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Clinical evidence in Asthma

Discover the core efficacy and safety data supporting Relvar Ellipta in asthma.

Relvar’s component combination delivers 24 hours of continuous efficacy with just one dose 1–6

24-hour forced expiratory volume in 1 second (FEV1) of Relvar 92/22mcg (placebo-adjusted curve), week 12 (end of study) 5

  • This was a randomised, double-blind, parallel-group study of Relvar compared with ICS alone for 12 weeks. Co-primary end points were change from baseline in trough FEV1 and serial (0–24 hours) weighted mean FEV15
  • In this study, neither co-primary superiority endpoint was met for Relvar compared with an ICS alone. 5

Relvar delivered 19.2 additional symptom-free hours per week vs. an ICS alone (p<0.001) 5

Mean additional symptom-free hours per week from baseline across 12 weeks 5

  • This was a randomised, double-blind, parallel-group study of Relvar compared with ICS alone for 12 weeks. Co-primary end points were change from baseline in trough FEV1 and serial (0–24 hours) weighted mean FEV15
  • In this study, neither co-primary superiority endpoint was met. 5

5. 46% of patients achieved meaningful improvements in their quality of life with Relvar* 7–10

Percentage of patients achieving a clinically meaningful improvement in QoL* 9-12

  • Relvar patients were significantly more likely to achieve clinically meaningful QoL improvements in a post-hoc analysis 7–10*
  • In this study, the primary superiority endpoint (improvement from baseline in 0–24h serial weighted mean [wm] FEV1 after 24 weeks) was not met.

* With 0.5 points (minimally clinically important difference from baseline) improvement in Asthma Quality of Life + 12 Questionnaire (AQLQ+12) score at Week 24. 9
† Post-hoc analysis: Health outcomes assessments evaluated in the ITT population of a 24-week randomized, double-blind, double-dummy, parallel group, multicenter study to assess efficacy and safety of Relvar Ellipta 92/22 mcg OD vs. Seretide 250/50 mcg BD (N=806). 8

Relvar is available in the Ellipta, an easy-to-use device that helps ensure drug delivery 1 11–14

95% of patients used Ellipta correctly first time  following initial demonstration and did not require additional instruction 11*

>99% of patients mastered Ellipta correctly by Day 14 11*

  • Ellipta offers highly consistent drug delivery to the lungs of asthma patients across all disease severities (ex vivo data) 13 14**

* Pooled data from three 12–24 week randomised, double-blind studies in which Relvar Ellipta 92/22 mcg OD or fluticasone furoate (FF) 92 mcg OD was delivered via the Ellipta dry powder inhaler (DPI) (N=989). 11
** Study 1: An in vitro performance of both components of Relvar Ellipta was observed to be consistent and reproducible, with little flow dependency, when delivered simultaneously at inhalation parameters that were representative of patients with all severities of asthma and COPD (N=105). All patients could generate a PIFR greater than 43 L/min.13 Study 2: Inhalation profiles representative of the full range of inhalation parameters for asthma and COPD patients were replicated using the Electronic Lung. Delivered dose was consistent for both components of Relvar for all patient severities. 14

Relvar is generally well tolerated in patients with asthma and COPD 1

The Phase III safety population for Relvar comprised 7,034 patients with asthma and 6,237 patients with COPD. 1

Safety and tolerability data from the Relvar clinical development programme 1

  • Relvar 92/22 mcg has a safety and tolerability profile in asthma similar to that for Seretide 1 7 15
  • In common with other ICS-containing medicines, Relvar Ellipta has the potential to cause systemic side effects, including adrenal suppression, cataracts, glaucoma and growth retardation in children (aged 12 years and older), particularly at high doses prescribed for long periods 1
  • In common with other ICS-containing medicines, there is an increased risk of pneumonia in COPD patients treated with Relvar 1 (note: Relvar 184/22 mcg is not licensed for COPD)
    • The incidence of pneumonia with Relvar is similar to that seen with other ICS/LABA combinations 1 15 16
    • Pneumonia occurred in 6-7% of patients receiving Relvar compared with 3% of patients receiving vilanterol alone 17

References:

  1. Relvar SmPC.
  2. Salter M et al. Am J Physiol Lung Cell Mol Physiol 2007; 293:L660–667.
  3. Valotis A & Högger P. Respir Res 2007; 8:54.
  4. Slack RJ et al. J Pharmacol Exp Ther 2013; 344:218–230.
  5. Bleecker ER et al. JACI In Practice 2014; 2:553–561.
  6. Rossios C et al. Eur J Pharmacol 2011; 670:244–251.
  7. Woodcock A et al. Chest 2013; 144:1222–1229.
  8. Woodcock A et al. Chest 2013; Online supplement: 1–7.
  9. Juniper EF et al. J Clin Epidemiol 1994; 47:81–87. 
  10. GSK. Data on file 113091. 2014; RECE/FFT/0148/14.
  11. Svedsater H et al. NPJ Prim Care Med 2014; 24:14019.
  12. Svedsater H et al. BMC Pulm Med 2013; 13:72.
  13. Prime D et al. Am J Respir Crit Care Med 2012; 185:A2941. 
  14. Hamilton M et al. Am J Respir Crit Care Med 2012; 185:A2940.
  15. Seretide Accuhaler SmPC, 2015.
  16. Kew KM et al. Cochrane Data Syst Rev 2014; 3:CD010115. doi:
  17. 1002/14651858.CD010115.pub2.
  18. Dransfield MT et al. Lancet Respir Med. 2013;1:210–223.

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