Effect of Dupilumab on Health-Related Quality of Life and Respiratory Symptoms in Patients With COPD and Type 2 Inflammation: BOREAS and NOTUS.
Summary
In pooled phase 3 RCTs in COPD with type 2 inflammation on triple therapy, dupilumab significantly improved SGRQ total (−3.4) and E-RS:COPD total (−0.9) vs placebo at 52 weeks, with consistent benefits across symptoms, activity/impacts, and breathlessness domains. These PRO gains complement previously reported exacerbation reductions.
Key Findings
- Dupilumab reduced SGRQ total score by −3.4 vs placebo at week 52 (P < .0001).
- E-RS:COPD total improved by −0.9 vs placebo (P = .0006), with domain benefits in breathlessness (−0.6) and cough/sputum (−0.2).
- Benefits were consistent across SGRQ symptoms (−3.5), activity (−4.0), and impacts (−2.9) domains.
- 1,660 patients (830 per arm) completed 52-week follow-up, enhancing robustness of PRO findings.
Clinical Implications
Supports considering dupilumab for COPD patients with type 2 inflammation not adequately controlled on triple therapy, emphasizing shared decision-making around symptom and quality-of-life benefits in addition to exacerbation reduction.
Why It Matters
Demonstrates clinically meaningful patient-reported improvements with dupilumab in COPD with type 2 inflammation, potentially shifting treatment paradigms toward biologics in selected COPD phenotypes.
Limitations
- PRO analysis though robust remains secondary to primary clinical endpoints
- Generalizability limited to COPD with type 2 inflammation on triple therapy over 52 weeks
Future Directions
Assess long-term durability, optimal patient selection biomarkers, and comparative effectiveness versus other biologics or anti-inflammatory strategies in COPD.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Pooled analysis of two phase 3 randomized, double-blind trials with prespecified outcomes
- Study Design
- OTHER