Dupilumab Efficacy in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation by Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Breathlessness and St. George's Respiratory Questionnaire (SGRQ) Activity Scores
Bibliographic record
Abstract
Abstract RATIONALE: Breathlessness, a primary symptom of COPD, can negatively impact patients’ health-related quality of life (HRQoL) and physical activity. Dupilumab, a human monoclonal antibody, blocks interleukin (IL)-4/IL-13 signaling, key and central drivers of type 2 inflammation. In the BOREAS and NOTUS trials, add-on dupilumab 300 mg every 2 weeks vs placebo reduced the rate of moderate or severe exacerbations and improved lung function in patients with COPD and type 2 inflammation on triple therapy; safety was consistent with the known dupilumab safety profile. In this analysis, we assessed efficacy of dupilumab in improving symptoms and HRQoL in patients with COPD by reducing breathlessness and improving activity. METHODS: BOREAS (NCT03930732) and NOTUS (NCT04456673), both phase 3, randomized, placebo-controlled trials, enrolled 1,874 patients (40 to 85 years) with COPD, moderate-to-severe airflow limitation, and type 2 inflammation (blood eosinophil count ≥300 cells/μL at screening). Patients were randomized to either dupilumab 300 mg (n = 938) or placebo (n = 936) subcutaneously every 2 weeks for 52 weeks. Endpoints evaluated were change from baseline to Week 52 in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) breathlessness domain score (range 0-17 points) and St. George's Respiratory Questionnaire (SGRQ) activity domain score (range 0-100 points). In both questionnaires, lower scores indicate improvement. Data are shown as least squares mean difference (95% CI) vs placebo. RESULTS: All randomized patients from BOREAS and NOTUS who had the opportunity to reach Week 52 (dupilumab n = 830; placebo n = 830) were included in this pooled analysis. At Week 52, dupilumab reduced E-RS:COPD breathlessness domain score by −0.57 (−0.85, −0.29) points (P < 0.0001) compared with placebo. Dupilumab reduced SGRQ activity domain score by −4.00 (−5.92, −2.08) points (P < 0.0001) at Week 52 compared with placebo. The degree of improvement in both measures was similar across the two studies. In BOREAS, E-RS:COPD breathlessness domain score was reduced by -0.65 (-1.02, -0.29) points (P = 0.0005) and SGRQ activity domain score was reduced by 4.60 (-7.17, -2.03) points (P = 0.0005). In NOTUS, E-RS:COPD breathlessness domain score was reduced by -0.46 (-0.89, -0.04) points (P = 0.033) and SGRQ activity domain score by -3.23 (-6.12, -0.35) points (P = 0.028). CONCLUSION: Dupilumab reduced E-RS:COPD breathlessness in patients with COPD and type 2 inflammation, which was accompanied by improved SGRQ activity domain scores reflective of better HRQoL
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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 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| 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".