Academic Journal
B15-03 Astegolimab Decreases Exacerbation Risk in Patients With COPD With Frequent Exacerbations, Irrespective of Blood Eosinophil Count: Pooled Analysis of the Pivotal Randomized Trials ALIENTO and ARNASA
| Τίτλος: | B15-03 Astegolimab Decreases Exacerbation Risk in Patients With COPD With Frequent Exacerbations, Irrespective of Blood Eosinophil Count: Pooled Analysis of the Pivotal Randomized Trials ALIENTO and ARNASA |
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| Συγγραφείς: | Wedzicha, J A, Agusti, A, Brightling, C E, Calverley, P, Chalmers, J D, Greening, N, Han, M K, Mohan, D, Ng, J, Papi, A, Roche, N, Saenz, R, Samara, K, Tal-Singer, R, Vogelmeier, C F, Yang, X, Celli, B |
| Πηγή: | American Journal of Respiratory and Critical Care Medicine ; volume 212, issue Supplement_1 ; ISSN 1073-449X 1535-4970 |
| Στοιχεία εκδότη: | Oxford University Press (OUP) |
| Έτος έκδοσης: | 2026 |
| Περιγραφή: | Rationale The efficacy and safety of astegolimab (anti-ST2 monoclonal antibody) in patients with COPD with frequent exacerbations were evaluated in two randomized, double-blind, placebo-controlled trials: Phase IIb ALIENTO (NCT05037929) and Phase III ARNASA (NCT05595642). Here, we present results from prespecified pooled analyses of both studies. Methods Both trials randomized patients with COPD (ALIENTO: aged 40-90 years, ARNASA: aged 40-80 years) who were current/former smokers and had a history of frequent exacerbations, regardless of chronic bronchitis or blood eosinophil counts [BEC] 1:1:1 to receive 476 mg astegolimab subcutaneously Q2W or Q4W or placebo, added to optimized maintenance therapy, for a 52-week treatment period. The primary endpoint in both trials was the annualized rate of moderate and severe COPD exacerbations. Key secondary endpoints included proportion of participants with a decrease of ≥ 4 points SGRQ-C total score, annualized rate of severe COPD exacerbations, and safety. Results 2676 participants were included in the pooled modified intent-to-treat (ITT) population (astegolimab Q2W, n = 892; astegolimab Q4W, n = 896; placebo, n = 888). Pooled participant characteristics were generally balanced between arms. Compared with placebo, astegolimab Q2W significantly reduced the rate of moderate and severe COPD exacerbations by 14.7% (Figure; RR 0.853 [95% CI 0.759, 0.959]; P=0.0077); Q4W data are also included in the figure. This exacerbation rate reduction for astegolimab Q2W versus placebo was consistent across prespecified subgroups such as current/former smokers, baseline BEC, and chronic bronchitis. A greater reduction in exacerbation rate with astegolimab Q2W versus placebo was observed in those with a history of > 2 (vs 2) exacerbations, or moderate airflow obstruction (GOLD II) (vs very severe). Compared with placebo, astegolimab Q2W nominally reduced severe exacerbations (32% reduction; RR 0.68 [95% CI 0.52, 0.87]; P=0.0028) and increased the proportion of ... |
| Τύπος εγγράφου: | article in journal/newspaper |
| Γλώσσα: | English |
| DOI: | 10.1093/ajrccm/aamag162.1748 |
| Διαθεσιμότητα: | https://doi.org/10.1093/ajrccm/aamag162.1748 https://academic.oup.com/ajrccm/article-pdf/212/Supplement_1/aamag162.1748/68305793/aamag162.1748.pdf |
| Rights: | https://academic.oup.com/pages/standard-publication-reuse-rights |
| Αριθμός Καταχώρησης: | edsbas.BFC696F |
| Βάση Δεδομένων: | BASE |
| FullText | Text: Availability: 0 CustomLinks: – Url: https://doi.org/10.1093/ajrccm/aamag162.1748# Name: EDS - BASE (ns324271) Category: fullText Text: View record from BASE |
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| Items | – Name: Title Label: Title Group: Ti Data: B15-03 Astegolimab Decreases Exacerbation Risk in Patients With COPD With Frequent Exacerbations, Irrespective of Blood Eosinophil Count: Pooled Analysis of the Pivotal Randomized Trials ALIENTO and ARNASA – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Wedzicha%2C+J+A%22">Wedzicha, J A</searchLink><br /><searchLink fieldCode="AR" term="%22Agusti%2C+A%22">Agusti, A</searchLink><br /><searchLink fieldCode="AR" term="%22Brightling%2C+C+E%22">Brightling, C E</searchLink><br /><searchLink fieldCode="AR" term="%22Calverley%2C+P%22">Calverley, P</searchLink><br /><searchLink fieldCode="AR" term="%22Chalmers%2C+J+D%22">Chalmers, J D</searchLink><br /><searchLink fieldCode="AR" term="%22Greening%2C+N%22">Greening, N</searchLink><br /><searchLink fieldCode="AR" term="%22Han%2C+M+K%22">Han, M K</searchLink><br /><searchLink fieldCode="AR" term="%22Mohan%2C+D%22">Mohan, D</searchLink><br /><searchLink fieldCode="AR" term="%22Ng%2C+J%22">Ng, J</searchLink><br /><searchLink fieldCode="AR" term="%22Papi%2C+A%22">Papi, A</searchLink><br /><searchLink fieldCode="AR" term="%22Roche%2C+N%22">Roche, N</searchLink><br /><searchLink fieldCode="AR" term="%22Saenz%2C+R%22">Saenz, R</searchLink><br /><searchLink fieldCode="AR" term="%22Samara%2C+K%22">Samara, K</searchLink><br /><searchLink fieldCode="AR" term="%22Tal-Singer%2C+R%22">Tal-Singer, R</searchLink><br /><searchLink fieldCode="AR" term="%22Vogelmeier%2C+C+F%22">Vogelmeier, C F</searchLink><br /><searchLink fieldCode="AR" term="%22Yang%2C+X%22">Yang, X</searchLink><br /><searchLink fieldCode="AR" term="%22Celli%2C+B%22">Celli, B</searchLink> – Name: TitleSource Label: Source Group: Src Data: American Journal of Respiratory and Critical Care Medicine ; volume 212, issue Supplement_1 ; ISSN 1073-449X 1535-4970 – Name: Publisher Label: Publisher Information Group: PubInfo Data: Oxford University Press (OUP) – Name: DatePubCY Label: Publication Year Group: Date Data: 2026 – Name: Abstract Label: Description Group: Ab Data: Rationale The efficacy and safety of astegolimab (anti-ST2 monoclonal antibody) in patients with COPD with frequent exacerbations were evaluated in two randomized, double-blind, placebo-controlled trials: Phase IIb ALIENTO (NCT05037929) and Phase III ARNASA (NCT05595642). Here, we present results from prespecified pooled analyses of both studies. Methods Both trials randomized patients with COPD (ALIENTO: aged 40-90 years, ARNASA: aged 40-80 years) who were current/former smokers and had a history of frequent exacerbations, regardless of chronic bronchitis or blood eosinophil counts [BEC] 1:1:1 to receive 476 mg astegolimab subcutaneously Q2W or Q4W or placebo, added to optimized maintenance therapy, for a 52-week treatment period. The primary endpoint in both trials was the annualized rate of moderate and severe COPD exacerbations. Key secondary endpoints included proportion of participants with a decrease of ≥ 4 points SGRQ-C total score, annualized rate of severe COPD exacerbations, and safety. Results 2676 participants were included in the pooled modified intent-to-treat (ITT) population (astegolimab Q2W, n = 892; astegolimab Q4W, n = 896; placebo, n = 888). Pooled participant characteristics were generally balanced between arms. Compared with placebo, astegolimab Q2W significantly reduced the rate of moderate and severe COPD exacerbations by 14.7% (Figure; RR 0.853 [95% CI 0.759, 0.959]; P=0.0077); Q4W data are also included in the figure. This exacerbation rate reduction for astegolimab Q2W versus placebo was consistent across prespecified subgroups such as current/former smokers, baseline BEC, and chronic bronchitis. A greater reduction in exacerbation rate with astegolimab Q2W versus placebo was observed in those with a history of > 2 (vs 2) exacerbations, or moderate airflow obstruction (GOLD II) (vs very severe). Compared with placebo, astegolimab Q2W nominally reduced severe exacerbations (32% reduction; RR 0.68 [95% CI 0.52, 0.87]; P=0.0028) and increased the proportion of ... – Name: TypeDocument Label: Document Type Group: TypDoc Data: article in journal/newspaper – Name: Language Label: Language Group: Lang Data: English – Name: DOI Label: DOI Group: ID Data: 10.1093/ajrccm/aamag162.1748 – Name: URL Label: Availability Group: URL Data: https://doi.org/10.1093/ajrccm/aamag162.1748<br />https://academic.oup.com/ajrccm/article-pdf/212/Supplement_1/aamag162.1748/68305793/aamag162.1748.pdf – Name: Copyright Label: Rights Group: Cpyrght Data: https://academic.oup.com/pages/standard-publication-reuse-rights – Name: AN Label: Accession Number Group: ID Data: edsbas.BFC696F |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1093/ajrccm/aamag162.1748 Languages: – Text: English Titles: – TitleFull: B15-03 Astegolimab Decreases Exacerbation Risk in Patients With COPD With Frequent Exacerbations, Irrespective of Blood Eosinophil Count: Pooled Analysis of the Pivotal Randomized Trials ALIENTO and ARNASA Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Wedzicha, J A – PersonEntity: Name: NameFull: Agusti, A – PersonEntity: Name: NameFull: Brightling, C E – PersonEntity: Name: NameFull: Calverley, P – PersonEntity: Name: NameFull: Chalmers, J D – PersonEntity: Name: NameFull: Greening, N – PersonEntity: Name: NameFull: Han, M K – PersonEntity: Name: NameFull: Mohan, D – PersonEntity: Name: NameFull: Ng, J – PersonEntity: Name: NameFull: Papi, A – PersonEntity: Name: NameFull: Roche, N – PersonEntity: Name: NameFull: Saenz, R – PersonEntity: Name: NameFull: Samara, K – PersonEntity: Name: NameFull: Tal-Singer, R – PersonEntity: Name: NameFull: Vogelmeier, C F – PersonEntity: Name: NameFull: Yang, X – PersonEntity: Name: NameFull: Celli, B IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 01 Type: published Y: 2026 Identifiers: – Type: issn-locals Value: edsbas Titles: – TitleFull: American Journal of Respiratory and Critical Care Medicine ; volume 212, issue Supplement_1 ; ISSN 1073-449X 1535-4970 Type: main |
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