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Real-World Safety and Effectiveness of Fluticasone Furoate/Vilanterol in Patients with Asthma and/or Chronic Obstructive Pulmonary Disease: A Post-Marketing Study in Korea

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Abstract

Background and Objective

Fluticasone furoate/vilanterol (FF/VI; RELVAR ELLIPTA) is approved in Korea for patients with asthma or chronic obstructive pulmonary disease (COPD). This study evaluated the effectiveness and safety of FF/VI in Korean patients with asthma and/or COPD over a 6-year period.

Methods

This was an open-label, multicentre, observational, post-marketing surveillance study in patients newly treated with FF/VI (100 or 200 μg/25 μg once daily). Safety endpoints were the incidence of adverse events (AEs), including unexpected AEs/adverse drug reactions (ADRs) and serious AEs/ADRs. Effectiveness was assessed after 24 weeks by Global Physician Assessment (logistic regression) and forced expiratory volume in 1 s (FEV1; paired t-tests).

Results

Of the 3426 patients enrolled across 45 hospitals between July 2014 and June 2020, 3216 were included in the safety analysis (50.5% female; mean age ± standard deviation [SD]: 58.6 ± 16.3 years). Overall incidence of AEs was 30.9% (n = 992); 4.1% (n = 132) were ADRs. Serious AEs were reported in 4.1% (n = 132) of patients; 0.1% (n = 4) were ADRs. Of 1543 patients analysed for symptomatic improvement, 89.2% (n = 1377) improved, 9.4% (n = 145) were unchanged, and 1.4% (n = 21) worsened. Mean FEV1 (difference ± SD) increased significantly in patients with asthma (0.09 ± 0.29 L; p < 0.0001), COPD (0.11 ± 0.24 L; p = 0.0011), or both (0.05 ± 0.18 L; p = 0.0399), indicating improved lung function.

Conclusion

In this real-world study, FF/VI administered to Korean patients was well tolerated and effective for the treatment of asthma and COPD. These results were consistent with other studies in Asian and global populations.

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Acknowledgements

Medical writing support for the development of this manuscript, under the direction of the authors, was provided by Andrew Briggs, BA, of Ashfield MedComms (Macclesfield, UK), an Inizio company, and was funded by GSK.

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Authors and Affiliations

  1. Sinchon Yonsei Hospital, 110, Seogang-ro, Mapo-gu, Seoul, 04094, Republic of Korea

    Eun-Yeong Cho

  2. GSK Korea, Seoul, Republic of Korea

    Jung-Eun Cho

  3. Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Republic of Korea

    Seung Hun Jang

  4. Wonkwang University School of Medicine, Iksan, Republic of Korea

    Ki-Eun Hwang

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  1. Eun-Yeong Cho
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Corresponding author

Correspondence to Eun-Yeong Cho.

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Funding

This study (204674) was funded by GSK.

Conflicts of Interest

Eun-Yeong Cho was an employee and shareholder, and Jung-Eun Cho is an employee, of GSK. Seung-Hun Jang and Ki-Eun Hwang declare no relevant conflict of interests. Trademarks are owned by or licensed to their respective owners (GSK [RELVAR ELLIPTA]).

Consent to Publish

Not applicable.

Consent for Participation

Informed consent was obtained from all individual participants included in the study.

Availability of Data and Material

Information on GSK’s data sharing commitments can be found at www.clinicalstudydatarequest.com.

Ethics Approval

This study adhered to the guidelines for local legislation and the ethical principles of the Declaration of Helsinki. The study protocol was approved by the Institutional Review Board of each study centre including Hallym University Sacred Heart Hospital (IRB approval number: 2016-S033).

Code Availability

Not applicable.

Author Contributions

All authors contributed to the writing of the manuscript, including reviewing and editing, and all provided their approval for the final version. Eun-Yeong Cho: Conceptualization, Methodology, Writing (original draft preparation), Supervision; Jung-Eun Cho: Conceptualization, Methodology, Writing (original draft preparation), Formal analysis; Seung Hun Jang: Investigation (including clinical data collection); Ki-Eun Hwang: Investigation (including clinical data collection).

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Cho, EY., Cho, JE., Jang, S.H. et al. Real-World Safety and Effectiveness of Fluticasone Furoate/Vilanterol in Patients with Asthma and/or Chronic Obstructive Pulmonary Disease: A Post-Marketing Study in Korea. Drug Saf 46, 951–960 (2023). https://doi.org/10.1007/s40264-023-01337-w

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  • DOI: https://doi.org/10.1007/s40264-023-01337-w

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