Real-world safety of FF/UMEC/VI in patients with asthma or COPD, and clinical outcomes in COPD: post-marketing surveillance in Korea

BACKGROUND: Fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) is a single-inhaler triple therapy administered via the ELLIPTA inhaler. FF/UMEC/VI 100/62.5/25µg was approved in Korea to treat COPD in 2018 and asthma in 2022 (100/62.5/25µg and 200/62.5/25µg). Safety and efficacy of FF/UMEC/VI are well established in global clinical trials, though Korean real-world evidence remains limited. METHODS: This Korean multicentre post-marketing surveillance assessed safety and clinical outcomes of FF/UMEC/VI 100/62.5/25µg in COPD (May 2018-May 2024) and safety of FF/UMEC/VI in asthma (100/62.5/25µg: August 2022-May 2024; 200/62.5/25µg: September 2022-May 2024). Safety was assessed by total, serious and unexpected adverse event (AE) and adverse drug reaction (ADR) incidence. For COPD, physicians assessed within-patient improvement in clinical outcomes (lung function [FEV1, FVC], exacerbations and symptoms [mMRC dyspnoea, CAT]). RESULTS: Overall, 606 patients with COPD and 132 patients with asthma were evaluated. Mean (SD) administration for FF/UMEC/VI 100/62.5/25µg 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 200/62.5/25µg. 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. Conclusions: FF/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.