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Cortisol suppression

For inhaled corticosteroids, measuring cortisol suppression is the most sensitive and easily monitored biomarker of adverse systemic effects.1

Relvar’s ICS – fluticasone furoate (FF) – is associated with lower cortisol suppression vs the ICS in BUD/Form (cortisol suppression [%] values were: 7% to 14% for FF (100 to 200 µg/day) and 13% to 44% for BUD (400 to 1,600 µg/day).*2–5

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Maximum licensed dose in ICS/LABA therapy and dose estimated to cause 20% cortisol suppression based on pharmacological modelling data1

Cortisol suppression graph Cortisol suppression graph

This graph has been independently created by GSK from the original data. The same results were first published in Daley-Yates PT. Br J Clin Pharmacol 2015;80:372–380.
Fluticasone furoate is not licensed for use as monotherapy in patients with asthma.

24-hour serum cortisol at Day 42 of treatment5

HPA graph HPA graph

LOCs to purchase copyrights for the reuse of this graph within their markets. Please ensure the correct statement is included to comply with the terms of the licence. It was first published in Allen A, et al. Clin Respir J 2013;7:397–406.

Modelling adherence impact graph Modelling adherence impact graph
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In a modelling study of moderate-to-severe asthma, cortisol suppression with the high dose of FF/VI (200/25 μg OD) was ≤11%, even at 90% adherence§10

GSK does not promote low adherence when using its products. These findings may not directly correlate to clinical outcomes in daily practice. Material from: ‘Peter Daley-Yates et al., Assessing the Effects of Changing Patterns of Inhaled Corticosteroid Dosing and Adherence with Fluticasone Furoate and Budesonide on Asthma Management, published 2023 Springer Nature reproduced with permission of SNCSC’. The original data were first published in Daley-Yates P, et al. Adv Ther 2023;40:4042–4059.

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Asthma control

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24-hour action

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Safety profile

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21st-century molecules[9, 11–13]

Relvar’s unique combination of fluticasone furoate, a potent inhaled corticosteroid, and vilanterol, an ultra-long-β2-agonist, delivers the everyday stability asthma patients need.9–11,14–21

Footnotes

*Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids.3 The values mentioned in this claim are from a study of FF, FP and BUD dosing (Daley-Yates P, et al. Br J Clin Pharmacol 2021;87:483–493) and are reported in the Relvar Summary of Product Characteristics.2,22
†100 to 200 µg/day for FF and 400 to 1600 µg/day for BUD. Dose ranges represent the licensed dosages for the marketed products. These values are from a study of the approved doses for FF, FP and BUD.22
‡Indirect data comparison based on PK/PD modelling. The model uses 20% cortisol suppression as the lowest boundary of detectable systemic exposure for corticosteroids, serving as a cut-off point above which the adverse events of corticosteroids become more likely.1
§This modelling study evaluated the bronchoprotection and systemic activity (cortisol suppression) profiles of FF and BUD across a range of adherence scenarios and real-world studies.10 Simulations were performed using a previously validated and published PK/PD model using data from published studies.22,23 These findings may not directly correlate to clinical outcomes in daily practice.10 Cortisol suppression above 20% was considered an indicator of higher systemic activity.10 Bronchoprotection was defined as the ability of an ICS to prevent a drop of >20% in FEV1 in an AMP challenge test.23 Study limitations: These results build on an earlier PK/PD modelling study, but assumptions on lung binding have not been directly validated by measurements in human lung tissue; the model only estimates the bronchoprotective effects of ICS through anti-inflammatory mechanisms; only widely available ICS and ICS-containing regimens were included in the analysis; no statistical significance was associated with these findings and p values were not calculated; future work is required to corroborate the current findings in clinical studies.10,24

Abbreviations

AE, adverse event; AMP, adenosine 5’-monophosphate; BD, twice daily; BUD, budesonide; DPI, dry powder inhaler; FEV1, forced expiration volume in 1 second; FF, fluticasone furoate; Form, formoterol; FP, fluticasone propionate; HFA, hydrofluoroalkane; HPA, hypothalamic-pituitary-adrenal; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; OD, once daily; PD, pharmacodynamics; PK, pharmacokinetics; VI, vilanterol.

Relvar Safety Information2

Contraindications
Hypersensitivity to the active substances or to any of the excipients.

Undesirable effects
Very Common: Headache, Nasopharyngitis.

Common: Infections and infestations, Oropharyngeal pain, Sinusitis, Pharyngitis, Rhinitis, Cough, Dysphonia, Abdominal pain, Arthralgia, Back pain, Fractures, Muscle spasms and Pyrexia.

References
  1. Daley-Yates P. Br J Clin Pharmacol 2015;80:372–380.
  2. Relvar Prescribing Information
  3. Daley-Yates P, et al. Eur J Endocrinol 2022;187:413–427. 
  4. O’Byrne PM, et al. Respir Res 2016;17:157. 
  5. Allen A, et al. Clin Respir J 2013;7:397–406. 
  6. Symbicort Turbohaler 400/12 Summary of Product Characteristics. Available from https://www.medicines.org.uk/emc/product/6775/smpc. Accessed April 2024 [LOCS TO LOCALISE].
  7. Seretide 500 Accuhaler Summary of Product Characteristics. Available from https://www.medicines.org.uk/emc/product/7596/smpc. Accessed April 2024 [LOCS TO LOCALISE].
  8. Fostair NEXThaler 200/6 Summary of Product Characteristics. Available from https://www.medicines.org.uk/emc/medicine/31250. Accessed April 2024 [LOCS TO LOCALISE].
  9. Global Datasheet Fluticasone furoate/vilanterol: v13, September.
  10. Daley-Yates P, et al. Adv Ther 2023;40:4042–4059.
  11. Bernstein DI, et al. J Asthma 2015;52:1073–1083.
  12. Braithwaite I, et al. Respir Med 2016;19:115–121.
  13. Center for Drug Evaluation and Research. Approval package for Breo Ellipta. Application number: 204275Orig1s000. Accessed April 2024.
  14. Woodcock A, et al. Lancet 2017;390:2247–2255.
  15. Averell CM, et al. J Asthma 2022;59;1805-1818.
  16. Svedsater H, et al. Respir Med 2018;141:198–206.
  17. Parimi M, et al. Adv Ther 2020;37:2916–2931.
  18. van der Palen J, et al. NPJ Prim Care Respir Med 2016;26:16079.
  19. van der Palen J, et al. Respir Med 2022;205:107031.
  20. Janson C, et al. Thorax 2020;75:82–84.
  21. Woodcock A, et al. Thorax 2022;77:1187–1192.
  22. Daley-Yates P, et al. Br J Clin Pharmacol 2021;87:483–493.
  23. Daley-Yates P, et al. Adv Ther 2022;39:706–726.
  24. Singh D, et al. Adv Ther 2022;39:1895–1914.

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Department of Pharmacovigilance & Drug Information
Drug Safety Center
Ministry of Health, Sultanate of Oman
Phone Nos. 0096822357687 / 0096822357690
Fax: 0096822358489
Email: pharma-vigil@moh.gov.om
Website: https://moh.gov.om/en/

 دائرة التيقظ و المعلومات الدوائية
مركز سلامة الدواء
وزارة الصحة, سلطنة عمان
هاتف: 0096822357687 / 0096822357690
0096822358489 :فاكس
pharma-vigil@moh.gov.om :البريد االكتروني
https://moh.gov.om/en/ : الموقع االكتروني

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PM-RCH-FFV-WCNT-250001 Date of preparation: July 2025