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Real-world Comparative Effectiveness in Patients with Asthma Newly Initiating Fluticasone Furoate/Vilanterol or Budesonide/Formoterol : A United Kingdom General Practice Cohort Study
Woodcock, Ashley (Manchester Academic Health Sciences Centre)
Blakey, John (Curtin University. Medical School)
Bourdin, Arnaud (University of Montpellier. Department of Respiratory Diseases)
Canonica, G. Walter (Humanitas University. Department of Biomedical Sciences)
Domingo, Christian (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Ford, Alexander (Adelphi Real World)
Hulme, Rosie (Adelphi Real World)
Tritton, Theo (Adelphi Real World)
Palomares, Ines (GSK. RWE & Health Outcomes Research, Global Health)
Sadhu, Sanchayita (GSK. Biostatistics)
Biswas, Arunangshu (GSK. Biostatistics)
Verma, Manish (GSK. Global Medical Affairs, General Medicine)

Data: 2025
Resum: Introduction: It is important that treatment recommendations reflect real-world data when available, as randomised controlled trials have stringent eligibility criteria and do not represent the entire asthma population or their usual ecosystem of care. Limited real-world evidence has compared the effectiveness of fluticasone furoate/vilanterol (FF/VI) and budesonide/formoterol (BUD/FOR) to date in asthma; we explored this in England using patients from general practice. Methodology: We retrospectively compared new FF/VI users and new BUD/FOR users from 1 December 2015 to 28 February 2019, based on de-identified data from the Clinical Practice Research Datalink. The baseline period pre-index was ≥ 1 year; the follow-up period was 1 year. At index, eligible adults (≥ 18 years) with diagnosed asthma had ≥ 1 prescription for FF/VI or BUD/FOR, ≥ 1 years' general practitioner registration and records eligible for linkage to Hospital Episode Statistics. Chronic obstructive pulmonary disease was an exclusion criterion. The primary study outcome assessed the overall asthma exacerbation rate in new FF/VI or BUD/FOR users. Secondary outcomes included oral corticosteroid (OCS) use and medication persistence (analysed using Kaplan-Meier curves). For each treatment comparison, propensity scores were generated and confounding between baseline group characteristics was adjusted via inverse probability of treatment weighting, separately carried out for each study outcome. Intercurrent events (ICEs) were considered for analyses, such as death, loss to follow-up, rescue-medication use, treatment discontinuation or switching. Results: Between groups, baseline attributes were well balanced. Annual per-person rates of exacerbation were numerically similar in the while on-treatment population (measuring outcome until ICE; FF/VI, 0. 1356; BUD/FOR, 0. 1583 [P = 0. 3023]). Patients who continued initiation treatment for 1 year without interruption had significantly lower annual per-person exacerbation rates with FF/VI (0. 0722 [n = 425]) versus BUD/FOR (0. 2258 [n = 546]) (rate ratio 0. 3197 [P = 0. 0003]). Patients indexed on FF/VI had significantly fewer OCS prescriptions and lower OCS dosage versus BUD/FOR (respective coefficients: - 0. 29 [P = 0. 0352]; 0. 41 [P = 0. 0004]) and improved treatment persistence (hazard ratio: 0. 62 [P < 0. 0001]). Conclusions: Patients who continued initiation treatment for a year without interruption had reduced exacerbation rates with FF/VI versus BUD/FOR. The FF/VI group also had reduced treatment discontinuation and OCS use.
Nota: Ashley Woodcock has given lectures for Orion and consulted for GSK and Orion. John Blakey reports grants or contracts from AstraZeneca, GSK, and Novartis; consulting fees from Boehringer Ingelheim, Chiesi, and GSK; payment or honoraria from AstraZeneca, Chiesi, and GSK; support for attending meetings and/or travel from AstraZeneca, Boehringer Ingelheim, and GSK; receipt of medical writing support from GSK and Teva; payment to their institution for advisory work from Asthma Australia; and unpaid advisory work from Asthma WA. Arnaud Bourdin has received grants, personal fees, non-financial support, and other support from Actelion, AstraZeneca, Boehringer Ingelheim, and GSK; personal fees, non-financial support, and other support from Chiesi, Novartis, and Regeneron; personal fees and non-financial support from Teva; personal fees from Gilead; non-financial support and other support from Roche; and other support from Nuvaira. Giorgio Walter Canonica reports having received research grants as well as being a lecturer or having received advisory board fees from: A. Menarini, AstraZeneca, Celltrion, Chiesi, Faes, Firma, Genentech, GSK, Hal Allergy, Innovacaremd, Novartis, OM Pharma, Red Maple, Sanofi-Aventis, Sanofi-Regeneron, Stallergenes Greer, and Uriach Pharma. Christian Domingo declares having received financial aid for travel support and speakers\u2019 bureaus from ALK-Abello, Allergy Therapeutics, AstraZeneca, Chiesi, GSK, Hall Allergy, Inmunotek, A. Menarini Diagnostics, MSD, Novartis, ROXALL, Sanofi, and Stallergenes. Alexander Ford, Rosie Hulme and Theo Tritton are employees of Adelphi Real World, which received funding for this study from GSK. Arunangshu Biswas, Ines Palomares, Manish Verma, and Sanchayita Sadhu are GSK employees; Arunangshu Biswas, Ines Palomares and Manish Verma hold financial equities in GSK.
Nota: This study, including study design, data collection, analysis, and interpretation, and medical writing and submission support for the manuscript, was funded by GSK (221182). The journal\u2019s Rapid Service Fee was funded by GSK.
Nota: This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distri- bution and reproduction in any medium or for- mat, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indi- cated otherwise in a credit line to the material. If material is not included in the article's Crea- tive Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain per- mission directly from the copyright holder. To view a copy of this licence, visit http://creativeco mmons.org/licenses/by-nc/4.0/.
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Llengua: Anglès
Document: Article ; recerca ; Versió publicada
Matèria: Asthma ; Budesonide/formoterol ; Comparative effectiveness ; England ; Fluticasone furoate/vilanterol ; General practice ; Real-world data
Publicat a: Pulmonary Therapy, Vol. 11, Num. 4 (December 2025) , p. 705-722, ISSN 2364-1746
Obra relacionada: Woodcock, Ashley [et al.]. «Correction : Real-world Comparative Effectiveness in Patients with Asthma Newly Initiating Fluticasone Furoate/Vilanterol or Budesonide/Formoterol: A United Kingdom General Practice Cohort Study». Pulmonary Therapy, Vol. 11 (October 2025), p. 723-724 https://doi.org/10.1007/s41030-025-00325-y

Correcció de l'article: https://ddd.uab.cat/record/326277
DOI: 10.1007/s41030-025-00313-2
PMID: 40956480


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