biostudies-literatureUnknown11(3)Beeh KM<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 (FEV₁), and exacerbations over 12 months. Post hoc responder analyses for CAT (≥ 2 units improvement), FEV₁ (≥ 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% FEV₁, 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, FEV₁ 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 FEV₁ 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.Pulmonary therapy443-459https://www.ebi.ac.uk/biostudies/studies/S-EPMC12373607biostudies-literatureClinically 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.PMC12373607Scheithe KKruger SSchmutzler HBeeh KMfalseClinically 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.<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 (FEV₁), and exacerbations over 12 months. Post hoc responder analyses for CAT (≥ 2 units improvement), FEV₁ (≥ 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% FEV₁, 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, FEV₁ 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 FEV₁ 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.2025-01-01T00:00:00Z2025 Sep2026-05-08T10:43:51.059Z2026-04-07T23:46:57.966ZS-EPMC123736074065243810.1007/s41030-025-00306-1