Table 1.
Demographic and Clinical Characteristics of Biologic-Treated Severe Asthma and Asthma–COPD Overlap Patients. Parameters of Clinical Response
| Variable | Asthma n = 297 | ACO n = 24 | p value |
|---|---|---|---|
| Male, frequency (%) | 80 (26.9) | 14 (58.3) | 0.002 |
| Age, median (IQR) | 57.4 (45.5–65.7) | 59.9 (52.7–64.7) | 0.26 |
| Non-smokers, frequency (%) | 261 (87.9) | 0 | |
| Ex-smokers, frequency (%) | 36 (12) | 20 (83.3) | |
| Current smokers, frequency (%) | 0 | 4(16.6) | |
| Smoking history (pack-yrs), median (IQR) | 5.0 (4.0–9.0) | 20.0 (11.3–30.0) | <0.001 |
| Diagnosis < 12 yrs (%) | 22.7 | 4.3 | 0.036 |
| Atopy (%) | 70.5 | 77.3 | 0.627 |
| Comorbidities (%) | |||
| -Rhinosinusitis. | 65.0 | 66.7 | >0.99 |
| -Nasal Polyps. | 36.4 | 25.0 | 0.375 |
| -Bronchiectasis. | 18.2 | 37.5 | 0.031 |
| -Obesity. | 8.2 | 0.0 | <0.005 |
| -Gastroesophageal reflux. | 20.5 | 12.5 | 0.435 |
| -Anxiety/depression | 25.3 | 4.2 | 0.706 |
| Post-bronchodilator FEV1/FVC (%), median (IQR) | 71.0 (61.5–77.1) | 57.4 (43.6–66.1) | <0.001 |
| Post-bronchodilator FEV1 (% predicted), median (IQR) | 80.5 (63.2–95.5) | 66.3 (50.4–80.7) | <0.001 |
| Post-bronchodilator FVC (% predicted), median (IQR) | 94.9 (82.3–108.2) | 94.6 (72.2–111.5) | 0.287 |
| FENO (ppb), median (IQR) | 39.0 (20.0–66.2) | 33.7 (10.8–58.3) | 0.327 |
| IgE (IU/mL) | 236.5 (91.0–532.8) | 451.0 (193.0–630.0) | 0.140 |
| Blood eosinophils (cells/mm3) | |||
| -Last recorded value, median (IQR) | 110.0 (22.5–310.0) | 109.0 (37.6–307.5) | 0.902 |
| -Maximum historical value, median (IQR) | 670.0 (330.0–1100.0) | 500.0 (200.0–1000.0) | 0.08 |
| High-dose ICS/LABA (%) | 100 | 100 | |
| LAMA (%) | 54.2 | 87.5 | <0.05 |
| Biologic therapy | |||
| -Omalizumab, n (%). | 132 (44.4) | 15 (62.5) | |
| -Mepolizumab, n (%). | 108 (36.3) | 5 (20.8) | |
| -Reslizumab, n (%). | 28 (9.4) | 1 (4.2) | |
| -Benralizumab, n (%). | 28 (9.4) | 3 (12.5) | |
| -Dupilumab, n (%). | 1 (0.3) | 0 | |
| Parameters of clinical response | |||
| ACT, median (IQR) | 22.0 (17.0–24.0) | 18.5 (14.0–23.3) | 0.096 |
| ACT<20 (%) | 36.5 | 59.1 | 0.109 |
| ≥1 severe exacerbation (%) | 27.3 | 70.8 | <0.001 |
| ≥1 hospitalization (%) | 8.1 | 29.2 | 0.004 |
| ≥1 unscheduled visit | 19.2 | 54.2 | <0.001 |
| Corticosteroid bursts, median (IQR) | 0.0 (0.0–1.0) | 2.0 (1.0–4.0) | <0.001 |
| ≥ 1 burst (%) | 37.5 | 83.3 | <0.001 |
| Maintenance corticosteroids (%) | 22.2 | 12.5 | 0.437 |
| Corticosteroids´ dose (prednisone equivalent, mg), mean (SD) | 12.5 (17.8) | 10.0 (5.0) | 0.594 |
| Clinical control (%) | 39.7 | 16.7 | 0.028 |
Notes: Atopy: Positive skin prick test or serum specific IgE. Clinical control: absence of severe exacerbations in the prior 12 months, ACT ≥ 20 and no need for systemic corticosteroids.
Abbreviations: ACO, asthma–COPD overlap; ACT, asthma control test; FENO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 second; FVC, Forced vital capacity; ICS, inhaled corticosteroids; IgE, immunoglobulin E; IQR, interquartile range; LABA, long-acting β-agonist; LAMA, long-acting muscarinic antagonist.