Table 2.
Randomized controlled trials with anti-IL-5 or anti-IL5Ra or anti-IL4Ra antibody treatments in COPD.
| Monoclonal antibody | Sources | Study design | Study arms | Eosinophil count subgroup | Duration of treatment | Treatment response |
|
|---|---|---|---|---|---|---|---|
| Intervention | Placebo | ||||||
| Anti-IL-5 | Dasgupta et al. (2017) [87] | Double-blind RCT | mepolizumab vs. placebo | – | 3 months and 6 months | - Mean blood eosinophil: 0.04 cells/mm3 (3 months) and 0.03 cells/mm3 (6 months) - Mean sputum eosinophil: 0.75% (3 months) and 0.5% (6 months) - Mean FEV1% post bronchodilator: 65.50% (3 months) and 63.50% (6 months) |
- Mean blood eosinophil: 0.23 cells/mm3 (3 months) and 0.26 cells/mm3 (6 months) - Mean sputum eosinophil: 3.15% (3 months) and 2.20% (6 months) - Mean FEV1% post bronchodilator: 43.50% (3 months) and 43.50% (6 months) |
| Anti-IL-5 | Pavord et al. (2017) [88] | Double-blind RCT | mepolizumab vs. placebo | <150 cells/µL, ≥150 cells/µL or ≥300 cells/µL | 12 months | Mean exacerbation rate in eosinophilic COPD: 1.40 events/year | Mean exacerbation rate in eosinophilic COPD: 1.71 events/year |
| Anti-IL-5 | Brightling et al. (2014) [89] | Double-blind RCT | Benralizumab vs. placebo | <200 cells/µL, ≥200 cells/μL or ≥300 cells/μL | 12 months | - Mean acute exacerbation rate by Poisson regression: 0.39 in ≥300 cells/µL - Mean pre-bronchodilator FEV1 change: 0.13 L |
- Mean acute exacerbation rate by Poisson regression: 0.76 in ≥300 cells/µL - Mean pre-bronchodilator FEV1 change: −0·06 L |
| Anti-IL-5 | Criner et al. (2019) [90] | Double-blind RCT | Benralizumab vs. placebo | <220 cells/µL or ≥220 cells/μL | 12 months | Relative risk (RR) of exacerbation in ≥220 cells/μL with benralizumab 100 mg: 0.88 (95% CI 0·77–0·99) | |
| Anti-IL-4/IL-13 | Bhatt et al. (2023) [91] | Double-blind RCT | Dupilumab vs. placebo | ≥300 cells/μL | 12 months | Mean exacerbation rate: 0.78 events/year | Mean exacerbation rate: 1.10 events/year |
| Anti-IL-4/IL-13 | Bhatt et al. (2024) [92] | Double-blind RCT | Dupilumab vs. placebo | ≥300 cells/μL | 12 months | Mean exacerbation rate: 0.86 events/year | Mean exacerbation rate: 1.30 events/year |
RCT: randomized controlled trial.