ALIENTO (NCT05037929) is a phase 2b, randomised, double-blinded trial in patients with moderate-to-severe COPD and a history of frequent exacerbations. Participants were aged 40 to 90 years and were current or former smokers. Randomisation (1:1:1) assigned participants to receive astegolimab every 2 weeks, astegolimab every 4 weeks, or placebo for 52 weeks. The primary endpoint was the annualised rate of moderate-to-severe exacerbations. A total of 1,301 participants were included in the study.
Prof. Neil Greening (University of Leicester, UK) presented the results [1]. The annualised rate of moderate-to-severe exacerbations after 52 weeks was 1.1 with astegolimab administered every 2 weeks, 1.22 with astegolimab administered every 4 weeks, and 1.31 with placebo. This corresponds to a risk reduction of 0.846 (95% CI 0.717-1.000; P=0.049) for astegolimab every 2 weeks versus placebo, but not a statistically significant difference for the regimen every 4 weeks. Furthermore, a greater effect was observed among participants who had experienced 2 or more exacerbations in the previous year. Safety was generally similar among the treatment groups, except for infections, which were more common with astegolimab every 2 weeks (46.8%) than with astegolimab every 4 weeks (43.4%) and placebo (42.5%) [1].
āIn conclusion, the primary endpoint was met for astegolimab every 2 weeks, but not the 4-weekly regimen,ā concluded Prof Greening. āThere were statistically significant reductions in moderate-to-severe exacerbations of 15.4%, and a numerical reduction of 29% for severe exacerbations.ā
- Greening N, et al. Randomised, placebo-controlled trial of astegolimab for COPD with frequent exacerbations: ALIENTO. ERS Congress, 27 Septemberā1 October 2025, Amsterdam, the Netherlands.
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Table of Contents: ERS 2025
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