ArticleTuberculosis and respiratory diseases2026
Real-World Safety of Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Asthma or Chronic Obstructive Pulmonary Disease (COPD), and Clinical Outcomes in COPD: Post-marketing Surveillance in Korea.
Article in Tuberculosis and respiratory diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundFluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) is a single-inhaler triple therapy administered via the ELLIPTA inhaler (GSK). FF/UMEC/VI 100/62.5/25 μg was approved in Korea to treat chronic obstructive pulmonary disease (COPD) in 2018 and asthma in 2022 (100/62.5/25 and 200/62.5/25 μg). Safety and efficacy of FF/UMEC/VI are well established in global clinical trials, though Korean real-world evidence remains limited.
methodsThis Korean multicentre post-marketing surveillance assessed safety and clinical outcomes of FF/UMEC/VI 100/62.5/25 μg in COPD (May 2018-May 2024) and safety of FF/UMEC/VI in asthma (100/62.5/25 μg: August 2022-May 2024; 200/62.5/25 μg: September 2022-May 2024). Safety was assessed by total, serious, and unexpected adverse event and adverse drug reaction (ADR) incidence. For COPD, physicians assessed within-patient improvement in clinical outcomes (lung function [forced expiratory volume in 1 second, forced vital capacity], exacerbations and symptoms [modified Medical Research Council dyspnoea, COPD Assessment Test]).
resultsOverall, 606 patients with COPD and 132 patients with asthma were evaluated. Mean±standard deviation administration for FF/UMEC/VI 100/62.5/25 μg was 254.11±119.97 days overall; 271.83±104.99 for COPD; 20.74±10.87 for integrated asthma; 34.17±13.06 days for asthma with FF/UMEC/VI 200/62.5/25 μg. ADRs occurred in 2.64% (16/606) of patients with COPD and 3.79% (5/132) with asthma. Most ADRs were mild; all serious/unexpected ADRs resolved. Of 33 patients with COPD who reported pneumonia, all events were considered unlikely to be treatment-related. Physicians determined improvement in 74.87% (283/378) of patients with COPD post- versus pre-FF/UMEC/VI administration.
conclusionFF/UMEC/VI was well tolerated in Korean patients with asthma or COPD, with no new safety concerns identified. In COPD, within-patient improvement was observed in clinical outcomes post-administration. These results support continued FF/UMEC/VI use in real-world clinical practice in Korea.
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