The Response to Biologics is Better in Patients with Severe Asthma Than in Patients with Asthma–COPD Overlap Syndrome

Figures & data

Figure 1 Stages of the patient inclusion.

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/mm^3)
-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.