, it may be more difficult to determine the right pick for your patient.

What are your priorities when choosing a triple therapy?

REDUCE HOSPITALISED EXACERBATIONS

Picking the appropriate triple therapy could help to avoid unnecessary hospital admission. Hospitalisation for a COPD exacerbation is associated with poor prognosis, including a ~50% risk of death within 5 years following a hospitalised exacerbation.3

Trelegy Ellipta is the only single inhaler triple therapy to deliver significant reduction in annual rate of hospitalised exacerbations vs. a LAMA/LABA (UMEC/VI▼)4

hospitalised exacerbations graph

Adapted from Lipson et al. 20184

Based on data up to 52 weeks. Co-primary endpoints of annual rate of on-treatment moderate/severe exacerbations for Trelegy Ellipta vs. both FF/VI and UMEC/VI were met4

Anoro▼ Ellipta (umeclidinium bromide/vilanterol) is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD)5 Anoro Ellipta Prescribing Information .

Learn about the design for the IMPACT trial here
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IMPROVE LUNG FUNCTION & QUALITY OF LIFE

Are you confident that your current triple therapy choice can offer the same improvements in lung function and health related quality of life vs ICS/LABA maintenance treatment?

Trelegy Ellipta delivered superior improvement in lung function vs an ICS/LABA6

lung function graph

Adapted from Lipson et al. 20176

Data from the FULFIL study comparing Trelegy Ellipta OD to Symbicort Turbohaler BD (BUD/FOR).6

Co-primary endpoints of change from baseline in trough FEV₁ and SGRQ score at Week 24 were both met.6

*MCID: Minimal Clinically Important Difference. Patients with COPD have been shown to perceive an improvement of ≥100mL in trough FEV₁ as beneficial.7

Learn about the design for the FULFIL trial here

Trelegy Ellipta delivered superior improvement in health-related quality of life vs. an ICS/LABA6

quality of life graph

Adapted from Lipson et al. 20176

HRQoL determined according to the St. George's Respiratory Questionnaire (SGRQ).6

SGRQ MCID=4.0 unit change. The figures have been rounded from -6.57 and -4.33, respectively6

Data from the FULFIL study comparing Trelegy Ellipta OD to Symbicort Turbohaler BD (BUD/FOR). Co-primary endpoints of change from baseline in trough FEV₁ and SGRQ score at Week 24 were both met6

What is the St. George’s Respiratory Questionnaire?

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DEVICE CHOICE MATTERS

Support the NHS long term plan to reduce inhaler carbon impact

carbon footprint

The NHS Long Term plan aims for a shift to low carbon inhalers to deliver a 4% reduction in overall NHS carbon footprint. In order to reach this target this requires reducing the carbon impact of inhalers by 50% by 2030.8,9

Metered Dose Inhalers (MDIs) contain hydrofluorocarbons (powerful greenhouses gases).9 In 2018, these propellants were estimated to be responsible for 4% of NHS’ entire carbon footprint.9

The British Thoracic Society position statement (2020) has provided recommendation on the use of low carbon inhalers where clinically safe and appropriate to do so.9 BTS recommends: "When a new class of inhaler is commenced, this is a dry powder inhaler."9

Ellipta is a propellant-free dry powder inhaler (DPI). DPIs have an 18x lower carbon footprint than Metered Dose Inhalers.9,10

BTS only recommends an inhaler device type. It does not endorse specific medicines. MDIs may still be the appropriate option for some patients and play an important role where there is clinical need and a DPI is not appropriate.

Read the full 2020 BTS Position statement here

Find out more on inhaler carbon impact

Choose to simplify triple therapy delivery for your patient

sitt

ICS/LAMA/LABA can be delivered in a number of inhaler combinations that can include multiple device types with different inhalation techniques and dosing regimens. Whilst NICE did not make a specific recommendation around whether an ICS/LABA/LAMA treatment should be delivered in multiple inhalers or a single inhaler, the July 2019 NICE COPD treatment guidelines recommend to “minimise the number of inhalers and the number of different types of inhaler”.11

NICE recommendations are for classes of medicine, they do not recommend Trelegy Ellipta specifically.

More on the NICE COPD Guidelines

Choose an easy-to-use device that helps patients get the right dose12-14

easy to use

Poor inhaler technique could be a reason why a patient's COPD symptoms are poorly controlled.14

4.8x fewer COPD patients made a critical error* with the Ellipta inhaler compared with MDI after reading the patient information leaflet (p<0.001).13

Even a severe COPD patient can generate sufficient inspiratory flow rate to benefit from Trelegy Ellipta.15-16

*Critical errors defined as errors that are likely to result in no, or minimal, medication being delivered to the lung. Critical errors: Ellipta vs. MDI (n=80) 13% (10/80) vs. 60% (48/80)13

Compare more devices on critical errors

Choose a cost-effective triple therapy17-18

cost effective chart

At £44.50, Trelegy Ellipta costs less than commonly prescribed multiple inhaler triple therapies in the UK17-18

The drug costs here are based on list prices and information for currently available COPD therapies, last checked and updated 24/11/2020.

*Spiriva HandiHaler; NB: All doses stated are delivered doses. BUD, budesonide; FOR, formoterol; FP, fluticasone propionate; mcg, microgram; MITT, multiple inhaler triple therapies; SAL, salmeterol; SITT, single inhaler triple therapy TIO, tiotropium; FF, fluticasone furoate; UMEC, umeclidinium; VI, vilanterol

SERETIDE (Salmeterol xinafoate/fluticasone propionate) Prescribing Information

More cost information

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RESOURCES TO SUPPORT PRESCRIBING

Identify patients who could benefit from Trelegy Ellipta

identify patients

See the indication, patient profile, plus guidance on spotting patients at risk of an exacerbation.

Find out more
nurse with patient

Order a demonstration device, Ellipta inhaler leaflet, and medicine change guides to support your patients.

Find out more

Footnotes

BTS, British Thoracic Society; BD, twice daily; BUD, budesonide; CAT, COPD assessment test; DPI, dry powder inhaler; FEV₁, forced expiratory volume in one second; FF, fluticasone furoate; FOR, formoterol; HRQoL, health-related quality of life; ICS, inhaled corticosteroid; ITT, intent-to-treat; LABA, long-acting ß₂-agonist; LAMA, long-acting muscarinic antagonist; OD, once daily; QoL, quality of life; pMDI, pressurised metered dose inhaler; SGRQ, St George’s Respiratory Questionnaire; UMEC, umeclidinium; VI, vilanterol

Trelegy Ellipta OD is indicated for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist.1

Trelegy Ellipta is generally well tolerated. Common adverse reactions include: headache, nasopharyngitis, influenza, upper respiratory tract infection, pneumonia, back pain, rhinitis, cough, pharyngitis, arthralgia, sinusitis, oropharyngeal pain, bronchitis, constipation, candidiasis of mouth and throat, urinary tract infection.1

In common with other corticosteroid-containing medicines, there is an increased risk of pneumonia in patients with COPD treated with Trelegy Ellipta.1

This is not an exhaustive list. Please consult the Summary of Product Characteristics for a full list of adverse reactions before prescribing.

  1. Trelegy Ellipta SmPC.
  2. https://www.nice.org.uk/guidance/ng168/chapter/1-Communicating-with-patients-and-minimising-risk
  3. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) 2020 pages 30 and 105.
  4. Lipson DA et al. N Engl J Med 2018; 378:1671–1680.
  5. ANORO Ellipta SmPC.
  6. Lipson DA et al. Am J Crit Care Med 2017; 196:438–446.
  7. Jones PW et al. Am J Respir Crit Care Med 2014; 189(3):250–255.
  8. The NHS Long Term Plan: https://www.longtermplan.nhs.uk/publication/nhs-long-term-plan/
  9. British Thoracic Society (BTS) (2020) Position Statement: Environment and Lung Health. https://www.brit-thoracic.org.uk/about-us/position-statements/
  10. Hillman, T. Mortimer, F and Hopkinson, N. (2013). Inhaled drugs and global warming: time to shift to dry powder inhalers. British Medical Journal. DOI: 10.1136/bmj.f3359.
  11. https://www.nice.org.uk/guidance/ng115/ (Last accessed: May 2020)
  12. Svedsater H et al BMC Pulm Med 2013; 13:1–14.
  13. van der Palen J et al. NPJ Prim Care Respir Med 2016;26:16079.
  14. Riley JH et al. Int J Chron Obstruct Pulm Dis 2016;11:1873–1880.
  15. Prime D et al. J Aerosol Med Pulm Drug Deliv 2015; 28:486-497.
  16. Grant AC et al. J Aerosol Med Pulm Drug Deliv 2015; 28:474-485.
  17. MIMS Available at: https://www.mims.co.uk/. (Accessed Jan 2020)
  18. GSK Data on file: Combined Triple Therapy Combinations for COPD UK/TLY/0089/18 (REF-3515)
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THREE MOLECULES WITH PROVEN EFFICACY

Trelegy Ellipta has been intentionally designed to provide your patients with sustained efficacy from today, so they can expect more from their tomorrows.2-3

Trelegy Ellipta is the only triple therapy for COPD to contain Fluticasone Furoate (ICS), Umeclidinium (LAMA) and Vilanterol (LABA) in one device¹. Three molecules specifically selected for their long duration of action.*1-8

*Fluticasone furoate and vilanterol are not licensed as monotherapies in COPD.

The clinical efficacy of the components of Trelegy Ellipta have been demonstrated in head-to-head (H2H) studies in their respective LAMA, ICS/LABA, and LAMA/LABA classes.

ics laba

ICS/LABA – Relvar Ellipta (Fluticasone Furoate/Vilanterol)

Significant reduction in mean annual rate of moderate/severe exacerbations by 8% vs. twice-daily ICS/LABAs with an absolute risk reduction of 0.16, in a pre-specified sub-analysis of a 52 week open label RCT that compared Relvar vs. GP prescribed usual care*9

*Analysis based on a subset of patients whose randomisation stratum and pre-randomisation treatment included an ICS and a LABA, of which a high proportion were on Seretide (FP/SAL). Patients could receive a LAMA throughout the treatment period in addition to their randomised treatment.9

Relvar Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy.
lama/laba

LAMA/LABA – Anoro Ellipta (Umeclidinium/Vilanterol)

Superior lung function improvement vs. Spiolto Respimat (TIO/OLO) with an extra 52mL improvement in trough FEV1*10

*8-week open label crossover study in patients not on maintenance therapy (for ≥2 weeks prior to randomisation)10

84mL greater improvement in trough FEV1 from baseline vs. Bevespi Aerosphere (GLY/FOR) and similar improvement for peak change from baseline in FEV1 within 2 hours of dosing*11

*In a 24 week, non-inferiority study of Bevespi Aerosphere vs Anoro Ellipta in moderate to severe COPD patients.11

lama/laba

LAMA – Incruse Ellipta (Umeclidinium)

Superior lung function improvement vs Spiriva Handihaler (TIO) with a difference of 59mL in trough FEV1 at day 85 in the per protocol population*12

*Details of the blinding process for the tiotropium comparator study discussed here can be found on page 1 of Supplementary material, Feldman G et al. International Journal of COPD 2016: 11 719-730.

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TRELEGY’S MOLECULE DESIGN

David Allen, Senior Vice President, Medicine Design, GSK Respiratory R&D, explains how the molecules of Trelegy Ellipta were designed to provide a long duration of action for patients with COPD.1-9

Learn more

See clinical data for Trelegy Ellipta

lungs

See data on lung function improvement, HRQoL improvement and exacerbation reduction vs commonly prescribed maintenance therapies.

Find out more

Identify patients who could benefit from Trelegy Ellipta

patients

See the indication, patient profile, plus guidance on spotting patients at risk of an exacerbation.

Find out more
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Footnotes

FF, fluticasone furoate; HRQoL, health-related quality of life; ICS, inhaled corticosteroid; LABA, long-acting ß₂-agonist; LAMA, long-acting muscarinic antagonist; OD, once daily; UMEC, umeclidinium; VI, vilanterol

Trelegy Ellipta OD is indicated for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist.1

Trelegy Ellipta is generally well tolerated. Common adverse reactions include: headache, nasopharyngitis, influenza, upper respiratory tract infection, pneumonia, back pain, rhinitis, cough, pharyngitis, arthralgia, sinusitis, oropharyngeal pain, bronchitis, constipation, candidiasis of mouth and throat, urinary tract infection.1

In common with other corticosteroid-containing medicines, there is an increased risk of pneumonia in patients with COPD treated with Trelegy Ellipta.1

This is not an exhaustive list. Please consult the Summary of Product Characteristics for a full list of adverse reactions before prescribing.

References

  1. Trelegy Ellipta SmPC.
  2. Lipson DA et al. Am J Respir Crit Care Med 2017; 196:438–446.
  3. Lipson DA et al. N Engl J Med 2018; 378:1671–1680.
  4. Incruse Ellipta (umeclidinium bromide) SmPC
  5. Kempsford et al. Pulm Pharmacol Ther. 2013; 26(2): 256-64
  6. Biggadike K et al. J Med Chem 2008; 51: 3349-3352
  7. Salter M et al. Am J Physiol Lung Cell Mol Physiol 2007; 293:L660-L667
  8. Lipson DA et al. Poster no. 372 presented at ATS 2017; Abstract number A3605.
  9. Vestbo J et al. N Engl J Med 2016; 375:1253-60
  10. Feldman GJ et al. Adv Ther 2017; 34:2518-2533
  11. Maltais F et al. Adv Ther 2019; 36:2434-2449
  12. Feldman GJ et al. Int J Chron Obstruct Pulmon Dis 2016; 11:719-730
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