{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["11(3)"],"submitter":["Beeh KM"],"pubmed_abstract":["<h4>Introduction</h4>Responder analyses provide information about characteristics associated with therapeutic benefits. Short-term responses may predict long-term benefits. We evaluated responders, clinically important improvement (CII), disease stability (DS), and the relation of short- to long-term responses in patients with chronic obstructive pulmonary disease (COPD) in ELLITHE.<h4>Methods</h4>ELLITHE was a multicenter, open-label, non-interventional effectiveness study between 2020 and 2022 evaluating the effects of treatment initiation with once-daily single-inhaler triple therapy (odSITT) FF/UMEC/VI (100/62.5/25 µg via ELLIPTA) on COPD Assessment Test (CAT), forced expiratory volume in 1 s (FEV<sub>1</sub>), and exacerbations over 12 months. Post hoc responder analyses for CAT (≥ 2 units improvement), FEV<sub>1</sub> (≥ 100 ml change), and exacerbations (no event) were performed. Composite endpoints CII and DS (CII = response to at least two outcomes; DS = absence of clinically important deterioration for all outcomes) were also evaluated.<h4>Results</h4>A total of 786 patients had available data for any analysis. At study completion, 53.3% of patients were CAT, 36.7% FEV<sub>1</sub>, and 90.2% exacerbation responders, with 22.1% responding to all outcomes; 64.3% had a CII, and 52.7% showed DS. CII and DS were more frequent in subjects with higher baseline CAT score, and DS in patients  on prior ICS/LABA therapy (all p < 0.05). Early (3 months) CAT, FEV<sub>1</sub> and CII response strongly predicted respective responses at study end (odds ratios = OR ranging from 6.3 to 7.4), and DS (OR from 3.0 to 4.2). In the patient subset with available baseline eosinophil counts, response was generally similar at < 150 versus ≥ 150 cells/μl.<h4>Conclusions</h4>Despite overlapping responses to single and composite outcomes with odSITT, individual patterns support a multidimensional approach to evaluate benefits in COPD. Responders had higher baseline CAT scores and frequency of prior dual therapies. Short-term responses of FEV<sub>1</sub> and/or CAT were reasonable predictors of long-term responses, including DS. DS was achievable for the majority of patients and may represent a useful outcome for future COPD research and management."],"journal":["Pulmonary therapy"],"pagination":["443-459"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12373607"],"repository":["biostudies-literature"],"pubmed_title":["Clinically Important Improvements and Disease Stability with Fluticasone Furoate/Umeclidinium/Vilanterol Once-Daily Single-Inhaler Triple Therapy in the ELLITHE Trial: A Post Hoc Responder Analysis."],"pmcid":["PMC12373607"],"pubmed_authors":["Scheithe K","Kruger S","Schmutzler H","Beeh KM"],"additional_accession":[]},"is_claimable":false,"name":"Clinically Important Improvements and Disease Stability with Fluticasone Furoate/Umeclidinium/Vilanterol Once-Daily Single-Inhaler Triple Therapy in the ELLITHE Trial: A Post Hoc Responder Analysis.","description":"<h4>Introduction</h4>Responder analyses provide information about characteristics associated with therapeutic benefits. Short-term responses may predict long-term benefits. We evaluated responders, clinically important improvement (CII), disease stability (DS), and the relation of short- to long-term responses in patients with chronic obstructive pulmonary disease (COPD) in ELLITHE.<h4>Methods</h4>ELLITHE was a multicenter, open-label, non-interventional effectiveness study between 2020 and 2022 evaluating the effects of treatment initiation with once-daily single-inhaler triple therapy (odSITT) FF/UMEC/VI (100/62.5/25 µg via ELLIPTA) on COPD Assessment Test (CAT), forced expiratory volume in 1 s (FEV<sub>1</sub>), and exacerbations over 12 months. Post hoc responder analyses for CAT (≥ 2 units improvement), FEV<sub>1</sub> (≥ 100 ml change), and exacerbations (no event) were performed. Composite endpoints CII and DS (CII = response to at least two outcomes; DS = absence of clinically important deterioration for all outcomes) were also evaluated.<h4>Results</h4>A total of 786 patients had available data for any analysis. At study completion, 53.3% of patients were CAT, 36.7% FEV<sub>1</sub>, and 90.2% exacerbation responders, with 22.1% responding to all outcomes; 64.3% had a CII, and 52.7% showed DS. CII and DS were more frequent in subjects with higher baseline CAT score, and DS in patients  on prior ICS/LABA therapy (all p < 0.05). Early (3 months) CAT, FEV<sub>1</sub> and CII response strongly predicted respective responses at study end (odds ratios = OR ranging from 6.3 to 7.4), and DS (OR from 3.0 to 4.2). In the patient subset with available baseline eosinophil counts, response was generally similar at < 150 versus ≥ 150 cells/μl.<h4>Conclusions</h4>Despite overlapping responses to single and composite outcomes with odSITT, individual patterns support a multidimensional approach to evaluate benefits in COPD. Responders had higher baseline CAT scores and frequency of prior dual therapies. Short-term responses of FEV<sub>1</sub> and/or CAT were reasonable predictors of long-term responses, including DS. DS was achievable for the majority of patients and may represent a useful outcome for future COPD research and management.","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Sep","modification":"2026-05-08T10:43:51.059Z","creation":"2026-04-07T23:46:57.966Z"},"accession":"S-EPMC12373607","cross_references":{"pubmed":["40652438"],"doi":["10.1007/s41030-025-00306-1"]}}