Stability of Blood Eosinophil Counts in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation in the BOREAS and NOTUS Trials
Bibliographic record
Abstract
Abstract RATIONALE: A subset of patients with COPD have elevated blood eosinophil counts (BEC), a marker for type 2 (T2) inflammation. Dupilumab blocks interleukin-4 and 13, central drivers of T2 inflammation. In BOREAS and NOTUS, dupilumab reduced exacerbations and improved lung function in patients with COPD and T2 inflammation. This post-hoc analysis assesses BEC stability over time in data pooled from BOREAS and NOTUS. METHODS: BOREAS (NCT03930732) and NOTUS (NCT04456673), phase 3, placebo-controlled trials, randomized 1,874 patients (40-85 years) with COPD, moderate-to-severe airflow limitation, and screening BEC ≥300 cells/µL to dupilumab 300mg (n=938) or placebo (n=936) q2w for 52 weeks. BEC were measured at screening, baseline (treatment day 1), and Weeks 4, 8, 12, 24, 36, 52, and 64. Proportions of patients with BEC <150, 150 to <300, and ≥300 cells/µL and BEC change from screening over the 52-week treatment period and 12-week follow were assessed. RESULTS: Median baseline BEC (Q1, Q3) were 340.0 (240.0, 460.0) and 330.0 (230.0, 460.0) cells/μL in the dupilumab and placebo arms, respectively. Median BEC were reduced by -10.0 (- 130.0, 110.0) and – 20.0 (- 120.0, 70.0) cells/μL at Week 12; by -30.0 (-140.0, 90.0) and -20.0 (-130.0, 80.0) cells/μL at Week 24; by -40.0 (-160.0, 80.0) and-40.0 (-140.0, 50.0) cells/µL at Week 52; and by -50.0 (-160.0, 40.0) and -30.0 (-140.0, 60.0) cells/μL after the 12-week follow-up period, for dupilumab and placebo, respectively. The proportion of patients with BEC <150, 150 to <300, and ≥300 cells/μL were 8.8%, 30.1%, and 61.2% (dupilumab) and 9.4%, 30.6%, and 60.0% (placebo) at baseline; 16.2%, 40.2%, 43.6% (dupilumab) and 15.2%, 35.4%, 49.3% (placebo) at Week 52; and 17.3%, 36.1%, 46.7% (dupilumab) and 13.4%, 37.7%, 48.9% (placebo) in the 12-week follow-up period (Figure). Approximately 62% of all participants had an BEC ≥150 at all visit times and approximately 20% of all participants were above 300 at all visit times (excluding screening). After 64 weeks, around 50% of patients had a BEC of ≥300 cells/mL in both dupilumab and placebo groups. Safety was consistent with the known dupilumab profile. CONCLUSIONS: For patients in BOREAS and NOTUS, BEC remained largely stable and elevated over the treatment and follow-up periods. Some variability in BEC may exist, and a review of BEC over time may be appropriate to identify patients with T2 inflammation.
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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 | 0.006 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.004 |
| 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 | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
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".