Trelegy Ellipta (fluticasone furoate/umeclidinium bromide/vilanterol) / GSK, Innoviva, Theravance Biopharma, Royalty - LARVOL DELTA

Comparative Effects of Triple Inhaled Therapy With Budesonide/Glycopyrronium/Formoterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol on Small Airway Disease in COPD Patients: A Randomized Crossover Study (clinicaltrials.gov) - P4 | N=22 | Completed | Sponsor: Thammasat University | Recruiting ➔ Completed

Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Trelegy Ellipta approved in China for use in adults with uncontrolled asthma (GSK Press Release) - "The approval means that FF/UMEC/VI is the first and only single inhaler triple therapy (SITT) approved for the maintenance treatment of both respiratory conditions in the country...Approval was based on GSK’s CAPTAIN study which showed that in patients uncontrolled on inhaled corticosteroids/long-acting beta agonist (ICS/LABA), the additional bronchodilation provided by FF/UMEC/VI demonstrated significant improvements in lung function compared with FF/VI."

China approval • Asthma • Immunology

Response to: Letter to the Editor Regarding "Comparative Effectiveness of FF/1 UMEC/VI and BUD/GLY/FORM in Patients with COPD Stepping Up From Dual Therapy". (PubMed, Adv Ther) - No abstract available

HEOR • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Letter to the Editor Regarding "Comparative Effectiveness of FF/UMEC/VI and BUD/GLY/FORM in Patients with COPD Stepping Up From Dual Therapy". (PubMed, Adv Ther) - No abstract available

HEOR • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

FF/UMEC/VI and BUD/GLY/FORM in Patients with COPD Stepping Up from Dual Therapy Stratified by Exacerbations and Prior Dual Therapy: A Subgroup Analysis of a Comparative Effectiveness Study. (PubMed, Adv Ther) - "Patients newly initiating FF/UMEC/VI following prior treatment with ICS/LABA or LAMA/LABA experienced a significantly lower rate of moderate-severe COPD exacerbations than those newly initiating BUD/GLY/FORM irrespective of number of prior exacerbations or prior dual therapy class."

HEOR • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Clinical Stability under FF/UMEC/VI Triple Inhaled Therapy: A 12-Month Real Life Retrospective Observational Study. (PubMed, Respir Med) - "This might have a relevant impact in clinical practice, especially in the setting of pulmonary rehabilitation. Nonetheless, further multicenter prospective studies are warranted to validate our findings and to identify predictors of treatment success."

Journal • Observational data • Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Mining of Adverse Event Signals Associated with Fluticasone Furoate/Umeclidinium/Vilanterol Triple Therapy: A Post-Marketing Analysis Based on FAERS. (PubMed, Pharmacy (Basel)) - "A total of 196 significantly disproportionate preferred terms (PTs) were identified, including previously undocumented AEs such as chronic eosinophilic rhinosinusitis, dysphonia, and vocal cord dysfunction. This post-marketing safety study revealed significant signals for dysphonia and vocal cord dysfunction associated with FF/UMEC/VI, suggesting that clinicians should remain vigilant for these events."

Adverse events • Journal • P4 data • Chronic Obstructive Pulmonary Disease • Dysphonia • Immunology • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis

Evaluating Asthma Clinical Remission with Inhaled Therapy: Post Hoc Analyses of CAPTAIN. (PubMed, Adv Ther) - P3 | "The results of this post hoc analysis demonstrate that CR is achievable with inhaled therapy in moderate-to-severe asthma and is more likely with FF/UMEC/VI than FF/VI. CR should be considered an attainable treatment goal for patients with asthma, irrespective of disease severity or treatment history."

Journal • Retrospective data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Relative particle size and distribution of inhaled triple therapies. (PubMed, Ann Allergy Asthma Immunol) - "BDP/FF/G delivers consistently smaller particles than either BUD/FF/G or FLU/VI/UMEC, translating into a commensurate higher extrafine particle fraction, in turn suggesting greater potential to target the small airways."

Journal • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

TETRIS - Prospective study to observe clinical outcomes of triple therapy in COPD patients: up to 12 months interim analysis. (PubMed, Respir Med) - P | "Overall, SITT dosed OD, specifically FF/UMEC/VI is associated with a significant reduction in hospitalisations due to exacerbations and improvement in symptoms at the 6-month and 1-year follow-up visits."

Clinical data • Journal • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Cost-effectiveness modeling of mortality risk reduction comparing two fixed-dose combination triple therapies in moderate-to-very severe chronic obstructive pulmonary disease. (PubMed, J Comp Eff Res) - "Due to a reduced mortality rate, more patients remained on BGF treatment than on FF/UMEC/VI, which induced higher treatment-related costs; however, the latter was offset by decreased end-of-life costs, as BGF avoided more deaths. BGF may improve health outcomes and reduce healthcare costs compared with FF/UMEC/VI in patients with moderate-to-very severe COPD in a UK setting."

HEOR • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

VENTURI (VENTilation Using Respiratory Imaging) (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: University of Alabama at Birmingham

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Optimizing COPD management in Latin America: a cost-effectiveness analysis of FF/UMEC/VI in Colombia. (PubMed, Expert Rev Pharmacoecon Outcomes Res) - "Sensitivity analyses confirmed the robustness of results, with FF/UMEC/VI remaining cost-effective in > 60% of simulations. FF/UMEC/VI is a cost-effective strategy for managing moderate-to-severe COPD in Colombia, offering improved clinical outcomes at an acceptable cost and supporting its adoption in treatment guidelines and reimbursement decisions."

HEOR • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Real-World Safety and Effectiveness of Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Asthma: Final Analysis of a Post-Marketing Surveillance in Japan. (PubMed, Adv Ther) - "FF/UMEC/VI was well tolerated and effective in the treatment of patients with asthma in Japan. ADRs were reported in 8.4% of patients and the incidence of CV events was low. No new safety concerns were identified."

Journal • P4 data • Real-world evidence • Asthma • Cardiovascular • Cough • Dysphonia • Immunology • Pulmonary Disease • Respiratory Diseases

The Centers for Medicare and Medicaid Services on Tuesday announced lower prices on…costly prescription drugs under Medicare… (MSN News) - "Here are the negotiated prices for the drugs, based on a 30-day supply, compared to the 2024 list price:...(i) Trelegy Ellipta, an asthma treatment: $175, down from $654...; (ii) Ofev, for idiopathic pulmonary fibrosis: $6,350, down from $12,622...; (iii) Breo Ellipta, a COPD drug: $67, down from $397."

Commercial • Asthma • Chronic Obstructive Pulmonary Disease • Idiopathic Pulmonary Fibrosis

Sundial-COPD: Outcomes of Once-Daily ICS/LABA/LAMA + PRN Respiratory Therapy Treatments in Hospitalized Patients With COPD Exacerbations (clinicaltrials.gov) - P4 | N=80 | Completed | Sponsor: Baylor Research Institute | Trial completion date: Sep 2023 ➔ Feb 2025 | Not yet recruiting ➔ Completed

Trial completion • Trial completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

GSK reported third quarter 2025 global net sales of approximately $1.0 billion (up 24% vs. the third quarter of 2024) and year-to-date net sales of approximately $2.9 billion (up 13% vs. 2024 year-to-date) (PRNewswire) - "On track to exceed full year (FY) 2025 global net sales of ~$3.4 billion required to trigger $50 million milestone from Royalty Pharma: Approximately $471 million of global net sales required in Q4 2025 to trigger the $50 million milestone; FY 2026 global net sales of ~$3.5 billion required to trigger an additional $100M milestone from Royalty Pharma."

Sales • Sales projection • Chronic Obstructive Pulmonary Disease • Immunology

Evaluating the Budget Impact of Single Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/Vilanterol) in Patients With Moderate to Severe Asthma in the Saudi Healthcare System (ISPOR-EU 2025) - "The introduction of FF/UMEC/VI in the management of uncontrolled asthma in the Saudi healthcare system is expected to save costs and reduce healthcare resource utilization. This treatment option may be a valuable consideration for Saudi healthcare payers aiming to optimize asthma management. GSK Funding: Study 224346"

Clinical • HEOR • Asthma • Immunology • Respiratory Diseases

From Varices to Viral Infiltrate: Diagnosing CMV Gastritis in a Cirrhotic, Immunocompromised Host (ACG 2025) - "We present a case of biopsy-proven CMV gastritis in a patient with metabolic-associated steatohepatitis (MASH) cirrhosis and chronic B-cell depletion from long-term rituximab therapy.Case Description/ A 68-year-old woman with compensated MASH cirrhosis, morbid obesity, rheumatoid arthritis (on rituximab for 9 years), interstitial lung disease (on fluticasone furoate/umeclidinium/vilanterol), atrial fibrillation on anticoagulation, prediabetes, hypothyroidism, and depression underwent upper endoscopy for variceal screening...Concurrent plasma CMV DNA by NAAT was elevated at 5,530 IU/mL.Given her immunocompromised status, close coordination with the infectious disease team was undertaken, and the patient was initiated on intravenous ganciclovir therapy. This case highlights the importance of maintaining a broad differential diagnosis when evaluating gastric mucosal changes in immunosuppressed patients with cirrhosis...Histologic evaluation remains essential, especially in..."

Atrial Fibrillation • Cardiovascular • CNS Disorders • Cytomegalovirus Infection • Depression • Dermatology • Endocrine Disorders • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Hepatology • Immunology • Infectious Disease • Inflammatory Arthritis • Interstitial Lung Disease • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity • Portal Hypertension • Psychiatry • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • CD68

Exacerbation Reduction in Patients with Asthma Following Escalation to FF/UMEC/VI from ICS/LABA: Retrospective Cohort Study. (PubMed, Pulm Ther) - "In patients who remain uncontrolled despite ICS/LABA treatment, escalating to FF/UMEC/VI is associated with reductions in asthma exacerbations, asthma-related hospitalizations, OCS use, SABA use, and asthma-related medical costs."

Journal • Retrospective data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Sex-Specific Safety Signals of Trelegy Ellipta: A FAERS Pharmacovigilance Analysis. (PubMed, Med Sci (Basel)) - " This FAERS-based analysis indicates distinct sex-specific safety signals for Trelegy Ellipta, particularly in cardiovascular, neuropsychiatric, and steroid-related domains. These findings are hypothesis-generating and highlight the importance of incorporating sex-disaggregated analyses into future pharmacovigilance and clinical studies."

Adverse events • Journal • Retrospective data • Cardiovascular • Chronic Obstructive Pulmonary Disease • CNS Disorders • Depression • Diabetes • Hypertension • Immunology • Infectious Disease • Mood Disorders • Musculoskeletal Diseases • Osteoporosis • Pain • Pneumonia • Psychiatry • Pulmonary Disease • Respiratory Diseases • Rheumatology • Sleep Disorder

Visualizing Improvements in Airway Dysfunction After Inhaled Therapy in Patients With Uncontrolled Asthma: A Narrative Review. (PubMed, Adv Ther) - "A recent study evaluating single-inhaler triple therapy in patients with uncontrolled moderate-severe asthma, despite inhaled corticosteroid/long-acting β2-agonist maintenance therapy, demonstrated that daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 200/62.5/25 µg) led to significantly improved 129Xe MRI VDP after only 6 weeks, which was in line with broader central/distal airway function and quality of life improvements. These results highlight the capacity of 129Xe MRI VDP to detect early responses to treatment. In addition, the mechanistic insights provided by 129Xe MRI VDP also indicated that these benefits are likely due to the combination of UMEC (a long-acting muscarinic antagonist) and an efficacious inhaled corticosteroid, addressing undertreated inflammatory bronchoconstriction, helping to restore airway caliber and function that more closely resemble the airways of a healthy individual.Videos available for this article."

Clinical • Journal • Review • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Airway mucus and 129Xe MRI ventilation after single inhaler triple therapy in asthma. (PubMed, ERJ Open Res) - "In participants with GINA4-5 asthma, who had been poorly controlled on ICS/LABA, single-inhaler FF/UMEC/VI resulted in improved VDP and FEV1 at 6-weeks. These improvements persisted 1-year later when airway markers were also significantly improved, consistent with the reversal of airway remodelling."

Journal • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

The Egyptian Drug Authority approves the launch of “Trelegy Ellipta” — a new hope for patients with chronic obstructive pulmonary disease (COPD) and asthma. (Ahram Online)

Launch non-US • Asthma • Chronic Obstructive Pulmonary Disease • Immunology

Comparable Clinical Outcomes with Tiotropium/Olodaterol or Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with COPD and Blood Eosinophil Count ≤300 Cells/μL. (PubMed, Int J Chron Obstruct Pulmon Dis) - "TIO/OLO initiators incurred lower pharmacy costs related to COPD and/or pneumonia than FF/UMEC/VI initiators. These results support treatment recommendations of reserving inhaled corticosteroids for frequent exacerbators and patients with elevated eosinophil counts."

Clinical • Clinical data • Journal • Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases