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Understanding the data behind TRELEGY Ellipta

Watch Professor Paul Jones give an overview of the IMPACT trial and explain the role of ICS in COPD (3 min video)

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Compare TRELEGY Ellipta lung function data to commonly used COPD treatments:

  • In the landmark IMPACT trial, TRELEGY Ellipta significantly improved SGRQ total scores vs. FF/VI at 52 weeks* 1

    Adapted from Lipson et al. 2018. 1
    The annual rate of on-treatment moderate/severe COPD exacerbations (primary endpoint) was significantly reduced with TRELEGY Ellipta vs. FF/VI and UMEC/VI (p<0.001 for both comparators). 1

  • In the FULFIL study, TRELEGY Ellipta significantly improved SGRQ total scores vs. Symbicort Turbuhaler (BUD/FOR) BD at 24 weeks* 2

    Adapted from Lipson et al. 2017. 2
    The co-primary endpoints of change from baseline in trough FEV1 and SGRQ score at Week 24 were both met in this study. 2

  • In the landmark IMPACT trial, TRELEGY Ellipta significantly improved SGRQ total scores vs. UMEC/VI at 52 weeks* 1

    Adapted from Lipson et al. 2018. 1
    The primary endpoint of the study (annual rate of on-treatment moderate/severe COPD exacerbations) was significantly reduced with TRELEGY Ellipta vs. FF/VI and UMEC/VI (p<0.001 for both comparators). 1

  • IMPACT was the first Phase III, randomised, double-blind, parallel-group, multicentre, 52-week trial to assess the efficacy and safety of the single-inhaler Triple Therapy TRELEGY Ellipta vs. an ICS/LABA (FF/VI 92/22 mcg) and vs. a LAMA/LABA (UMEC/VI 55/22 mcg) in symptomatic patients on COPD maintenance treatments who had experienced at least one exacerbation in the last 12 months. 1,  4

    Primary endpoint 1

    Annual rate of on-treatment moderate/severe COPD exacerbations for TRELEGY Ellipta vs. both comparators.

    Other key endpoints 3

    • Lung function: change from baseline in trough FEV1 at Week 52 3
    • Health-related quality of life: change from baseline in SGRQ score at Week 52 3

    Key inclusion criteria 13

    Patients aged 40 years or older with COPD and a CAT score ≥ 10 with:

    • FEV1 <50% predicted and ≥1 moderate/severe exacerbations 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 13

    Patients were excluded if they had any of the following:

    • A current diagnosis of asthma or other respiratory disorders
    • Pneumonia or other respiratory tract infection unresolved ≤14 days or ≤7 days, respectively, prior to screening
    • Unresolved exacerbation ≤14 days prior to screening
    • Oral/systemic corticosteroid use ≤30 days prior to screening
  • The efficacy and safety of TRELEGY Ellipta OD were compared in the FULFIL study with Symbicort Turbuhaler (BUD/FOR 320/9 mcg) BD. 2

    The FULFIL study was a Phase III, randomised, double-blind, double-dummy, parallel-group, multicentre, 24-week study. Patients underwent a 2-week run-in period, during which medications at screening were unchanged from their pre-study COPD maintenance therapy, followed by a 24-week treatment period. 2

    A subset of 430 patients (TRELEGY Ellipta OD n=210, Symbicort Turbuhaler (BUD/FOR 320/9 mcg) BD n=220) remained on blinded study treatment for up to 52 weeks (the EXT population). Efficacy endpoints and safety were assessed up to Week 52 in the EXT population. 2

    Co-primary endpoints 2

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

    Some secondary/other endpoints 2

    • Annual rate of moderate/severe COPD exacerbations
    • Change from baseline CAT score

    Key inclusion criteria 2

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

    Key exclusion criteria 2

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

Footnotes:

*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
†Difference takes into account standard errors.

Indications:

Trelegy▼ Ellipta (fluticasone furoate/umeclidinium/vilanterol 92/55/22 mcg) is indicated as maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of a ICS and a LABA or a combination of a LAMA and a LABA6

Relvar Ellipta (fluticasone furoate/vilanterol 92/22 mcg) 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 therapy7

Anoro▼ Ellipta (umeclidinium/vilanterol 55/22 mcg) is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD8

Abbreviations:

BD, twice-daily; BUD, budesonide; CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; EXT, extension; FEV1, forced expiratory volume in one second; FF, fluticasone furoate; FOR, formoterol; ICS, inhaled corticosteroid; LABA, long-acting ß2-agonist; LAMA, long-acting muscarinic antagonist; OD, once-daily; SGRQ, St George’s Respiratory Questionnaire; UMEC, umeclidinium; VI, vilanterol.

References:

  1. Lipson DA et al. N Engl J Med 2018; 378:1671–1680.
  2. Lipson DA et al. Am J Respir Crit Care Med 2017; 196(4):438–446.
  3. Lipson DA et al. N Engl J Med 2018; 378:1671–1680 (supplementary material).
  4. Lipson DA et al. N Engl J Med 2018; 378:1671–1680 (supplementary material protocol).
  5. Jones PW. COPD 2005; 2:75–79.
  6. TRELEGY Ellipta SmPC, 2018.
  7. Relvar Ellipta (fluticasone furoate/vilanterol 92/22 mcg) SmPC, 2018.
  8. Anoro▼ Ellipta (umeclidinium/vilanterol 55/22 mcg) SmPC, 2018.
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Trelegy, Relvar, Anoro and Ellipta are registered trademarks of the GlaxoSmithKline group of companies.