Exacerbation Reduction in Patients With Asthma Following Initiation of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) in the United States
Bibliographic record
Abstract
Abstract Rationale: In the United States (US), up to 50% of patients with asthma remain uncontrolled despite adherence to inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) dual therapy, requiring escalation to triple therapy.Although the efficacy of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy has been demonstrated in clinical trials, real-world evidence on the clinical and economic benefits is sparse.This study evaluated the impact of FF/UMEC/VI on patients with asthma previously on ICS/LABA. Methods: This was a retrospective, longitudinal, pre-post claims study using Medicaid, commercial, and Medicare insurance data from the Komodo Health database. Data were collected from September 9, 2019, to December 31, 2023; the index date was the first pharmacy claim for FF/UMEC/VI. Eligible patients were adults with asthma with ≥12 months of continuous insurance coverage prior to and following the index date (pre- and post-initiation periods) who received ICS/LABA for ≥30 consecutive days during the pre-initiation period. Outcomes assessed included asthma-related exacerbations, oral corticosteroid (OCS) use, short-acting beta-agonist (SABA) use, asthma-related healthcare resource utilization (HRU, emergency department [ED] visits), and asthma-related medical costs. Odds/rate ratios (ORs/RRs; 95% confidence intervals [CIs]) of asthma-related exacerbations were compared pre-initiation versus post-initiation using logistic/Poisson regression models. OCS bursts, SABA canisters, and HRU were analyzed using Poisson regression models (RRs [95% CIs]); asthma-related medical costs were compared pre-initiation versus post-initiation using mean differences from generalized linear models. Results: Of 17,959 eligible patients, mean (standard deviation) age was 50.6 (14.1) and the majority were female (68.2%, n=12,240). Odds of any asthma-related exacerbations were significantly reduced by 52% post- versus pre-initiation (OR [95% CI]: 0.48 [0.46, 0.50], p<0.001); rates were reduced by 38% (RR [95% CI]: 0.62 [0.61, 0.64], p<0.001) (Figure). Rates of OCS bursts were 30% lower (RR [95% CI]: 0.70 [0.69, 0.72], p<0.001), SABA use 18% lower (RR [95% CI]: 0.82 [0.81, 0.83], p<0.001), asthma-related ED visits 39% lower (RR [95% CI]: 0.61 [0.58, 0.64], p<0.001) (Figure), and asthma-related medical costs 46% lower (mean difference [95% CI]: −$1115 [−$1771, −$459], p<0.001) post- versus pre-initiation. Conclusions: Significant reductions in asthma-related exacerbations, as well as lower OCS and SABA use, and reductions in asthma-related ED visits and medical costs were associated with the post-initiation period of FF/UMEC/VI treatment compared with the pre-initiation period. This provides novel, real-world evidence of the benefits of escalation to FF/UMEC/VI from ICS/LABA therapy in patients with asthma in the US, helping to inform treatment decisions in real-world clinical practice.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".