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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

Year: 2025

Type: article

Abstract: 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. 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. 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]). 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. In this study, people in England beginning one of two common, daily, treatments for their asthma: budesonide/formoterol (shortened as BUD/FOR) or fluticasone furoate/vilanterol (shortened as FF/VI), were compared to determine how well the treatments work. Adults with asthma, starting these treatments from December 2015 to February 2019, were chosen from a database, holding information from general practice as well as hospital visits. Data were de-identified, meaning that study researchers were not able to tell who each patient was. The study did not include anyone with obstructive lung disease. The primary study question asked if asthma exacerbation rates were different in the groups who began BUD/FOR versus FF/VI. The frequency and dose of additional oral corticosteroids, and how many patients continued the new asthma treatment for 12 months were other study questions. In the interests of fairness, attributes of patients for both groups were examined and balanced. Per year, for every hundred patients, the FF/VI group had 14 exacerbations (2267 patients in total), similar to the 16 exacerbations in the BUD/FOR group (7776 patients in total). Of the patients continuing treatment without interruption for a whole year, the overall number of exacerbations was significantly lower in the FF/VI group (7/100 patients [425 patients overall]) than in the BUD/FOR group (23/100 patients [546 patients overall]). Compared to patients treated with BUD/FOR, those treated with FF/VI had reduced use of oral corticosteroids and had a 38% lower risk of stopping treatment.

Source: Pulmonary Therapy

DOI: 10.1007/s41030-025-00313-2