Use of Systemic Corticosteroids and Antibiotics in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation Receiving Dupilumab
Bibliographic record
Abstract
Abstract RATIONALE: A subset of patients with chronic obstructive pulmonary disease (COPD) have type 2 inflammation. Dupilumab, a human monoclonal antibody, blocks interleukins 4 and 13, key and central drivers of type 2 inflammation. In BOREAS and NOTUS, add-on dupilumab vs placebo reduced moderate or severe exacerbation rates and improved lung function in patients with COPD and type 2 inflammation (screening blood eosinophil counts ≥300 cells/µL). Systemic corticosteroids (SCS) and antibiotics are often prescribed together for relief of COPD exacerbations. Long-duration or repeat treatment with SCS is associated with adverse and serious adverse events. This post hoc analysis pooled data from the BOREAS and NOTUS trials to evaluate whether dupilumab reduced the burden of SCS and antibiotic use, compared with placebo, in patients with COPD and type 2 inflammation. METHODS: BOREAS (NCT03930732) and NOTUS (NCT04456673) were phase 3, randomized, placebo-controlled trials in which patients with COPD, moderate-to-severe airflow limitation, and type 2 inflammation, on triple therapy, were randomized to dupilumab 300 mg or placebo every 2 weeks for 52 weeks. This analysis evaluated SCS and antibiotic use for patients in the intention-to-treat population with ≥1 moderate or severe exacerbation within 1 year prior to baseline or during the 52-week treatment period. RESULTS: For patients with ≥1 moderate or severe exacerbation within 1 year prior to baseline (dupilumab: n = 937; placebo n = 936), the annualized total SCS intake duration (mean [SD]) was 17.5 (25.2) and 21.9 (33.8) days for dupilumab and placebo (P = 0.05), respectively, and annualized total antibiotic intake duration (mean [SD]) was 24.6 (55.3) and 26.9 (56.8) days for dupilumab and placebo (P = 0.56), respectively. For patients with ≥1 moderate or severe exacerbation during the 52-week treatment period (dupilumab: n = 338; placebo: n = 394), annualized total SCS intake duration (mean [SD]) was 16.1 (22.1) and 22.2 (34.1) days for dupilumab and placebo (P = 0.008), respectively, and annualized total antibiotic intake duration (mean [SD]) was 23.0 (49.2) and 24.8 (49.4) days for dupilumab and placebo (P = 0.67), respectively. Safety of dupilumab was consistent with the known dupilumab safety profile. CONCLUSIONS: In BOREAS and NOTUS, dupilumab vs placebo reduced exacerbation events and decreased the cumulative number of days exposed to SCS or antibiotic, despite differences in exacerbation clinical treatment practices and regardless of whether patients exacerbated during or within the year prior to the study period.
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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 | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| 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".