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Watch: Professor Wisia Wedzicha of Imperial College London explores the real-world evidence from the Comparative Effectiveness Study.
There is now UK head-to-head real-world data for Trelegy Ellipta (FF/UMEC/VI) versus Trixeo (BUD/GLY/FOR)1
Looking for real-world evidence vs Trimbow pMDI (BEGF) ?
Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long acting β2-agonist (LABA) or a combination of a LABA and a long-acting muscarinic antagonist (LAMA)2.
Why choose Trelegy Ellipta for your eligible patients with COPD?
The efficacy and safety of Trelegy Ellipta has been investigated in two randomised controlled trials: IMPACT and FULFIL2
Over 14,000 patients with COPD previously treated with dual-therapy were evaluated in a retrospective real-world comparative effectiveness study in the USA.1
In a weighted cohort study of patients with COPD, 10,093 Trelegy Ellipta and 3,926 BUD/GLY/FOR initiators previously on dual therapy (ICS/LABA or LAMA/LABA) were included.1
The average age of participants was 74 years, with a Quan-Charlson Comorbidity Index score of 2.61
Adapted from Wedzicha JA et al, Adv Ther (2025)
Inclusion Criteria
- ≥1 dispensed Trelegy Ellipta or BUD/GLY/FOR on or after 1st January, 2021
- The first claim defined the index date and the study cohort
- ≥12 months of continuous clinical activity prior to the index date*
- ≥2 medical claims with a diagnosis of COPD on separate dates during the baseline period or on the index date
- Use of dual therapy (ICS/LABA or LAMA/LABA) as the latest COPD treatment in the 90 days prior to SITT initiation
Exclusion criteria
- <40 years of age on the index date
- ≥1 SITT dispensing any time prior to the index date
- Dispensing for both Trelegy Ellipta and BUD/GLY/FOR on the index date
- ≥1 diagnosis of asthma, cystic fibrosis, lung cancer, interstitial lung disease, or alpha-1 antitrypsin in any position during the baseline period
Results are reflective of the population studied and may not be generalisable.
*Clinical activity was defined as consecutive quarters with at least one medical and at least one pharmacy claim and was used as a proxy for continuous insurance coverage BUD/GLY/FOR - budesonide/glycopyrronium/ formoterol fumarate dihydrate.
†KRD data ranged from January 1, 2016 to December 31, 2023.
The study involved a US Medicare COPD population stepping up from dual therapy1
Patients were weighted using the overlap weighting approach based on the propensity score to adjust for confounding factors. Variables used in the PS calculation included: age, sex, race, year of index date, physician specialty at index, US region, pulmonary testing at baseline, Quan-CCI score, COPD exacerbations at baseline & on the index date, baseline medication use (agents with ≥5% use in either group), baseline all-cause healthcare resource utilisation and medical costs, SITT pharmacy costs on the index date, and comorbidities (conditions with ≥5% prevalence in either group)
| Weighted cohorts | ||
|---|---|---|
| KEY PATIENT CHARACTERISTICS2 | Trelegy Ellipta (FF/UMEC/VI) (n=10,093) |
BUD/GLY/FOR (n=3,926) |
| Observation period, days, mean ±SD | 360 ± 278 | 347 ± 274 |
| Age, years, mean ± SD | 73.7 ± 8.5 | 73.7 ± 8.2 |
| Female, n (%) | 5,443 (53.9) | 2,117 (53.9) |
| Quan-CCI score, mean (SD)* | 2.6 (1.8) | 2.6 (1.9) |
| Controller medications, n (%)* | ||
| Dual therapy | ||
| ICS/LABA | 6,680 (66.2) | 2,599 (66.2) |
| LAMA/LABA | 3,837 (38.0) | 1,493 (38.0) |
| LAMA | 856 (8.5) | 333 (8.5) |
| Multiple inhaler triple therapy | 615 (6.1) | 239 (6.1) |
| ≥1 COPD exacerbation during baseline (excluding index date), n (%) | ||
| Moderate-severe | 4,988 (49.4) | 1,945 (49.6) |
| Severe | 813 (8.1) | 316 (8.1) |
*Evaluated during the 12-month baseline period, not including the index date.
Adapted from Wedzicha JA et al, Adv Ther (2025).
Trelegy Ellipta significantly reduced the annual rate of moderate-severe exacerbations by 18% vs BUD/GLY/FOR1
Adapted from Wedzicha JA et al, Adv Ther (2025).
Results are reflective of the population studied and may not be generalisable. A retrospective real-world weighted cohort comparative effectiveness study study (CES) of patients with COPD previously treated with dual therapy (LAMA/LABA or ICS/LABA) in the USA. There are no head-to head RCTs comparing single-inhaler triple therapies in COPD. In their absence, comparative effectiveness may be assessed via real-world data.
One exacerbation signals risk. Trelegy Ellipta significantly lowers the risk of time to first moderate-severe exacerbation by 14% at 12 months compared to BUD/GLY/FOR, protecting patients before outcomes worsen.1
Trelegy Ellipta showed a 15% significantly lower risk of time to first moderate COPD exacerbation at 12 months compared to BUD/GLY/FOR2
HR at 12 months 0.85 (95% CI: 0.80-0.91); p<0.001. Absolute risk 38.8% vs 43.9% (difference -5.1%). KM-estimated.
No of patients still at risk at 12 months:
n=2,472 Trelegy Ellipta, n=844 BUD/GLY/FOR
Trelegy Ellipta showed a 8% numerically lower risk of time to first severe COPD exacerbation at 12 months compared to BUD/GLY/FOR. Not statistically significant2
HR at 12 months 0.92 (95% CI: 0.80-1.05); p=0.213. Absolute risk 9.6% vs 10.6% (difference -1.0%). KM-estimated.
No of patients still at risk at 12 months:
n=3,752 Trelegy Ellipta, n=1,366 BUD/GLY/FOR
Adapted from Wedzicha JA et al, Adv Ther (2025). A retrospective real-world weighted cohort comparative effectiveness study study (CES) of patients with COPD previously treated with dual therapy (LAMA/LABA or ICS/LABA) in the USA. There are no head-to head RCTs comparing single-inhaler triple therapies in COPD. In their absence, comparative effectiveness may be assessed via real-world data.
HR and risk were estimated from time to event analysis. P values for the secondary and exploratory outcomes were not adjusted for multiplicity.2
Results are reflective of the population studied and may not be generalisable.
Trelegy Ellipta significantly lowered the risk of all-cause mortality by 18% vs BUD/GLY/FOR at 12 months1
While exploratory findings may provide valuable insights, they are not typically designed to demonstrate definitive clinical efficacy1
Adapted from Wedzicha JA et al, Adv Ther (2025). A retrospective real-world weighted cohort comparative effectiveness study study (CES) of patients with COPD previously treated with dual therapy (LAMA/LABA or ICS/LABA) in the USA. There are no head-to head RCTs comparing single-inhaler triple therapies in COPD. In their absence, comparative effectiveness may be assessed via real-world data.
HR and risk were estimated from time to event analysis. P values for the secondary and exploratory outcomes were not adjusted for multiplicity.1
Results are reflective of the population studied and may not be generalisable.
The study is a Comparative Effectiveness Study, therefore, safety was not evaluated.
Based on the summary of product characteristics:2
Trelegy Ellipta is indicated as maintenance treatment in adult patients with moderate-to-severe COPD who are not adequately treated by a combination of an ICS and a LABA or a combination of LAMA and LABA
Trelegy Ellipta is NOT indicated for the treatment of asthma.
Side effects
Common (≥1/100 to <1/10): pneumonia, upper respiratory tract infection, bronchitis, pharyngitis, rhinitis, sinusitis, influenza, nasopharyngitis, candidiasis of mouth and throat, urinary tract infection, headache, cough, oropharyngeal pain, constipation, arthralgia, back pain.
Other important side effects include
Uncommon (≥1/1,000 to <1/100): viral respiratory tract infection, dysgeusia, dysphonia, dry mouth, fractures, supraventricular tachyarrhythmia, tachycardia, atrial fibrillation, vision blurred, glaucoma, eye pain.
Rare (≥1/10,000 to <1/1,000): anxiety, tremor, intraocular pressure increased, muscle spasms, dysuria, hypersensitivity reactions, including anaphylaxis, angioedema, urticaria and rash; hyperglycaemia; palpitations and urinary retention.
Systemic effects: Systemic effects of ICS may occur, particularly at high doses for long periods, but much less likely than with oral corticosteroids.
Not for acute use - there are no clinical data to support the use of Trelegy Ellipta for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Deterioration of disease - increasing use of short-acting bronchodilators to relieve symptoms may indicate deterioration of disease control. In the event of deterioration of COPD during treatment with Trelegy Ellipta, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken. Patients should not stop therapy with Trelegy Ellipta without physician supervision since symptoms may recur after discontinuation.
This is not an exhaustive list. Please consult the Summary of Product Characteristics for a full list of adverse reactions, special warnings and precautions.
Trelegy Ellipta’s tolerability profile is in line with the known profiles of its component molecules2
Pneumonia: in common with other ICS-containing medicines, there is an increased risk of pneumonia in patients with COPD treated with Trelegy Ellipta, including pneumonia requiring Hospitalisation1. There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD, as the clinical features of such infections overlap with the symptoms of COPD exacerbations. Risk factors for pneumonia in patients with COPD include current smoking, older age, low body-mass index and severe COPD2
Paradoxical bronchospasm: Administration of fluticasone furoate/umeclidinium/vilanterol may produce paradoxical bronchospasm with an immediate wheezing and shortness of breath after dosing and may be life-threatening. If paradoxical bronchospasm occurs, treatment should be discontinued immediately. The patient should be assessed and alternative therapy instituted if necessary2
Cardiovascular effects, such as cardiac arrhythmias (e.g., atrial fibrillation and tachycardia), may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including UMEC and VI, respectively. Therefore, Trelegy Ellipta should be used with caution in patients with unstable or life-threatening cardiovascular disease2
Real-world evidence for Trelegy Ellipta vs Trixeo (BUD/GLY/FOR)
In a retrospective real-world weighted cohort comparative effectiveness study (CES) of patients with COPD previously treated with dual therapy (LAMA/LABA or ICS/LABA) in the USA. Results are reflective of the population studied and may not be generalisable. n= 10,093 Trelegy Ellipta; n= 3,926 BUD/GLY/FOR.
What could this data mean for your patients with moderate to severe COPD?
Why make Trelegy Ellipta your triple therapy of choice?
Abbreviations
BUD, budesonide; CI, confidence interval; COPD, chronic obstructive pulmonary disease; FOR, formoterol fumarate dihydrate; GLY, glycopyrronium; HR, hazard ratio; ICS, inhaled corticosteroid; KM, Kaplan-Meier; LABA, long-acting beta 2-agonist; LAMA, long-acting muscarinic antagonist; PPY, per patient-year; RR, rate ratio; SITT, single inhaler triple therapy; PS, propensity score.
References
- Wedzicha JA et al, Adv Ther 2025. https://doi.org/10.1007/s12325-025-03295-4.
- Trelegy Ellipta, Summary of Product Characteristics.
- Feldman G;International Journal of Chronic ObstructivePulmonary Disease;2016;11:719-730.
- Kempsford R;Pulmonary Pharmacology & Therapeutics;2013;26;256-264.
- Hanania NA;CHEST;2012;142;119-127.
- Rossios C et al. European Journal of Pharmacology;2011;670:244-251.
- van der Palen J;NPJ Primary Care Respiratory Medicine;2016;26:16079;1-8.
- Riley JH et al; Int J Chron Obstruct Pulmon Dis;2016;11;1873-1880.
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to GSK on 0800 221 441 or UKSafety@gsk.com.
September 2026 | PM-GB-FVU-WCNT-250002 (V2.0)
