Impact of varying lung function threshold on clinical remission in asthma with FF/UMEC/VI: CAPTAIN post hoc analysis

<bold>Rationale:</bold> Clinical remission (CR) is an emerging composite outcome in asthma assessed after 52 weeks and includes stabilisation/optimisation of lung function (LF) as one of the components. This CAPTAIN post hoc analysis assessed the impact of different LF thresholds on a CR composite outcome in patients receiving FF/UMEC/VI or FF/VI. <bold>Methods:</bold> CAPTAIN compared FF/UMEC/VI vs FF/VI in adults with uncontrolled moderate–severe asthma despite ICS/LABA. The CR composite endpoint, defined as no systemic corticosteroid use, no severe exacerbations, ACQ-5 total score ≤1.5 and change from baseline in trough FEV<sub>1</sub> ≥0mL (LF stabilisation) or FEV<sub>1</sub> ≥100mL (LF optimisation), was assessed at Weeks 24 and 52 (w24, w52) for FF/UMEC/VI 100/62.5/25 or 200/62.5/25µg, and FF/VI 100/25 or 200/25µg. <bold>Results:</bold> A greater proportion of patients met the components of CR at w24 and achieved CR at w52 with FF/UMEC/VI vs FF/VI, regardless of LF threshold or FF dose. Stabilisation of LF vs optimisation increased the proportion of patients achieving CR (<bold>Figure</bold>). <bold>Conclusions:</bold> LF stabilisation and optimisation were attained with FF/UMEC/VI and FF/VI within the composite of CR. The relative difference between arms was consistent irrespective of LF threshold, FF dose, or timepoint. LF may be a major contributor to CR for patients with uncontrolled moderate–severe asthma not considered for biologics therapy. <bold>Funding:</bold> GSK (205715/<ext-link>NCT02924688</ext-link>) <fig><object-id>erj;64/suppl_68/PA1199/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>

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Published
2024-09-14
DOI
https://doi.org/10.1183/13993003.congress-2024.pa1199
Primary Topic
Inhalation and Respiratory Drug Delivery
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article
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article

Impact of varying lung function threshold on clinical remission in asthma with FF/UMEC/VI: CAPTAIN post hoc analysis

David Slade, Stephen Weng, Njira Lucia Lugogo, Mohamed Hamouda et al.
Inhalation and Respiratory Drug Delivery
article

Impact of varying lung function threshold on clinical remission in asthma with FF/UMEC/VI: CAPTAIN post hoc analysis

David Slade, Stephen Weng, Njira Lucia Lugogo, Mohamed Hamouda, Emmeline Igboekwe, Jodie Crawford, Alison Moore, Ian Pavord, Stephen E. Gould, Stephen G. Noorduyn, John Oppenheimer
article en

Abstract

<bold>Rationale:</bold> Clinical remission (CR) is an emerging composite outcome in asthma assessed after 52 weeks and includes stabilisation/optimisation of lung function (LF) as one of the components. This CAPTAIN post hoc analysis assessed the impact of different LF thresholds on a CR composite outcome in patients receiving FF/UMEC/VI or FF/VI. <bold>Methods:</bold> CAPTAIN compared FF/UMEC/VI vs FF/VI in adults with uncontrolled moderate–severe asthma despite ICS/LABA. The CR composite endpoint, defined as no systemic corticosteroid use, no severe exacerbations, ACQ-5 total score ≤1.5 and change from baseline in trough FEV<sub>1</sub> ≥0mL (LF stabilisation) or FEV<sub>1</sub> ≥100mL (LF optimisation), was assessed at Weeks 24 and 52 (w24, w52) for FF/UMEC/VI 100/62.5/25 or 200/62.5/25µg, and FF/VI 100/25 or 200/25µg. <bold>Results:</bold> A greater proportion of patients met the components of CR at w24 and achieved CR at w52 with FF/UMEC/VI vs FF/VI, regardless of LF threshold or FF dose. Stabilisation of LF vs optimisation increased the proportion of patients achieving CR (<bold>Figure</bold>). <bold>Conclusions:</bold> LF stabilisation and optimisation were attained with FF/UMEC/VI and FF/VI within the composite of CR. The relative difference between arms was consistent irrespective of LF threshold, FF dose, or timepoint. LF may be a major contributor to CR for patients with uncontrolled moderate–severe asthma not considered for biologics therapy. <bold>Funding:</bold> GSK (205715/<ext-link>NCT02924688</ext-link>) <fig><object-id>erj;64/suppl_68/PA1199/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>

Rutgers, The State University of New Jersey (US), Age UK (GB), Michigan Medicine (US), Glaxosmithkline (Finland) (FI), GlaxoSmithKline (Canada) (CA), Durham VA Medical Center (US), Oxford BioMedica (United Kingdom) (GB), GlaxoSmithKline (Germany) (DE), Dubai Pharmacy College (AE), McMaster University (CA)
Openalex Percentile: Top 63%
Inhalation and Respiratory Drug Delivery
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