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Relvar FAQs

Asthma

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  • Q - Many of my patients with asthma have been taking Seretide for many years without any problems. Why would I recommend Relvar when Seretide works perfectly well?

    A: Relvar patients were significantly more likely to achieve clinically meaningful QoL improvements in a post-hoc analysis vs Seretide. 14–17*

    In this study, the primary superiority endpoint (24-hour FEV1) was not met. 14**

    Once-daily Relvar has been shown to be more likely to lead to clinically meaningful improvements in patients’ quality of life compared with twice-daily Seretide. 14–17 (Relvar is licensed for patients uncontrolled on ICS alone and ‘as-needed’ SABA and for patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist.) 1

    *46% vs 38%, p=0.023, a post hoc responder analysis 14–17 With 0.5 points (minimal clinically important difference from baseline) improvement in total Asthma Quality of Life Questionnaire (+12 points) score at week 24. 15

    **Primary endpoint: Improvements from baseline in 0–24 h serial weighted mean (wm) FEV, after 24 weeks. Relvar Ellipta: 341 ml; Seretide 377 ml – the adjusted mean treatment difference was not statistically significant (-37 ml [95% CI: -88, 15], p=0.162. 14

  • Q - What is Relvar Ellipta?

    A: Relvar is a maintenance COPD medicine that contains fluticasone furoate, an inhaled corticosteroid (ICS) with potent anti-inflammatory activity, and vilanterol, a selective long-acting ß2-agonist (LABA) with bronchodilator activity. 1 Relvar comes in the Ellipta – an easy-to-use device which helps your patients receive the benefit of their medication. 23

  • Q - Doesn’t the use of inhaled corticosteroid-containing medicines, such as Relvar and Seretide (fluticasone - salmeterol), increase the risk of pneumonia in COPD patients?

    A: ICS-containing medicines are well established as effective treatments in COPD. 1819 Relvar demonstrates a positive impact on exacerbations, lung function, and quality of life vs placebo and LABA alone. 2021

    The incidence of pneumonia with Relvar is similar to that seen with other ICS-containing medicines. 121–23

    In an integrated analysis of two replicate 12-month studies in a total of 3,255 COPD patients with an exacerbation in the preceding year, there was a higher incidence of pneumonia (97.9 events per 1000 patient-years) reported in patients receiving Relvar Ellipta 92/22 mcg OD vs those receiving vilanterol (VI) 22 mcg OD (42.3 events per 1000 patient-years). 1

    Risk factors for pneumonia in patients with COPD receiving Relvar Ellipta include current smokers, patients with a history of prior pneumonia, patients with BMI <25 kg/m2 and patients with a FEV1<50% predicted. These factors should be considered when Relvar is prescribed, and treatment should be re-evaluated if pneumonia occurs. 1

  • Q - I’m considering taking my patients with COPD off ICS. What would the implications be?

    A: The decision to withdraw ICS must remain with the prescribing physician, based on benefit–risk to the individual. However, abrupt withdrawal has been shown to lead to increased risk of exacerbations. 24–26

    A number of clinical trials involving patients with a history of exacerbations have shown that withdrawal of ICS may lead to an increase in exacerbation frequency and decreased lung function. 2425

  • Q - Should I use a long-acting muscarinic receptor agonist (LAMA) - LABA instead of ICS - LABA in patients at risk of exacerbations?

    A: ICS/LABAs are well established as effective treatments to reduce exacerbations, improve lung function and improve quality of life vs placebo and LABA alone, 1819and are recommended by Global Initiative for Obstructive Lung Disease (GOLD) COPD treatment guidelines as a treatment for GOLD C/D patients (patients with a high risk of exacerbations and either fewer or more symptoms, respectively). 27 The ICS significantly contributes to exacerbation reduction with ICS/LABA. 19

  • Q - What are the benefits of the Ellipta inhaler?

    A: In contrast to some other inhalers, the Ellipta dry powder inhaler (DPI) is simple to use, comes pre-filled and ready to administer. 1

    B: The GSK COPD portfolio offers a range of once-daily treatments delivered using the same inhaler. Therefore, COPD patients using more than one GSK product may not need to be trained to use multiple devices.

  • Q - What is Relvar Ellipta licensed for in COPD?

    A: Relvar Ellipta 92/22 mcg is indicated for the symptomatic treatment of adults with COPD with a FEV1 <70% predicted normal (post-bronchodilator) and an exacerbation history, despite regular bronchodilator therapy. 1

  • Q - Have any results come out of the Salford Lung Study (SLS) that show how my patients with COPD could benefit from Relvar?

    Results from the SLS showed that once-daily Relvar 92/22 mcg significantly reduced moderate/severe COPD exacerbations compared with a twice-daily ICS/LABA. 28

    *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. 28Primary comparison was Relvar Ellipta (n=1,135) vs <usual care> (n=1,134). 29This analysis was based on all ITT patients with ≥1 moderate/severe exacerbation in the year prior to randomisation. In this primary effectiveness analysis population, the rate of moderate/severe exacerbations was 1.74 exacerbations per year in the FF/VI OD group, compared with 1.90 per year in the usual care group, indicating an 8.4% (95% CI: 1.1, 15.2; p=0.02) lower rate in the FF/VI group. In common with other ICS-containing medicines, there is an increased risk of pneumonia in patients with COPD treated with Relvar. 128

  • Q - How many COPD exacerbations per year could 12 months of treatment with Relvar prevent, as evidenced by SLS COPD?

    An 8% rate reduction, means that Relvar can help prevent 1 moderate/severe COPD exacerbation for every 7 patients treated over 12 months compared with twice-daily ICS/LABA* (NNT=6.25) 28

  • Q - What was usual care in the SLS COPD stdy?

    A: In SLS COPD, usual care was a physician-determined COPD maintenance treatment in accordance with usual clinical practice. Of all ITT patients with ≥1 exacerbation in the year prior to randomisation (n=2,269), at baseline: 28

    • 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)
  • Q - What makes the SLS study design pioneering?

    • The SLS was 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) 28
    • The ITT population comprised 2,799 primary care patients with COPD who had experienced ≥1 exacerbation in the last 3 years. There were minimal exclusion criteria, and so the population closely represented patients seen in everyday practice 28
    • 2,269 patients (81%) had ≥1 moderate/severe exacerbation in the year before the trial and made up the primary effectiveness analysis population 28
    • 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 28
    • Primary endpoint: mean annual rate of moderate/severe COPD exacerbations, in the primary effectiveness analysis population 28
    • All secondary endpoints were analysed on the ITT population and included an analysis of patients’ CAT and EQ-5D score 28 **


    *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. 28Primary comparison was Relvar Ellipta (n=1,135) vs usual care (n=1,134). 29This analysis was based on all ITT patients with ≥1 moderate/severe exacerbation in the year prior to randomisation. In this primary effectiveness analysis population, the rate of moderate/severe exacerbations was 1.74 exacerbations per year in the FF/VI OD group, compared with 1.90 per year in the usual care group, indicating an 8.4% (95% CI: 1.1, 15.2; p=0.02) lower rate in the FF/VI group. In common with other ICS-containing medicines, there is an increased risk of pneumonia in patients with COPD treated with Relvar. 128

    **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). 283031

    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.

  • Q - How can I find out more about the SLS - its study design and results?

    A: For more information about the SLS, please visit SLS portal.

  • Q - What is the safety profile for ICS - LABAs for patients with COPD?

    A: No prescription medicine can be regarded as completely ‘safe’ – all are associated with both benefits and a potential risk of side effects. The benefit–risk profile of both Relvar (fluticasone furoate/vilanterol) and Seretide (fluticasone propionate/salmeterol) is favourable within their licensed indications. 122

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

References:

  1. Relvar Ellipta 92/22mcg and Relvar Ellipta 184/22mcg Summary of Product Characteristics
  2. Thomas M et al. Inhaler errors after reading the patient information leaflet in patients with asthma: Ellipta compared with three inhaler devices. ATS, Poster 2016; 10289. 
  3. van der Palen et al. Inhaler errors after reading the patient information leaflet in patients with COPD a comparison of Ellipta with five inhaler devices. ATS. 2016. Poster 8197.
  4. Bernstein DI et al. Fluticasone furoate (FF)/vilanterol (100/25 mcg or 200/25 mcg) or FF (100mcg) in persistent asthma. J Asthma. 2015; 52(10): 1073–1083.
  5. Bateman ED et al. Once-daily fluticasone furoate (FF)/vilanterol reduces risk of severe exacerbations in asthma versus FF alone. Thorax. 2014; 69: 312–319.
  6. Bernstein DI et al. Fluticasone furoate (FF)/vilanterol (100/25 mcg or 200/25 mcg) or FF (100mcg) in persistent asthma. J Asthma. 2015; 52(10) Online supplement
  7. GSK Data on file. The aerodynamic particle size of fluticasone furoate and vilanterol delivered from Relvar/Breo Ellipta. 2014; 2014N188664_00.
  8. Morrow PE. Aerosol characterization and deposition. Am Rev Respir Dis 1974; 110: 88–99.
  9. Swift DL. Generation and respiratory deposition of therapeutic aerosols. Am Rev Respir Dis 1980; 122: 71–77.
  10. GlaxoSmithKline Local Label.
  11. Kempsford RD et al. The efficacy of once-daily fluticasone furoate/vilanterol in asthma is comparable with morning or evening dosing. Resp Med 2013; 107(12): 1873–1880.
  12. Svedsater H et al. Ease of use of the ELLIPTA dry powder inhaler: data from three randomised controlled trials in patients with asthma. npj Prim Care Resp Med. 2013; 13:72.
  13. Global Initiative for Asthma. Global strategy for asthma management and prevention 2016. Available at: http://ginasthma.org/2016-gina-report-global-strategy-for-asthma-management-and-prevention/ (Accessed 16/11/2016).
  14. Woodcock A et al. Efficacy and safety of fluticasone furoate/vilanterol compared with fluticasone propionate/salmeterol combination in adult and adolescent patients with persistent asthma: a randomized trial. Chest. 2013; 144(4): 1222–1229.
  15. Woodcock A et al. Efficacy and safety of fluticasone furoate/vilanterol compared with fluticasone propionate/salmeterol combination in adult and adolescent patients with persistent asthma: a randomized trial. Chest. 2013; Online supplement: 1–7.
  16. Juniper EF et al. Determining a minimal important change in a disease-specific quality of life questionnaire. J Clin Epidemiol. 1994; 47(1): 81–87.
  17. GSK. Data on file 113091. 2014; RECE/FFT/0148/14.
  18. Nannini LJ et al. Combined corticosteroid and long-acting beta2-agonist in one inhaler versus placebo for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2013; (11). 
  19. Nannini LJ et al. Combined corticosteroid and long-acting beta2-agonist in one inhaler versus long-acting beta2-agonists for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012; (9).
  20. 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.
  21. Agusti A et al. A comparison of the efficacy and safety of once-daily fluticasone furoate/vilanterol with twice-daily fluticasone propionate/salmeterol in moderate to very severe COPD. Eur Respir J. 2014; 43(3): 763–772.
  22. Seretide Accuhaler Summary of Product Characteristics. GlaxoSmithKline; 2015. 
  23. Kew KM et al. Inhaled steroids and risk of pneumonia for chronic obstructive pulmonary disease. Cochrane Data Syst Rev. 2014; Issue 3. Art. No.: CD010115. DOI:10.1002/14651858.CD010115.pub2.
  24. Anzueto A et al. Effect of fluticasone propionate and salmeterol 250/50 on COPD exacerbations and impact on patient outcomes. Journal of COPD. 2009; 6: 320–329.
  25. Ferguson GT et al. Effect of fluticasone propionate and salmeterol 250/50 on COPD exacerbations. Resp Med. 2008; 102: 1099–1108. 
  26. Magnussen H et al. Withdrawal of inhaled glucocorticoids and exacerbations of COPD. N Engl J Med 2014. 371(14): 1285–1294.
  27. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease (Updated 2017). http://goldcopd.org/gold-2017-global-strategy-diagnosis-management-prevention-copd/(Accessed 16/11/2016).
  28. Vestbo J et al. Effectiveness of Fluticasone Furoate-Vilanterol in COPD in Clinical Practice. NEJM. 2016. DOI: 10.1056/NEJMoa1608033. 
  29. Vestbo J et al. Effectiveness of Fluticasone Furoate-Vilanterol in COPD in Clinical Practice. NEJM. 2016. DOI: 10. 1056/ NEJMoa1608033 Supplement.
  30. COPD Assessment Test (CAT). http://www.catestonline.org/images/ pdfs/CATest.pdf. (Accessed 01/08/2016).
  31. Jones PW. COPD assessment test – rationale, development, validations and performance. COPD. 2013; 10: 269-271.

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