S1 Randomised, placebo-controlled trial of astegolimab for COPD with frequent exacerbations: ALIENTO
Bibliographic record
Abstract
Rationale The randomised, double-blind, placebo-controlled Phase IIb ALIENTO trial (NCT05037929) evaluated efficacy and safety of astegolimab (anti-ST2) in COPD. Methods Participants (current/former smokers, aged 40–90 years, history of frequent exacerbations) were randomised 1:1:1 to astegolimab SC 476 mg Q2W or Q4W, or placebo, for 52 weeks. Efficacy and safety endpoints were evaluated. Results 1301 participants were treated (Q2W, n=433; Q4W, n=437; placebo, n=431; 79% on ICS/LABA/LAMA at baseline). Annualised rate of moderate/severe COPD exacerbations (primary endpoint) was significantly lower with astegolimab Q2W vs placebo (adjusted rate reduction 15%; P=0.0494), but not Q4W vs placebo (figure 1). There were numerical decreases with astegolimab Q2W in moderate/severe COPD exacerbation rate in participants with baseline EOS <300 cells/µL (RR 0.87 [95% CI 0.73, 1.04]; P=0.1210), severe exacerbation rate (RR 0.71 [95% CI 0.49, 1.05]; P=0.0883), and change from baseline to Week 52 in SGRQ-C (difference in adjusted mean –1.87 [95% CI –4.01, 0.26]; P=0.0857). No differences were seen in other secondary endpoints (Week 52). Adverse events were balanced between treatment arms. Conclusions Astegolimab Q2W decreased annualised COPD exacerbation rate by 15% (P=0.0494) vs placebo in the overall ALIENTO population (irrespective of smoking status or EOS level), with trends for improvement in some other clinical outcomes.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.050 | 0.004 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".