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Greater annualised moderate/severe exacerbation reduction vs. other COPD single-inhaler Triple Therapies

In a network meta-analysis (NMA) of 23 randomised controlled trials (RTCs) involving adult COPD patients eligible for triple therapy, 17 of which reported moderate/severe exacerbation endpoint. Analysis based on a Frequentist Fixed Effect (FE) model.

  • New data - Single Inhaler Triple Therapies compared in a NMA

    Watch the short video below to hear from Professor David Halpin who will provide an overview of:

    • What a network meta-analysis is and how they sit in the evidence hierarchy
    • How this particular network meta-analysis was structured and it’s limitations
    • An overview of the key conclusions from this network meta-analysis

    LAMA/LABAs are indicated as maintenance bronchodilator treatments to relieve symptoms in adult patients with COPD.

    Difference in annualised exacerbation incidence of Trelegy vs. other COPD single inhaler triple therapies

    NA

    In a network meta-analysis (NMA) of 23 randomised controlled trials (RTCs) involving adult COPD patients eligible for triple therapy, 17 of which reported moderate/severe exacerbation endpoint. Analysis based on a Frequentist Fixed Effect (FE) model.
    Other NMAs exist which differ in their methodology and study inclusion which do not show any statistical differences between different SITTs.

  • Trelegy Ellipta delivered superior reduction in annual rate of moderate/severe exacerbations vs. an ICS/LABA4

    Exacerbation reduction graph Trelegy vs ICS/LABA

    Adapted from Lipson et al. 20174
    FULFIL was a Phase III, randomised, double-blind, double-dummy, parallel-group, multicentre, 24-week study designed to assess the efficacy and safety of the single-inhaler Triple Therapy Trelegy Ellipta OD (FF/UMEC/VI) vs. Symbicort Turbohaler BD (BUD/FOR), with an extension to 52 weeks in a subset of patients4
    The extension population was comprised of a subset of patients in the ITT population (N=1,810) who were enrolled into the 52-week extension phase of the study and remained on blinded treatment for up to 52 weeks4
    The co-primary endpoints of change from baseline in trough FEV1 and SGRQ score at Week 24 were both met in this study4
    In another double blind, 52 week, randomised control trial Trelegy demonstrated a 13% reduction (non-significant) in hospitalised exacerbations vs an ICS/LABA, (Relvar, fluticasone furoate/vilanterol) (ARR: 0.02, p=0.064)5

  • Trelegy Ellipta is the only triple therapy that demonstrated a reduction in hospitalised exacerbations compared with a LAMA/LABA (umeclidinium/vilanterol) in a pre-specified analysis

    Hospitalised exacerbation reduction graph Trelegy vs LABA/LAMA

    Adapted from Lipson et al. 20185
    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 met5
    LAMA/LABAs are indicated as maintenance bronchodilator treatments to relieve symptoms in adult patients with COPD

Key trial design

  • FULFIL was a Phase III, randomised, double-blind, double-dummy, parallel-group, multicentre, 24-week study designed to assess the efficacy and safety of the single-inhaler triple therapy Trelegy Ellipta OD (FF/UMEC/VI) vs. Symbicort Turbohaler BD (BUD/FOR), with an extension to 52 weeks in a subset of patients.4

    FULFIL study design

    Co-primary endpoints:

    • Change from baseline in trough FEV1 and SGRQ score at Week 24

    Secondary endpoints include:

    • Annual rate of moderate/severe COPD exacerbations

    Key inclusion criteria

    • Patients with COPD with a FEV1 <50% and a CAT score ≥10, or
    • Patients with a FEV1 ≥50% to <80% and a CAT score ≥10, and either ≥2 moderate exacerbations in the past year or ≥1 severe exacerbation in the past year*
    • Aged ≥40 years

    Key exclusion criteria:

    • Current diagnosis of asthma causing patient symptoms
    • Unresolved pneumonia or severe COPD exacerbation

    *A moderate exacerbation was defined as having worsening symptoms of COPD that required treatment with oral/systemic corticosteroids and/or antibiotics. A severe exacerbation was defined as worsening symptoms of COPD that required treatment with inpatient hospitalisation

  • IMPACT is the first trial to assess, over 52 weeks, the efficacy and safety of the single-inhaler triple therapy Trelegy Ellipta (FF/UMEC/VI) vs. an ICS/LABA (Fluticasone Furoate/Vilanterol) and vs. a LAMA/LABA (Umeclidinium/Vilanterol ), in symptomatic patients on COPD maintenance treatments who had experienced at least one exacerbation in the last 12 months.5

    (Fluticasone Furoate/Vilanterol)
    IMPACT study design

    Primary endpoints:

    • Annual rate of on-treatment moderate/severe exacerbations* for Trelegy Ellipta vs. ICS/LABA (FF/VI) and LAMA/LABA (UMEC/VI)

    Secondary endpoints include:

    • Lung function: change from baseline in trough FEV1 at Week 52
    • Health-related quality of life: change from baseline in SGRQ score at Week 52

    Other endpoints include

    • On-treatment all-cause mortality

    Key inclusion criteria:

    • Patients aged 40 years or older with COPD and a CAT score ≥10 with:
      • FEV1 <50% predicted and ≥1 moderate/severe exacerbation in the previous year, or
      • FEV1 ≥50% to <80% predicted and ≥2 moderate exacerbations or 1 severe exacerbation in the previous year
    • Patients were required to be receiving daily maintenance therapy for COPD for at least 3 months prior to screening

    Key exclusion criteria:

    • Current diagnosis of asthma or other respiratory disorders
    • Unresolved pneumonia or COPD exacerbation, or respiratory tract infection ≤14 days or 7 days, respectively
    • Oral/systemic corticosteroid use ≤30 days prior to screening

    *A moderate exacerbation was defined as an exacerbation leading to treatment with antibiotics or systemic glucocorticoids. A severe exacerbation was one resulting in hospitalisation or death

COPD Triple Therapy vs. dual bronchodilator therapy - what is the difference for patients?

Watch Professor Paul Jones, GSK Global Medical Expert, give an overview of the IMPACT trial which aimed to determine the patient benefit that could be achieved by adding an inhaled corticosteroid to dual bronchodilator therapy.

Prescribing Information Links

Trelegy Ellipta Prescribing Information (pdf)

Anoro Ellipta (umeclidinium/vilanterol) Prescribing Information

Relvar Ellipta (Fluticasone furoate/vilanterol) Prescribing Information (pdf)

Seretide Accuhaler 50/500 (salmeterol/fluticasone propionate) Prescribing Information

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.2

Anoro Ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD)6

Relvar Ellipta 92/22mcg is indicated for the symptomatic treatment of adults with COPD with a FEV1 <70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilation therapy3

Seretide (50 micrograms salmeterol and 500 micrograms fluticasone propionate) is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.

Footnotes

BD, twice daily; BUD, budesonide; CAT, COPD assessment test; FEV1, forced expiratory volume in one second; FF/UMEC/VI, fluticasone furoate, umeclidinium, vilanterol; FOR, formoterol; ICS, inhaled corticosteroid; ITT, intent-to-treat; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist; OD, once daily; QoL, quality of life; SGRQ, St George’s Respiratory Questionnaire; ARR, absolute risk reduction

References

  1. Poster;P649;Ismaila;ATS;2022
  2. TRELEGY Ellipta SmPC
  3. RELVAR Ellipta SmPC
  4. Lipson DA et al. Am J Crit Care Med 2017; 196:438-446.
  5. Lipson DA et al. N Engl J Med 2018; 378:1671-1680.
  6. ANORO Ellipta SmPC.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441.

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June 2022 | PM-GB-FVU-WCNT-200013 (V6.0)