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MLT_GIB/OTH/0007/17m
Date of preparation: March 2018

Efficacy in COPD

Pioneering new data from the Salford Lung Study in COPD (SLS COPD) show that once-daily Relvar 92/22 mcg can benefit the patients with COPD you see every day. 1

Significantly fewer moderate/severe exacerbations vs usual care and vs twice-daily ICS/LABA

SLS COPD showed that once-daily Relvar 92/22 mcg significantly reduced moderate/severe COPD exacerbations compared with usual care and compared with a twice-daily ICS/LABA 1*

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    *Patients could receive a LAMA throughout the treatment period in addition to their randomised treatment. Subset of patients randomised to an ICS/LABA ± LAMA strata and were taking an ICS/LABA at baseline. 1In common with other ICS-containing medicines, there is an increased risk of pneumonia in patients with COPD treated with Relvar. 12

    ICS/LABA=inhaled corticosteroid/long-acting β2-adrenoceptor agonist; ITT=intention to treat; LAMA=long-acting muscarinic antagonist; NNT=number needed to treat; RCT=randomised controlled trial.  

  • In the Relvar SLS COPD study, usual care was a physician-determined COPD maintenance treatment in accordance with usual clinical practice. Of all ITT patients with ≥1 moderate/severe exacerbation in the year prior to randomisation (n=2,269) at baseline: 1

    • 88% were on an ICS-containing regimen 
    • 54% were on triple therapy (ICS/LABA + LAMA)
    • 12% were on a bronchodilation therapy only (LAMA, LABA or LAMA + LABA)

    Salford Lung Study design

    • A 52-week, prospective, comparative, open-label, randomised controlled trial comparing the effectiveness and safety of once-daily Relvar 92/22 mcg* with existing COPD maintenance therapies (usual care) 1
    • The ITT population comprised 2,799 primary care patients** with COPD who had experienced ≥1 exacerbation in the last 3 years. 13There were minimal exclusion criteria, and so the population closely represented patients seen in everyday practice 1
    • 2,269 patients (81%) had ≥1 moderate/severe exacerbation in the year before the trial and made up the primary effectiveness analysis population 1
    • Primary endpoint: mean annual rate of moderate/severe COPD exacerbations, in the primary effectiveness analysis population 1
    • All secondary endpoints were analysed on the ITT population and included an analysis of patients’ CAT and EQ-5D score 1†‡
    • A subset of 908 patients in the usual care arm and 927 in the in the FF/VI OD group were on twice-daily ICS/LABA* treatment at baseline 1

    *Patients could receive a LAMA throughout the treatment period in addition to their randomised treatment. 1
    **Three patients in the Relvar (FF/VI) group never took the trial medication, so the ITT population was 2,799. 13
    †CAT: COPD Assessment Test™ (a questionnaire designed to measure the impact of COPD on patients’ wellbeing and daily life; quality of life was measured via the European Quality of Life-5 Dimensions (EQ-5D questionnaire). 14
    ‡Analysis based on patients who completed the CAT questionnaire at baseline and at Month 12 (i.e. usual care arm n=1,325; FF/VI n =1,317). 1

    ICS/LABA=inhaled corticosteroid/long-acting β2-adrenoceptor agonist; ITT=intention to treat; LAMA=long-acting muscarinic antagonist; NNT=number needed to treat; RCT=randomised controlled trial.  

Improvement in COPD-related health status

Relvar significantly reduced the impact of COPD symptoms* on patients’ everyday lives, compared with usual care 1**

*As measured by the COPD Assessment Test (CAT), a self-completion questionnaire comprising eight questions covering domains relating to the impact of COPD symptoms such as cough, chest tightness, breathlessness, sleep and energy 14
**Patients could receive a LAMA throughout the treatment period in addition to their randomised treatment 1

 

 

  • … so your patients can see themselves doing the things they want, not just the things that COPD lets them.

    A minimal clinically important difference is defined as a decrease of 2 points on the CAT scale 5

    Odds ratio = 1.51
    (95% CI: 1.28, 1.77; p<0.001)

     

    Salford Lung Study design

    • A 52-week, prospective, comparative, open-label, randomised controlled trial comparing the effectiveness and safety of once-daily Relvar 92/22 mcg* with existing COPD maintenance therapies (usual care) 1
    • The ITT population comprised 2,799 primary care patients** with COPD who had experienced ≥1 exacerbation in the last 3 years. 13There were minimal exclusion criteria, and so the population closely represented patients seen in everyday practice 1
    • 2,269 patients (81%) had ≥1 moderate/severe exacerbation in the year before the trial and made up the primary effectiveness analysis population 1
    • Primary endpoint: mean annual rate of moderate/severe COPD exacerbations, in the primary effectiveness analysis population 1
    • All secondary endpoints were analysed on the ITT population and included an analysis of patients’ CAT and EQ-5D score 1†‡
    • A subset of 908 patients in the usual care arm and 927 in the in the FF/VI OD group were on twice-daily ICS/LABA* treatment at baseline 1

    *Patients could receive a LAMA throughout the treatment period in addition to their randomised treatment. 1
    **Three patients in the Relvar (FF/VI) group never took the trial medication, so the ITT population was 2,799. 13
    †CAT: COPD Assessment Test™ (a questionnaire designed to measure the impact of COPD on patients’ wellbeing and daily life; quality of life was measured via the European Quality of Life-5 Dimensions (EQ-5D questionnaire). 14
    ‡Analysis based on patients who completed the CAT questionnaire at baseline and at Month 12 (i.e. usual care arm n=1,325; FF/VI n =1,317). 1

    ICS/LABA=inhaled corticosteroid/long-acting β2-adrenoceptor agonist; ITT=intention to treat; LAMA=long-acting muscarinic antagonist; NNT=number needed to treat; RCT=randomised controlled trial.

     

24-hour efficacy

Relvar could help your patients through moments of their day with 24 hours of continuous efficacy from just one daily dose 26

  • A dose-finding study (incomplete block crossover design) examining 24-hour spirometric profile of Relvar 92/22 mcg administered once-daily in the morning after 28 days of treatment in patients with COPD (n=54). Primary endpoint: time-adjusted (weighted mean) 0 to 24-hour FEV1 (AUC) at the end of each 28-day treatment period (period days 28–29). 6

     

Sustained lung function improvements

Improved lung function is sustained over an entire year, 7so that your patients can hold on to what’s important

  • *Pooled analysis.
    Vilanterol monotherapy is not licensed for use in COPD.

  • Two replicate 52-week studies on 1622 and 1633 patients with at least one COPD exacerbation that required antibiotics and/or systemic/oral corticosteroids or hospitalisation in the 12 months prior to Visit 1, and a smoking history of ~10 pack-years. The primary endpoint was annual rate of moderate/severe exacerbations. 7

References

  1. Vestbo J et al. Effectiveness of Fluticasone Furoate-Vilanterol for COPD in Clinical Practice. NEJM. 2016. DOI: 10.1056/NEJMoa1608033.
  2. Relvar Ellipta Summary of Product Characteristics, GlaxoSmithKline
  3. Vestbo J et al. Supplement to effectiveness of Fluticasone Furoate-Vilanterol for COPD in Clinical Practice. NEJM. 2016. DOI: 10.1056/NEJMoa1608033: 1-13.
  4. COPD Assessment Test (CAT). http://catestonline.org/images/pdfs/CATest.pdf (Last accessed: December 2016.
  5. Kon SSC et al. Minimum clinically important difference for the COPD Assessment Test: a prospective analysis. Lancet Respir Med. 2014; 2: 195–203.
  6. Boscia JA et al. Effect of once-daily fluticasone furoate/vilanterol on 24-hour pulmonary function in patients with chronic obstructive pulmonary disease: a randomized, three-way, incomplete block, crossover study. Clin Ther. 2012; 34(8): 1655–1666.e5.
  7. Dransfield MT et al. Once daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomized controlled trials. Lancet Resp Med. 2013; 1(3):210–223.

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