You are now leaving GSK Malta Health Portal

You are about to leave a GSK Website. By clicking this link, you will be taken to an external website that is not owned or controlled by GSK, and GSK is not responsible for the content provided on this site. If you do not wish to leave this website, click on “Go Back” below:

Continue

Go back

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

Relvar efficacy in asthma

Review the latest once-daily Relvar data, and learn how 24-hour continuous efficacy could benefit your patients with asthma.

24-hours of continuous efficacy

Relvar provides 24-hour continuous efficacy from just one daily dose 1

  • A 12-week randomised, double-blind, stratified, parallel-group, multicentre study comparing Relvar Ellipta 92/22 mcg OD with fluticasone furoate (FF) 92 mcg (primary objective) and Relvar Ellipta 92/22 mcg OD with Relvar Ellipta 184/22 mcg OD (descriptive comparison only) in patients with moderate to severe persistent asthma (n=1039). 1

     

Improvements in symptoms 

Relvar gives patients 13 additional symptom-free hours per week vs ICS alone 1*

*treatment difference 7.8%; 95% CI: 2.9%, 12.6%; p=0.0022>

 

  • A 12-week randomised, double-blind, stratified, parallel-group, multicentre study comparing Relvar Ellipta 92/22 mcg OD with fluticasone furoate (FF) 92 mcg (primary objective) and Relvar Ellipta 92/22 mcg OD with Relvar Ellipta 184/22 mcg OD (descriptive comparison only) in patients with moderate to severe persistent asthma (n=1039). 1

<… and a 25% reduction in annual rate of severe exacerbations vs ICS alone 3**

**rate 0.14 vs 0.19 per year, respectively; rate reduction 95% CI: 5%, 40%; p=0.014) 5

  • A ≥24–78 week, double-blind, placebo-controlled (with rescue medication) study comparing Relvar Ellipta 92/22 mcg OD with fluticasone furoate (FF) 92 mcg OD in patients with asthma with ≥1 recorded exacerbation in the last 1 year (n=2019). 3

Night-time symptoms

24 hours of continuous efficacy from one daily dose means that Relvar works both day and night to keep your patients’ symptoms under control… 

  • Once-daily Relvar delivers between 1.7 and 2.7 additional symptom-free nights per week,* so that your patients’ sleep is less interrupted because of their asthma. 4

    *vs baseline for patients with at least one night of symptoms at baseline (post-hoc analyses) 4

  • Post-hoc analysis from a study of change from baseline in the percentage of symptom-free 24-hour periods during a 12-week treatment. Asthma symptoms were recorded in a daily eDiary by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom-free. The baseline value was derived from the last 7 days of the daily eDiary prior to the randomisation of the participant. Change from baseline was calculated as the averaged value during the 12-week treatment period minus the baseline value. The analysis was performed using an ANCOVA model with covariates of baseline, region, sex, age, and treatment group. 4

Improvements in Quality of Life (QoL)

Once-daily Relvar leads to clinically meaningful improvements in patients’ quality of life compared with twice-daily Seretide... 5–8

**46% vs 38%, p=0.023, a post hoc responder analysis 5–8 With 0.5 points (minimal clinically important difference from baseline) improvement in total Asthma Quality of Life Questionnaire (+12 points) score at week 24. 7

…which could mean that your patients feel up to everyday challenges.

  • Relvar patients were significantly more likely to achieve clinically meaningful QoL improvements in a post-hoc analysis vs Seretide. 5,6,8*
    In this study, the primary superiority endpoint (24-hour FEV1) was not met.
    5**

    **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. 5

  • 24-week randomised, double-blind, double-dummy, parallel-group, multicentre study to assess efficacy and safety of OD Relvar Ellipta 92/22 mcg vs BD Seretide 250/50 mcg (n=806). 5

References:

  1.  Bernstein DI et al. Fluticasone furoate (FF)/vilanterol (100/25 mcg or 200/25 mcg) or FF (100mcg) in persistent asthma. J Asthma. 2015.
  2.  Bernstein DI et al. Fluticasone furoate (FF)/vilanterol (100/25 mcg or 200/25 mcg) or FF (100mcg) in persistent asthma. J Asthma. 2015; Online Supplement: Table S3.
  3.  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.
  4.  Leather DA et al. Fluticasone furoate (FF)/vilanterol (VI) once daily reduces asthma symptoms both day and night. British Thoracic Society, London, UK, 02–04 December 2015; Poster 152.
  5.  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.
  6.  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.
  7.  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
  8.  GSK. Data on file 113091. 2014; RECE/FFT/0148/14.

Relvar and Ellipta are registered trademarks of the GlaxoSmithKline Group of Companies