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Astegolimab for COPD With Frequent Exacerbations: Pooled Analysis of the ALIENTO and ARNASA Trials
Jadwiga A Wedzicha1, Àlvar Agustí2,3,4,5, Christopher E Brightling6
1National Heart and Lung Institute, Imperial College London, London, United Kingdom.
Rationale:
The efficacy and safety of astegolimab, an anti-ST2 monoclonal antibody, was evaluated in participants with chronic obstructive pulmonary disease (COPD) and frequent exacerbations in the pivotal ALIENTO and ARNASA trials.
Objectives:
To report the prespecified pooled analysis of ALIENTO and ARNASA.
Methods:
ALIENTO and ARNASA were randomized, double-blind, placebo-controlled trials with similar designs and included participants with COPD, a history of frequent exacerbations, and who were current/former smokers, irrespective of blood eosinophil count and chronic bronchitis. Participants were randomized 1:1:1 to astegolimab 476 mg every 2 weeks, every 4 weeks or placebo for 52 weeks, plus optimized maintenance therapy. The primary endpoint was annualized rate of moderate/severe exacerbations. Secondary endpoints included annualized rate of severe exacerbations. A hierarchical statistical plan was followed with hypothesis testing of secondary efficacy endpoints gated on the primary efficacy endpoint success.
Measurements And Main Results:
2682 participants were included in the pooled intent-to-treat population. Astegolimab significantly reduced the annualized rate of moderate/severe exacerbations by 15% in the every 2 weeks arm (adjusted rate ratio 0.85 [95% CI, 0.76-0.96]; P = .0077) and by 12% in the every 4 weeks arm (rate ratio 0.88 [95% CI, 0.78-0.99] P = .0265). A nominally significant reduction in the annualized rate of severe COPD exacerbations (rate ratio 0.68 [95% CI, 0.52-0.87]; P = .0028) was observed for astegolimab every 2 weeks vs. placebo. Astegolimab was well tolerated.
Conclusions:
Astegolimab every 2 weeks reduced the annualized rate of moderate/severe exacerbations in a clinically heterogeneous population of participants with COPD and frequent exacerbations.
Trial Registration Numbers:
ClinicalTrials.gov: NCT05037929; NCT05595642.
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